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English

Operating instructions

ATMOS
Diagnostic Cube

512.0000.B
2013-08 Index: 11

Table of Contents
1.0
1.1
1.2
1.3
1.4
1.5
1.6

Introduction ............................................................... 3-9


Notes on operating instructions...................................... 3
Intended use .................................................................. 4
Function ......................................................................... 5
Explanation of pictures and symbols.............................. 6
Scope of supply.......................................................... 7-8
Transport and storage .................................................... 9

2.0

For your safety ........................................................... 10

3.0
3.1
3.2
3.3
3.3.1
3.3.2
3.4
3.4.1
3.4.2
3.5
3.5.1

Setting up and starting up .................................... 11-22


Front view..................................................................... 11
Rear view ..................................................................... 11
Installation and starting up ........................................... 12
Installation of the software ........................................... 12
Connecting the modules .............................................. 13
Installation of the iHandle (optional accessory)............ 15
Mounting the probe handle to the iHandle ................... 15
iHandle software configuration ..................................... 16
Configuration of the system settings ............................ 17
Configuration of the iHandle
in the diagnostic programme ........................................ 17
Configuration of the
patient management .................................................... 17
Configuration of the system settings
without network ............................................................ 18

3.5.2
3.5.3

Further information, accessories, consumables and


spare parts are available from:

ATMOS

MedizinTechnik GmbH & Co. KG


Ludwig-Kegel-Strae 16
79853 Lenzkirch
Germany
Phone +49 7653 689-0
Fax
+49 7653 689-190
+49 7653 689-292 (Service Centre)
atmos@atmosmed.de
www.atmosmed.de
2

4.0
4.1
4.2
4.3

4.7.3.3
4.7.4
4.7.4.1
4.7.4.2
4.7.5

Operation ............................................................... 19-40


Starting the diagnostic software ................................... 19
Patient management ............................................... 20-21
Application of the software
and execution of the measurements ............................ 20
Individual measurement parameter settings for the
diagnostic programme............................................. 21-22
Measurement ATMOS Rhino 31................................... 23
Measurement with nose olives ..................................... 24
Measurement with nose mask ..................................... 25
Provocation measurement ...................................... 25-26
Illustration of a measurement curve ............................. 27
Illustration of a number of
measuring curves ......................................................... 28
Loading saved measurements ATMOS Rhino 31 ........ 29
Measurement ATMOS Sono 31.................................... 30
To change parameters during a measurement ............ 31
Gain graphs.................................................................. 31
Measurement ............................................................... 32
Loading saved measurements ATMOS Sono 31 ......... 33
Measurements ATMOS Tymp 31 ................................. 34
Handling of the clinical impedance meter probe .......... 34
Operating and control elements
of the clinical impedance meter probe ......................... 34
Handling of the ear plugs ............................................. 34
Functional tests ............................................................ 34
Compliance, peak and stapedius reflex measurement 35
Measuring screen and settings .................................... 35
Start screen compliance, peak and
stapedius reflex measurement ..................................... 35
Commencing the measurement ................................... 36
Eustachian tube function test (TFT measurement) ...... 37
Measuring screen and adjustments ............................. 37
Commencing the measurement ................................... 38
Loading of stored measurements ATMOS Tymp 31..... 39

5.0
5.1
5.2
5.3

Cleaning and disinfection .................................... 40-41


General information on cleaning and disinfection ........ 41
Cleaning the device surface ......................................... 41
Cleaning and disinfection plan ..................................... 41

6.0
6.1

Maintenance and servicing ....................................... 42


Basic information.......................................................... 42

7.0
7.1
7.1.1
7.1.2

Troubleshooting .................................................... 43-45


Permanent power supply of the USB port .................... 43
Windows 7 (32 Bit) ....................................................... 43
Windows XP ................................................................. 45

8.0

Accessories and consumables............................ 46-47

9.0

Technical specications ....................................... 48-49

10.0

Disposal ...................................................................... 50

11.0

Notes on EMC ........................................................ 51-53

12.0

Declaration of conformity.......................................... 54

4.4
4.5
4.5.1
4.5.2
4.5.3
4.5.4
4.5.4.1
4.5.5
4.6
4.6.1
4.6.2
4.6.3
4.6.4
4.7
4.7.1
4.7.1.1
4.7.1.2
4.7.2
4.7.3
4.7.3.1
4.7.3.2

ATMOS General terms and conditions

1.0

Introduction

1.1 Notes on operating instructions


These operating instructions contain important notes on how to operate the ATMOS Diagnotic Cube
safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs
and down-time. That increases, amongst other things, the reliability and service-life of the device.
These operating instructions serve not only for new operating personnel to be instructed in its use,
but also for use as a reference manual. Reproduction of these instructions even in part only with
the written permission of ATMOS.
These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safety
and readiness for use of your ATMOS Diagnostic Cube and are therefore a must besides regular
cleaning.
Repair work and safety inspections may be carried out only by expert personnel authorised by
ATMOS. By applying only original spare parts you will have the guarantee that operational safety,
readiness for work and the value of your ATMOS Diagnostic Cube will be preserved.
The user is responsible for the backup of data. ATMOS assumes no responsibility in case of any
data loss, neither in case of any malfunction.
The product ATMOS Diagnostic Cube bears CE marking CE 0124 according to the EC Directive
of the council for medical products 93/42/EEC and meets the essential requirements of
Appendix I of this Directive.
The quality management system applied at ATMOS has been certified according to
international standards EN ISO 9001 and EN ISO 13485.
Prior to start-up please peruse chapter 2.0 For your safety, in order to be prepared for any
possible dangerous situations.

ATMOS Diagnostic Cube

REF

512.0000.0

ATMOS Rhino 31 with olive measuring probe


ATMOS Rhino 31 with mask measuring probe

REF
REF

512.1000.0
512.1600.0

Rhinomanometry module
Windows versions WinXP / Win7 Prof 32 Bit/64 Bit / Win8 64 Bit
ATMOS Sono 31

REF

512.1200.0

Ultrasonic A-scan module


Windows versions WinXP / Win7 Prof 32 Bit/64 Bit / Win8 64 Bit
ATMOS Tymp 31

REF

512.1100.0

Clinical impedance meter module


Windows versions WinXP / Win7 Prof 32 Bit/64 Bit / Win8 64 Bit

1.0
1.2

Introduction
Intended use
ATMOS Tymp 31

ATMOS Rhino 31
Designation:

ATMOS Rhinomanometry module

Designation:

Main function:

determination of the
nasal flow resistance

ATMOS clinical impedance meter


module

Main function:

Application:

for application on human beings


and only by trained ENT physicians,
audiologists and practise nurses

determination and display of the


eardrum's mobility

Application:

for application on human beings


and only by trained ENT physicians
and audiologists

- determination of the
nasal flow resistance

Specification of the
main functions:

Specification of the
main functions:

- nasal provocation test


(allergology)
Application organ:

nose

Duration of application:

temporarily

Application environment:

clinic or practice

Contraindication:

none

ATMOS Sono 31
Designation:

ATMOS sonography module

Main function:

diagnostics of the paranasal


cavities including secretion and
tissue status

Application:

for application on human beings


and only by trained ENT physicians
and audiologists

Specification of the
main functions:

diagnostics of the paranasal


cavities including secretion and
tissue status

Application organ:

paranasal cavities

Duration of application:

temporarily

Application environment:

clinic or practice

Contraindication:

none

- determination and display of the


eardrum's mobility
- determination of the minimum
triggering level of the stapedius
reflex (ipsi- and contralateral)
- eustachian tube function test
- high-frequency clinical impedance
meter
for children

Application organ:

ear

Duration of application:

temporarily

Application environment:

clinic or practice

Contraindication:

inflamed auditory canal


inflamed tympanic membrane
during recovery after ear
surgery
injuries and foreign body

1.0
1.3

Introduction
Function

ATMOS Rhino 31
The ATMOS Rhino 31 is used for determining the respiration
flow, this is performed by means of an annular diaphragm spiroceptor which is connected to the patient by means of a breathing
mask or nasal olives. The differential pressure determination
is then taken by means of the anterior method (choana versus
mask interior pressure/olive pressure).
Data are shown in real time as a rhinogram and afterwards
as a flow-pressure-diagram, as a value table and bar graph.
The data processing is done by the ATMOS Rhino 31 software
and the obtained values and results are saved. For printing a
Windows printer connected to the device can be used.
For an easy evaluation of the results up to three examinations
can be graphically displayed simultaneously. For easy evaluation a comparison of the curves is shown both tabularly and graphically. The results of the calculation include a patented data
processing system CAR (computer aided rhinomanometry).
This process supports the rejection of artefacts. This provides
the examiner with more objective examination results.
The results are saved in an individual patient data file out of
which they can be printed via a Windows printer. The Rhino
31 diagnostic software is network-compatible and can be integrated into a patient EDP or a hospital information system.
ATMOS Sono 31
The quick and easy to perform ultrasound examination with
the Sono 31 computer module is a fully harmless examination
method for detecting the condition of the maxillary sinuses.
For each of the four cavities there is a corresponding graph
which shows the echo performance of the ultrasound. Echoes
develop when the acoustic impedance changes, this occurs
on the border between bones, tissue, liquids (secretion) and
air. The bigger the impedance difference, the stronger is the
reflection. An ultrasound probe is used both as a sender and
receiver for ultrasonic waves.
Ultrasonic waves are almost completely reflected on the
transition areas between bones or tissue and air. This fact is
used for the diagnostic evaluation. Consequently in a healthy
and air-filled frontalis or maxillary sinus only a front wall echo
can be seen. Mucosal swelling, secretion accumulation, cysts
or neoplastic changes produce additional characteristic late
echoes.
Free text comments can be added to the graphical display
of the examination results, whereby here a dialogue field for
each individual sinus is available. Furthermore there is also
a dialogue field for the overall assessment. All test readings
and evaluations are saved in a database and are available
for later viewing. For printing a Windows printer connected to
the device can be used. The Sono 31 diagnostic software is
network-compatible and can be integrated into a patient EDP
or a hospital information system.

