Atmos Variotherm plus User manual

Variotherm plus
GA1GB.140302.0 2017-03 Index 30
0124
Operating Instructions
English
Valid for devices delivered after July 2002.

2
Content
1.0 Introduction.........................................................3
1.1 Notes on operating instructions ............................3
1.2 Intended use .........................................................4
1.3 Function ................................................................4
1.4 Explanation of symbols.........................................4
2.0 For your safety....................................................5
2.1 Advice for the user for maintaining hygienic
status ....................................................................6
3.0 Setting up and starting up .................................7
3.1 Scope of supply ................................................... 7
3.2 Illustrations............................................................8
3.3 Connections........................................................11
3.3.1 Electrical connection...........................................11
3.3.2 Connecting a nystagmograph.............................11
3.3.3 Connecting a equipotential bonding connection .11
3.3.4 Water connection ................................................12
3.3.5 Connection of the irrigation handle .....................12
3.4 Starting up...........................................................12
4.0 Operation...........................................................13
4.1 Adjusting temperatures.......................................13
4.2 Selecting temperature levels...............................13
4.3 Adjusting stimulation time ...................................13
4.4 Adjustingowquantity ........................................13
4.5 Description of operating modes ..........................14
4.5.1 Thermal process for reducing bacterial count.....14
4.5.2 Irrigation mode....................................................14
4.5.3 Stimulation mode ................................................14
4.5.4 Energy saving mode ...........................................14
5.0 Cleaning and care.............................................15
5.1 General information on cleaning and disinfection15
5.2 Recommended disinfectants...............................15
5.3 Cleaningmethodforhandlewithjetconnection
 forwaterirrigationtip ..........................................16
6.0 Maintenance and Service.................................17
6.1 Decalcication.....................................................17
6.2 Replacementoflter...........................................17
6.3 Sending in the device..........................................17
7.0 Troubleshooting................................................18
8.0 Accessories and spare parts...........................19
8.1 Accessories.........................................................19
8.2 Spare parts .........................................................19
9.0 Technical data ...................................................20
10.0 Disposal.............................................................22
11.0 Notes on EMC....................................................23

3
1.0 Introduction
1.1 Notes on operating instructions
These operating instructions contain important notes on
howtooperatetheVariothermplus,correctlyandeffectively.
Therefore,theyareintendednotonlyfornewoperating
personneltobeinstructedinitsuse,butalsoforuseas
areferencemanual.Theyhelptoavoidrisks,andalsoto
reducerepaircostsanddown-times.Furthermore,reliability
andservice-lifeoftheequipmentwillbeincreased.For
these reasons these operating instructions must always
be kept available near the appliance.
Priortorstusepleaseperusethechapter“Foryour
safety”,inordertobepreparedforanypossibledangerous
situations.Todothisduringwork,wouldbetoolate.
The basic principles are:
Judicious and careful work provides best protection
against accidents!
Operational safety and readiness for use of the device
dependnotonlyonyourcapabilities,butalsoonthecare
and maintenance given to the Variotherm plus. For this
reasonregularcleaningandserviceworkareamust.Major
maintenanceandrepairworkmaybecarriedoutonlyby
expertpersonnelauthorisedbyATMOS.Incaseofrepairs
you should insist that only original spare parts are used. You
willthenhavethewarrantythatoperationalsafety,readiness
forworkandthevalueofyourdevicewillbepreserved.
• The product Variotherm plus 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Variothermpluscomplieswithallapplicable
requirements of the Directive 2011/65/EC restricting the
use of certain hazardous substances in electrical and
electronicequipment(“RoHS”).
• The declaration of conformity and our general standard
termsandconditionscanbeobtainedonourwebsiteat
www.atmosmed.com.
• ThequalitymanagementsystemappliedatATMOShas
beencertiedaccordingtointernationalstandardsEN
13485.
• Reprints-alsoinextracts-onlywithpermissioninwritten
formbyATMOS.
Short cuts / symbols contained in these operating
instructions:
• Indicating a list
- Subdivision of a list/activity
Therecommendedsequencemustbefollowedineach
case!
)Indicating particularly important advice!
ªDescribing the effect of an activity.
ATMOS
MedizinTechnikGmbH&Co.KG
Ludwig-Kegel-Straße16
79853 Lenzkirch
Germany
Phone: + 49 7653 689-0
Fax:
+ 49 7653 689-190
+497653689-393(ServiceCentre)
E-mail: [email protected]
Internet:www.atmosmed.de

