Atmos Hygrotherm Plus User manual

Hygrotherm
plus
GA1GB.140301.0 2021-07 Index 27
0124
Operating Instructions
English

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 equipotential bonding connection .11
3.3.3 Water connection ................................................11
3.3.4 Connection of the irrigation handle .....................12
3.3.5 Connection of further accessories ......................12
3.4 Starting up...........................................................12
4.0 Operation...........................................................13
4.1 Selecting temperature level ................................13
4.2 Description of operating modes ..........................13
4.2.1 Thermal process for reducing bacterial count.....13
4.2.2 Irrigation mode....................................................13
4.2.3 Energy saving mode ...........................................13
5.0 Cleaning and care.............................................14
5.1 General information on cleaning and disinfection14
5.2 Recommended disinfectants...............................14
5.3 Cleaning method for handle with jet connection
for water irrigation tip ..........................................15
6.0 Maintenance and Service.................................16
6.1 Decalcication.....................................................16
6.2 Replacementoflter...........................................16
6.3 Changing the fuses.............................................16
6.4 Sending in the device..........................................16
7.0 Troubleshooting................................................17
8.0 Accessories and spare parts...........................18
8.1 Accessories.........................................................18
8.2 Spare parts .........................................................18
9.0 Technical data ...................................................19
10.0 Disposal.............................................................20
11.0 Notes on EMC....................................................21
12.0 Notes..................................................................22

3
1.0 Introduction
1.1 Notes on operating instructions
These operating instructions contain important notes on
how to operate the Hygrotherm plus safely, correctly, and
e󰀨ectively.Therefore,theyareintendednotonlyfornewop-
erating 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, reliabil-
ity 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 situa-
tions. 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 Hygrotherm 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 authorized 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 Hygrotherm plus bears the CE marking CE-
0124 in accordance with EC Council Directive 93/42/EEC
concerning medical devices and meets the basic require-
ments of Annex I to this directive.
• The product Hygrotherm plus complies with all applicable
requirements of the Directive 2011/65/EU restricting the
use of certain hazardous substances in electrical and
electronicequipment(“RoHS”).
• The declarations of conformity and our general 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standardEN
13485.
• Reprints—also in extracts—only with permission in writ-
ten 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e󰀨ectofanactivity.
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Telephone: + 49 7653 689-0
Fax:
+ 49 7653 689-190
+497653689-393(ServiceCenter)
E-mail: [email protected]
Internet: www.atmosmed.com

4
1.0 Introduction
1.2 Intended use
Name: ATMOS Hygrotherm
Main function: Heating of the supplied water to
body temperature and generation
of a targeted jet of water with a
denedowrate.
Intended use / in-
tended purpose:
Irrigation of the external auditory
canal.
Intended users /
user prole:
Doctors and medically trained
personnel.
Intended patient
group:
Patients of all ages without restric-
tions.
Medical condition
to be diagnosed,
treated or moni-
tored:
Reduction in hearing due to ceru-
men in the auditory canal.
Application organ: Ear
Application time: Temporary(<60min).
Application site: Outpatient medical facilities, e.g.,
ENT practices, hospital outpatient
clinics, ambulatory healthcare
centers.
Criteria for patient
selection:
Patients with a physiological ear-
drum and external auditory canal.
Indications: Hearing loss due to impacted ear
wax.
Medical contrain-
dications:
Pathological eardrum.
Other contraindi-
cations:
Pathological external auditory
canal.
Warning notes: n/a
The product is: active
Sterility / specic
microbial condi-
tion:
Non-sterile
Single-use product
/ reprocessing:
Hose tips for the irrigation handle
against retrograde contamination
only suitable for single use.
All other product components are
reusable. Options for reprocessing
according to the operating instruc-
tions.
1.3 Function
• Operating the main switch (,Fig.1)automatically
activates the thermal process for reducing bacterial count
(seesection4.2.1).
• Then, automatic change into the irrigation mode. Here,
irrigationswithwaterwarmedupto37°Candaowofat
least400ml/mincanbee󰀨ected.
1.4 Explanation of symbols
Observe operating instructions!
According to ISO 7000/0434 DIN
30600/1008 IEC 348
Type B applied part
Fuse according to IEC 417/5016, DIN
30600/0186
°C Temperature in degree centigrade
•Heating ON
•HeatingOFF(energysavingmode)
Equipotential connection
DIN 30600 495, ISO 417 5021
Connection for waste water
Connection for water
CE marking
On/o󰀨
Caution
Handle