ATMOS Tymp 31
The ATMOS Tymp 31 is a diagnostic device for the objective
measurement and examination of the eardrum, ossicular
chain, stapedius reflex and the eustachian tube. Here the ear
of the test subject is exposed to precise pressure conditions
and is filled with acoustic sound in different frequencies and
levels. The aim of this examination is to determine the flexibility
(compliance, reciprocal value of the acoustic impedance), the
pressure in the middle ear at maximum impedance (peak), the
minimum triggering level of the stapedius reflex by four different
frequencies (500, 1000, 2000 and 4000 Hz) and in order to
determine the function of the eustachian tube.
In order to perform this diagnostic investigation a probe is
placed into the entrance of the subjects auditory canal. It is
then sealed with the help of an adapter. A tone is sent via the
probe into the ear (probe tone). At the same time it is exposed
to an increase and decrease in pressure. The reflected echoes
are determined and calculated by the ATMOS Tymp 31 software and are shown both as a graph and in tabular form. According to the preselected examination method, a result is shown
on the monitor. Due to a variety of adjustment possibilities, it
can be adapted to suit the examination on the physiology of
the test subjects as well as the preferences of the examiner. In
the everyday clinical life freely selectable standard parameters
simplify the application of the Tymp 31.
The results are saved in an individual patient data file out of
which they can be printed via a Windows printer. It is easy to
integrate the data into the practice or clinics EDP system.
The ATMOS Tymp 31 corresponds with the current requirements for correct accounting with the insurance companies,
all data is available for assessment and is documented electronically for verification.
The ATMOS Tymp 31 diagnostic software is network-compatible and can be integrated into a patient EDP or a hospital
information system.

1.0

Introduction

1.4 Explanation of pictures and symbols


Short cuts / symbols contained in this manual
Follow the arrows
whilst proceeding,
sequence
Please press where
the dot indicates
Please read,
important information

General information

Move, plug ... in this


direction

Numeration

Turn, shift ... in this


direction

Subnumeration

Please observe
hygiene requirements!

Replace

Check

click

Engage, check correct


fit

Pictures contained in this manual

Warning,
especial diligent notice !

Important information

Symbols of the ATMOS Diagnostic Cube


Foot switch

~
2

Alternating current
This product is not re-sterilisable.
Repeated reuse of components
which are marked with a 2 is
forbidden. In case of repeated reuse
these components lose their function
and there is a high infection risk.
DC connection

Application part type B


SN

Serial number

REF

Order number
Manufacturing date
The CE sign shows that this product
meets the appropriate requirements
of the EC guidelines.
Protection class II
Fuse
Please observe operating instruction!

1.0
1.5

Introduction
Scope of supply

Prior to dispatch, this ATMOS Diagnostic Cube was subjected to an extensive functional test and has been carefully
packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt
(see delivery note).

ATMOS Diagnostic Cube equipped with the relevant module respectively modules, probe support, installation CA and operating instructions.

Connection cable kit comprising mains cable, power supply unit with unit
cable and USB cable

Foot switch (optional accessory)

iHandle (intelligent probe support, optional accessory) for automatic starting of diagnostics by removing the measuring
probe from the support (figure shows maximum equipment).

1.0 Introduction

ATMOS Rhino 31

Alternatively supplied with

or

Measuring probe with olives in 3 sizes,


50 filter plates and test block

ATMOS Sono 31

Measuring probe with nose mask, 50 filter plates


3 sets nose adapters 50 pieces and test block

Ultrasonic gel

US tester coupler 2 cm (test piece)

ATMOS Tymp 31

Ultrasonic probe with connecting cable

clinical impedance meter probe


with connecting cable

Set of ear plugs (2x size 6, 5x size 5,


5x size 4, 5x size 3, 5x size 2, 2x size 1)

Contra headphone (optional accessory)

1.0 Introduction
1.6

Transport and storage

The transport of the device may be effected only in a


dispatch carton upholstered and offering sufficient protection.

Ambient conditions
Transport/Storage:

-10...+50 C;
30...95 % air humidity
non-condensing at air
pressure 500...1060 hPa

Operation:

+15...+35 C;
30...95 % air humidity
non-condensing at air
pressure 700...1060 hPa

Please document and report damages in transit immediately.


Room temperature prior to starting up for the first time
following transport at temperatures below freezing. The
unit may not be operated if it has not acclimatised as
this might damage it.

2.0

For your Safety

Important
safety instructions

Dispose of the packing material in a proper manner.


Before the device is connected a check must be made

to see that the mains voltage and mains frequency


given on the device agree with the values of the supply
system.

Only regular and undamaged mains connection and


extension cables must be used.

The ATMOS Diagnostic Cube is designed in accordance

To disconnect the device from the mains first pull out

Before commissioning the device, mains cables,

The ambient conditions specified in section 9.0 must

with IEC 60601-1/EN 60601-1. It is a device which


meets the VDE protection class II. It may be connected
to a properly installed wall power point socket.

accessories, connecting leads and hoses should be


checked for any damage. Damaged leads and hoses
must be replaced immediately. The function of the device
should be checked prior to use.

The ATMOS Diagnostic Cube is not designed for operation within areas where there is a risk of explosion
(M and G). Areas that are at risk from explosions can
arise due to the use of combustible anaesthetics, skin
cleaning and skin disinfecting materials.

No liquid may enter the device. If liquid has entered the


device it must be checked by the customer service before it is used again.

The user has to check correct function of optical and


acoustic indicators prior to use.

Mechanically defective probes may not be used.


Please handle the swivel arm with great care. There is a
hazard of crushing.

Please do not lean on the swivel arm. It has only a limited loading capacity and no locking device.

The Rhino twin tube contains phthalates which are

categorised as toxic for reproduction in category 2. This


applies particularly to children, pregnant and
breastfeeding women. As a preventive measure we
recommend avoiding direct contact with the skin. The
residual risk, which may arise through possible exposure
and due to the short term application, can be valued as
insignificant compared to the benefit of the product.

the plug from the wall socket. Only then disconnect the
connection cable from the device. Never touch the plug
or cable with wet hands.
be strictly observed.

The control panel should always be clearly in view for


the operators and be easy to reach.

The ATMOS Diagnostic Cube meets the resistance to


jamming of the standard IEC 601-1-2/EN 60601-1-2
Electromagnetic compatibility - Medical electrical
devices.

No guarantee claims can be accepted for damage which


is produced by using third party accessories or third
party consumable materials.

ATMOS cannot guarantee perfect functioning neither will


it be liable for damage to people or property if:

Any non-original ATMOS parts are used,


the user instructions given in this manual are not followed exactly or are disregarded,
Assembly, resetting, alterations,extensions and
repairs are not carried out by people authorised by
ATMOS.
These operating instructions correspond to the design
of the device and the situation of the safety standards
on which they are based when they were printed. The
circuits, processes, names, software programmes and
devices are all covered by patents.

This product is not re-sterilisable. Repeated reuse of

components which are marked with a 2 is forbidden.


In case of repeated reuse these components lose their
function and there is a high infection risk.

The ATMOS Tymp 31 may only be operated with

matching earplugs. Please check the earplugs on any


damage!

The ATMOS Diagnostic Cube may be operated only in

rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich
environments.

Warning: ultrasonic devices should not be used in HFsurgery if possible. Thus the risks of burnings can be
excluded

10

3.0

Setting up and starting up

Always set up the device on a level, firm surface.


3.1

Front view

Diagnostic Cube
probes
iHandle, intelligent probe support
connection ATMOS Tymp 31 probe
connection ATMOS Rhino 31 probe
connection ATMOS Sono 31 probe
LED status display

3.2

Rear view

jack for power supply from power supply unit


jack for USB 2.0 for connection to the computer
jack for USB 2.0 connection of the foot switch
jack socket for contra headphone (only in connection with
ATMOS Tymp 31 module)
manufacturing date (year and month)
date for the next safety-related check. The relevant punchings indicate year and month.

11

3.0

Setting up and starting up

3.3

Installation and starting up

For the operation of the ATMOS Diagnostic Cube the prior


installation of drivers and software is required. You will find
them on the supplied installation CD.
Prior to the device installation the system requirements (Windows version WinXP / Win7 Prof 32 Bit / Win8 64 Bit) of the
computer system and the installation location of the ATMOS
Diagnostic Cube must be checked. They have to comply with
the information in accordance with the technical data (chapter
9.0).
System requirements:
Operating system Windows XP from SP2,
Windows 7 (32 Bit/64 Bit) or Win8 64 Bit
Available hard disk capacity: 10 MB
Processor performance: min. 1 GHz
Available main memory: 1 GB RAM
Graphic resolution min. 800 x 600
At least 2 USB-2.0 connections (optional:
further USB interfaces for printers or
network connections)

3.3.1

2.