4
1.0 Introduction
1.2 Intended use
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
Specication
of the main
functions:
Producesajetofwaterforthe
ear irrigation at body temperature
(37°C)withaowrateof400ml/
min for the removal of cerumen.
Stimulation of the vestibular organ
withadenedowandaxed
temperature 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
1.3 Function
• Operatingthemainswitchontheexaminationunit
automatically activates the thermal process for reducing
bacterialcount(seesection4.5.1).
• Then,automaticchangeintotheenergysavingmode.
• Whenremovingtheirrigationhandlefromitsholder,
automaticchangeintotheirrigationmode.Here,the
auditorycanalcanberinsedwithwaterwarmedupto
37°Candaowofatleast400ml/min.
• Possibilitytoswitchtothestimulationmodefor
stimulatingthevestibularorganwithareducedowof
water.
TheVariothermplusisequippedwithatimerfor
preselecting the stimulation duration.
1.4 Explanation of symbols
Observe operating instructions!
According to ISO /7000/0434 DIN
30600/1008 IEC 348
Type B equipment as to IEC 417
FuseaccordingtoIEC417/5016,DIN
30600/0186
°C Temperature in degree centigrade
sTimer adjustment in seconds
Start
Stop
Timer
Cold stimulation level
Warm stimulation level
37°C Irrigationlevel(wateratatemperaturevalue
of37°C)
•HeatingON
•HeatingOFF(energysavingmode)
Control output for connecting a
nystagmograph (graphical recorder as to
DIN30600,IEC4175192)
Equipotential connection
DIN30600495,ISO4175021
Connectionforwastewater
Connectionforwater
Low Reducedow(forstimulationofthe
vestibule)
High Highow(forrinsingtheauditorycanal)

5
2.0 For your safety
• The Variotherm plus 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
safety socket.
• The unit must be installed by a specialist authorized by
ATMOS(seechapter3.3).
• The Variotherm plus 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.
• Makesurepriortoeveryapplicationoftheequipmentthat
it is technically safe and in proper condition. Damaged
cables must be replaced immediately!
• Correctcongurationinassemblyofcountry-specic
connections:
- green/yellow:protectiveconductor(PE)
- blue:neutralconductor(N)
- blackorbrown:phase(L)
• Itisessentialthatthecountry-specicrequirementsfor
connection of medical equipment to the public drinking
watersupplyareconsidered.Whenindoubt,please
contactyourlocalATMOSpartner.
• The control panel must be clearly visible and accessible
fortheuser.Ensuresufcientstabilityontheinstallation
surface.
)In the thermal process for reducing bacterial count hot
waterisbeingductedthroughtheirrigationhandle.
Please do not take the handle from its holder or spray
water!
)Metalpartscanbehot!
)Priortospraying,thewatertemperaturemustbechecked
bytheuser(display)!
• Switchoffmainswitchafternishingworkinpracticeand
closewatervalveofsupply.
• The Variotherm plus may be operated only in rooms
usedformedicalpurposes,butnotinareassubjectto
explosion hazards and in oxygen rich environments.
• Alladditionalequipmentwhichisconnectedtothe
analogue and digital interfaces of the device must meet
therequirementsofrelevantENspecications(e.g.EN
60950 for data processing equipment and EN 60601 for
electricalmedicalequipment).Inaddition,congurations
mustsatisfysystemspecicationEN60601-1-1.When
additional equipment is connected to the signal input or
signaloutputsectiononthedevice,thepersoncarrying
outtheconnectionisdeemed„asystemconguration
operator“andassuchisresponsibleformeetingthe
requirementsofsystemspecicationEN60601-1-1.For
answerstoadditionalquestions,pleasecontactyourlocal
specialistsupplierortheATMOSTechnicalService.
• Theirrigationjetmustnotgetintocontactwith
contaminated material.
• Onlyusethewarmwaterjetwhenatubetipisinstalled!
• Takecautiontoavoidinjurytotheeardrumwhen
introducingthewaterjet!
• For hygienic reasons jet connections must be changed
after each patient. This also prevents retrograde
germinationofthewarmwatersystem.
• Use only for irrigation of auditory canal!
• 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.
• Please note:
Amedicalinsulatingtransformerwithearthleakage
monitor or any similar safety system acc. to EN 60 601-1
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.
• Theowratehastobecheckedafterswitchonorat
leastonceadaywithameasuringcup.Thequantityof
500ml/minmaynotbeexceeded.Thewaterjethastobe
straight.

