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ATMOS® S 61 Servant ENT workstationENT treatment unit

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Further information, accessories, consumables and spare parts are available from:

ATMOSMedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 1679853 LenzkirchGermanyPhone +49 (0) 76 53 / 689-0Fax:+49 7653 / 689-190+49 7653 / 689-493 (Service Center)[email protected]

Table of contents

4.4 Thermal nystagmus stimulation, Variotherm .......194.4.1 Overview .............................................................194.4.2 Switching on........................................................194.4.3 Activation of the Variotherm ................................204.4.4 Perform the thermal nystagmus stimulation........204.4.5 Time setting (1-99 sec.) ......................................204.4.6 Temperature setting ............................................204.4.7 Adjustingflowquantity ........................................214.4.8 Information about the service display of the ATMOS® S 61 Servant up from software version V 1.2 .......................................................214.5 Ear irrigation bowl with separate suction channel (530.2070.0)..............................224.6 Compressed-air system ......................................224.6.1 Activation ............................................................224.6.2 Adapt / deposit sprayer .......................................234.6.3 Ear irrigation module compressed air (REF 530.2080.0) ...............................................234.7 LED-Light system................................................234.8 Instrument heating ..............................................244.8.1 Mirrorquick-heater ..............................................244.8.2 Heating module for instrument tray .....................244.9 Clipboard endoscopy ..........................................254.9.1 Option LED Light Cube .......................................254.9.2 Option endoscope management (heated) ..........254.9.3 Hook for the headlight with automatic switching .25

5.0 Cleaning and care .............................................265.1 General information on cleaning and disinfection 265.1.1 Cleaning the unit surface ....................................265.1.2 Secretion canister (without autom. secretion canisterevacuation),bacterialfilterand suction hose ........................................................275.1.3 Medicament sprayers..........................................275.1.4 Instrument trays ..................................................275.1.5 Endoscopequivers .............................................275.1.6 Ear irrigation bowl ...............................................275.1.7 Hose tip and jet connection.................................275.2 Recommended instrument disinfectants .............285.3 Recommended surface disinfectants ..................295.4 Recommended endoscope disinfectants ............30

6.0 Hygiene plan ......................................................31

7.0 Maintenance and Service .................................337.1 Replacing the fuse ..............................................337.2 Changingthebacterialfilter ................................337.3 Changing the hose box of the hose pump ..........337.4 Hygrotherm/Variotherm:Decalcification ............347.5 Hygrotherm / Variotherm: Filter replacement ......347.6 Sending in the device..........................................34

8.0 Troubleshooting ................................................35

9.0 Consumables, Accessories, Spare Parts .......379.1 Consumables ......................................................379.2 Accessories .........................................................379.3 Spare parts .........................................................38

10.0 Technical data at complete equipment ...........39

11.0 Disposal .............................................................40

12.0 Notes on EMC ....................................................41

1.0 Introduction .........................................................31.1 Notes on operating instructions ............................31.2 Intended use .........................................................31.2.1 ATMOS® S 61 Servant ENT workstation ...............31.2.2 Hygrotherm ...........................................................41.2.3 Variotherm .............................................................41.3 Function ................................................................41.4 Explanation of pictures and symbols ....................5

2.0 For your safety ....................................................62.1 For your safety ......................................................62.2 Hygrotherm / Variotherm: Important advice for maintaining the hygienic status........................7

3.0 Setting up and starting up .................................83.1 Requiredconnectionsforallunitsof ATMOS® S 61 Servant .........................................83.2 Electrical connection .............................................83.3 Water connection ..................................................93.4 Waste water drain ...............................................103.5 Setting up proposal .............................................103.6 Controlsandoptionswhenfullyequipped ..........113.7 Rear view ............................................................123.8 Assembly of secretion canister ...........................123.8.1 Mount secretion canister .....................................123.9 Adjustment of front feet .......................................133.10 Connections in the service compartment ............133.10.1 Hoses ..................................................................13

4.0 Operation ...........................................................144.1 On / off switch .....................................................144.2 Suction system....................................................144.2.1 Control and display of the suction performance..144.2.2 Hose rinsing system............................................144.2.3 Evacuation of the reusable canister system .......154.2.4 Disposable canister system ................................164.3 Ear irrigation module Hygrotherm .......................174.3.1 Overview .............................................................174.3.2 Switching on........................................................174.3.3 Activation of the Hygrotherm...............................184.3.4 Perform the ear irrigation ....................................184.3.5 Temperature setting ............................................18

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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 Directiveofthecouncilformedicalproducts93/42/EECandmeetsthebasicrequirementsofAppendixIofthe directive.

• The product ATMOS®S61ServantENTworkstationcomplieswithallapplicablerequirementsoftheDirective2011/65/ECrestrictingtheuseofcertainhazardoussubstancesinelectricalandelectronicequipment(“RoHS”).

• The declaration of conformity and our general standard terms and conditions can be obtained on our website at www.atmosmed.com.

• ThequalitymanagementsystemappliedatATMOShasbeencertifiedaccordingtointernationalstandardsEN ISO 13485.

• 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

1.2.1 ATMOS® S 61 Servant ENT workstation

Name: ATMOS® S 61 Servant ENT workstationMain 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• MirrorquickheaterMedical indications / application: Standard ENT examination and/or therapySpecification 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 5.600 K

User profile: Doctors and medical assistantsPatient groups: Patients of all ages with and without restrictionsApplication organ: Mouth to pharynx, auditory canal to the ear drum and the nasal cavitiesApplication 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: activeSterility: 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.

1.0 Introduction

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1.0 Introduction

1.2.3 Variotherm

Name: ATMOS® Variotherm

Main function: Device for rinsing the auditory canal and stimulation of the vestibular organ

Medical indications / application:

Stimulation of the vestibular organ

Specification of the main functions:

Produces a jet of water for the ear irrigation at body temperature (37°C)withaflowrateof400ml/min for the removal of cerumen.Stimulation of the vestibular organ withadefinedflowandafixedtemperature for the functional testing.

Application organ: Auditory canal to the drumhead

Application time: For the short-term application (max. 60 minutes) on patients.

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.

Contraindications: Do not apply to an infected resp. contaminated auditory canal or to a perforated eardrum.

The product is: active

Sterility: Not necessary

Single-use product / reprocessing:

No single use product

1.2.2 Hygrotherm

Name: ATMOS® Hygrotherm

Main function: Device for the irrigation of the auditory canal

Medical indications / application:

Ear irrigation, cleaning of the ear

Specification of the main functions:

Produces a jet of water for the ear irrigation at body temperature (37°C)withaflowrateof400ml/min for the removal of cerumen.

Application organ: Auditory canal to the drumhead

Application time: For the short-term application on patients (max. 60 minutes).

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.

Contraindications: Do not apply to an infected resp. contaminated auditory canal or to a perforated eardrum.