Detailed instructions on how to install drivers and software you


will find in the separate installation instructions.
You must have the full administration authorisation for your
computer and for the partition C:\ write and read protect
must be inactive.
Installation of drivers and software is performed in several
steps:
1. Installation of the files for the basic device into the
iHandle (option).
Creating the directories C:\AGHDiag,
C:\AGHDiag\Data, C:\AGHDiag\iHandle, C:\
AGHDiag\USB (or C:\AGHDiag\Driver)
Creating the patient data base in the folder
C:\AGHDiag\Data
Installation of the programme for controlling the
iHandle support in the folder C:\AGHDiag\iHandle

Installation of the files for the individual diagnostic


software:
Programme surface for rhinomanometry in the
folder C:\AGHDiag\Rhino31
Programme surface for sonography in the
folder C:\AGHDiag\Sono31
Programme surface for clinical impedance meter in
the folder C:\AGHDiag\Tymp 31
Installation of the measuring value data base for the
individual diagnostic modules in the folder
C:\AGHDiag\Data

3.

Installation of the USB driver for operating the ATMOS


Diagnostic Cube and the iHandle by means of the
Windows hardware manager when the drivers are
manually selected from the folder C:/AGHDiag\USB
(resp. C:\AGHDiag\Driver).

4.

Installation of the iHandle control.

5.

Installation of the individual diagnostic programmes


with regard to the iHandle control.

6.

If required, starting up the use of the data base and the


patient administration in the network.

Installation of the software

Important: Do not connect the ATMOS Diagnostic Cube


until the installation of the software is completed! The
installation may only be performed with the help of the
service department (manufacturer) or a qualified dealer!

12

Copying the USB driver into the folder C:/AGHDiag\


USB (resp. C:\AGHDiag\Driver)

3.0

Setting up and starting up


3.3.2 Connecting the module
Prior to assembling and connecting the module to the computer, check whether the parts provided show any signs of damage (transport damage). If damage is visible please contact our
service department for information on how to proceed.
Usually the installation of diagnostic devices is performed by
our service technicians or competent contracting party. They
are also responsible for the installation of the driver for the
USB-interface.

connection for ultrasonic probe


connection for probe (mask or olive)
connection for clinical impedance meter probe
foot switch, connection on the rear side or to PC

ATMOS Rhino 31
Simply attach the hose of the rhinomanometer probe to the
front side of the device. This is done by pressing down the
metal lever on the connector of the rhino module.
By pressing down on the metal lever the probe-hose is then
easily connected to the module. When the catch has clicked
in, you may then test for the correct fit by pulling gently on the
hose. In order to obtain a correct fit, the connector must sit
firmly in the socket.

ATMOS Rhino 31

ATMOS Sono 31

ATMOS Sono 31

Press the connector to the socket with the guide pin turn
to the right as far as it will go then the connector clicks into
the socket. When the catch has clicked in the correct fit can
be tested by gently pulling on the connector. In order to obtain
a correct fit the connector must sit firmly in the socket. In the
same way press the ultrasound head and ultrasound cable
until it clicks into place.
ATMOS Tymp 31
Connect the jack to the device and fasten the screws in order
that the jack fits tightly you may then test for the correct fit by
pulling gently on the hose. The connector must sit firmly in
the socket

ATMOS Tymp 31

13

3.0

Setting up and starting up


Rear side

Rear side

iHandle, connection USB to the PC

14

connection for power supply unit


USB to the computer
USB to the foot switch
connection for headphones (option)

Attention must be paid when connecting the USB connections


to the PC and the iHandle resp. to the foot switch, so that the
wires do not get mixed up. This cannot happen if the supplied
accessories are used (each connector has a different shape).
A USB-B connector is used for the connection to the PC or
iHandle, for the connection of the footswitch a USB-A connector is required. Please also pay attention to the lettering
instructions on the rear side of the module. Finally the power
supply connector is fitted to the module. After the driver installation and system configuration (chapter 3.4) the ATMOS
Diagnostic Cube is ready for use.
The functionality of the device is indicated when the green
light on the front is illuminated. When the light is red then the
module is in the measuring mode.

3.0

Setting up and starting up

3.4

Installation of the iHandle


(optional accessory)

As an optional accessory the iHandle can facilitate your work with


the ATMOS diagnostics Cube. In the picture on the left you can
see a complete configuration of the iHandle with three probes.
The software is installed and set up on the delivery of the device.

3.4.1

Mounting the probe support to


the handle

Required tools:
Crosstip screwdriver (PH2), hexagon socket screw key (2.5),
Allen key, ball-shaped (3), 1 small side cutter, 1 cable tie

1. Loosen the 2 screws on the


rear of the probe support.

2. Remove the rear wall of the


probe support.

3. Screw the rear wall laterally


to the iHandle.

4. Remove the cable tie from


the cable.

5. Open the cover of the


iHandle.

6. Feed the cable through the


hole at the iHandle.

7. Fix the rear wall of the


probe support.

8. Please take care to connect


plug x with socket x. Plug
and socket are marked.

9. Connect the plug with


the socket.

10. Tie up the cable with a


cable tie.

11. Close the cover of


the iHandle.

12. Fix the iHandle to the


Diagnostic Cube housing

15

3.0

Setting up and starting up


3.4.2

iHandle-Software conguration

Usually our service technicians or competent contracting party


carry out the first installation of the iHandle. They also install the
driver for the USB interface.
After the manual start with the iHandle software the configuration
options can be executed. Subsequently the iHandle software is
installed in the autostart folder of the Windows system software.
It is then automatically available.
In the settings exe.files in the line for the iHandle there is
a path defined to the programs to be started when a probe is
removed from the support. In the line other modules further
diagnostic modules can be integrated into the handle button. These can be called up by a mouse click. In the line pictures icons
are defined for the control elements of the software.

In the tab system the user language is defined and the ID


number of the port of the iHandle for the Windows-system is
specified.
In the system settings for the iHandle software, on the one hand
the language file is defined and on the other hand the joystick
port for the iHandle sensor. When no control unit e.g. joystick,
gamepad or iHandle are connected to the PC the software shows
no entries in the ID and status bar (see fig. above).
The menu language is realised by means of special lanugage
files. According to the selected language the path to the associated language file is shown in the option menu "system". Therefore, it is possible to change the menu language later, in case any
other language file is available.

16

iHandle and foot switch are controlled via the Windows "human
interface device". For further information regarding the installation
of the control port which is required for the function, please see
the separate installation instructions.

3.0

Setting up and starting up


3.5

Conguration of the system settings

3.5.1 Conguration of the iHandle


in the diagnostic programme
The port settings for the iHandle have to be made additionally and separately in every diagnostic programme. For
further information please see the separate installation
instructions.

3.5.2 Configuration of the


patient management
After the installation of the software start the programme
with the adjustments button in order to call up the options.
During the installation all directory folders and settings for a
single-user operation are automatically set and the database
is installed on your local computer. Modifications in these
settings should only be conducted by a qualified administrator.
If the software is not connected to a pracis EDP the buttons
"import" and "export" are not in use.
In order to apply settings the modifications must be
confirmed with the ok button .

17

3.0

Setting up and starting up


3.5.3

Conguration of the system settings


without network

Must be conducted on each module!


During the installation all directory folders and settings for a
single-user operation are automatically programmed and the
database is installed on your local computer. Modifications in
the settings should only be conducted by a qualified administrator.
The import and export paths must be left blank.

As a user of diagnostics you are responsible for the data protection. We assume no liability in the case of data loss! For the
integration in the practice software there is usually a partition
available on the server for this purpose. Here the diagnostics
data is saved and the practice software is integrated in the
routine back-up. Please ask your service software supplier for
information regarding this.
Network settings and GDT settings have to be made by a
trained technician.

18

4.0

Operation
4.1 Starting the diagnostic software
Depending on the level of integration into the practice EDP
or which device configuration you have chosen, the ATMOS
Diagnostic Cube software can be started in various ways.
After the installation of the Diagnostic Cube the technician
will explain to you the relevant start-up options.

Single-user
without EDP integration

Network
without EDP integration

Network
with EDP integration

Measuring station
without the iHandle

Measuring station
with the iHandle

Viewer station
(without diagnostics)

Diagnostic icon on the desktop


or selection over the Windows
programme option.

Remove the probe.

Patient management will be


started.

Patient management will be


started.

Diagnostic icon on the desktop


or selection over the Windows
programme option.

Remove the probe.

Diagnostic icon on the desktop


or selection over the Windows
programme option.

Patient management will be


started

Patient management will be


started.

Patient management will be


started.

Diagnostic icon in the practice


software or command via key
combination.

Remove the probe.

Click the entry in the patient


sheet of the practice software
or command via key combination.

Diagnostics will be started.

Diagnostics will be started.

Diagnostics will be started.