6
2.0 For your safety
2.1 Important instructions for the maintenance of the hygiene status of warm water
irrigation units
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.
Requirement for taking into use
ThewaterwhichisprovidedbythehouseholdconnectionmustatleastmeettheWHOguidelinesorthecountry-specic
guidelinesfordrinkingwater.
Connection
Freshwatermustowthroughthewallconnectionforaperiodofapprox.1minutepriortotheunitbeingconnected.*
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.*
Carryoutthermalcleaningatleast3timesbeforepatientuse.*
*ThisworkiscarriedoutbytheATMOSservicetechnician.
Running operation
Beforebeginningthesurgicaloperation,switchontheunitandawaitthethermalcleaningprocess.
Afterthedevicehadbeenidleforalongperiodoftime,(weekend,duringholidays,etc.)thethermalcleaningprocessmust
be initiated and repeated.
Werecommendthatthedevicebeswitchedoffandonevery2hoursandnotlongerthan4hourstostartthethermal
cleaning mode.
Exchange and disinfection required for contact parts such as the jet connection after each patient (prevention of retrograde
germication).
Beforeeveryuse,spraywaterandcheckthetemperature.
Service
Ensurethatthesuspendedparticlelterishygienicallychanged(seecommissioning)(disposeoflterandcarefullycleanthe
lterglass).Ensurethatnocontactismadewiththecontaminatedparts.
Carry out thermal cleaning after each service.
Werecommendthatthenumberofgermsinthewaterberegularlydeterminedattheinputandoutputoftheunit.Inthecase
ofacomplaint,datameasurementsmustbeprovewhetherthecontaminantsare"water"or"skin”bacteria.

7
3.0 Setting up and starting up
3.1 Scope of supply
Quantity
1 Variotherm plus basic unit
1 Irrigation handle
1 Double-barrelled hose
3Jetconnectionshort,straight(80mm)
1 Splash guard
1 Rubber bush for splash guard
2 Three-holes gasket
1Hosetipsforjetconnection(30pcs)
1G3/4i-G1/4a-screwing(water-tapG3/4
onlterG1/4)
1 Cap nut G3/4
1Waterltercomplete
2Gasket(f.G1/4a)13x18x1
1G1/4a-G3/4a-reducer(lterG1/4on
waterhoseG3/4)
1WatersupplyhoseG3/4i,L=3m
1WastewaterhoseG1/4i,L=3m
2Gasket(f.G1/4i)10x15x1
1 Cardboard 455 x 340 x 250 mm
1 Padding for cardboard
1 Operating Instructions

8
3.0 Setting up and starting up
3.2 Illustrations
Variotherm plus
3 0 3 7
—
 

  

11 
3
[[
030 4
4
[
   

Fig. 1. Front view
1Mainswitch
2KeyswitchforheatingON/OFF(energysaving
mode)
3Codingswitchforwarm-stimulationlevel
4Codingswitchforcold-stimulationlevel
5Codingswitchforstimulationtime
6Keyswitchforselectingtheirrigationlevel(37°C)
7Keyswitchforselectingthewarm-stimulationlevel
(e.g.44°C)
8Keyswitchforselectingthecold-stimulationlevel
(e.g.30°C)
9Keyswitchforstart/stopofthestimulation
10Temperaturedisplay(two-gurenumber,resolution
1°C),currentvalueindication
11Displayofstimulationtime(two-gurenumber,
resolution1s)

9
Fig. 3. Side view
1Support for handle
2Connection for double-barrelled hose
3Connectionforwastewaterhose*
4Connectionforwatersupplyhose
3.0 Setting up and starting up
F 14 AH


Fig. 2. Rear view
1Type plate
2Control output for controlling a nystagmograph
3Deviceplugwithfusecompartment
4Equipotential bonding connection




p=+2000...+6000hPa
t=+7...+19,5°C
Pressdownring


*

10
3.0 Setting up and starting up
Fig. 4. Irrigation handle
1Handle
2Connection for double-barrelled hose
3Three-holes gasket
4Adjustingscrew
5Setscrew
6Valve plunger
7Jet connection
8Splash guard
9Cap
10 Double-barrelled hose










The sprayer tube must be exchanged after each
patient.
!


11
3.0 Setting up and starting up
Fig. 5.
3.3 Connections
3.3.1 Connection to electrical power line
• According to the directions of VDE 0107 and VDE
0100,medicallyusedroomshavetobeequippedwith
aleakagecurrentprotectivecircuit(FIprotectivecircuit)
withanominalleakagecurrentof<0.03A.Installation
mustcorrespondwithVDE0107.
• Connect the mains cable to the mains supply (,g.2).
• Insertthepowerpluginacorrectlyinstalledsocketwith
earthing contact.
3.3.2 Connecting a nystagmograph
• WhencontrollinganENG(electro-nystagmograph)or
aCNG(computer-nystagmograph)atoutput(,g.2),
please connect only recording equipment approved by
ATMOS.ConnectingcableavailablefromATMOS(see
section8.0).
• Attheendofthestimulationtime,atriggersignalfora
nystagmograph is available at the rear 3-pole DIN socket.
This outlet is an electrically isolated photo transistor.
Theemitterconnectionwhichhastobeconnectedto
the ground line of the trigger inlet at the nystagmograph
is attached to pin 3. The open-collector connection is
located on pin 1 and is to be connected to the positive
supplyvoltage(+5Vor+12V)bymeansofapull-
up resistance. The maximum collector voltage of the
transistormaynotexceed80MA.
3.3.3 Connecting a equipotential bonding
connection
• Connection for potential equalization (,g.2).
ConnectingcableavailablefromATMOS(seesection
8.0).