The product is: active

Sterility: Not necessary

Single-use product / reprocessing:

No single use product

1.3 FunctionThe 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

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1.0 Introduction

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Icons for the ATMOS® S 61 Servant ENT workstation

Foot switch

Timer (ATMOS® Variotherm)

Off (feed-in, power connection)

On (feed-in, power connection)

Alternating current

Ground wire connectionWarning, special diligent notice

Application part type B

Fuse according to IEC 417/5016, DIN 30600/0186

Potentialequalisation

Short cuts / symbols contained in these operating instructions

Please press where dot indicates

Subnumeration

Numeration

General informationFollow the arrows

Activate the optional foot switch Replace

CheckPlease read, important information

Move, plug... in this direction

Engage, check correctfit

Turn, shift ... in this direction

Mirrorquickheater

Suction

Compressed air

Adjustment

WARNING: The ATMOS® S 61 Servant workstation may only be removed from the system frame when the microscope is in the park position.

Do not lean against it!

Please observe operating instructions!

1.4 Explanation of pictures and symbols

click

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2.0 For your safety

!2.1 For your safety• The ATMOS® S 61 Servant ENT workstation is produced

according to IEC 601 / EN 60601 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.

• Correctconfigurationinassemblyofcountry-specificconnections:

- 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 601-1 / EN 60601-1).

• The mains voltage indicated on the type plate must correspond to the values of the supply network.

• Makesurepriortoeveryapplicationoftheequipmentthatit 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,touchingthelightsourcewitheitherthefingersor 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!

• TheENTunitrequirescleanwater(drinking-waterquality)fortheoperation.Incasethecleanwatercannotbeprovidedbythewatersupply,apre-filtermustbeinstalled.Therelevantcountryspecificregulationsfortheinstallation must be considered!

• Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 isrequired,ifseveraldevicesareconnectedoveronecommon 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!

• Theambientconditionsspecifiedinthe"Technicaldata"must be strictly observed!

• Switchoffmainswitchafterfinishingworkinpracticeandclose 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 immunitytointerferencerequirementsofIEC601-1-2/EN 60601-1-2 „Electromagnetic Compatibility – Medical Electrical Devices“.

• The ATMOS® S 61 Servant ENT workstation may not be operated with devices not complying with the requirementsofstandardEN60601-1„MedicalElectricalEquipment“andEN60601-1-2„ElectromagneticCompatibility“(MedicalElectricalEquipment).

• 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.• Itisnotallowedtouseflammablesubstanceswiththe

device.• The system frame for 2 modules incl. microscope must

bescrewedintothefloor.

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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!

• Aftertheunitisswitchedontheflowratemustbechecked 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 statusFor 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 ThewaterwhichisprovidedbythehouseholdconnectionmustatleastmeettheWHOguidelinesorthecountry-specificguidelines for drinking water.

Connection PriortoconnectingtheATMOSunitfreshwatermustflowthroughthewallconnectionforaperiodofapprox.1minute.* Ensure that the installation is hygienically carried out! Disinfect the threaded connections with 70 % alcohol before screwing themintoplace.*

Weardisposablegloveswhencarryingoutmaintenanceworkonpartswhichcomeintocontactwiththewater.**ThisworkiscarriedoutbytheATMOSservicetechnician.

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 Ensurethatthesuspendedparticlefilterishygienicallychanged(seestartingup)(disposeoffilterandcarefullycleanthefilterglass).Ensurethereisnocontactwiththecontaminatedparts.

Dependingonthequalityoftheavailabledrinkingwater,abiofilmgrowthcannotbeexcluded.We, therefore, recommend to testthedrinkingwaterqualityatregularintervals(acc.toISO6222)atthedrinkingwaterconnectionontheunitandontheapplicationpart.Ifthereisasignificantriseingermsbetweenthedrinkingwaterconnectionandtheapplicationpartthenabiofilmremovingprocesswithsubsequent disinfection by the ATMOS service must be performed.

8

ca.

250

<150

160

>350

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 ServantFlexible multi-port distributors may not be used as a power supply for the ATMOS® S 61 Servant workstation, ATMOS® S 61 ServantvisionorforanoptionalHForradiofrequencysurgicaldevice.

Unit / Device Maximum required connectionsATMOS® S 61 Servant ENT workstation 1 x earthing contact socket outletATMOS® S 61 Servant vision 1 x earthing contact socket outlet (basic version) or

1xfixedconnectionfortheintegratedcameraorstroboscopeLEDATMOS® S 61 Servant instruments 3 x earthing contact socket outletWater separating system (WTA) 1 x earthing contact socket outletMonitor 1 x earthing contact socket outletPatient chair 1 x earthing contact socket outletAnadequatenumberofsocketoutletswithearthingcontactshouldbemountedforpossibleconnectionoffurtherelectricallyoperated 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 linePrerequisites• Installation acc. to IEC 60346-7-710: 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.3meters,preferablyleft(fig.).Thismayonlybecarriedoutbyauthorizedqualifiedpersonnel.• 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.

3.0 Setting up and starting up

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3.3 Water connectionRequirementsforwatersupply:• 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.• Requiredpressureindomesticwatersystem:>2bar,but<5bar.• ThewaterwhichisprovidedbythehouseholdconnectionmustatleastmeettheWHOguidelinesandthecountry-specific

guidelines for drinking water.• Country-specificregulationsfortheinstallationmustbeconsideredwhentheunitisconnectedtothepublicwatersupply.• 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.• Thereisnospecialcalcificationsafetydeviceintegratedinthewatersystem.Acalcificationsafetydevicemustbeconnected

when the respective drinking water is of hardness grade 3 (14 - 21°dH resp. 2.5 - 3.8 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 °dH1 (soft) ≤1.3 ≤7.3 Calcificationprotection

systemisnotrequired2 (medium) 1.3 to 2.5 7.3 to 143 (hard) 2.5 to 3.8 14 to 21.3 Calcificationprotection

systemisrequired4 (very hard) >3.8 >21.3

• 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 particlefilter

Water connection with water tap 3/4“ external threadandparticlefilter

10

250

640

979,51961

1550

740

1730

730

630

2940

445


3.4 Waste water drainPrerequisites:• PermanentlyinstalledconnectionfittingwithG3/4"externalthreador• Drain outlet, standard HT 40 or HT 50 (connection adapters can be ordered for the adoption of the discharge hose:

510.2130.0 for HT 40; 510.2129 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 mAn anti-syphon trap is integrated in the unit!• ConnectwastewaterhosewithunitandtheG3/4“connectionfitting.Therebyfitenclosedgasketsintothescrewing.

3.5 Setting up proposal

3/4“ wall connection Conical hose connectionStandard HT

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3.6 Controls and options when fully equipped

On / Off switch

Display vacuum1 Hose rinsing

Adjustment vacuum

Display compressed air

Adjustment compressed air

Automatic suction equipment

Ear irrigation / thermal nystagmus stimulation

Mirror quick heater

Nebulization of medications (compressed air)

Heating module for instrument tray

Clipboard

Compressed air

max. 2 kg! LED light source

LED headlight

The plastic adapter of the hose rinsing system ( 1 ) is a consumable (REF 506.2228.1), exchange weekly. It is removed by twisting it out with a slight rotation.

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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 canisterPrior to use, check the system for leak tightness, otherwise it is possible that the vacuum cannot built up!