19

4.0

Operation
4.2

Patient management

When the Diagnostic Cube software is not integrated into the


practice EDP, then the patients data e.g. number, first name, surname, optionally and if desired, date of birth should be entered
into the patient database of the Diagnostic Cube. The purpose of
this is the personalised storage of measurements and is compulsory if the documentation is exclusively conducted electronically.
This information is subject to the data safety obligations as proof
for the health insurance.
When integration into the practice EDP is available (GDT
interface) access to the patient management is blocked because all patient-related data is automatically adopted.
How to use the patient management
When opening the diagnostics with the desktop icon or the Windows programme list, then the patient software is automatically
started.
The patient management can be opened by clicking the handshake button on the measuring screen.

Form view of the patient management


Patient search by first name, name or number

Patient data - patient number is a mandatory field, the rest of


the information should be filled in at ones own discretion.
Confirmation button for entering and abandoning the process.
Button segment for adding, changing and deleting records.
By clicking on the "new" button, new patient data can be
added.
By clicking on the "change" button, patient data can be
modified or added.

Without patient data.

20

4.0

Operation
!

Diagnostics may only be conducted by medically specialied


personnel who have been trained in advance on the use of
this diagnostic device. Please pay attention to the Medical
Device Act and only use this device after previous training
according to the Medical Device Act.

4.3
Entering examiner

Application of the software


and execution of the measurements

The description of the measurement and execution processes


complies with the device version and the software status
which are supplied with these operating instructions. The manufacturer is not liable for any errors which could occur as a
result of differences from other versions of operating instructions or from a device version which does not comply.

4.4

Individual measurement parameter


settings for the diagnostic
programme

In order to ensure a practice-oriented measurement process


it is recommended that the measurement parameters in the
software settings are individualised. Click the tool button to
open the settings on the measurement screen.
These settings are only related to the relevant diagnostic
programme and must be adapted for all the diagnostic programmes.
Selecting examiner

In the register card user you can enter a practice name or


the name of the attending doctor. This appears on the printout of the measurement. In addition up to 8 user-codes can
be defined here, these may be chosen prior to a measurement via the pull-down menu. This serves for the complete
documentation of a measurement.
The register card output gives you the possibility to define
the print-out or the output format of an electronic image file.
The latter is an advantage for the integration into a clinic
software.

21

4.0

Operation
ATMOS Rhino 31
In the register card measurement the type of probe used for
the software is defined. In addition the analysis results (print
parameters) for the evaluation can be adopted. The default
value 75,150 and 300 pa complies with the standard German
norm.

ATMOS Rhino 31

ATMOS Sono 31
In the register card "measurements" the standard adjustments
of the gain can be adjusted.

ATMOS Sono 31

ATMOS Tymp 31
In the register card measurement the age control for the
automatic parameter settings can be defined. In addition the
pressure values as well as the probe frequencies for certain
age groups are adjusted. There are three age groups available these are defined by the upper and lower age groups:

The limit of the upper age group, downwards


(from 6 to max.12 years)
The limit of the lower age group, upwards, adjustable
in months (from 2 to max. 24 months)
Sound level parameters of the lower age group

ATMOS Tymp 31

Sound level parameters of the middle age group


Sound level parameters of the upper age group
For activating the age control click on the checkbox

22

4.0

Operation
4.5

The filters and nose adapters should only be used once for

2 each patient. Failure to comply could result in a danger of

All parts which come into contact with the patient must be
disinfected.

Attention when using the applied parts! There is danger of


injury to the patient when applying the olives and nose adapters.

Function test:

test block

Measurement ATMOS Rhino 31

infection. The filters cannot be reprocessed!

Test block
Connection for measuring hose
Handpiece

Connection for connecting hose


Handle
Please connect the test block with the handle (see Fig.
on the right). Afterwards please connect the measuring hose
to the connection and the connecting hose to the
connection .
Start measuring, take the test block and breathe in and out
through the mouth for several times. Stop measuring and
repeat the same procedure for the other side. The resulting
graphs are symmetrical on both sides. The tabular values
must be identical for the right and the left side. The difference Fl. L/R should not exceed 1 (see chart on the left).
After completion of the measurement the test block must
be cleaned and disinfected (ATMOS Green & Clean SK or
Green & Clean MK) and the filter plates must be renewed.
Measurement
Before you begin the measurements the size of the nose
mask resp. the olives must be chosen in accordance with
the anatomy of the person. The probe must have an air-tight
fit. In order to achieve a premium measurement the person
must be informed regarding the measurement procedure.
Their collaboration could have a positive influence on the
measurement and avoid repetition. The Diagnostic Cube
software always starts automatically on the right side of the
nose. A manual changeover can be conducted by clicking on
the respective button. (L,R)
Each time the Rhino 31 software is started an automatic
pressure balance is performed. In the case of air pressure
variations due to extreme weather conditions, a second
comparison should be initiated manually. To do this click the
adjustment button on the measurement tab.

23

4.0

Contra olive

Operation
It is recommended that when the probe is placed on the
person they should breathe in and out several times. This
will help them get used to the slightly increased breathing resistance. When you feel the person has a normal breathing
rate and a normal breathing intensity then the measurement
can be started by pressing the foot switch.
It is recommended that the measurement is conducted for
at least the duration of the recording of the flow-process. By
renewed pressing of the footswitch all measurements are
held, the measuring values are adopted in the value table
and an automatic change of sides can be initiated.
After the person is prepared for the measurement on the
other side (usually the left) the footswitch is pressed and the
recording of the nasal breathing is restarted. The measurement is saved only after the second measurement is
completed and if applicable an annotation in the dialogue
field was made.

4.5.1 Measurement with nose olives


If the rhinomanometry measurement is performed with nose
olives then attention should be paid to the following:
1.

The size of the olive must be chosen so that the


nostril is sealed. No air should pass through the
olive.

2.

Under no circumstances should the olive be


inserted into the nostril.

3.

The pressure of the olive against the nostril should


not interfere with the nose form or nasal breathing.

4.

The black handpiece with the olive attachment


should be held to the nostrile which is to be
measured. The olive at the end of the hose seals
the contradictory nostril.

5.

Prior to the measurement it is recommended that


the person breathes in and out a couple of times so
that a normal breathing pattern is documented.
(the person should get used to the breathing
resistance of the olive).

6.

Having concluded the measurement, the olives


must be cleaned and disinfected (ATMOS Green
& Clean SK, 1 per day by machine) and the filter
should be renewed.

Handpiece

To exchange the filter, screw the one olive from the support
and with the help of the bayonet catch pull the other olive
from the probe body. The filter can be removed with the help
of tweezers.
Attention: When exchanging the filter of the probe the new
filter should be inserted no deeper than to the sealing ring
(rubber ring)!

Please pay attention to the chapter 5.3 cleaning and


disinfection!

24

4.0

Operation
4.5.2 Measurement with nose mask
It the measurement is performed with a nose mask, then
attention should be paid to the following:
1.

The size of the mask must be chosen to suit the


persons nose area, it must be completely covered
and must be airtight. No air is allowed on the
contact sites between mask and skin.

2.

The size of the nose adapter must be chosen so


that it is easy to insert into the nostril but still
guarantees a good sealing.

3.

The nose adatper must be disposed of after the


measurement.

After the measurement the mask should be cleaned and


disinfected (ATMOS Green & Clean SK) and the filter int
he handpiece should be renewed.
Attention: When exchanging the probe pad of the measuring probe, the new hygiene pad should be inserted no
deeper than to the sealing ring (rubber ring)!
Please pay attention to the chapter 5.3 Cleaning and
disinfection!

4.5.3 Provocation measurement


For provocation measurements attention should be paid to
the following:
1.

Each of the three measurements is saved


individually.

2.

The procedure and process for the provocation is


described by the manufacturer these tests. The
Rhino 31 is only an instrument which records the
results of this test and its documentation.

3.

For obtaining a comparison of up to three


measurements, one on top of the other, these
must be called up as described in chapter 4.5.4.1.

4.

Provocation must be active.

25

4.0

Operation

Measuring screen after programme start-up / without


measurement
Graph for the flow follow-up
Register cards for illustration of the measuring results
(see chapter 4.5.4 Illustration of a measurement curve)

Legend for the measuring graph including date, time


and type of probe
Settings, patient administration, help menu and system
information
Real-time recording of the rhinogram and graphic
result
Information on the patient
Starting the measurements
Opening the comment/dialogue field for documentation
Calling up already recorded measurements
Selection of the side to be measured

12

11

Printing according to printer settings

12

Recording the performed measurement

11

The performed measurements can be recorded either in putting the measuring probe back into the iHandle, clicking on the
"save" button or confirming the security query with "yes" when
the Rhino 31 software is closed down.

26

4.0

Operation
4.5.4 Illustration of a measurement curve

Recorded flow process during the measurement.

By clicking the individual register cards the examiner


obtains various information possibilities.

Legende zur Messkurve

The register card "chart" shows the individual values


for the inspiration and expiration at three different
pressure values as well as the coefficient of
resistance.

