English

Variotherm plus
Operating Instructions

0124
GA1GB.140302.0 2017-03 Index 30
Valid for devices delivered after July 2002.

Downloaded from www.Manualslib.com manuals search engine

 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 flow 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 disinfection.15
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 Decalcification......................................................17
6.2 Replacement of filter............................................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

Downloaded from www.Manualslib.com manuals search engine

 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 first 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 certified 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:

ATMOS
• Indicating a list
-- Subdivision of a list/activity
The recommended sequence must be followed in each
MedizinTechnik GmbH & Co. KG case!
Ludwig-Kegel-Straße 16
79853 Lenzkirch )) Indicating particularly important advice!
Germany
ªª Describing the effect of an activity.
Phone: + 49 7653 689-0
Fax:
+ 49 7653 689-190
+ 49 7653 689-393 (Service Centre)
E-mail: [email protected]
Internet: www.atmosmed.de

Downloaded from www.Manualslib.com manuals search engine

 1.0 Introduction

1.2 Intended use 1.4 Explanation of symbols

Name: ATMOS® Variotherm Observe operating instructions!

According to ISO /7000/0434 DIN
Main function: Device for rinsing the auditory canal
30600/1008 IEC 348
and stimulation of the vestibular
organ Type B equipment as to IEC 417
Medical Stimulation of the vestibular organ
indications /
Fuse according to IEC 417/5016, DIN
application:
30600/0186
Specification Produces a jet of water for the
of the main
functions:
ear irrigation at body temperature
(37°C) with a flow rate of 400 ml/
°C Temperature in degree centigrade

min for the removal of cerumen.

Stimulation of the vestibular organ
s Timer adjustment in seconds

with a defined flow and a fixed Start

temperature for the functional
testing.
Application organ: Auditory canal to the drumhead Stop
Application time: For the short-term application (max.
60 minutes) on patients.
Timer
Application site: In clinics and practices for ENT
doctors and phoniatricians. The
therapy with the ATMOS stimulation Cold stimulation level
and irrigation device may only be
performed by medical trained staff.
Contraindications: Do not apply to an infected resp. Warm stimulation level
contaminated auditory canal or to a
perforated eardrum.
The product is: active
Irrigation level (water at a temperature value
Sterility: Not necessary
37°C of 37°C)
Single-use product No single use product
/ reprocessing: • Heating ON

1.3 Function
• Heating OFF (energy saving mode)

• Operating the main switch on the examination unit

automatically activates the thermal process for reducing Control output for connecting a
bacterial count (see section 4.5.1) . nystagmograph (graphical recorder as to
DIN 30600, IEC 417 5192)
• Then, automatic change into the energy saving mode.
• When removing the irrigation handle from its holder, Equipotential connection
automatic change into the irrigation mode. Here, the DIN 30600 495, ISO 417 5021
auditory canal can be rinsed with water warmed up to
37°C and a flow of at least 400 ml/min.
Connection for waste water
• Possibility to switch to the stimulation mode for
stimulating the vestibular organ with a reduced flow of Connection for water
water.
The Variotherm plus is equipped with a timer for Low Reduced flow (for stimulation of the
preselecting the stimulation duration. vestibule)
High High flow (for rinsing the auditory canal)