Insertbacterialfilter( 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

3.8.1 Mount secretion canister

Intake for foam prevention:The hose connection with intake ensures a smoother liquidsurface.Therebyalowerfoamformationandprolongedfilterdurability are the result.

7 Suction hose (only for automatic)006.0008.0, 220 mm

Hose connection (grommet) 1

340.0057.0

Secretion canister lid 2

530.1108.0

Seal 3

320.0013.0

Bacterial filter 4

340.0054.0

Splash guard 5

312.0827.0

Secretion canister 6

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First start-upPrior 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.Aftertransportation/storageofthedeviceatlowtemperaturesandpriortofirststart-upitshouldbekeptatroomtemperatureforat least four hours. If the device is not acclimatised the formation of condensation water is possible and a malfunction might be the result.

3.9 Adjustment of front feet

3.10 Connections in the service compartment3.10.1 Hoses

Adjustthescrewsofthefeetthroughtheboreholeswithaflat-bladedscrewdriverscaled4-5.

Insert phone jack into marked jack

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 compartmentOpen the tap on the treatment unit. Check whether all connections are leakproof.

Connect compressed-air hose in the service compartment

Insert application parts into the hanging strip

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4.0 Operation

4.2 Suction systemDonotoperatethesuctionsystemwithoutabacterialfilter.Alwaysusethesplashguard,thiswillprolongtheservicelifeofthebacterialfilter.Theguaranteewillexpireinthecaseofimproperuse!Changethebacterialfilterregularly.Seedetailsinchapter5.0.The hose attachment must be exchanged after each patient.

!

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.

After each application rinse the suction hose thoroughly. Add the suction hose (without canula) with the suction nipple to the suctionattachmentforthehoserinsingandsoakuptherinsingfluidatleast30sec.

Display vacuum

Adjustment vacuum

at least 30 sec.

4.1 On / off switch

4.2.1 Control and display of the suction performance

4.2.2 Hose rinsing system

After switching on the mains switch, all integrated and connected devices are ready for operation.

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4.0 Operation

Refilling storage canister for hose rinsing

Mount secretion canister

A) Fully automatic refilling (530.1060.0)Ifrequired,thewaterstoragecanisterwillbeautomaticallyrefilled.

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 (530.1050.0)Fill the canister with water and/or a non-foaming instrument disinfectant.

4.2.3 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) ManuallyEmpty 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 (530.1070.0)Thesecretioncanisterisemptiedautomaticallywhenthefillinglevelisreached.

Suction hose (only for automatic)006.0008.0, 220mm

Intake for foam prevention

Hose connection (grommet)340.0057.0

Secretion canister lid530.1108.0

Seal320.0013.0

Bacterial filter340.0054.0

Splash guard312.0827.0

Secretion canister The hose connection with intake ensures a smoother liquidsurface.Therebyalowerfoamformationandprolongedfilterdurability are the result.

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4.0 Operation

4.2.4 Disposable canister system

A) Receptal

B) Medi-Vac

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4.0 Operation

4.3 Ear irrigation module Hygrotherm

4.3.1 Overview

Front view

1

2

3

3

1 Temperature display (double-digit, resolution 1°C), actual value indication

2 Setting mode for the temperature

3 Adjustment button up or down

Irrigation handle

3

10

8

6

7

4

5

9

1

2

1 Handle

2 Connection for double-barrelled hose

3 Three-hole gasket

4 Knurled screw

5 Release lever

6 Valve plunger

7 Jet connection

8 Splash guard

9 Sealing cap

10 Double-barrelled hose

4.3.2 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!

18

4.0 Operation

4.3.3 Activation of the Hygrotherm

Remove the handle from the support. The Hygrotherm is automatically activated via the installed light barrier. The adjustmentcontroloftheHygrothermrequiresca.20s,untilthe desired temperature is reached. Check the temperature indication! As long as the temperature of the actual value deviatesfromthetargetvalue,theLEDbutton„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

4.3.4 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

4.3.5 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 36-38°C . By releasing the button „set“ the new set temperature is adopted and the target temperature is displayed again on the temperature indicator.

Heating off:Press the „set“ button to turn the heating on and off.

3

!

19

4.0 Operation

4.4 Thermal nystagmus stimulation, Variotherm

4.4.1 Overview

Front view21 3

4

56789

1 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 indication4 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 period9 Button to Start/Stop the stimulation (150 ml/min)

Irrigation handle

3

10

8

7

6

11

9

1

2

4

5

1 Handle

2 Connection for double-barrelled hose

3 Three-hole gasket

4 Adjusting screw

5 Release lever

6 Valve plunger

7 Jet connection

8 Splash guard

9 Sealing cap

10 Double-barrelled hose

11 Set screw

4.4.2 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!

20

4.0 Operation

4.4.3 Activation of the Variotherm

Remove the handle from the support. The Variotherm is automatically activated via the installed light barrier. The adjustmentcontroloftheVariothermrequiresca.20s,untilthe desired temperature is reached. Check the temperature indication! As long as the temperature of the actual value deviatesfromthetargetvalue,theLEDbutton„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.

Handle thermal nystagmus stimulation

On / off switch nystagmus binoculars

Connection nystagmus binoculars

Ear irrigation bowl

4.4.4 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 ifrequiredsettime press (flashingapprox.10sec.) 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

4.4.5 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.

2

8

4.4.6 Temperature setting

You can apply the Variotherm at temperatures from 20°C to 47°C. Theminimumtemperatureisdefinedbythetemperatureofthetap water.

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 handleKeep 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.

2

8 7 6 5

!

21

4.0 Operation

4.4.7 Adjusting the flow quantity

Prior to stimulation the set screw 11 must be locked in the upwards position.2 Adjustment possibilities:• High:Flowquantityforearirrigation• Low:FlowquantityforstimulationofthevestibulePrior 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.Forfineadjustmentoftheflowthesetscrew 4 must be screwed in or out.

) Periodicallycheckthewaterflowforthestimulationofthevestibular organ and readjust, if necessary.

114

4.4.8 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 RemarksImmediately after start-up the LED test starts.

Start-up Lights up Lights up YesBoth LEDs light up simultaneously during switch on (duration: 500 ms).

Subsequentlyafunctionalandaggregatetestfollows.Forthispurposesixflashingsignalslightup(time-ratiolightup/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 timeOperating time suction pump Second light up Yes Critical operating timeOperating time suction pump 2 Third light up Yes Critical operating timeOperating time hose pump Fourth light up Yes Critical operating timeOperating time drainage pump Fifth light up Yes Critical operating timeAnnual maintenance Sixth light up Yes Annual maintenance is dueBattery voltage Seventh light up Yes Low battery voltage

If one of the above maintenance cases occurs, please contact your local ATMOS® Service partner.

22

4.0 Operation

4.5 Ear irrigation bowl with separate suction channel (530.2070.0)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 suitableforanyothersuctionprocedureinthemedicalfield!Theliquidpumpisnotsuitableforsuckingoffbiggerparticles,forexample, 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.

!

• Makesureequipmentandhosesarefirmlyconnectedinordertobuildupasufficientpressure.• If you use politzer olives, control pressure in acc. with the appliance.