12
3.3.4 Water connection
• Local requirements:
- Water-tapwithG3/4"externalthread.
- Drinkingwater!
- Inputwaterpressure:+2000...+6000hPa.
- Feedtemperature:+7...+19.5°C(recommended),
butatleast0.5°Cbelowtherequiredlowestcold
stimulation value.
- Drainagettings(Art.Nr.502.0880.0)
• Connectiontowatersupplyandwastewater:
- Therearecountry-specicregulationsforthe
installationtobeconsideredwhentheunitis
connectedtothepublicwatersupply.Tocomplywith
therulesaccordingtoEN1717,anunpressurized
waterseparationwithoverowisrequired.
Therefore,ATMOSrecommendstoinstallthewater
separationunitATMOSAquaClean,REF502.1200.0
betweenthewatersupplyandthedeviceinorderto
meet the connection requirements according to EN
1717.
- Priortoconnectingtheunittothewatersupplythe
feedlinemustbeushedcleanbyopeningthewater
tapforaminuteandallowingfreeowofthetap
water.
- Connectthelterunittothewater-tapbymeansof
adaptor and gasket.
- Insertthegasketsinthecapnutsofthewatersupply
hose.
- Jointhenutswiththelterconnectionandtheunit
connection (,g.3).
- Insertthegasketsinthecapnutsofthewastewater
hose.
- Jointhenutswiththeunitconnection(,g.3)and
thedrainagettings.
- Thereisnospecialcalcicationsafetydevice
integratedinthewatersystem.Suchasystemisto
beconnectedwhentherespectivedrinkingwateris
of hardness grade 3 (14 - 21°d resp. 2.5 - 3.8 mmol/l
=hardwater)andwithhardnessgrade4(from21°d
resp.from3.8mmol/l=veryhardwater).
Pleasecontactyourlocalwatersupplierand/or
plumber.
Water
hardness
Millimol per
litre
°dH
1(soft) ≤1.3 ≤7.3 Calcication
protection system
is not required
2
(medium)
1.3 to 2.5 7.3 to 14
3(hard) 2.5 to 3.8 14 to 21.3 Calcication
protection system
is required
4 (very
hard)
> 3.8 > 21.3
Closethewatertapwhentheunitisnotinuse!
!
3.0 Setting up and starting up
3.3.5 Connection of the irrigation handle
• Inserta"three-holesgasket"(,g.4)inthedouble-
barrelledhoseandscrewit(,g.4)ontheunit
connection (,g.3).
)Useonly"three-holesgaskets"ortheunitwillnotfunction
correctly!
• Inserta"three-holesgasket"intheirrigationhandleand
screwitonthefreeendofthedouble-barrelledhose.
• Openthewater-tap.Checkwhetherallconnectionsare
tight.
3.4 Starting up
• Insert the handle in its holder; the jet must point to
reverse side of the unit.
• Switchontheunit(,g.1).
• Automaticdisplaytestwithdigitalnumbers"88"and
acousticwarningsignal.
• Automaticactivationofthethermalprocesswillbeginfor
reducing bacterial count. Duration: 5 min.
• Automaticchangeintotheirrigationmode(37°C).
• When the irrigation mode is not used (handle is not
removedfromitssupport)theunitchangeintotheenergy
saving mode after 5 min.

13
4.0 Operation
Beforeswitchingontheunit,makesurethatthehandleisin
itsholder(jetmustpointtoreversesideoftheunit).
4.1 Adjusting temperatures
• Number of temperature levels: 3
- Onelevelxedto37°Cirrigationtemperature.
- Twovariabletemperaturelevels(20°C-47°C)(48°C
+49°Conlyfortestingpurposes).
• Temperatesettingbycodingswitch(,,g.1).
- leftswitch:foradjustingthe"ten"partition
- rightswitch:foradjustingthe"one"partition
ªlowerkeys(+):Temperatureincrease
ªupperkeys(-):Temperaturedecrease
• Standard settings:
- Levelforirrigationmode:37°Cxed
- Level for cold stimulation: 30°C
- Levelforwarmstimulation:44°C
4.2 Selecting temperature levels
• Afteroperatingthemainpowerswitch,theautomatic
activation of the thermal process begins for reducing
bacterialcount,followedbytheautomaticactivationof
thetemperaturelevel"irrigationmode"(37°C).
• Forselectingthedesiredtemperaturelevel,usethe
respective key (,,,g.1).
ªDisplay of the active level by illuminated diodes.
ªDisplayofthewatertemperature(currentvalue)in°C.
4.3 Adjusting stimulation time
• Bymeansofcodingswitch(,Fig.1).
4.4 Adjusting ow quantity
• Priortostimulationturnthesetscrew(,g.6)upwards
and arrest it.
• 2 adjusting possibilities:
- High:Flowquantityforearirrigation
- Low:Flowquantityforstimulationofthevestibule
Priortoearirrigationthesetscrewisturneddownwards,
inserted into the handle and then adjusted by turning it
downwardsagain.
Forneadjustmentoftheowtheadjustingscrew(,g.
6)isturnedinrespectivelyout.
)Periodicallycheckthewaterowforthestimulationofthe
vestibularorganandreadjust,ifnecessary.
Fig. 6. Irrigation handle
1Setscrew
2Adjustingscrew