Downloaded from www.Manualslib.com manuals search engine

 2.0 For your safety

• The Variotherm plus is produced according to IEC 601/ • Only use the warm water jet when a tube tip is installed!
EN 60601 and listed in the following classes: • Take caution to avoid injury to the eardrum when
-- VDE Class of protection 1 introducing the water jet!
-- Class IIa (EEC 93/42).
• For hygienic reasons jet connections must be changed
• The device may only be connected to a properly installed after each patient. This also prevents retrograde
safety socket. germination of the warm water system.
• The unit must be installed by a specialist authorized by • Use only for irrigation of auditory canal!
ATMOS (see chapter 3.3).
• ATMOS is not liable for personal injury and damage to
• The Variotherm plus may only be used under the property if
supervision of skilled staff who have been authorised -- no original ATMOS parts are being used,
by ATMOS and trained in its operation (IEC 601-1 / EN -- the advice for use in these operating instructions is
60601-1). not being observed,
• The mains voltage indicated on the type plate must -- assembly, new settings, alterations, extensions
correspond to the values of the supply network. and repairs have been carried out by personnel not
• Make sure prior to every application of the equipment that authorised by ATMOS.
it is technically safe and in proper condition. Damaged • Please note:
cables must be replaced immediately! A medical insulating transformer with earth leakage
• Correct configuration in assembly of country-specific monitor or any similar safety system acc. to EN 60 601-1
connections: is required, if several devices are connected over one
-- green/yellow: protective conductor (PE) common power supply. The transformer must correspond
-- blue: neutral conductor (N) to the power consumption of all the devices to be
-- black or brown: phase (L) connected.
• It is essential that the country-specific requirements for • The flow rate has to be checked after switch on or at
connection of medical equipment to the public drinking least once a day with a measuring cup. The quantity of
water supply are considered. When in doubt, please 500 ml/min may not be exceeded. The water jet has to be
contact your local ATMOS partner. straight.
• The control panel must be clearly visible and accessible
for the user. Ensure sufficient 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 finishing 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 specifications (e.g. EN
60950 for data processing equipment and EN 60601 for
electrical medical equipment). In addition, configurations
must satisfy system specification 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 configuration
operator“ and as such is responsible for meeting the
requirements of system specification 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.

Downloaded from www.Manualslib.com manuals search engine

 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
ˆˆ The water which is provided by the household connection must at least meet the WHO guidelines or the country-specific
guidelines for drinking water.
Connection
ˆˆ Fresh water must flow through the wall connection for a period of approx. 1 minute prior to the unit being connected.*
ˆˆ Ensure that the installation is hygienically carried out! Disinfect the threaded connections with 70 % alcohol before screwing
them into place.*
ˆˆ Wear disposable gloves when carrying out maintenance work on parts which come into contact with the water.*
ˆˆ Carry out thermal cleaning at least 3 times before patient use.*
* This work is carried out by the ATMOS service technician.
Running operation
ˆˆ Before beginning the surgical operation, switch on the unit and await the thermal cleaning process.
ˆˆ 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.
ˆˆ 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.
ˆˆ Exchange and disinfection required for contact parts such as the jet connection after each patient (prevention of retrograde
germification).
ˆˆ Before every use, spray water and check the temperature.
Service
ˆˆ Ensure that the suspended particle filter is hygienically changed (see commissioning) (dispose of filter and carefully clean the
filter glass). Ensure that no contact is made with the contaminated parts.
ˆˆ Carry out thermal cleaning after each service.
ˆˆ 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.

Downloaded from www.Manualslib.com manuals search engine

 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
3 Jet connection short, straight (80 mm)
1 Splash guard
1 Rubber bush for splash guard
2 Three-holes gasket
1 Hose tips for jet connection (30 pcs)
1 G3/4i-G1/4a-screwing (water-tap G3/4
on filter G1/4)
1 Cap nut G3/4
1 Water filter complete
2 Gasket (f.G1/4a) 13x18x1
1 G1/4a-G3/4a-reducer (filter G1/4 on
water hose G3/4)
1 Water supply hose G3/4i, L = 3 m
1 Waste water hose G1/4i, L = 3 m
2 Gasket (f. G1/4i) 10x15x1
1 Cardboard 455 x 340 x 250 mm
1 Padding for cardboard
1 Operating Instructions

Downloaded from www.Manualslib.com manuals search engine

 3.0 Setting up and starting up

3.2 Illustrations

 
11    

30 37
   

[3 0 [3 0 [4 4


Variotherm plus

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-figure number, resolution
1°C), current value indication
11 Display of stimulation time (two-figure number,
resolution 1s)

Downloaded from www.Manualslib.com manuals search engine

 3.0 Setting up and starting up

F 14 AH


  
Fig. 2. Rear view
1 Type plate
2 Control output for controlling a nystagmograph
3 Device plug with fuse compartment
4 Equipotential bonding connection

p = +2000...+6000hPa
t= +7...+19,5°C

Fig. 3. Side view   

1 Support for handle
2 Connection for double-barrelled hose
3 Connection for waste water hose *
4 Connection for water supply hose

* 
 

Press down ring

Downloaded from www.Manualslib.com manuals search engine

 3.0 Setting up and starting up











Fig. 4. Irrigation handle

1 Handle
2 Connection for double-barrelled hose
3 Three-holes gasket
4 Adjusting screw
5 Set screw
6 Valve plunger
7 Jet connection
8 Splash guard
9 Cap
10 Double-barrelled hose

! The sprayer tube must be exchanged after each

patient.