4.6.1 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.

Nebulization of medications (compressed air)

Handle conpressed air

Ear irrigation module (compressed air)

4.6 Compressed-air system

23

4.0 Operation

4.6.2 Adapt / deposit sprayer

Adapt: Deposit:

1

23

Insert () the handle onto the medication bottle. Engage, then lift medication bottle with the handle from the support ().By pulling the trigger, compressed-air will be applied into the sprayer ().

1

2

Insert the medication bottle top down in the support.Press activator () and pull handle () backwards.

• 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”!

4.6.3 Ear irrigation module compressed air (REF 530.2080.0)

1

2

Adjusting leverVent valve

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!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.

4.7 LED-Light systemOn / off LED

LED port (for light source or headlight), optional connection for nystagmus binoculars

LED port (for light source or headlight)

!

24

A

4.0 Operation

Press A.Themirrorquick-heaterheatsupfor10secondsandthenswitchesoffautomatically.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!

4.8.2 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.

!

4.8 Instrument heating

4.8.1 Mirror quick-heater

Cleananddisinfectthestoragequiversregularly!Fordetailspleaseobservetheinstructionsinchapter“5.0Cleaningandcare”.

25

4.0 Operation

4.9 Clipboard endoscopyIntegration of 3-channel endoscope management for rigid andflexibleendoscopes.

4.9.1 Option LED Light Cube

The LED Light Cube is automatically activated when the unit is switched on. With a simple rotary motion the adapters are screwed in uptothestoppositionandfixedintheClipboard.Thelightconductors 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.

4.9.3 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 4.8.1. 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.

Screwing in the adapter

Clipboard with connected light conductors

Operating the control panel

Clipboard with connected headlight

4.9.2 Option endoscope management (heated)

Endoscope heating is activated automatically when the unit isswitchedon.Thequiversareheatedto41°C.

26

5.0 Cleaning and care

5.1 General information on cleaning and disinfectionPrior to cleaningSet 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 disposableclothtoabsorbanyliquid.

• If any disinfectant is spilled, make sure to dry wipe the surfaceimmediatelyinordertopreventtheliquidfrompenetrating gaps and edges.

• 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 Please observe that the alcohol contained in these agents could corrode or cloud the protective covers if employed on a long term basis.

) Alwaysobservetheconcentrationspecificationsandinstructions 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.

5.1.1 Cleaning the unit surface

• 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!

27


5.1.2 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.

- Disposeofsecretionproperly.Griplidsystemfirmly,openlidofthefilterhousingbyturninganti-clockwiseandremovefilter.Thoroughlyrinseallpartsunderrunning water. A detergent or cleaning agent may also beusedifrequired.

• ChecktheDDSbacterialfilter/oversuctionstop: - TheDDSbacterialfilter/oversuctionstopare

disposable products. - Prior to each use please check whether the DDS bacterialfilterisdryandclean.WetordirtyDDSbacterialfiltersmustbereplacedwithnewones.

- When the vacuum is adjusted to “max” and the suction hose shows more than -0,3 bar then the DDS bacterialfiltermustbereplaced.

- ReplacetheDDSbacterialfilteratleastonceaday.OnlyuseoriginalATMOSbacterialfilters.

- The device may never be operated without DDS bacterialfilter/oversuctionstop.

• Suction system and hose attachment: - After every use, rinse out the suction system by drawinginasmallamountofrinsingfluid(e.g.specialcleanser for suction systems 080.0006.0, dosage: 10 ml to 1 l water).

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,donotusemorethan1lrinsingliquidandsubsequentlyemptythecanister.

5.1.3 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 mayalsobeusedifrequired.

- 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.

5.1.4 Instrument trays

• Before disinfection, thoroughly rinse the trays under running water. A detergent or cleaning agent (surface disinfectant)mayalsobeusedifrequired.

- Thoroughly rinse to eliminate all residues from these substances.

- Subsequentlydisinfectwithoneofthedisinfectantsmentioned in 5.3.

Melamine and anodized aluminium trays cannot be sterilised.

5.1.5 Endoscope quivers

• Themetalquiversfortheendoscopeholdermustonlybeused to hold endoscopes, which in advance must be cleaned and disinfected.Thequiversmustbecleaneddailyandsubsequentlydisinfected.Todothis,thestopper at the lower end must be removed.

5.1.6 Ear irrigation bowl

• The ear irrigation bowl is not autoclavable! Cleaning and disinfection (also machine cleaning) up to 93 °C.

5.1.7 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.

!

28


5.2 Recommended instrument disinfectants

Manual disinfection of instrumentsDisinfectant Ingredients in 100 g ManufacturerKorsolex® med AF (Application concentrate)

N-dodecylpropane-1,3-diamineN-(3-aminopropyl)-N-dodecylpropane-1,3-diaminesurfactants, corrosion inhibitorsph-value regulators, foam inhibitors

15.6 g5.1 g

Bode Chemie, Hamburg

Korsolex® basic(Application concentrate)

glutaral(ethylenedioxy)dimethanolsurfactants, salts, corrosion inhibitors

15.2 g19.7 g


Korsolex® plus(Application concentrate)

N-(3-aminopropyl)-N-dodecylpropane-1,3-diaminedidecyldimethylammonium chloridesurfactants, corrosion inhibitorscomplexing agents, ph-inhibitors

9.2 g13.0 g


Korsolex® extra(Application concentrate)

(ethylenedioxy)dimethanolglutaralbenzyl-C12-18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloridesurfactants, foam inhibitors, corrosion inhibitors

15.3 g7.5 g1.0 g1.0 g


neodisher® Septo MED(Application concentrate)

N-(3-aminopropyl)-N-dodecylpropane-1,3-diaminedidecyldimethylammonium chloridenon-ionic surfactants, perfumes

9.2 g13.0 g

Dr. Weigert, Hamburg

neodisher® Septo 3000(Application concentrate)

glutaral(ethylenedioxy)dimethanol

15.2 g19.7 g

Dr. Weigert, Hamburg

Sekusept® PLUS(Application concentrate)

glucoprotamin 25 g Ecolab, Düsseldorf

Sekusept® aktiv(Application concentrate)

Sodiumpercarbonate, non-ionic surfactants, phosphonates Ecolab, Düsseldorf

Gigasept® Instru AF(Application concentrate)

CocospropylendiaminguanidindiacetatePhenoxypropanolsBenzalkonium chloridenon-ionic surfactants, ph-value regulators, corrosion inhibitors

14 g35 g2.5 g

Schülke & Mayr, Norderstedt

Gigasept® FF (neu)(Application concentrate)

succindialdehydedimethoxytetrahydrofuraneanionic and non-ionic surfactants, perfumes, methylisothiazolinone

11.9 g3.2 g


Gigazyme®

(Application concentrate)non-ionic surfactantsenzymes, corrosion inhibitors

5 - 15 g Schülke & Mayr, Norderstedt

Automatic disinfection of instrumentsDisinfectant Ingredients in 100 g ManufacturerDismoclean® 24 Vario(Application concentrate)

surfactants, micro-encapsulated enzymes, corrosion inhibitors, complexing agents


Dismoclean® 28 alka med(Application concentrate)

alkali dispenser, complexing agents, corrosion inhibitors, surface active materials