14
4.0 Operation
4.5 Description of operating modes
4.5.1 Thermal process for reducing bacterial
count
Purpose:
Reductionofbacteriacountinthewarmwatercircuitto
prevent or clear a contaminated system.
Activation:
Occurseachtimetheunitisswitchedon.
• Condition for starting the correct thermal process for
reducing bacterial count:
- The irrigation handle must be inserted in the holder
ontheside(jetpointingtoreversesideoftheunit).
ªIfnot,awarningsignalisgiven(warningalsosounds
whenthehandleisremovedduringthethermal
cleaningprocedure).
ªAdditionally,theerrorcode"F0"isshown(disappears
whenhandleisreturned).
)In the thermal process for reducing bacterial count hot
waterisbeingductedthroughtheirrigationhandle.
Please do not take the handle from its holder or spray
water!
)Metalpartsoftheirrigationhandleandofthedouble-
barrelledhosewillbehot!Pleasedonottouchmetal
parts during the thermal cleaning procedure!
• Duringthethermalprocessforreducingbacterialcount,
thetemperaturedisplayshowsa'd'ontherstsegment
andtheremainingtime(inminutes)onthesecond
segment.
• Aftercoolingdownto37°Ctheunitwillautomatically
switchintoirrigationmode.
4.5.2 Irrigation mode
Purpose:
Rinsing of the auditory canal.
Properties:
• Temperature:37°C,permanentlyset.
• Positionoftheadjustinglever:High(seeg.6,page13).
Activation:
• Automatically after completion of thermal cleaning
procedure and taking out the handle or by key (,g.1).
• When the irrigation mode is not used (handle remains
inholder)theVariothermpluschangesintotheenergy
saving mode after 5 min.
• Reactivation of the irrigation mode by taking the handle
out of the holder or activating a key on the temperature
control unit.
• Ifthe37°Cpushbuttonisrepeatedlypressed,theheating
isswitchedoff.
ªWaterwithfeedtemperatureisavailable.
4.5.3 Stimulation mode
Purpose:
Stimulation of the vestibular organ.
Properties:
• Temperature: corresponds to the preselected cold or
warmstimulationlevel
• Positionoftheadjustinglever:Low(seeg.6,page13).
• Duration: as pre-set by the timer.
Activation:
• Initially select the type of stimulation by actuating either
warm-stimulationorcold-stimulationkey(,,g.1)
(seesection4.1forpre-settingoftemperature)
ªWaterwithpre-settemperaturevalueowstohandle.
• Wait for 20 seconds.
• Operatethe"timer-start-key".
• Preparation for stimulation:
- Operateunit15secondsinholdingposition,sothat
the jet can be positioned correctly in the auditory
canal.
)Duringthisperiod,thewaterisdirected,viathehandle,
into the drain in order to guarantee an optimum
temperaturestability;withanopticalindicationbythe
ashinggureintemperaturedisplay.
Do not start stimulation by operating the release lever at
the handle until you hear the audible signal!
• Carrying out the thermo-stimulation by actuating release
lever at handle (,g.4).
• At the end of the stimulation period a control signal for a
recording unit is issued at the nystagmograph output.
• After completion of the stimulation the unit remains in a
holding position for 15 seconds so that the handle may
be removed from the auditory canal.
ªDuringthistime,waterowsintothedrain;againan
opticalindicationismadebyashingtemperature
value.
• Repeatedactuationofthe"timer-start-key"leadsto
stopping timer operation.
• Second actuation of the currently active key effects
deactivation of the pertaining stage.
ªHeatingisswitchedoffcompletely.
ªStimulationwithcoldwater(feedtemperature).
4.5.4 Energy saving mode
Purpose:
Reduction of energy consumption.
Activation:
• Actuationofkey"heatingon/off”(,g.1).
ªHeatingisswitchedoff.
• Afterveminutesofnon-useoftheunit.