5
2.0 For your safety
• The Hygrotherm 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).
• In order to avoid the danger of an electric shock, this
device should only be connected to an earthed power
connection.
• The unit must be installed by a specialist authorized by
ATMOS(seechapter3.3).
• The Hygrotherm plus may only be used under the
supervisionofskilledsta󰀨whohavebeenauthorized
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su󰀩cientstabilityontheinstallation
surface.
• In order to safely disconnect the device from the mains
power supply, the power cable must be removed from the
IEC power connector of the Hygrotherm!
)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o󰀨mainswitchafternishingworkinpracticeand
close water valve of supply.
• The ATMOS Hygrotherm plus may be operated only
in rooms used for medical purposes, but not in areas
subject to explosion hazards and in oxygen-rich
environments.
• The irrigation jet must not get into contact with
contaminated material.
• The irrigation jet must be disinfected after each use.
• The irrigation jet may only be used when a hose tip is
attached!
• Take caution to avoid injury to the eardrum when
introducing the water jet!
• For hygienic reasons, hose tips 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
authorized by ATMOS.
• Please note:
A medical isolation 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.
• After switching on the device or at least once a week,
theowratemustbecheckedusingavolumemeasuring
funnel. 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 irri-
gation units
Forlooseningcerumenintheauditorycanalandstimulatingtheorganofequilibrium,ATMOSo󰀨ersthewarmwaterunitHygro-
thermplus(37°C).
These units heat the drinking water which comes from the household connection to the preselected temperature. The oper-
atinginstructionsmustbefollowed,ortheincreasednumberofpathogensintherinsewatercana󰀨ect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o󰀨andonevery2hoursandnotlongerthan4hourstostartthethermalclean-
ing mode.
Contactparts,e.g.,hosetips,mustbereplacedaftereverypatient(preventionofretrogradecontamination).
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.
Dependingonthequalityofthedrinkingwateravailable,abiolmgrowthcannotbeexcluded(despiteourpatentedthermal
processforreducingbacterialcount).Wethereforerecommendtestingthedrinkingwaterqualityatregularintervals(acc.
toISO6222)atthedrinkingwaterconnectionontheunitandontheappliedpart.Incaseofasignicantriseofgerms,a
biolm-removingprocesswithfollowingdisinfectioncanbecarriedout.

7
3.0 Setting up and starting up
3.1 Scope of supply
Quantity Description
1 Basic unit
1 Irrigation handle with connection hose
3 Jet connection for irrigation handle 80
mm
1 Splash guard for attachment to jet con-
nection
1 Hose tips
1Waterltercpl.3/4"A–3/4"l
1 Water supply hose
1 Waste water hose
1 Power cable
1 Operating Instructions

8
3.0 Setting up and starting up
3.2 Illustrations
Fig. 1. Front view
1Main switch
2Key switch for heating ON/OFF (energy saving
mode)
3Temperaturedisplay(two-gurenumber,resolution1
°C),actualvalueindication
Hygrotherm plus
3 7
—



F 14 AH


Fig. 2. Rear view
1Type plate
2Device plug with fuse compartment
3Equipotential bonding connection

9
3.0 Setting up and starting up



p = +2000...+6000hPa
t = +7...+19.5 °C
Fig. 3. Side view
1Support for handle
2Connection for double-barrelled hose
3Connectionforwastewaterhose*
4Connection for water supply hose

10
3.0 Setting up and starting up











Fig. 4. Irrigation handle
1Handle
2Connection for double-barrelled hose
3Three-hole gasket
4Knurled screw
5Release lever
6Valve plunger
7Jet connection for irrigation handle
8Splash guard for attachment to jet connection
9Cap
10 Double-barrelled hose
Hose tip
The jet connection must be disinfected after each pa-
tient. The hose tips are disposable products and must
be disposed of with household waste.
!
The irrigation handle with connection hose and all as-
sociated accessories are to be considered as applied
parts of the device.
!
11
11