Dismoclean® twin basic / twin zyme


Dismoclean® twin basic alkali dispenser, complexing agents, corrosion inhibitorsDismoclean® twin zyme surface active materials, enzymes, stabilisers, corrosion inhibitorsneodisher® FA Phosphates 15 - 30 g Dr. Weigert, Ham-

burgneodisher® MediClean forte(Application concentrate)

non-ionic and anionic surfactantsenzymes

< 5 g Dr. Weigert, Ham-burg

Thermosept® alka clean forte(Application concentrate)

non-ionic surfactantsanionic surfactantsNTA (nitrilotriacetic acid) and its saltsenzymes, poly carboxylatescorrosion inhibitors

< 5 g< 5 g< 5 g< 5 g


Thermosept® RKN-zym non-ionic surfactants,enzymes, corrosion inhibitors, glycols

5 - 15 g Schülke & Mayr, Norderstedt

29


5.3 Recommended surface disinfectants

Coated surfacesDisinfectant Ingredients in 100 g ManufacturerGreen & Clean SK Di alkyl dimethyl ammonium chloride

Alkyl dimethyl ethyl benzyl ammonium chlorideAlkyl dimethyl benzyl ammonium chloride

< 1 g< 1 g< 1 g

Metasys, Rum (Austria)

Dismozon® pur(Granulate)End of product 12/2014

magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie, Hamburg

Dismozon® plus(Granulate)

magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, Hamburg

Kohrsolin® FF(Application concentrate)

glutaralbenzyl-C12-C18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloride

5 g3 g3 g


Perform® Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt

Terralin® Protect(Application concentrate)

benzyl-C12-16 alkyldimethyl-, chloride2-phenoxyethanolaminoalkylglycinenon-ionic surfactants, perfumes

22 g17 g0.9 g


Other surfacesDisinfectant Ingredients in 100 g ManufacturerDismozon® pur(Granulate)End of product 12/2014

magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie, Hamburg

Dismozon® plus(Granulate)

magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, Hamburg

Kohrsolin® FF(Application concentrate)

glutaralbenzyl-C12-18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloride

5 g3 g3 g


Perform® Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt

Terralin® Protect(Application concentrate)

benzyl-C12-16 alkyldimethyl-, chloride2-phenoxyethanolaminoalkylglycinenon-ionic surfactants, perfumes

22 g17 g0.9 g


Surface disinfection F 312 alkyl-benzyl-dimethyl-ammonium chloridenon-ionic surfactants, complexing agents, hexyl cinnamal, butyl phenyl methyl proionale, linalool

13 g Dürr Dental, Bi-etigheim-Bissingen

When disinfectants containing aldehyde and amine are used on the same object colour changes may occur.

30


5.4 Recommended endoscope disinfectants

Manual disinfection of endoscopesDisinfectant Ingredients in 100 g ManufacturerHelipur® H plus N glutaral

2-propanolethyl hexanolsurfactants, complexing agents, corrosion inhibitors, colorants, perfumes

12 g,7.5 g0.5 g

BBraun, Melsungen

Helix® Ultra peracetic acid BBraun, MelsungenKorsolex® basic glutaral

(ethylenedioxy)dimethanolsurfactants, salts, corrosion inhibitors

15.2 g19.7 g

Bode Chemie,Hamburg

neodisher® MediClean forte (Application concentrate)



Sekusept® aktiv (Application concentrate)

Sodiumpercarbonate, non-ionic surfactants, phosphonates Ecolab, Düsseldorf

Automatic disinfection of endoscopesDisinfectant Ingredients in 100 g Manufacturer

Korsolex® basic glutaral(ethylenedioxy)dimethanolsurfactants, salts, corrosion inhibitors

15.2 g19.7 g

Bode Chemie,Hamburg

neodisher® MediClean forte(Application concentrate)



Gigasept® FF (neu)(Application concentrate)

succindialdehydedimethoxytetrahydrofuraneanionic and non-ionic surfactants, perfumes, methylisothiazolinone

11.9 g3.2 g


Endozime® AW Plus

2-propanol Ruhof, Mineola (USA)

AdaptacleanTM Potassium hydroxide, surfactants ASP, Norderstedt

31

6.0 Hygiene Plan

What How

Notices

When Who

Parts to be reprocessedC

CleaningD

DisinfectionS

Sterilization

Afte

r eac

h ap

plic

atio

nD

aily

Wee

kly

Mon

thly

Qualifi ed and trained staff who are familiar

with reprocessing. (Please fi ll in the

responsible person -> use a water-based

overhead marker)

Secretion canisterHose connection (grommet) X X2,4,5 Cleaning and disinfection (manual or automatic) X

Secretion canister lid X X2,4,5 Cleaning and disinfection (manual or automatic) X

Seal X X2,4,5 Cleaning and disinfection (manual or automatic) X

Bacterial fi lter Exchange daily or when blocked X

Splash guard X X2,4,5 Cleaning and disinfection (manual or automatic) X

Float ball X X Cleaning and disinfection (manual or automatic) X

Suction hose in the canister X X2,4,5 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 systemSuction nozzle for hose rinsing X X3 Wipe cleaning and disinfection X

Silicone attachment pieceX X2,4,5.6 Cleaning and disinfection (manual or automatic) X

Exchange of the silicone attachment X

Suction nippleX Manual cleaning after each application X

X2,4,5.6 Cleaning and disinfection (manual or automatic) X

Secretion suction hoseX Rinse the secretion hose with the hose rinsing system

after each application; X

X2,4,5.6 Exchange or disinfection of the hose X

Storage canister hose rinsing X X2,4,5.6 Cleaning with a brush; cleaning and disinfection (automatic or manual) X

Ear irrigation / Thermal nystagmus stimulationEar irrigation bowl X X2,4,5 Cleaning and disinfection (manual or automatic) X

Handle X X3 Wipe cleaning and disinfection X

Jet connection X X2,4,5.6 Cleaning and disinfection (manual or automatic) X

Splash guard X X2,4,5 Cleaning and disinfection (manual or automatic) X

Hose tip (disposable) Exchange after each application X

Rinsing attachment X X2,4,5 Cleaning and disinfection (manual or automatic) X

Hygiene fi lter See operating instructions for hygiene fi lter X

Rinsing lid with rinsing hose X X2,4,5 Cleaning and disinfection (manual or automatic) X

Rinsing bottle X X2,4,5.6 Cleaning and disinfection (manual or automatic); cleaning in the dishwasher with the glass care programme X

Medication nebulisation / PolitzerHandle compressed air X X3 Manual cleaning and disinfection X

Sprayer jetX Cleaning after each application X

X2,4,5.6 Cleaning and disinfection (manual or automatic) X

Sprayer head X2,4,5 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

Sprayer bottle X X2,4,5.6 Cleaning in a cleaning and disinfection device; weekly or when changing the medication X

Politzer olive X X2,4,5.6 Exchange after each application, cleaning and disinfection X

Politzer connection X X2,4,5.6 Exchange after each application, cleaning and disinfection X