The value table of the rhinogram contains the following


measuring values:

Fl . L = flow left nostril determined at a pressure difference of


75, 150 and 300 Pa
Fl . R = flow right nostril determined at a pressure difference
of 75, 150 and 300 Pa
Fl . L+R = in case that the flow values for both nostrils are
available, then the sum of the flow values is shown at 75, 150
and 300 Pa: Fl .L+R = flow left nostril + flow right nostril
FI. L/R = relation between left and right nostril
FI. L-R = difference left to right nostril
Fl inc L = percentage increase of the flow value of left nostril
Fl inc R = percentage increase of the flow value of right nostril
from 75 to 150 resp. 150 and 300 Pa
Fl.L/(R+L) = relation between left nostril and total flow

Fl.R/(R+L) = relation between right nostril and total flow


RES L = output of the resistance values of the left nostril
RES R = output of the resistance values of the right nostril
RES L+R = output of the resistance values of the left and the
right nostril

The register card "graphic" makes a visual


registration easier and is helpful for diagnostic
analysis.

27

4.0

Operation
4.5.4.1

Illustration of a number of
measuring curves

Three measurements, one on top of the other after,


for example, a provocation measurement or for the
postoperative control (before-after comparison).

The chart shows the first curve according to the


legend.

The value table of the rhinogram contains the following


measuring values:
Fl . L = flow left nostril determined at a pressure difference of
75, 150 and 300 Pa

Fl . R = flow right nostril determined at a pressure difference


of 75, 150 and 300 Pa
Fl . L+R = in case that the flow values for both nostrils are
available, then the sum of the flow values is shown at 75, 150
and 300 Pa: Fl .L+R = flow left nostril + flow right nostril
FI. L/R = relation between left and right nostril
FI. L-R = difference left to right nostril
Fl inc L = percentage increase of the flow value of left nostril
Fl inc R = percentage increase of the flow value of right nostril
from 75 to 150 resp. 150 and 300 Pa

Fl.L/(R+L) = relation between left nostril and total flow


Fl.R/(R+L) = relation between right nostril and total flow
RES L = output of the resistance values of the left nostril
RES R = output of the resistance values of the right nostril
RES L+R = output of the resistance values of the left and the
right nostril

28

The register card "comparison" shows the inspiration


and expiration values of the curves at 150 Pa as well
as the ratio of the curves to one another in percent.

The bar graph shows both the absolute and the


comparison values for an intuitive visual evaluation.

4.0

Operation
4.5.5 Loading saved measurements
ATMOS Rhino 31
Depending on the equipment and the system configuration all
saved measurements can be displayed again. If integration
into the practice PC system has been done, a measurement
can be opened in the patient file by a click on the entry.
Without integration, with a click on the button Load on the
software surface all patient-related measurements will be displayed in chronological order. Up to three measurements can
be chosen from this list. These measurements will be displayed on the screen with date and in different colours.
This is how to activate saved measurements

Click here in order to open the saved measurements


of the relevant patient

Click on one of the saved measurements. It will be


marked blue. For selecting more than one and up to
three measurements simultaneously keep the
"Strg" key pressed.

Open the chosen measurement on the screen with a


click on the okay button.

Choosing the saved measurement data.

29

4.0

Operation
4.6

Measurement ATMOS Sono 31

Measuring mode is immediately activated after start-up of the


Sono 31 software and the connected module.
Initial measuring point:
Gain factor:
Gain graph:
Scaling:
Zoom:

By clicking on the control elements shown on the measuring


screen the measuring parameters can be modified. For details
please see chapter 4.4.

By clicking on the tool button the standard settings have to be


adjusted prior to starting the measurement. Afterwards patient
and user have to be selected.

Measuring screen after programme


start-up / without measurement
Graph for frontalis right and left

maxilaris, right
12
A
frontalis to 4 cm, maxilaris to 8 cm
deactivated

Graph for maxilaris right and left

11

Settings, patient administration, help menu and system


information

Parameters for the measurement


By a mouse click the sinus to be measured can be shown
or the sides swapped.
Information on the patient
Starting the measurement
Opening the comment/dialogue field for documentation
Saving the performed measurement
Printing according to printer settings
11

30

Calling up already recorded measurements

Function test:
Apply ultrasonic gel onto the ultrasonic probe and put the "UStester-coupler-2 cmm" onto the probe (see figure on the left).
The peak of the curve must be at 2 cm.

4.0

Operation
4.6.1 To change parameters during a
measurement
After start-up of the programme the measurement parameters
are set as shown on the left. These are the standard values for
a maxillaris measurement. By clicking on the + and - symbols
the overall gain can be changed. The gain curve is chosen in
accordance with the maxilaris.

After changing to the frontalis sinus level, the measurement


parameters are set as shown on the left. These are the standard values for a frontalis measurement. By clicking on the +
and - symbols the overall gain can be changed. The gain curve
is chosen in accordance with the frontalis.
With the zoom button a graphic enlargement with regard to
the depth illustration can be achieved. It is only a stretching in
horizontal direction.

4.6.2 Gain curves


Gain curve 1:
Depth regulation for a maxillaris examination

Gain curve 2:
Depth regulation for a frontalis examination

Gain curve 3:
Centre amplification for cysts, inclusions (bell-shaped curve)

31

4.0

Operation
4.6.3 Measurement

Please handle the Sono probe with special care! It is a sensitive measuring instrument which may be destroyed in case of
any vibration, shock or any other mechanical impact.
A sufficient amount of Sono gel must be applied to the probe.
Without Sono gel the ultrasonic waves cannot invade loss-free
into the body. After the measurement the ultrasonic probe must
be cleaned carefully from all gel residues!
The ATMOS Sono 31 software offers the possibility to get
through the measurement sequence either by the user surface
or via foot switch. Both procedures are described below.
The software starts automatically with the setting for the examination of the right maxillaris. The picture can either be recorded
by using the foot switch or through clicking on the Start/Stop
button on the software surface.

Changing to the left maxillaris either by using the foot


switch or with a click on the lower right half of the face
within the graphic.

When the next, not yet selected sinus will be chosen, the
ATMOS Sono 31 is directly in the measurement mode. If the
activation has been done via clicking on the software surface,
and an already made record should be overwritten, a further
click on the start/stop button or using the foot switch is necessary in order to activate the measurement mode.

Changing to the right either frontalis by using the


foot switch or with a click on the upper left half of the
face within the graphic.

After activation of the foot switch or by a click on the relevant


sinus in the selective graphic
The procedure is repeated for all sinuses. The parameter will
be loaded automatically according to the settings.

32

Changing to the left frontalis either by using the foot


switch or with a click on the upper right half of the face
within the graphic. When all four sinuses (or only
those which are requested) are examined, the
measurements can be saved. This is either possible
with the button save on the user surface or by
means of the iHandle if available and adjusted
over .

Save via iHandle by clicking the save button or over


the conformation message when closing the software

4.0

Operation
4.6.4 Loading saved measurements
ATMOS Sono 31
Depending on the equipment and the system configuration all
saved measurements can be displayed again. If integration
into the practice PC system has been done, a measurement
can be opened in the patient file by a click on the entry.
Without integration, with a click on the button Load on the
software surface all patient-related measurements will be
displayed in chronological order. Up to three measurements
can be chosen from this list.
This is how to activate saved measurements

Click here in order to open the saved measurements


of the relevant patient

Click on one of the saved measurements. It will be


marked blue.

Open with a click on the okay button the chosen


measurement on screen.

33

4.0

Operation
4.7

Measurements ATMOS Tymp 31

Prior to the application of the ATMOS Tymp 31 the tympanic


membrance has to be examined for any possible perforations/
injuries. No measurement may be performed in case of an injured/perforated tympanic membrane, inflamed auditory canal
or any foreign body in the auditory canal and during recovery
after an ear surgery.

Prior to the examination it must be checked whether there is


any foreign body, water or cerumen in the auditory canal and
if need be it has to be removed.

4.7.1 Handling of the clinical impedance


meter probe
Prior to the measurement the choice of the earplug which is
connected to the probe tip is important. In order to guarantee
a sealed measuring system the size must be selected to suit
the ear which is to be measured. A reliable result and a correct measuring process are only guaranteed with the correct
choice of earplugs.

4.7.1.1 Operating and control elements


of the clinical impedance meter
probe
When the quick blinking on the control LED is red this
signalises that the module is ready to measure the right side.
During the measurement the LED changes to a continuous
red.
When the measurement is completed the LED changes to
green (measurement completed). When triggering the button
on the probe the side for the next measurement is activated.
With each triggering the side changes again.
When the quick blinking of the control LED is blue this
signalises that the module is ready to measure the left side.
During the measurement the LED changes to a continuous
blue.
If the measurement is interrupted because the module
recognises a leaky system or a probe blocking, then the LEDchanges to purple .

4.7.1.2 Handling of the ear plugs


After completion of the measurements the earplug must be
removed from the probe tip and has to be cleaned with an
disinfectant cleaning agent.
Please observe chapter 5.0 "Cleaning and Care".

4.7.2

!
34

Functional tests

Prior to each use the user must check the functional safety
and the overall condition of the device. For this purpose the
test medium which is included in the delivery (test-volume on
the probe holder 0.85-1.0 ccm) is available.
Never press used ear plugs to the test volume at the probe
support! There is a risk of contamination.

4.0

Operation
4.7.3 Compliance, peak and
stapedius reex measurement
This measurement is the most common diagnostic which is
performed with a clinical impedance meter Therefore, it is
also the measurement mode which after the activation of the
module is automatically opened and marked Tymp.
The device is immediately ready to measure and the set or
automatically set parameters (chapter 4.4) are used for the
following measurements. The ipsilateral measurement of the
stapedius reflex is automatically activated as a standard.