11
3.0 Setting up and starting up
Fig. 5.
3.3.3 Water connection
• Local requirements:
- WatertapwithG3/4"externalthread.
- Drinking water!
- Inputwaterpressure:+2000...+6000hPa(6bar).
- Feedtemperature:+7...+19.5°C(recommended),
but at least 0.5 °C below the required lowest cold
stimulation value.
- Drainagettings(art.no.502.0880.0)
• Connection to water supply and waste water:
- Therearecountry-specicregulationsfortheinstal-
lation 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 sepa-
rationwithoverowisrequired.
Therefore, ATMOS recommends installing 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
adapter 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 (,Fig.3).
- Insert the gaskets in the cap nuts of the waste water
hose.
- Join the nuts with the unit connection (,Fig.3)and
thedrainagettings.
- Thereisnospecialcalcicationsafetydeviceinte-
grated 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 (medi-
um)
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!
!
3.3 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 leak-
agecurrentprotectivecircuit(FIprotectivecircuit)with
a nominal leakage current of < 0.03 A. Installation must
correspond with VDE 0107.
• Connect the power cable to the mains supply (,Fig.2).
• Insert the power plug in a correctly installed socket with
earthing contact.
3.3.2 Connecting a equipotential bonding connec-
tion
• Connection for potential equalization (,Fig.2).Con-
nectingcableavailablefromATMOS(seesection8.0).

12
3.0 Setting up and starting up
3.3.4 Connection of the irrigation handle
• Inserta“three-holegasket”(,Fig.4)inthedouble-bar-
relled hose and screw it (,Fig.4)ontheunitconnection
(,Fig.3).
)Useonly“three-holegaskets”ortheunitwillnotfunction
correctly!
• Inserta“three-hole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.
3.3.5 Connection of further accessories
• Connect 7to 1via a Luer lock connection. To do this,
turn 7clockwise 1until you feel resistance. Slide 8onto
7. The hose tips are attached to the tip of the 7.
3.4 Starting up
• Insert the handle in its holder; the jet must point to re-
verse side of the unit.
• Switch on the unit (,Fig.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totheirrigationmode(37°C).
• When the irrigation mode is not being used (handle is not
removedfromitssupport),theunitchangesto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 Selecting temperature level
• 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).
4.2 Description of operating modes
4.2.1 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 clean-
ing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-bar-
relled 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seg-
ment.
• After cooling down to 37 °C, the unit will automatically
switch to irrigation mode.
4.2.2 Irrigation mode
Purpose:
Rinsing of the auditory canal.
Properties:
• Temperature: 37 °C, permanently set.
• Waterow:atleast400ml/min,afterturningopenthe
limiter screw on the release lever of the handle (, Fig.
4).
Activation:
• Automatically after completion of thermal cleaning proce-
dure and taking out the handle.
• When the irrigation mode is not being used (handle
remainsinholder),theHygrothermpluschangesinto
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.
4.2.3 Energy saving mode
Purpose:
Reduction of energy consumption.
Activation:
• Activationofkey“heatingon/o󰀨”(,Fig.1).
ªHeatingisswitchedo󰀨.
• Afterveminutesofnon-useoftheunit.

14
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 Hygrotherm plus resist most common
surface disinfectants.
However, do not use
• disinfectants which contain concentrated organic or inor-
ganic 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 manu-
facturer of the disinfectants, including all concentration
specications.
)The described actions relating to cleaning and disinfec-
tion or sterilization do not substitute the relevant instruc-
tions 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, Norder-
stedt
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 < 5 g
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, Norder-
stedt
When using disinfectants containing aldehyde and amine on the same object, color changes may occur.

15
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 (dispos-
ables).Thesehosetipsmustbedisposedofaftereachapplicationtothepatient.
What How
Details
When Who
C D S
After each application Daily Weekly Monthly
Qualiedandtrained
sta󰀨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
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
Recommended disinfectants
3)Surface disinfection for coat-
ed surfaces:
Other surfaces: 4)Manual disinfection of instru-
ments:
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mustbewipedwithaclean(disposable)wipewhichisdampenedwithdisinfectantsolution;the
entire surface must be wiped thoroughly, do not dry 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

16
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 test-
ingarecarriedoutprofessionally,originalsparepartsareusedandwarrantyclaimsremainuna󰀨ected.
• At least every 12 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS recom-
mendsaninspectionaccordingtothemanufacturer’sspecications.
• Please observe the corresponding service instructions.
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su󰀩cientlyushed.TheHygrotherm
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.
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o󰀨unitafterappearanceof“F1”.
- Unscrew plexiglass cup (,Fig.6)fromlterbody
(,Fig.6)byturninganti-clockwise.
- Extractltercartridge(,Fig.6)andreplacewith
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. 6. Water lter




6.3 Changing the fuses
• Switcho󰀨thedevice.
• Disconnect the power cable from the device.
• Disconnect the fuse holder from the mains supply.
• Replacebothfuses(F8A,250V).
• Mount the fuse holder.
• Connect the device to the mains supply.
6.4 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ship-
ment”andtherespectiveDecontamination certicate.
)This form is enclosed with each delivery and can be
found at www.atmosmed.com.
• The device must be well padded and packed in suitable
packaging.
• PlaceformQD434“Deliverycomplaint/returnshipment”
and the corresponding Decontamination certicate in
an envelope.
• A󰀩xtheenvelopetotheoutsideofthepackage.
• Send the product to ATMOS or to your dealer.