Endoscope managementPlastic quiver X X2,4,5 Cleaning with a brush; disinfection X

Metal quiver X X2,4,5.6 Cleaning with a brush; disinfection (automatic or manual) X

Fixation adapter for plastic quiver X X2,4,5 Cleaning and disinfection (manual or automatic) X

Protective sleeve (tefl on element for metal quiver) X X2,4,5 Cleaning and disinfection (manual or automatic) X

Cleaning and disinfection planATMOS® S 61 Servant

32

6.0 Hygiene Plan

What How

Notices

When Who

Parts to be reprocessedC

CleaningD

DisinfectionS

Sterilization

Afte

r eac

h ap

plic

atio

nD

aily

Wee

kly

Mon

thly

Qualifi ed and trained staff who are familiar

with reprocessing. (Please fi ll in the re-

sponsible person, use a water-based over-

head marker)

Instrument management

ENT instruments X X2,4,5 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 X4 Cleaning and disinfection (manual) X

Instrument bowl with cover X X4 Cleaning with a brush; disinfection (manual) X

VisualizationATMOS® Cam 21 / 31 X X3 Wipe cleaning and disinfection X

ATMOS® Strobo 21 LED X X3 Wipe cleaning and disinfection X

ATMOS® LS 31 LED X X3 Wipe cleaning and disinfection X

Flexible Endoscope X X1,7,8 X1 Immediate pre-cleaning after application X

Rigid endoscope X X1,7,8 X1 Immediate pre-cleaning after application X

Laryngoscope X X1,7,8 X1 Immediate pre-cleaning after application X

Light cable X X3 Wipe cleaning and disinfection X

Light grip X X3 Wipe cleaning and disinfection X

Microscope X X3 Wipe cleaning and disinfection X

Headlight X X3 Wipe cleaning and disinfection X

Radiofrequency surgeryATMOS® RS 221 (surface) X X3 Wipe cleaning and disinfection X

Ergonomic handles X X1,2,4.5 X1 Wipe cleaning and disinfection X

Bipolar tweezers X X1,2,4.5 X1 Immediate pre-cleaning after application;Cleaning and disinfection (manual or automatic);Use of enzymatic detergents

X

Bipolar electrode X X1,2,4.5 X1 X

Bipolar electrode cable X X1,2,4.5 X1 Immediate pre-cleaning after application;Cleaning and disinfection (manual or automatic);Use of enzymatic detergents

X

Neutral electrode X X1,2,4.5 X1 X

Neutral electrode cable X X1,2,4.5 X1 Immediate pre-cleaning after application;Cleaning and disinfection (manual or automatic);Use of enzymatic detergents

X

ENT electrodes X X1,2,4.5 X1 X

SurfacesHousing X X3 Wipe cleaning and disinfection X

Roller shutter X X3 Wipe cleaning and disinfection X

System frame X X3 Wipe cleaning and disinfection X

Drawers X X3 Wipe cleaning and disinfection X

Writing surface X X3 Wipe cleaning and disinfection X

Instrument deposit X X3 Wipe cleaning and disinfection X

Mirror preheater X X3 Wipe cleaning and disinfection X

Tongue patches and swab dispenser X X3 Wipe cleaning and disinfection;

Daily or when refi lling X

Waste disposal X X3 Wipe cleaning and disinfection;Daily or when refi lling X

Instrument tray X X3 Wipe cleaning and disinfection;Daily or when refi lling X

ATMOS MedizinTechnik GmbH & Co. KGLudwig-Kegel-Str. 16 79853 Lenzkirch/GermanyPhone +49 7653 689-0 Fax +49 7653 [email protected] www.atmosmed.de

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 13485.The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250 always have to be considered.

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.

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

Wrong concentration of disinfectants may lead to material damage!

GA3GB.110100.0 2017-12 Index: 14

Recommended disinfectants3) 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)

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)

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.

33

7.0 Maintenance and Service

7.2 Changing the bacterial filter• To this please attend the articles 4.7 and 5.2.4 in this operating instructions!• Setthevacuumcontrollerto"maximum"(rightstop).• Assoonasthevacuumgaugeshowsavacuumvalue>-0.3bar,whilethesuctionhoseisopen,thefilterhastobereplaced.• UseonlyoriginalATMOSbacterialfilters.ThedevicemayneverbeoperatedwithoutDDSbacterialfilter/oversuctionstop.Toensureproperfunctionoftheautomaticsecretioncanisterevacuationsystem,thefillinglevelelectrodesmustalwaysbeclean and free from sediments!Ifthereisnodrasticvacuumatthehandleafterassemblyofthesecretioncanister,checkwhetherthebacterialfilterisintheright position.

7.3 Changing the tube box of the tube pumpThe tube cassette is located in the unit's pump compartment. It may only be replaced by authorized personnel!

• The ATMOS®S61ServantENTworkstationisequippedwithmaintenance-freepumpsforsuctionandcompressedair.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 62353. ATMOS recommendsaninspectionaccordingtothemanufacturer‘sspecifications.

- WithintegratedVariotherm:Carryoutaninspectionaccordingtothemanufacturer‘sspecificationsevery12months.

7.1 Replacing the fuseThe fuses are located on the back of the unit.

34

7.0 Maintenance and Service

7.4 Hygrotherm / Variotherm: DecalcificationDependingonwheretheunitisusedifthetapwaterisknownformineralprecipitation,preventivedecalcificationshouldbecarried out:• Close tap.• Unscrewthefilterglass.• Fillglasswithapprox.100mlofdecalcifieronacetic/citric,orlacticacidbase(forinst.Citrosteril,byFresenius).• Screw screw-top jar again.• Reopen the tap.• Switch on the device.• Remove the irrigation handle from the support for 10-15 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• Ifthefiltercartridgeiscontaminatedordiscolouredthen

thefilterelementmustbereplacedasfollows: - Close water supply tap. - Brieflyswitchontheunittoreducepressureinthefilterhousing.

- Switchofftheunitwhen"F1"appearsonthedisplay. - Unscrew plexiglass canister (,fig.7)fromfilter

housing (,fig.7)byturninganti-clockwise. - Removefiltercartridge(,fig.7)andreplaceitwitha

new one (Art.No. 502.0891.0).• Thefilterelementmustnotcomeintocontactwith

contaminated objects in order to prevent the ingress of germs into the water system.

Filter housingFilter cartridgeSealingPlexiglass canister

1

2

3

4

1

2

3

4

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 www.atmosmed.com.• The device must be well padded and packed in suitable packaging.• Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate in an

envelope.• Affixtheenvelopetotheoutsideofthepackage.• Send the product to ATMOS or to your dealer.