4.7.3.1 Measuring screen and settings


When you open the clinical impedance meter software and
a module is connected, the system is automatically ready to
measure. The settings and the parameters are set according
to the configuration.
In case that other measuring parameters are requested for a
patient it is possible to adjust them manually directly on the
measuring screen. These settings are not saved and for any
further measurement the in the configuration preset values
are reused.

4.7.3.2 Start screen compliance, peak and


stapedius reex measurement
In case that other values for the measuring parameters or any
other stapedius reflex mode are requested it is necessary to
adjust these settings prior to start measurements. As soon
as the measurement has started (probe in the ear confirmed
tightness and system started measurement) it is no longer
possible to make any adjustments.

Information on the current patient


Choice of the diagnostics which need to be performed
(Tymp or TFT)
Numerical results of the measurements

Diagram for the compliance measurement, right and left

Parameter for the measurement


Choice of methods for the reflex measurements

Settings, patient administration, help menu and


system information
Results of the stapedius reflex measurement

35

4.0

Operation
4.7.3.3

Commencing the measurement

For commencing the measurement, place the probe into


the persons ear. As soon as the probe recognises a closed
system (sealed ear) the measurement commences automatically. When the LED is green then the measurement is completed. When the LED is purple then the measurement must
be repeated. If the latter reoccurs then a different earplug
should be selected to seal the measuring system.

Measurement of compliance, peak and volume of the right


ear.

Measurement of the stapedius reflex and right ear ipsilateral


measurement.

When the measurement on the right ear is completed (red/


green blinking LED during the calibration; when the LED is
blinking red the probe is ready for measuring) press the button
on the probe and software to conduct a measurement of the
left side (blue light is blinking). The measuring process, as for
the right ear is conducted once again.
Please note:
When pressing the button on the probe during calibration
(before the LED is blinking), the measurement is restarted
resp. the existing measurement is overwritten.

36

Prior to starting the measurement please warn the patient


against loud tones and uncomfortable pressure/vacuum.

4.0

Operation
When all the measurements are completed the curve of the
tympanogram and the stapedius reflex measurement are
shown and the compliance, peak and the volume are diagrammed.

Table view of the measuring values

Tympanogram

Stapedius reflex measurement


Saving the measurement

Print out on the printer preselected


A form for comments or findings can be opened here

4.7.4 Eustachian tube function test


(TFT measurement)

The TFT or eustachian tube function test is mainly performed


to prove correct and sufficient function of the eustachian tube.
Mentionable is that this test is part of the fitness test for divers
and airmen.
This measurement requires a certain amount of cooperation
from the probanden, for this reason the measuring procedure is not automatically conducted by the software. Here the
doctor decides if a measurement was successful then it is
manually switched to the next measuring step.

4.7.4.1 Measuring screen and adjustments


Information on the current patient
Choice of the diagnostics which need to be performed
(Tymp or TFT)
Numerical results of the measurements

Diagram for the 3 measurements

Parameter for the measurement


Choice of methods for the clinical impedance meter
measurement

Settings, patient administration, help menu and


system information
In case that other values for the measuring parameters or any
other stapedius reflex mode are requested it is necessary to
adjust these settings prior to start measurements. As soon
as the measurement has started (probe in the ear confirmed
tightness and system started measurement) it is no longer
possible to make any adjustments.

37

4.0

Operation
4.7.4.2 Commencing the measurement
The measurement starts with a normal clinical impedance
meter without any reflex part.
Afterwards the patient has to perform the valsalva manoeuvre
(Valsalva manoeuvre is performed by moderately forceful
attempted exhalation against a closed airway, usually done by
closing one's mouth and pinching one's nose shut).
For the third part of the measurement the patient is asked to
swallow this is the last performed measurement.
During the measurement sequence the manual switch over
from "Tymp" to "Valsalva" and finally to "Swallow" is important.
After completion of the measuring sequence the curves for the
3 tympanograms for the right and the left ear are shown and
the values for compliance, peak and the volume are shown in
a table.
The proceddings for printing out, recording and the possibility
to enter comments are identical like in chapter 4.7.3.3.

38

4.0

Operation
4.7.5 Loading of stored
measurements ATMOS Tymp 31
Depending on the equipment and the system configuration all
saved measurements can be displayed again. If integration
into the practice PC system has been done, a measurement
can be opened in the patient file by a click on the entry.
Without integration, with a click on the button Load on the
software surface all patient-related measurements will be
displayed in chronological order. With a click on the ok button
the measurements are shown on the screen.

Click here in order to open the saved measurements


of the relevant patient

Click on one of the saved measurements. It will be


marked blue.

Open with a click on the okay button the chosen


measurement on screen.

Legend regarding the measurement method for the


specific selection of saved measurements.

39

5.0

Cleaning and disinfection

5.1 General information on cleaning and disinfection


Before cleaning
Medical devices like the ATMOS Diagnostic Cube must always offer a maximum in safety and function.
We therefore recommend prior to each application:

if
necessary

The described measures to clean and to disinfect


or sterilise do not replace the instructions given in
the particular company!

All disinfects used to disinfect ATMOS Dignostic


Cube have to be legally marketed disinfectants.

Always observe the concentration specifications


and instructions by the respective manufacturer!

During cleaning and disinfection there is a risk of


unpleasant or dangerous vapours. Therefore,
please observe the manufacturer's instructions
for use.

5.2 Cleaning the device surface


If liquid has penetrated the unit, it may not be operated again until it has been checked by the authorised customer service centre.

Disconnect the power cord from the mains prior to cleaning and disinfection of the device surface.

The unit itself can be wiped off with a moist (not wet) cloth.
The surfaces of the ATMOS Diagnostic Cube can be cleaned / disinfected with products of the following active irgredients:
QAV (quartanary ammonium compounds)

Do not use

Disinfectants containing concentrated organic or anorganic acids or bases, since these may cause corrosion damages.
Disinfectants containing chloramides or phenol derivatives since these may cause stress cracks in the material used for
the housing of the unit.

Discolouration may result if disinfectants containing aldehydes and amines are used on the same object.
After each measurement all parts which have come into direct contact with the patient must always be cleaned and
disinfected (ATMOS Green & Clean MK or ATMOS Green & Clean SK). In addition the filters in the adapters for the
rhinomanometry must be exchanged. All parts which are marked as single-use products (filter) may not be reused (see
chapter 5.3 "Cleaning and disinfection plan")!
After reporcessing all parts have to pass through visual inspection with regard to any residues or any contamination.

40

5.0

Cleaning and disinfection

5.3 Cleaning and disinfection plan

Disinfection

Who

Monthly

Cleaning

Recommendations

Weekly

When

Daily

Parts to be reprocessed

How
After each
procedure

What

Qualied and trained staff who are


familiar with reprocessing. (Please ll
in the responsible
person -> use a
water-based overhead marker)

ATMOS Rhino 31
Test block
Measuring olive

X
X

Pressure probe and hose

Measuring probe mask

manual cleaning and disinfection,


exchange of olives after each patient
machine reprocessing, 85C, with recommended agents
(see below)
manual cleaning and disinfection,
exchange of olives after each patient
machine reprocessing, 85C, with recommended agents
(see below)

wipe cleaning and disinfection

machine reprocessing, 85C, with recommended agents


(see below)

Nose adapter
Annular diaphragm
spiroceptor

manual cleaning and disinfection

Hose system

X
X
X
X
X
X

single-use product

wipe cleaning and disinfection

machine reprocessing, 85C, with recommended agents


(see below)

Filter hygiene pad

wipe cleaning and disinfection

single-use product

ATMOS Sono 31
Ultrasonic probe

wipe cleaning and disinfection

wipe cleaning and disinfection

ATMOS Tymp 31
Handle

Ear plugs

manual cleaning and disinfection with Orliclean,


exchange of ear plugs after each patient
machine reprocessing, 85C, with recommended agents
(see below)

X
X

Please observe additional hygiene requirements from the manufacturer!

Manual cleaning and disinfection: immerse in cleaning and disinfectant solution; pay attention to the manufacturer`s instructions regarding the duration of
effect. Rinse with demineralized water, if necessary clean the hollow spaces with a small brush.

Recommended disinfectants
Surface disinfection
for coated surfaces:

Other surfaces:

Manual instruments disinfection:


Korsolex extra (Bode Chemie)
Sekusept aktiv (Ecolab)
Gigasept FF neu (Schlke & Mayr)

Tested:
Green & Clean SK (ATMOS)
Experience with:
Dismozon pur (Bode Chemie)
Kohrsolin FF (Bode Chemie)
Perform (Schlke & Mayr)
Terralin Protect (Schlke & Mayr)
Dismozon pur (Bode Chemie)
Kohrsolin FF (Bode Chemie)
Bacillocid rasant (Bode Chemie)
Mikrobac forte (Bode Chemie)
Perform (Schlke & Mayr)
Terralin Protect (Schlke & Mayr)
Surface disinfectant FD 312 (Drr Dental)
Quick disinfection B 30 (Orochemie)
Machine disinfection of instruments:
Dismoclean 28 alka one (Bode Chemie)
Dismoclean twin basic/twin zyme (Bode Chemie)
Thermosept alka clean forte (Schlke & Mayr)
Thermosept RKN-zym (Schlke & Mayr)

Wrong concentration of disinfectants may lead to damage!