10

Downloaded from www.Manualslib.com manuals search engine

 3.0 Setting up and starting up

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 (, fig. 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 (, fig. 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 (, fig. 2).
Connecting cable available from ATMOS (see section
8.0).

Fig. 5.

11

Downloaded from www.Manualslib.com manuals search engine

 3.0 Setting up and starting up

3.3.4 Water connection 3.3.5 Connection of the irrigation handle

• Local requirements: • Insert a "three-holes gasket" (, fig. 4) in the double-
-- Water-tap with G3/4" external thread. barrelled hose and screw it (, fig. 4) on the unit
-- Drinking water! connection (, fig. 3).
-- Input water pressure: +2000...+6000 hPa. )) Use only "three-holes gaskets" or the unit will not function
-- Feed temperature: +7...+19.5°C (recommended), correctly!
but at least 0.5°C below the required lowest cold
• Insert a "three-holes gasket" in the irrigation handle and
stimulation value.
screw it on the free end of the double-barrelled hose.
-- Drainage fittings (Art.Nr. 502.0880.0)
• Open the water-tap. Check whether all connections are
• Connection to water supply and waste water:
tight.
-- There are country-specific regulations for the
installation to be considered when the unit is
connected to the public water supply. To comply with 3.4 Starting up
the rules according to EN 1717, an unpressurized
• Insert the handle in its holder; the jet must point to
water separation with overflow is required.
Therefore, ATMOS recommends to install the water reverse side of the unit.
separation unit ATMOS Aqua Clean, REF 502.1200.0 • Switch on the unit (, fig. 1).
between the water supply and the device in order to • Automatic display test with digital numbers " 8 8 " and
meet the connection requirements according to EN
acoustic warning signal.
1717.
-- Prior to connecting the unit to the water supply the • Automatic activation of the thermal process will begin for
feed line must be flushed clean by opening the water reducing bacterial count. Duration: 5 min.
tap for a minute and allowing free flow of the tap • Automatic change into the irrigation mode (37°C).
water. • When the irrigation mode is not used (handle is not
-- Connect the filter unit to the water-tap by means of removed from its support) the unit change into the energy
adaptor and gasket. saving mode after 5 min.
-- Insert the gaskets in the cap nuts of the water supply
hose.
-- Join the nuts with the filter 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 fittings.
-- There is no special calcification 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 Millimol per °dH

hardness litre
1 (soft) ≤ 1.3 ≤ 7.3 Calcification
2 1.3 to 2.5 7.3 to 14 protection system
(medium) is not required

3 (hard) 2.5 to 3.8 14 to 21.3 Calcification

4 (very > 3.8 > 21.3 protection system
hard) is required

! Close the water tap when the unit is not in use!

12

Downloaded from www.Manualslib.com manuals search engine

 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 fixed 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 (, , fig. 1).
-- left switch: for adjusting the "ten" partition
-- right switch: for adjusting the "one" partition
ªª lower keys (+): Temperature increase
ªª upper keys (-): Temperature decrease

• Standard settings:
-- Level for irrigation mode: 37°C fixed
-- 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 (, , , fig. 1).
ªª Display of the active level by illuminated diodes.
ªª Display of the water temperature (current value) in °C.

4.3 Adjusting stimulation time

• By means of coding switch (, Fig. 1).