15
5.0 Cleaning and care
5.1 General information on cleaning and
disinfection
The jet connection which comes into contact with the
patient must be disinfected after each use.
The hose tips must be exchanged after each use.
The surfaces of the Variotherm plus resist most of the
common surface disinfectants.
However, do not use
• disinfectantswhichcontainconcentratedorganicor
inorganic acids as they could cause corrosion damage.
• Disinfectantscontainingchloramides,phenolderivatives
oranionictensides,asthesemaycausestresscracksin
the material used for the housing of the unit.
You may also use disinfectant sprays or disinfectant tissues
for cleaning and disinfection.
)SetmainswitchofthedevicetoOFFpriortocleaning
and disinfection!
Wipetheunitsurfacewithaclothmoistenedwithacleaning
or disinfecting solution. Take care that no liquid penetrates
the device. The cleaning agents and disinfectants listed in
section 5.2 are all suitable.
)Spilledliquidmustimmediatelybedrywiped.
)Alwaysobservetheinstructionsforusebythe
manufacturerofthedisinfectants,includingall
concentrationspecications.
)The described action relating to cleaning and disinfection
resp. sterilisation do not substitute the relevant
instructionswhichmustbeadheredtopriortooperation.
5.2 Recommended disinfectants
Manual disinfection of instruments
Disinfectant Ingredients in 100 g Manufacturer
Korsolexbasic
(Applicationconcentrate)
glutaral 15.2 g BodeChemie,Hamburg
(ethylenedioxy)dimethanol 19.7 g
surfactants,salts,corrosioninhibitors
Sekusept aktiv
(Applicationconcentrate)
sodiumpercarbonate,phosphonates Ecolab,Düsseldorf
non-ionic surfactants
GigaseptFFnew
(Applicationconcentrate)
succindialdehyde 11.0 g Schülke&Mayr,
Norderstedt
dimethoxytetrahydrofurane 3.0 g
corrosion inhibitors
non-ionic surfactants and perfumes
Automatic disinfection of instruments
Disinfectant Ingredients in 100 g Manufacturer
NeodisherMediClean
forte
(Applicationconcentrate)
NTA 5-15 g Dr.Weigert,Hamburg
non-ionic surfactants <5g
enzymes
preserving agents
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)
magnesium monoperoxyphthalate hexahydrate 95.8 g BodeChemie,Hamburg
Green&CleanSK
(Applicationconcentrate)
Alkyl dimethyl benzyl ammonium chloride <1g Metasys,Rum(Austria)
Dialkyldimethylammoniumchloride
Alkyl dimethyl ethyl benzyl ammonium chloride
Perform Pentapotassiumbis(peroxymonosulphate)-bis(sulphate) 45.0 g Schülke&Mayr,
Norderstedt
When using disinfectants containing aldehyde and amine at the same object colour changes may occur.

16
5.0 Cleaning and care
5.3 Cleaning method for handle with jet connection for water irrigation tip
TheATMOSappliancesVariothermandATMOSHygrothermareused,accordingtotherules,withdisposablehosetips
(disposables).Thesetipsmustbedisposedoffaftereachapplicationtothepatient.
WhenusingthehosetipsATMOSrecommendsareprocessinginlinewiththebelowcleaninganddisinfectionplan.
What How
Details
When Who
C D S
After each application Daily Weekly Monthly
Qualiedandtrained
staffwhoarefamiliar
withreprocessing.
(Pleasellinthe
responsible person
->useawater-based
overheadmarker)
Parts to be reprocessed Cleaning Disinfection Sterilization
Ear irrigation / Thermal nystagmus stimulation
Ear irrigation
bowl X X2,4,5 Cleaning and disinfection (manual or automatic) X
Handle X X3Wipe 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lter See operating instructions for hygiene
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
Recommended disinfectants
3)Surface disinfection for
coated surfaces:
Other surfaces: 4)Manualdisinfectionof
instruments:
5)Automatic disinfection of instruments:
• Green&CleanSK(ATMOS)
• Dismozon®plus(BodeChemie)
• Kohrsolin®FF(BodeChemie)
• Perform®(Schülke&Mayr)
• Terralin®Protect(Schülke&Mayr)
• Dismozon®plus(BodeChemie)
• Kohrsolin®FF(BodeChemie)
• Bacillocid®rasant(BodeChemie)
• Mikrobac®forte(BodeChemie)
• Perform®(Schülke&Mayr)
• Terralin®Protect(Schülke&Mayr)
• SurfacedisinfectantFD312(Dürr
Dental)
• QuickdisinfectionB30(Orochemie)
• Korsolex®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)
• Dismoclean®21clean(BodeChemie)
• Dismoclean®24Vario(BodeChemie)
• Dismoclean®28alkaone(BodeChemie)
• Dismoclean®twinbasic/twinzyme(BodeChemie)
• neodisher®FA(Dr.Weigert)
• neodisher®FAforte(Dr.Weigert)
• neodisher®MediCleanforte(Dr.Weigert)
• Thermosept®alkacleanforte(Schülke&Mayr)
• Thermosept®RKN-zym(Schülke&Mayr)
Forconcentrations,contacttime,temperature,materialcompatibility,pleaseseetherelevantinformationfromthemanufacturer.
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