For concentrations, contact time, temperature, material compatibility, please see the relevant information from the
manufacturer.
The above stated hygiene requirements are based on the regulations according to the Medical Devices Act, the Medical Devices Operator Ordinance, 18 IfSG and the recommendations of the Robert
Koch Institute.
Definition of the required reprocessing steps result from the recommendations of the Robert Koch Institute: Requirements for the reprocessing of medical products. The medical products were categorised in the risk groups uncritical, semicritical and critical. The reprocessing steps stated in this diagram have to be performed. Any additional reprocessing measures are at the operators discretion.
All the recommended disinfectants which are stated herein are listed disinfectants (VAH/RKI) and have been tested on their suitability of use on the ATMOS Diagnostic Cube ATMOS MedizinTechnik
cannot be hold liable for any damage caused by wrong concentration of the disinfectants or by the application of any other disinfectants.
Patients with suspicion of a clinical disease or who developed a transmissible spongiform encephalopathy (CJK, vCJK, etc.) have to be treated at facilities which are able to provide for the necessary
preventive measures against infection. The reprocessing of the reusable instruments and material may only be performed at facilities which have an externally certified QM Management acc. to DIN
EN ISO 13485/13488.
The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250 always have to be considered.

41

6.0
6.1

Maintenance and servicing


Basic information

Carry out a visual inspection of the unit prior to each use

including hoses and connection cable. Damaged cables


and hoses must be replaced immediately.

Maintenance or opening and repair of the ATMOS

Diagnostic Cube may only be carried out by ATMOS


or a specialist authorised by ATMOS. In this case,
attention should be paid to the protective technical and
hygiene measures, the notes on safety plus the descriptions in the servicing instructions for the ATMOS
Diagnostic Cube.

For repair, this device can be returned to ATMOS.

Prior to sending in the device it must be thoroughly


cleaned and the surface must be disinfected.

Send in the device including all the accessories but


without any consumables!

ATMOS cannot guarantee perfect functioning neither


will it be liable for damage to people or property if:
any non-original ATMOS parts are used,
the user instructions given in this manual are not
followed exactly or are disregarded,
assembly, resetting, alterations, extensions
and repairs are not carried out by people authorised
by ATMOS.

No warranty rights shall exist in the event of damage or

failure caused by the use of non-ATMOS accessories or


non-ATMOS consumables.

When the operating instructions stated in this manual

are observed there is no health hazard. Nevertheless,


we recommend at least every 2 years, depending on
the type of application, the hygienic reprocessing of the
device within the scope of the safety-related inspection
and the checking of the measuring accuracy.

Pay attention to regulations and instructions valid for the


respective application range.

According to the Medical Devices Act maintenance is

required for the Diagnostic Cube at least every 2 years


(safety-related control and medical technical check).
Please get in touch with the manufacturer prior to
expiration of this deadline in order to fix a date. A pressure calibration is performed automatically during each
software start. Only in certain cases when the weather
changes drastically (change from high pressure to low
pressure) a manual calibration might be required. In this
case please go to the tab "measurement" and click on
the button "calibration".

42

7.0

Troubleshooting

Description

Possible reasons

Measures

Diagnostic-software is not opened

Start-up software

Power supply not available (LED on


power supply has to shine), power plug
to be connected to the Diagnostic Cube
No USB connection between Diagnostic
Cube and Computer, USB device entry
within the device control of the Windows
software (system control device manager USB controller, entry AGH USB
2.0 must exist twice.
Measurement does not start-up

Error message via software:


data base error

Measurements starts but no


graphic is recorded

Socket and probes must be connected acc.


to the regulations, should the failure still
exists please contact the customer service
of the manufacturer.

Probe is not connected to the right


Diagnostic Cube connection, removing
probe should not be able without releasing the holder equipment.
USB port is switched-off because of the
energy-saving option

Permanent power supply of the USB port,


make the relevant settings in the operating
system (see page 44-45).

ATMOS Tymp 31
connection has any leakage (ear plugs)

Check size of the ear plugs and repeat the


measurement

ATMOS Tymp 31
probe must be applied either at the bottom of the ear canal or the upper part of
the ear canal.

Check position of the probe and repeat the


measurement.

No network connection to the server


(if necessary through the network administrator)
Insufficient user permissions of the user
(user must have local administrator
permission).
ATMOS Rhino 31 and ATMOS Tymp 31
Probe tube has no correct connection to
the probe and to the Diagnostic Cube
ATMOS Rhino 31 and ATMOS Tymp 31
Probe and probe tubes are
contaminated or blocked

Re-start computer, re-start server if there is


a network inclusion, if the failure still exists
please contact the customer service of the
manufacturer.

Provide correct connection of the probe


tube, if necessary clean probe and probe
tube, if the failure still exists please contact
the customer service of the manufacturer.

Print function does not work

Incomplete measurement

Complete measurement and print.

No reaction of the programme


surface

Window of the patient menu is still opened in the background.

Bring the window for patient administration


to the front by means of the alt and tab key.

System crash of the measuring


programme

The already opened measuring programme is started a second time via the
iHandle.

Make sure that all the manually opened


programmes are closed prior to using the
iHandle.

Graphs shown during measurement with the ATMOS Rhino 31


are too steep.

Mix up of hose connections at the


probe.

Remove and change the mixed up hoses at


the measuring probe.

For any other malfunctions please switch-off the diagnostic software and disconnect the ATMOS Diagnostic Cube immediately
from the power supply. Contact the Customer service of the manufacturer.

43

7.0

Troubleshooting
7.1

Permanent power supply of the


USB port

7.1.1 Windows 7 (32 Bit/64 Bit)


Path to the energy option
All control Panel Items Power Options
Edit Plan Settings
Over change advances power settings you will get to the
option Power Options, please select there USB settings and
switch it off.

USB energy options settings

44

7.0

Troubleshooting
7.1.2 Windows XP
Please activate system control Windows XP and with a double
click on system you will get to the system properties.

Activate under system properties hardware and click on


device manager.

Now, please select USB Root Hub.

Remove the checkmark automatc switch-off in order to save


energy.

45

8.0

Accessories, consumables and spare parts


REF
Accessories
ATMOS Rhino 31 with olive measurement
Measuring olive, size 3

512.1054.0

Pressure olive, size 3

512.1058.0

Measuring olive, size 2

512.1055.0

Pressure olive, size 2

512.1059.0

Measuring olive, size 1

512.1056.0

Pressure olive, size 1

512.1060.0

ATMOS Rhino 31 with mask measurement


Nose mask, large, for adults

105.2014.5

Nose mask, small, for children

105.2012.5

ATMOS Tymp 31
Contra lateral headset

512.1120.0

Included in delivery:
Headset and connection set
Integration accessories diagnostic room / treatment unit
iHandle support for handle with automatic switching
Specification:
Automatic software control if the relevant measuring probe is removed from the
support.
Built-in sensors in the probe supports, USB control electronics in additional
casing
Medical Touch Screen PC
Windows PC with touchscreen

512.0500.0

512.1400.0

Included in delivery:
Touch Screen PC 17", power supply, IEC mains cable, operating instructions
Technical data:
100240 V, 50/60 Hz
Intel Core 2 duo mobile 2.2 GHz
2 GB memory, 500 GB HDD
Microsoft Windows 7 Pro 32-bit / 64-bit
english
Integration in the existing practice software
via GDT interface
Support arm for integration into ATMOS S 61 Servant
Support arm for monitor/PC via VESA adapter
Technical data:
Maximum load-bearing capacity 25 kg
Support arm for integration into ATMOS C 21 /C 31/ Servant 5
Support arm for monitor/PC via VESA adapter
Technical data:
Maximum load-bearing capacity 25 kg

46

512.1500.0
512.1300.0

512.1350.0

8.0

Accessories, consumables and spare parts


Consumables
ATMOS Rhino 31
Filter for olive measurement
set of filter plates (50 x large, 50 x small)

512.1030.0

Filter for mask measurement


filter plates (50 x large)

512.1040.0

Nose adapter size 1, 12 mm (50 pieces)

512.1061.0

Nose adapter size 2, 15 mm (50 pieces)

512.1062.0

Nose adapter size 3, 18 mm (50 pieces)

512.1063.0

ATMOS Sono 31
Ultrasonic contact gel

507.0603.1

bottle 250 ml
ATMOS Tymp 31
Set of earplugs

512.1120.0

24 different earplugs
(5 pieces of size 2, 3, 4, 5 plus 2 pieces of size 1 and 6)
1 x cleaning filament
312.1031.0

Spare parts
Rhino Measuring probes
Measuring probe with measuring olives

512.1020.0

Included in delivery:
Measuring probe with connecting hose,
measuring olives in 3 sizes, 1 pair of each size,
set of filter plates (50 x large, 50 x small) REF 512.1030.0
Measuring probe with nose mask for adults

512.1010.0

Included in delivery:
Measuring probe with connecting hose, nose adapter,
nose mask large, filter plates (50 x large) REF 512.1040.0

47

9.0

Technical specications

Voltage power supply


(REF 313.0080.0 and
REF 313.0081.0)
Power supply
Diagnostic Cube

100-240 V~; 50/60 Hz

12 V DC, max. 5 A

Current consumption
power supply

Max. 0.8 A (90 V~)

Power input power supply

max. 60 W

Other power sources

via USB for intelligent handle control

Fuses

integrated in power supply and Diagnostic Cube

Power cable

over socket (IEC) on power supply


Unit to be installed as stand-alone unit or for system integration on support arm

Device variations

Holder for handgrip mountable on unit or support arm


Optional iHandle for intelligent handle control for automatic programme call up

Interfaces

1 x USB 2.0 exit to PC, socket type B


1 x USB 2.0 i.e. for intelligent handle control, socket type B
1 x voltage supply DC in 2.5 x 5.5 mm from power supply

System requirements PC

Operation system Windows XP (SP2) or Windows 7 (Pro 32 Bit/64 Bit)

For installation in patients


surrounding only medical
approved PC are permitted

Free hard-drive capacity: 10 MB excl. data (80 GB)


Available working memory: min. 1 GB
Graphic resolution: min. 600x800
Min. 2 USB-2-connections
Network connection possible over galvanic isolated network coupler.
Non-medical PC can be connected only via USB coupler to the unit or over a
medical isolation transformer to the power supply system!