4.4 Adjusting flow quantity

 • Prior to stimulation turn the set screw (, fig. 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 fine adjustment of the flow the adjusting screw (, fig.
6) is turned in respectively out.
Fig. 6. Irrigation handle
)) Periodically check the water flow for the stimulation of the
1 Set screw vestibular organ and readjust, if necessary.
2 Adjusting screw

13

Downloaded from www.Manualslib.com manuals search engine

 4.0 Operation

4.5 Description of operating modes 4.5.3 Stimulation mode

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

14

Downloaded from www.Manualslib.com manuals search engine

 5.0 Cleaning and care

5.1 General information on cleaning and You may also use disinfectant sprays or disinfectant tissues
for cleaning and disinfection.
disinfection
)) Set main switch of the device to OFF prior to cleaning
The jet connection which comes into contact with the and disinfection!
patient must be disinfected after each use. Wipe the unit surface with a cloth moistened with a cleaning
The hose tips must be exchanged after each use. or disinfecting solution. Take care that no liquid penetrates
The surfaces of the Variotherm plus resist most of the the device. The cleaning agents and disinfectants listed in
common surface disinfectants. section 5.2 are all suitable.
However, do not use )) Spilled liquid must immediately be dry wiped.
• disinfectants which contain concentrated organic or )) Always observe the instructions for use by the
inorganic acids as they could cause corrosion damage. manufacturer of the disinfectants, including all
concentration specifications.
• Disinfectants containing chloramides, phenol derivatives
or anionic tensides, as these may cause stress cracks in )) The described action relating to cleaning and disinfection
the material used for the housing of the unit. 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 glutaral 15.2 g Bode Chemie, Hamburg
(Application concentrate) (ethylenedioxy)dimethanol 19.7 g
surfactants, salts, corrosion inhibitors
Sekusept aktiv sodiumpercarbonate, phosphonates Ecolab, Düsseldorf
(Application concentrate) non-ionic surfactants
Gigasept FF new succindialdehyde 11.0 g Schülke & Mayr,
(Application concentrate) dimethoxytetrahydrofurane 3.0 g Norderstedt
corrosion inhibitors
non-ionic surfactants and perfumes
Automatic disinfection of instruments
Disinfectant Ingredients in 100 g Manufacturer
Neodisher MediClean NTA 5-15 g Dr. Weigert, Hamburg
forte non-ionic surfactants < 5g
(Application concentrate) enzymes
preserving agents
Surfaces

Disinfectant Ingredients in 100 g Manufacturer

Dismozon pur magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie, Hamburg
(Granulate)
End of product 12/2014
Dismozon plus magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, Hamburg
(Granulate)
Green & Clean SK Alkyl dimethyl benzyl ammonium chloride < 1 g Metasys, Rum (Austria)
(Application concentrate) 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.

15

Downloaded from www.Manualslib.com manuals search engine

 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 When Who

Qualified and trained
staff who are familiar

application
Details

After each
C D S with reprocessing.

Monthly
(Please fill in the

Weekly
Parts to be reprocessed Cleaning Disinfection Sterilization
responsible person

Daily
-> use a water-based
overhead marker)

Ear irrigation / Thermal nystagmus stimulation

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

Handle X X3 Wipe cleaning and disinfection X

Cleaning and disinfection (manual or

Jet connection X X2,4,5.6 X
automatic)
Cleaning and disinfection (manual or
Splash guard X X2,4,5 X
automatic)
Hose tip
Exchange after each application X
(disposable)
Rinsing Cleaning and disinfection (manual or
X X2,4,5 X
attachment automatic)
See operating instructions for hygiene
Hygiene filter X
filter
Rinsing lid with Cleaning and disinfection (manual or
X X2,4,5 X
rinsing hose automatic)
Cleaning and disinfection (manual or
Rinsing bottle X X2,4,5.6 automatic); cleaning in the dishwasher X
with the glass care programme