17
6.0 Maintenance and Service
• Decalcicationandchangingoflter(seesections6.1,6.2)shouldbecarriedoutimmediatelybytheuserwhenrequired.
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.
• Carryoutaninspectionaccordingtothemanufacturer‘sspecicationsevery12months.
6.1 Decalcication
Ifthetapwaterinthearea,wheretheunitisused,isknownformineralprecipitation,preventivedecalcicationshouldbecarried
out:
• Closewatertap.
• Ifapplicable,dismantlelterwhenmountedverticallyatwatertap.
• Unscrewscrewedglassoflter.
• Fillscrewedglasswithapprox.100mlofdecalcieronacetic/citric,orlacticacidbase(forinst.Citrosteril,byFresenius).
• Screwglassonagain.
• Installlterverticallyagain,ifapplicable.
• Openwatertapagain.
• Switchonthedevice.
ªDecalcicationtakesplaceautomaticallyinthethermalprocessforreducingbacterialcount.Aftertheunithasbeeninthis
modefor5minutesthewaterpassageshavebeendecalciedandcleaned,andalsosufcientlyushed.TheVariotherm
plusisagainfullyreadyforoperation.Whenwaterpassagesareheavilycalcied,amodiedproceduremaybecome
necessary,withaprolongedreactionperiodforthedecalcier.
Recommendation:Calcicationsafetydevice502.0995.0.
6.2 Replacement of lter
• Whentheltercartridgeisverydirty(darkcolour)the
ltercartridgeistobeexchangedasfollows:
- Closewatertapofsupply.
- Switchonunittoreducepressureinthelterbody.
- Switchoffunitafterappearanceof"F1".
- UnscrewPlexiglasscup(,g.7)fromlterbody(,
g.7)byturninganti-clockwise.
- Extractltercartridge(,g.7)andreplacebynew
one(Art.No.502.0891.0).
• Thelterelementmustnotcomeintocontactwith
contaminated objects in order to prevent the ingress of
germsintothewatersystem.
Filter body
Filter cartridge
Sealing ring
Plexiglass cup
Fig. 7. Water lter




6.3 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 certicate.
)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 certicate in an
envelope.
• Afxtheenvelopetotheoutsideofthepackage.
• SendtheproducttoATMOSortoyourdealer.

18
7.0 Troubleshooting
Error in temperature display
"F0" Handleisnotinitssupport • Inserthandleinitssupporttoallowthermalprocessforreducing
bacterial count to start (jet connection must point to the back of
the unit.
• Replacehandle(Art.No.502.0963.0)
"F1" Nowater(waterpressure<0,5bar) • Check,whetherthewatersupplydeliversapressureofatleast
2bar(didyouopenthewater-tap?).
• Filterclogged?
"F2" -5 V is missing (supply voltage on the control
board)
• Inform the service staff.
"F3" Break of the safety NTC • Inform the service staff.
"F4" Safetyswitchingdoesnotreact(49°C
comparator)
• Havethesafetyswitching(temperaturecontroller)checkedbythe
service staff.
"F5" Break of the regulating NTC • Inform the service staff.
"F6" Differentswitchsettingsinthehandleholder • Handlemustbecorrectlyinsertedinitssupport.
• Otherwiseinformtheservicestaff.
"F7" Temperaturetoohigh(>48°C),displayonlyin
the stimulation and irrigation mode but not in
the thermal cleaning procedure
• Check,whethertemperaturesettingistoohigh.Ifnecessary,
adjustdesiredtemperaturetoavalueof<48°Cbymeansofthe
codingswitches.
• Inform the service staff.
"F8" Short-circuit of the regulating NTC • HavetemperaturefeeleroftheregulatingNTCcheckedbythe
service staff.
"F9" No heating performance (excess temperature
switch),def.Semi-conductorrelayorregulator)
• Informtheservicestaff(internalexcesstemperatureswitchmight
havereleased).
)Iferrorscannotbecorrectedwiththeassistanceofthetrouble-shootinglist,pleaseinformtheservicestafforsendinthe
device for repair. Do not start any attempts to repair the unit yourself!