35

8.0 Troubleshooting

Description Cause Measure

Electric power supplyNo function, main switch is active, control light does not light up

No voltage to power plug Check house fuse, possibly it burnt throughCable/plug defect Exchange cable/plug

SuctionLow or no suction rate, but vacuum gauge indicates vacuum

Suction hose is clogged Clean suction hoseActive oversuction protection Check oversuction protectionFilter moistened/blocked Replacefilter

Low or no suction rate, but vacuum gauge indicates few or no vacuum

System leaky Check all joints, new assembly of the systemSuction hose snapped off Remove breaks, pass hose a different wayVacuum controller is open Set regulator to higher/maximum vacuumSecretion penetrated the suction pump

Inform the service department

Suction pump does not switch on or off

Draggled/defect light barrier in suction hose holder

Clean both light barriers openings in the suction hose holder, if necessary inform service department

No suction, but force pump is operating

Positions of handles have been mixed up

Insert handles in the right holder

Compressed airCompressed air pump does not switch on or off

Draggled/defect light barrier in compressed air holder

Clean both light barriers openings in the compressed air holder, if necessary inform service department

No compressed air, but suction pump is operating

Positions of handles have been mixed up

Insert handles in the right holder

Noadequatepressurebuild-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 heaterHeater does not switch on Switch or control unit defect Inform service department to exchange the

switch or control unitInsufficientornoheaterpower Single or all three heater coils

defect, no glowChange heater coil

Automatic secretion canister evacuationCanister will not be drained when filledabovethesensorlimit

Sensordoesnotdetectfillinglevel Clean canister thoroughly

Pump does not activate when suction hose is returned

Pump defect Inform the service department

Effluentpumpdoesnotactivateafterswitching off the draining pump

Pump defect Inform the service department

Effluentpumpdoesnotswitchoff Effluentpipeblocked Remove blockageElectrodesintheeffluentcanisterare dragged and thereby hot-wired

Cleaneffluentcanisterorletelectrodesbecleaned

Effluentpumpdoesnotstart Device is fed with demineralised water via water connection

Please use drinking water

36

8.0 Troubleshooting

Description Cause Measure

Automatic filling of the hose rinsing containerContaineroverflows Charging valve does not close Inform the service department

Sensordoesnotdetectfillinglevel Sensor defect - inform the service departmentContainerdoesnotgetfilled Water supply is interrupted Assure water supply

Safety switch in the container is not activated

Place hose rinsing container correctly in the holderClean canister thoroughly

LED power supplyLED light source does not light Switch to position 0 Depending on used jack, set switch in position I

or IIPlug/cable/LED light source defect Inform service department to exchange the

defective part

Nystagmus binoculars connectionNystagmus 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 systemNo heating Temperature sensor, control or

heating element defectiveInform the service department

Hygrotherm / VariothermError 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

the control board)• Inform the service staff.

„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.

37

9.0 Consumables, Accessories, Spare Parts

9.1 Consumables

Consumables for disposable secretion management REFReceptal® 1.0 l bag, not autoclavable 312.0463.0

Receptal® 1.0 l external container 312.0464.0

Disposable suction hose, not autoclavable (10 pcs.) 006.0058.0

Consumables for suction equipment REFDDS bacterial filter for secretion canister (10 pcs) 340.0054.0

Special cleaner for suction systems2 bottles, each 500 ml

080.0006.0

9.2 Accessories

Accessories for ear irrigation / thermal nystagmus stimulation REFEar irrigation bowl 505.0353.0

Ear irrigation bowl with separate suction channel fortheindependentuseoftheearirrigationbowl.Clipboard(REF530.0010.0)isrequired

530.2070.0

Jet connection for water irrigation handle 80 mm 508.0427.0


Hose tips, 30 pcs.flexiblehosetips,tobeslippedonjetconnectionforexactguidingofthewaterjet

502.0844.0

Splash protection to be slipped on jet connection 501.0331.0

Accessories for nystagmus stimulation REFConnection for nystagmus binoculars 530.4015.0

Nystagmus binoculars(connectionfornystagmusbinocularsisrequired) 530.4016.0

Accessories for compressed air system REFSprayer bottle 000.0577.0

Sprayer, straight 506.5225.0

Sprayer with rotatable nozzle (360° rotation) 506.5120.0

Sprayer for powdery medications 505.0253.0

Spare nozzle for straight sprayer 505.0280.0

Spare nozzle for sprayer with rotatable nozzle (360° rotation) 000.0219.0

Spare hose for sprayer bottle, after change of medication (pack of 10) 506.5229.0

Accessories for light module economy REFLithium-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.

507.4510.0

Universal battery quick charging power pack (100-240 V) 011.1199.0

Accessories for instrument management REFInstrument tray, melamine, 190 x 150 mm 000.0746.0

Instrument tray, aluminium-anodized, 184 x 142 mm 508.0058.0

Instrument tray, stainless steel, 180 x 140 mm 508.0058.2

38

9.3 Spare parts

Spare parts for ear irrigation / thermal nystagmus stimulation REFIrrigation handle 530.1190.0

Rubber bush for splash guard 501.0331.1

3-hole-sealing device side 501.0320.0

3-hole-sealing handle side 530.1186.0

Double lumen hose for irrigation handle 530.1181.0


Hygienefilterforwaterrinsing 000.0918.0

9.0 Consumables, Accessories, Spare Parts

39

10.0 Technical data at complete equipment

Voltage 230 V~ ± 10 %; 50/60 Hz Special voltage:100 V~ ± 10 %; 50/60 Hz115 V~ ± 10 %; 50/60 Hz127 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. 2,300 VAFuses 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• Powerdensity(freeflow) 40 l/min• Vacuum -91kPa(-910mbaror682,5mmHg)@NN,optionallyinfinitelyvariable• Secretion canister DDS 1,0 lSuction system professional• Powerdensity(freeflow) 55 l/min• Vacuum -95kPa(-950mbaror712,0mmHg)@NN,optionallyinfinitelyvariable• Secretion canister DDS 1,0 lCompressed-air system• Powerdensity(freeflow) 20 l/min• Pressure Min.220kPa,infinitelyvariable• Sprayer Forliquid,oilyandpowderymaterialsEar irrigation basic• Water temperature 37.5 °C +/- 2 °CEar irrigation professional (Hygrotherm)• Water temperature Adjustable 36 - 38 °C +/-0.5 °C• Flow Max. 450 l/min (adjustable on the handle)Thermal nystagmus stimulation (Variotherm)• Water temperature 3 adjustable levels from 20 – 47 °C +/-0.5 °C• Flow Max. 450 l/min (adjustable on the handle)• Timer setting 1 – 99 s• Interface Nystagmograph triggeringInstrument heating• Temperature Approx. 37 °CLight module economy• LED power supply 700 mA regulatedLED cold light module• Number of channels 2• Light intensity Min. 200 klx• Colour temperature 5500 K +/- 10 %Operating time Continuous operationProtective earth conductor resistance Max.0.1ΩEarth leakage current Max. 0.5 mAEnclosure leakage current Max. 0.1 mAPatient leakage current Max. 0.1 mAAmbient conditions for transport/storage• Temperature -10...+50 °C• Humidity without condensation 30...95 %• Pressure 500...1060 hPa

Pleasenotethetechnicalspecificationsofthesingledevicesintheseparateoperatinginstructions!