Recommended disinfectants
Surface disinfection for
3)
Other surfaces: 4)
Manual disinfection of 5)
Automatic disinfection of instruments:
coated surfaces: instruments:
• Green & Clean SK (ATMOS) • Dismozon® plus (Bode Chemie) • Korsolex® AF (Bode Chemie) • Dismoclean® 21 clean (Bode Chemie)
• Dismozon® plus (Bode Chemie) • Kohrsolin® FF (Bode Chemie) • Korsolex® basic (Bode Chemie) • Dismoclean® 24 Vario (Bode Chemie)
• Kohrsolin® FF (Bode Chemie) • Bacillocid® rasant (Bode Chemie) • Korsolex® plus (Bode Chemie) • Dismoclean® 28 alka one (Bode Chemie)
• Perform® (Schülke & Mayr) • Mikrobac® forte (Bode Chemie) • Korsolex® extra (Bode Chemie) • Dismoclean® twin basic/twin zyme (Bode Chemie)
• Terralin® Protect (Schülke & Mayr) • Perform® (Schülke & Mayr) • neodisher® Septo MED (Dr. Weigert) • neodisher® FA (Dr. Weigert)
• Terralin® Protect (Schülke & Mayr) • neodisher® Septo 3000 (Dr. Weigert) • neodisher® FA forte (Dr. Weigert)
• Surface disinfectant FD 312 (Dürr • Sekusept® PLUS (Ecolab) • neodisher® MediClean forte (Dr. Weigert)
Dental) • Sekusept® aktiv (Ecolab) • Thermosept® alka clean forte (Schülke & Mayr)
• Quick disinfection B 30 (Orochemie) • Gigasept® Instru AF (Schülke & Mayr) • Thermosept® RKN-zym (Schülke & Mayr)
• Gigazyme® (Schülke & Mayr)
• Gigasept FF neu (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

16

Downloaded from www.Manualslib.com manuals search engine

 6.0 Maintenance and Service

• Decalcification and changing of filter (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 specifications every 12 months.

6.1 Decalcification
If the tap water in the area, where the unit is used, is known for mineral precipitation, preventive decalcification should be carried
out:
• Close water tap.
• If applicable, dismantle filter when mounted vertically at water tap.
• Unscrew screwed glass of filter.
• Fill screwed glass with approx. 100 ml of decalcifier on acetic / citric, or lactic acid base (for inst. Citrosteril, by Fresenius).
• Screw glass on again.
• Install filter vertically again, if applicable.
• Open water tap again.
• Switch on the device.
ªª Decalcification 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 decalcified and cleaned, and also sufficiently flushed. The Variotherm
plus is again fully ready for operation. When water passages are heavily calcified, a modified procedure may become
necessary, with a prolonged reaction period for the decalcifier.
Recommendation: Calcification safety device 502.0995.0.

6.2 Replacement of filter


• When the filter cartridge is very dirty (dark colour) the  Filter body
filter cartridge is to be exchanged as follows:
-- Close water tap of supply.  Filter cartridge
-- Switch on unit to reduce pressure in the filter body.   Sealing ring
-- Switch off unit after appearance of "F 1".  Plexiglass cup
-- Unscrew Plexiglass cup (, fig. 7) from filter body (,
fig. 7) by turning anti-clockwise.
-- Extract filter cartridge (, fig. 7) and replace by new

one (Art.No. 502.0891.0).
• The filter element must not come into contact with
contaminated objects in order to prevent the ingress of 
germs into the water system.

Fig. 7. Water filter

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 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.
• Affix the envelope to the outside of the package.
• Send the product to ATMOS or to your dealer.

17

Downloaded from www.Manualslib.com manuals search engine

 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 • Inform the service staff.
board)
"F3" Break of the safety NTC • Inform the service staff.
"F4" Safety switching does not react (49°C • Have the safety switching (temperature controller) checked by the
comparator) 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 • Check, whether temperature setting is too high. If necessary,
the stimulation and irrigation mode but not in adjust desired temperature to a value of <48°C by means of the
the thermal cleaning procedure 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 • Inform the service staff (internal excess temperature switch might
switch), def. Semi-conductor relay or regulator) 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!