17
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sta󰀨.
“F3” Break of the safety NTC • Informtheservicesta󰀨.
“F4” Safety switching does not react (49 °C com-
parator)
• Havethesafetyswitching(temperaturecontroller)checkedbythe
servicesta󰀨.
“F5” Break of the regulating NTC • Informtheservicesta󰀨.
“F6” Di󰀨erentswitchsettingsinthehandleholder • Handle must be correctly inserted in its support.
• Otherwise,informtheservicesta󰀨.
“F7” Temperaturetoohigh(>48°C),displayonlyin
the stimulation and irrigation mode but not in
the thermal cleaning procedure
• If error does not disappear after a short moment, inform service
sta󰀨.
“F8” Short-circuit of the regulating NTC • Have temperature feeler of the regulating NTC checked by the
servicesta󰀨.
“F9” No heating performance (excess temperature
switch),def.Semi-conductorrelayorregula-
tor)
• Informtheservicesta󰀨(internalexcesstemperatureswitchmight
havereleased).
)Iferrorscannotbecorrectedwiththeassistanceofthetrouble-shootinglist,pleaseinformtheservicesta󰀨orsendinthe
device for repair. Do not start any attempts to repair the unit yourself!

18
8.0 Accessories
8.1 Accessories
Description .....................................................................................................................................................REF
Waterpre-lter,backwashable(ENTunits)......................................................................................................502.0990.0
Waterltercpl.3/4"A–3/4"I/ .............................................................................................................................530.2085.0
Jet connection for irrigation handle 80 mm ......................................................................................................508.0427.0
Jet connection for irrigation handle 110 mm ....................................................................................................508.0429.0
Hose tips ..........................................................................................................................................................502.0844.0
Splash guard for attachment to jet connection.................................................................................................501.0331.0
ATMOSAquaclean(stimulationandirrigationdevices) ..................................................................................502.1200.0

19
9.0 Technical data
Voltage 220–240V~±10%;50/60Hz
Current consumption 6.8 A
Power consumption 1500 VA
Fuses F 8 A 250 V
Modes of operation • Thermal process for reducing bacterial count
• Irrigation mode
• HeatingOFF(energysavingmode)
Water temperature 37°C±0.5°C
Temperature indication Indicationaccuracy±0.5s±½digit
Flow rate 400ml/min±10%
Feed temperature of the water +7...+36.5 °C
Water quality Drinking water
Operating pressure Min.:+2000hPa(2bar);max.:+6000hPa(6bar)
Connections • Power connection via IEC socket
• Equipotential equalization
• WatersupplyG¾"externalthread
• WaterdrainageG¼"externalthread
• Connection for double-barrelled hose
Operating time Continuous operation
Protective earth conductor resistance
Earth leakage current
Enclosure leakage current
Patient leakage current
max. 0.1
max. 0.5 mA
max. 0.1 mA
max. 0.1 mA
Ambient conditions: transport/storage
• Temperature
• Humidity without condensation
• Pressure
−20...+50°C
5...90% air humidity without condensation
at an air pressure of 700...1060 hPa
Ambient conditions: operation
• Temperature
• Humidity without condensation
• Pressure
+10...+35 °C
20...80% air humidity without condensation
at an air pressure of 700...1060 hPa
Max. operational altitude ≤3000m
Dimensions HxWxD 14.5 x 37 x 32 cm
Weight ~5.5kg
Periodic tests Repeat test of the electrical safety every 12 months. Recommended: in-
spectionaccordingtomanufacturer'sspecications.
Safetyclass(EN60601-1) I
Degree of protection
Type B applied parts
Protection class IPX0
CE marking
IDno.(REF) 502.0901.0
Issue of the technical data: 2020

20
10.0 Disposal
• Packaging material, cardboard and/or PE foam can be fully recycled or returned to your supplier.
• The Hygrotherm plus does not contain any hazardous materials.
• The housing is recyclable.
• The component parts of the Hygrotherm plus must be disposed of correctly and the materials are to be separated carefully.
• The electronics circuit boards must be fed into the appropriate recycling process.
• Hose tips are disposable products and must be disposed of with household waste after use.
This document is subject to change without notice.