40

10.0 Technical data at complete equipment

Ambient conditions operation• Temperature +10...+35°C• Humidity without condensation 30...95 %• Pressure 700...1060 hPaMaximum operational altitude ≤3000mContamination level Class 2Overvoltage category IIDimensions HxWxD 88.5 x 41.2 x 54.0 cmWeight 10 - 40 kgPeriod tests Repeat test of the electrical safety every 12 months. Recommended:

inspectionaccordingtothemanufacturer‘sspecifications.With integrated Variotherm: Inspection according to the manufacturers specificationsevery12months.

Safety class (EN 60601-1) IDegree of protection Application parts type BFType of protection IP X0ClassificationaccordingtoAppendixIXECDirective 93/42/EEC

Class II a

CE marking CE 0124GMDN code 11585UMDNS code 10-585Ident No. 530.0000.0 (230 V~)

530.0001.0 (100 V~)530.0002.0 (115 V~)530.0003.0 (127 V~)

Technical data unchanged since: 05.02.2018

• 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.

11.0 Disposal

41

12.1 Guidelines and Manufacturer´s Declaration - Emissions

The ATMOS®S61Servantworkstationisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeroruser of the ATMOS® S 61 Servant workstation should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - GuidanceRF Emissions acc.to CISPR 11 Group 1 The ATMOS® S 61 Servant workstation uses RF energy only

for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronicequipment.

RF Emissions acc. to CISPR 11 Class BThe ATMOS® S 61 Servant workstation is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions according to IEC 61000-3-2

Class A

Voltagefluctuations/flickeraccordingto IEC 61000-3-3

Corresponds

12.2 Guidelines and Manufacturer's Declaration - Immunity

The ATMOS®S61ServantENTworkstationisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer or user of the ATMOS® S 61 Servant ENT workstation should ensure that it is used in such an environment.

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - GuidanceElectrostatic discharge (ESD) according to IEC 61000-4-2

± 6 kV Contact± 8 kV Air

± 6 kV Contact± 8 kV Air

Floors should be wood, concrete, or ceramic tile.Iffloorsaresynthetic,therelativehumidity should be at least 30 %.

Fast electrical transient/burst IEC 61000-4-4

± 2 kV Mains± 1 kV I/Os

± 2 kV Mains Mainspowerqualityshouldbethatofatypical commercial or hospital environment.

Surges IEC 61000-4-5 1 kVCommon2 kVDifferential

1 kVCommon2 kVDifferential

Mainspowerqualityshouldbethatofatypical commercial or hospital environment.

Magneticfieldatpowerfrequency50/60Hzacc.to IEC 61000-4-8

3 A/m Inapplicable Powerfrequencymagneticfieldsshouldbe that of a typical commercial or hospital environment.

• MedicalelectricalequipmentissubjecttospecialprecautionswithregardtoEMCandmustbeinstalledacc.tofollowingEMC notes.

• PortableandmobileHFcommunicationfacilitiescaninfluencemedicalelectricalequipment.• The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced

interferenceimmunityoftheequipmentorsystem.

12.0 Notes on EMC

42

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - GuidanceVoltage Dips / Dropout IEC 61000-4-11

< 5 % UT (>95%DipoftheUT) for 0.5 Cycle

40 % UT

(60% Dip of the UT) For 5 cycles

70% UT

(30 % Dip of the UT) For 25 cycles

< 5 % UT (>95%DipoftheUT) for 5 s

< 5 % UT (>95%DipoftheUT) for 0.5 Cycle

40 % UT

(60% Dip of the UT) For 5 cycles

70% UT

(30 % Dip of the UT) For 25 cycles

< 5 % UT (>95%DipoftheUT) for 5 s

Mainspowerqualityshouldbethatofatypical commercial or hospital environment. If the user of the ATMOS® S 61 Servant ENTworkstationrequirescontinuedfunctionduring interruptions of the energy supply, it is recommended to supply the ATMOS® S 61 Servant ENT workstation from an uninterruptible power supply or a battery.

NOTE UT is the mains alternating current prior to application of the test levels.

12.3 Guidelines and Manufacturer´s Declaration - ImmunityThe ATMOS®S61ServantENTworkstationisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer or user of the ATMOS® S 61 Servant ENT workstation should ensure that it is used in such an environment.

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance

Conducted RF IEC 61000-4-6

3 Veff

150 kHz to 80 MHz3 V

Portableandmobilecommunicationsequipmentshould be separated from the ATMOS® S 61 Servant ENT Workstation incl. the cables by no less than the distances calculated/listed below.Recommended distances:d=1.167*√(P)d=1.167*√(P)d=2.33*√(P)where „P“ is the max. power in watts (W) and d is the recommended separation distance in meters (m).Fieldstrengthsfromfixedtransmitters,asdeterminedby an electromagnetic site (a) survey, should be less than the compliance level (b).Interferencemayoccurinthevicinityofequipmentcontaining following symbol:

Radiated RF IEC 61000-4-3

3 V/m80 MHz to 2.5 GHz 3 V/m

12.0 Notes on EMC

43

12.0 Notes on EMC

12.4 Recommended safety distance between portable and mobile RF Communications equipment and the ATMOS® S 61 Servant ENT workstation

NOTE1By80MHzand800MHzthehigherfrequencyrangeapplies.

NOTE 2These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and reflectionofbuildings,objectsandpeople.aThefieldstrengthofstationarytransmitters,suchasbasestationsofcellularphonesandmobileterrainradioequipment,amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environmentinregardtostationarytransmitters,astudyofthelocationistobeconsidered.Ifthemeasuredfieldstrengthatthe location where the ATMOS® S 61 Servant ENT workstation is used exceeds the above compliance level, the ATMOS® S 61 Servant ENT workstation is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed arrangement or another location for the ATMOS® S 61 Servant ENT workstation.

bWithinthefrequencyrangeof150kHzto80MHzthefieldstrengthshouldbebelow3V/m.

The ATMOS® S 61 Servant ENT workstation is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS® S 61 Servant ENT workstation can help prevent electromagnetic interferencebymaintainingaminimumdistancebetweenportableandmobileRFCommunicationsequipmentandtheATMOS® S 61 Servant ENT workstation as recommended below, according to the maximum output power of the communications equipment.

Safety distance, depending on transmit-frequency mNominal output of the

transmitterW

150 kHz to 80 MHzd = 1.167 * √(P)

80 MHz to 800 MHzd = 1.167 * √(P)

800 MHz to 2.5 GHzd = 2.33 * √(P)

0.01 0.1167 0.1167 0.2330.1 0.37 0.37 0.741.0 1.167 1.167 2.3310 3.7 3.7 7.37100 11.67 11.67 23.3

For transmitters for which the maximum nominal output is not indicated in the above table, the recommended safetydistancedinmeters(m)canbedeterminedusingtheequationbelongingtotherespectivecolumnwhereasPisthemaximumnominaloutputofthetransmitterinwatts(W)acc.tomanufacturer´sspecification.NOTE1By80MHzand800MHzthehigherfrequencyrangeapplies.

NOTE 2These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorptionandreflectionofbuildings,objectsandpeople.

ATMOS MedizinTechnik GmbH & Co. KG

Ludwig-Kegel-Straße 16

79853 Lenzkirch / Germany

Phone: +49 7653 689-0

[email protected]

www.atmosmed.com

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