18

Downloaded from www.Manualslib.com manuals search engine

 8.0 Accessories and spare parts

8.1 Accessories
Description......................................................................................................................................................REF
Calcification safety device.................................................................................................................................502.0995.0
Jet connection extra long, straight (110 mm)....................................................................................................508.0429.0
Rinsing connection (Teflon) 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 fittings 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 filter complete.........................................................................................................................................502.0890.0
Filter element for water filter..............................................................................................................................502.0891.0
Gasket (for G1/4a) 13x18x1..............................................................................................................................055.0018.0
G1/4a-G3/4a-reducer (filter 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

19

Downloaded from www.Manualslib.com manuals search engine

 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 flow in the irrigation mode 450 ml/min: Standard unit and variant 250/450 ml/min
(high flow) 400 ml/min: Variant 400/400 ml/min
500 ml/min: Variant 500/500 ml/min
Water flow in the stimulation mode 150 ml/min: Standard unit 150/450 ml/min (adjustable)
(low flow) 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 max. 0,1 Ω
Earth leakage current max. 0.5 mA
Enclosure leakage current max. 0.1 mA
Patient leakage current max. 0.1 mA
Ambient conditions -20...+50°C
Transport / storage 5...90 % air humidity without condensation
air pressure of 700...1060 hPa
Ambient conditions +10...+35°C
Operation 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 specifications every 12 months.
Safety class (EN 60601-1) I
Degree of protection Type B
Protection class IPX0
Further classifications according to other VDE protection class 1 (IEC 601/EN 60601)
regulations
Classification according to Appendix IX EC Class IIa
Directive 93/42/EEC
CE marking CE 0124

20

Downloaded from www.Manualslib.com manuals search engine

 9.0 Technical data

GMDN code 34891

UMDNS code 10-548
ID No. (REF) 502.0900.0
Canadian Classification
Device group Ear, nose, throat
PNC 77ETP
Risk Class 2
Description STIMULATOR, CALORIC (WATER)
Issue of the technical data: 2017-01-27

21

Downloaded from www.Manualslib.com manuals search engine

 10.0 Disposal

• Packaging material, cardboard and/or PE foam, can be fully recycled or returned to your supplier.
• The Variotherm plus does not contain any hazardous materials.
• The housing is recyclable.
• The component parts of the Variotherm 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.
• Used hose tips, which no longer can be disinfected, must be discarded into domestic waste immediately.

This document is subject to change without notice.

22

Downloaded from www.Manualslib.com manuals search engine

 11.0 Notes on EMC

i • Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following
EMC notes.
• Portable and mobile HF communication facilities can influence medical electrical equipment.
• The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced
interference immunity of the equipment or system.

11.1 Guidelines and Manufacturer´s Declaration - Emissions

The ATMOS® Variotherm plus is designed for operation in the environment specified below. The customer or user of the ATMOS
Variotherm plus should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF Emissions acc.to CISPR 11 Group 1 The ATMOS Variotherm plus 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 electronic
equipment.
RF Emissions according to CISPR Class B
11 The ATMOS Variotherm plus is suitable for use in all
Harmonic emissions according to Class B establishments, including domestic and those connected
IEC 61000-3-2 directly to a public power supply network that supplies
Voltage fluctuations/flicker according Corresponds buildings used for residential purposes.
to IEC 61000-3-3

i The device may not be used directly next to other devices or piled up with other devices. If operation next to or piled with other
devices is necessary, please watch the device to check its intended operation in this arrangement.

11.2 Guidelines and Manufacturer's Declaration - Immunity

The ATMOS Variotherm plus is designed for operation in the electromagnetic environment specified below. The customer or
user of the ATMOS Variotherm plus should ensure that it is used in such an environment.

Electromagnetic Environment -
Immunity Test IEC 60601- Test Level Compliance Level
Guidance
Electrostatic discharge ± 6 kV Contact ± 6 kV Contact Floors should be made of wood or
(ESD) according to IEC concrete or tiled with ceramic tiles. If
61000-4-2 floors are synthetic, the relative humidity
± 8 kV Air ± 8 kV Air
should be at least 30 %.

EFT IEC 61000-4-4 ± 2 kV Mains ± 2 kV Mains Mains power quality should be that
of a typical commercial or hospital
environment.
± 1 kV I/Os Inapplicable
Surges IEC 61000-4-5 1 kV 2 kV Mains power quality should be that
Differential Differential of a typical commercial or hospital
environment.
1 kV 1 kV
Common Common
Magnetic field at power 3 A/m Inapplicable Power frequency magnetic fields should
frequency 50/60 Hz acc. be that of a typical commercial or
to IEC 61000-4-8 hospital environment.