19
8.0 Accessories and spare parts
8.1 Accessories
Description .....................................................................................................................................................REF
Calcicationsafetydevice................................................................................................................................502.0995.0
Jetconnectionextralong,straight(110mm) ...................................................................................................508.0429.0
Rinsingconnection(Teon)forstimulatingthevestibularorgan......................................................................501.0355.0
ExtensionofsupplyhoseG3/4a-G3/4i,L=1,5m.............................................................................................501.0315.6
Wastewaterhose,speciallength,G1/4a-G1/4a(pleaseindicatedesiredlength)...........................................502.0881.1
DrainagettingsastoDIN1988 ......................................................................................................................502.0880.0
Connecting cable for a nystagmograph ...........................................................................................................502.0850.0
Connectingcablefortheequipotentialcompensation,L=5m ........................................................................008.0596.0
8.2 Spare parts
Description .....................................................................................................................................................REF
Variothermplus,basicunit,220-240VAC,50/60Hz ......................................................................................502.0900.0
Variothermplus,basicunit,110-127VAC,50/60Hz.......................................................................................502.0900.1
Irrigation handle 4+ ..........................................................................................................................................502.0963.0
Double-barrelled hose......................................................................................................................................510.0412.0
Jetconnectionshort,straight(80mm)..............................................................................................................508.0427.0
Splash guard ....................................................................................................................................................501.0331.0
Rubber bush for splash guard..........................................................................................................................501.0331.1
Throttlingnozzle0.5mm(150ml/min).............................................................................................................502.0946.0
Throttlingnozzle0.7mm(250ml/min).............................................................................................................502.0946.1
Three-holes gasket ..........................................................................................................................................501.0320.0
Hosetipsforjetconnection(30pcs)................................................................................................................502.0844.0
G3/4a-G3/4i,L=3m.........................................................................................................................................502.0768.1
CapnutG3/4(tobeincludedinorder).............................................................................................................052.0035.1
Waterltercomplete ........................................................................................................................................502.0890.0
Filterelementforwaterlter.............................................................................................................................502.0891.0
Gasket(forG1/4a)13x18x1.............................................................................................................................055.0018.0
G1/4a-G3/4a-reducer(lterG1/4onwaterhoseG3/4)....................................................................................502.0724.1
SupplyhosewithconnectionG3/4i,L=3m....................................................................................................501.0315.7
WastewaterhosewithconnectionG1/4,L=3m............................................................................................502.0882.0
Gasket(forG1/4i)10x15x1..............................................................................................................................055.0003.0
Powercablewithprotectivecontactsocket(Germany),L=3m ......................................................................507.0859.0
PowercablewithBritishplugBS1363A(UK),L=2.5m...................................................................................008.0762.0
FuseF8A(quick-acting)250VbreakingcapacityH(1500A)........................................................................008.0767.0
Fuseforspecialvoltage(110-127VAC):F15A(quick-acting)breakingcapacity10kA....................................008.0766.0
Front foil Variotherm plus ................................................................................................................................060.0357.0

20
9.0 Technical data
Voltage 220-240V~±10%;50/60Hz
Special voltage 100-127V~±10%;50/60Hz
Current consumption max.6.8A(220-240V~);14.8A(100-127V~)
Powerconsumption max. 1500 W
Connections Powerconnection;controloutputforanystagmograph;equipotential
equalization;watersupplyG3/4"externalthread;waterdrainageG1/4"
external thread; connection for double-barrelled hose
Fuses F8A(f.220-240V~);F15A(f.110-127V~)
Stimulation time Adjustable by timer from 1 up to 99 sec.
Timer indication Indication accuracy ± 0.5 s ± ½ digit
Water temperature 20°C - 47°C
Temperature indication Indicationaccuracy±0.6°C±½digit(canonlybeguaranteewith
unchangedambientconditions)
Feedtemperatureofthewater +7...+19.5 °C
Water quality Drinkingwater
Waterowintheirrigationmode
(highow)
450 ml/min: Standard unit and variant 250/450 ml/min
400 ml/min: Variant 400/400 ml/min
500 ml/min: Variant 500/500 ml/min
Waterowinthestimulationmode
(lowow)
150ml/min:Standardunit150/450ml/min(adjustable)
250ml/min:Variant250/400ml/min(adjustable)
400ml/min:Variant400/400ml/min(adjustable)
500ml/min:Variant500/500ml/min(adjustable)
Operating time Continuous operation
Operating pressure Atleast:+2000hPa(2bar);max:+6000hPa(6bar)
Protective earth conductor resistance
Earth leakage current
Enclosure leakage current
Patient leakage current
max.0,1Ω
max. 0.5 mA
max. 0.1 mA
max. 0.1 mA
Ambient conditions
Transport / storage
-20...+50°C
5...90%airhumiditywithoutcondensation
air pressure of 700...1060 hPa
Ambient conditions
Operation
+10...+35°C
20...80%airhumiditywithoutcondensation
air pressure of 700...1060 hPa
Maximumoperationalaltitude ≤3000m(NN)
Contamination level Class 2
Overvoltage category II
DimensionsHxWxD 14.5 x 37 x 31.5 cm
Weight Approx.5,5kg
Period tests Inspectionaccordingtothemanufacturersspecicationsevery12months.
Safetyclass(EN60601-1) I
Degree of protection Type B
Protection class IPX0
Furtherclassicationsaccordingtoother
regulations
VDEprotectionclass1(IEC601/EN60601)
ClassicationaccordingtoAppendixIXEC
Directive 93/42/EEC
Class IIa
CE marking CE 0124