23

Downloaded from www.Manualslib.com manuals search engine

 11.0 Notes on EMC

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment -
Guidance
Voltage Dips / Dropout < 5 % UT < 5 % UT Mains power quality should be that of a
IEC 61000-4-11 (> 95 % Dip of the UT) (> 95 % Dip of the UT) typical commercial or hospital environment.
If the user of the ATMOS® Variotherm plus
for 0.5 Cycle for 0.5 Cycle
requires continued operation upon the
occurrence of disruptions in the energy
40 % UT 40 % UT supply, the ATMOS® Variotherm plus should
(60% Dip of the UT) (60% Dip of the UT) make use of an uninterruptible power
supply or a battery.
For 5 cycles For 5 cycles

70% UT 70% UT
(30 % Dip of the UT) (30 % Dip of the UT)
For 25 cycles For 25 cycles

< 5 % UT < 5 % UT
(>95 % Dip of the UT) (>95 % Dip of the UT)
for 5 s for 5 s
NOTE UT is the mains alternating current prior to application of the test levels.

11.3 Guidelines and Manufacturer´s Declaration - Immunity

The ATMOS® Variotherm plus is designed for operation in the electromagnetic environment specified below. The customer or
user of the ATMOS Variotherm plus should ensure that it is used in such an environment.

IEC 60601- Test

Immunity Test Compliance Level Electromagnetic Environment - Guidance
Level
Conducted Portable and mobile radio equipment should be used
disturbances 3 Veff no closer to the ATMOS Variotherm plus, including
3V cables, than the recommended distance calculated
acc. to IEC 61000- 150 kHz to 80 MHz
4-6 according to that which applies to the transmission
frequency.
Radiated 3 V/m 3 V/m
Recommended distances:
HF disturbances 80 MHz to 2.5 GHz
d = (3.5 / V1) * √(P)
acc. to IEC 61000-
4-3 d = (3.5 / E1) * √(P) 80-800 MHz
d = (7 / E1) * √(P) 0.8-2.5 GHz
where „P“ is the max. power in watts (W) and d is the
recommended separation distance in meters (m).
Field strengths from fixed transmitters, as determined
by an electromagnetic site (a) survey, should be less
than the compliance level (b).
Interference may occur in the vicinity of equipment
containing following symbol:

24

Downloaded from www.Manualslib.com manuals search engine

 11.0 Notes on EMC

NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and
reflection of buildings, objects and people.

a
The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment,
amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic
environment in regard to stationary transmitters, a study of the location is to be considered. If the field strength measured at
the site where the ATMOS® Variotherm plus is used exceeds the compliance level above, the ATMOS® Variotherm plus must
be observed to demonstrate proper function. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the ATMOS® Variotherm plus.

b
Within the frequency range of 150 kHz to 80 MHz the field strength should be below 3 V/m.

11.4 Recommended separations between portable and mobile RF Communications

equipment and the ATMOS® Variotherm plus
The ATMOS® Variotherm plus is intended for use in an electromagnetic environment in which HF disturbances are controlled.
The customer or user of the ATMOS® Variotherm plus can thereby help to prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile HF communication equipment (transmitters) and the ATMOS® Variotherm plus -
depending on the output of the communication device as indicated below.

Safety distance, depending on transmit-frequency m

Nominal output of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter d = [ 3,5 / 3] √P d = [ 3.5 / 3] √P d = [ 7.0 / 3] √P
W
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.2 1.2 2.4
10 3.69 3.69 7.38
100 11.66 11.66 23.32
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended safety distance
d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal
output of the transmitter in watts (W) acc. to manufacturer's specification.

NOTE 1
With 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and
reflection of buildings, objects and people.

25

Downloaded from www.Manualslib.com manuals search engine

 For your notes

26

Downloaded from www.Manualslib.com manuals search engine

 For your notes

27

Downloaded from www.Manualslib.com manuals search engine

 ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-370
[email protected]

www.atmosmed.com

Downloaded from www.Manualslib.com manuals search engine