48

PC software in general

For device control and data archiving


(also independent from a practice EDP)
Program start via icons or intelligent handle control or activation out of the practice
EDP system (MediStar)
Start/stop and store over foot switch
Input of the examiner optional
Transfer of patient data via GDT
Data transfer after end of measurement via GDT interface to the practice PC system
Patient-related storage in data base
Print-out over windows printer possible
Graphic output for transfer into the clinical information system
Access privileges management and passwordprotected options settings

ATMOS Rhino 31

- Measuring the nasal breathing resistance under use of a breathing mask


or nose olives
- Real-time display of the development curve
- Pressure measuring range: -500 Pa to 500 Pa
- Flow measuring range: max. 700 ml/s
- After measuring presentation of the breathing development curve and the
tabular values
- Averaging of the curve acc. to the CAR algorithm
- Automatic measuring sequence control

ATMOS Sono 31

- Ultrasonic A-mode
- Pulse frequency ultrasonic probe 100 Hz
- Probe measuring frequency 3.5 MHz
- Transmitting performance: 0.06 mW/cm
- Amplification setting: 80dB
- Switching between the depth ranges 8 and 4 cm within the
automatic measuring sequence control or manually
- Permanent 4-picture presentation
- Comment line (diagnosis and finding/measurement picture)

9.0

Technical specications

ATMOS Tymp 31

- Measuring of the tympanic membrane flexibility (compliance) with probe sound


226 Hz, optional high frequency 667 Hz and 1000 Hz.
Pressure range: +200daPa to 600daPa, in 100 daPa steps after
age classification or manually
Compliance range: 0.4 to 5 ml (cm)
- Measuring the stapedius reflex with 500/1000/2000 and 4000 Hz and 75/85/95 dB
SPL, optional 105dB SPL ipsi and contra
- Automatic start and measuring sequence control
Display of the compliance curves, the significant measuring data and reflex charts
- tube function test (l and r)

Support arm

Mountable at system frame of ATMOS S 61 and at the microscope column of the


ATMOS C 21, ATMOS C 31 and ATMOS Servant 5.
Radius 50 cm, rotatable over mounting point at system frame, inclusion of the
housing, handle holder mountable, optional intelligent handle control, monitor
attachment VESA 100, inclination adjustable +/- 15

Operating time

Continuous operation

Ground wire resistance

max. 0.1

Earth leakage current

max. 0.5 mA

Housing leakage current

max. 0.1 mA

Patient leakage current

max. 0.1 mA

Ambient conditions
Transport/storage

-10+50C
30.95% air humidity without condensation at air pressure 5001060 hPa

Operation

+10.+35C

Dimensions: HxWxD
Diagnostic Cube

62 x 280 x 270 mm, without holder

Power Supply

35 x 60 x 120 mm

Support arm

Radius: 50 cm between rotating points


Max. width 78 cm

3095% air humidity without condensation at air pressure 7001060 hPa

Weight
Diagnostic Cube
Power supply
Foot switch
Support arm (w/o equipment)

ca. 4,0 kg (with full equipment)


0.5 kg
0.4 kg
5.0 kg

Regular safety controls

A safety-related control has to be performed every 2 years.

Protection class (EN60601-1)

II, protective ground wire connection of power supply only for EMC protection

Degree of protection

Application part type B

Protection type

IP X0

Classification acc. to Annex IX


EC Directive 93/42/EEC

Class IIa

CE marking

CE 0124

GMDN code

17228 (ATMOS Rhino 31)


40768 (ATMOS Sono 31)
36717(ATMOS Tymp 31)

UMDNS code

15-737 (ATMOS Rhino 31)


15-659 (ATMOS Sono 31)
15-634 (ATMOS Tymp 31)

Ident No.

512.0000.0
512.1000.0 (ATMOS Rhino 31)
512.1200.0 (ATMOS Sono 31)
512.1100.0 (ATMOS Tymp 31)

49

10.0 Disposal
The ATMOS Diagnostic Cube is not comprised of any hazardous materials.
The materials of the housing can be recycled completely.
Prior to disposal, device and accessories must be decontaminated.
The materials are to be separated carefully.
Pay attention to country-specific regulations for disposal (e. g. waste incineration).
Disposal within the EC
The device is a high-quality medical product with a long service life. After its life cycle it must be disposed of professional.
According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please observe
existing national laws and rules for disposal of old devices.
Disposal within the Federal Republic of Germany
In the Federal Republic of Germany the law for electrical devices (ElektroG) rules the disposal of electrical devices. It must
be assumed that those devices could be contaminated. Therefore, this type of device is excluded from the law for electrical
devices. In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional disposal.
Prior to disposal respectively before transport all hoses must be removed. The device surface must be disinfected.

50

11.0 Notes on EMC


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 Diagnostic Cube is intended for use in the electromagnetic environment specified below. The customer
or user of the ATMOS Diagnostic Cube should ensure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF Emissions
CISPR 11

Group 1

The ATMOS Diagnostic Cube 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
CISPR 11

Class B

Harmonics IEC 61000-3-2

Class A

Flicker
IEC 61000-3-3

match

The ATMOS Diagnostic Cube is suitable for use in


all establishments, including domestic, and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.

11.2 Guidelines and Manufacturer's Declaration - Immunity for


ATMOS Diagnostic Cube
The ATMOS Diagnostic Cube is intended for use in the electromagnetic environment specified below. The customer
or user of the ATMOS Diagnostic Cube should ensure that it is used in such an environment.

IEC 60601Test Level

Compliance Level

ESD
IEC 61000-4-2

6 kV Contact

6 kV Contact

8 kV Air

8 kV Air

EFT
IEC 61000-4-4

2 kV Mains
1 kV I/Os

2 kV Mains
inapplicable
1 kV I/Os

Mains power quality should be that


of a typical commercial or hospital
environment.

Surges
IEC 61000-4-5

1 kV Differential
2 kV Common

1 kV Differential
2 kV Common

Mains power quality should be that


of a typical commercial or hospital
environment.

Power Frequency
50/60 Hz
Magnetic field
IEC 61000-4-8

3 A/m

applicable
3 A/m

Power frequency magnetic fields


should be that of a typical commercial or hospital environment.

Immunity Test

Electromagnetic Environment - Guidance


Floors should be wood, concrete,
or ceramics tile. If floors are synthetic, the relative humidity should
be at least 30%.

51

11.0 Notes on EMC


Immunity Test
Voltage Dips / Dropout
IEC 61000-4-11

NOTE

IEC 60601Test Level

Compliance Level

< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle

< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle

40 % UT
(60% Dip of the UT)
for 5 Cycles

40 % UT
(60% Dip of the UT)
for 5 Cycles

70% UT
(30 % Dip of the UT)
for 25 Cycles

70% UT
(30 % Dip of the UT)
for 25 Cycles

< 5 % UT
(>95 % Dip of the UT)
for 5 s

< 5 % UT
(>95 % Dip of the UT)
for 5 s

Electromagnetic Environment - Guidance


Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
ATMOS Diagnostic Cube demands continued function even in
case of interruptions of the energy
supply, it is recommended to supply the ATMOS Diagnostic Cube
from an uninterruptible current
supply or a battery.

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

11.3 Guidelines and Manufacturer's Declaration - Immunity


The ATMOS Diagnostic Cube is intended for use in the electromagnetic environment specified below. The customer
or user of the ATMOS Diagnostic Cube should ensure that it is used in such an environment.

Immunity Test

IEC 60601Test Level

Conducted RF
IEC 61000-4-6

V1 = 3 Veff
150 kHz to 80 MHz

Radiated RF
IEC 61000-4-3

E1 = 3 V/m
80 MHz to 2,5 GHz

Compliance Level

Electromagnetic Environment Guidance

3V

Portable and mobile communications


equipment should be separated from the
ATMOS Diagnostic Cube incl. the cables
by no less than the distances calculated/
listed below.

3 V/m

Recommended distances:
d = [ 3,5 / V1] P
d = [ 3,5 / E1 ] P
80 MHz to 800 MHz
d = [ 7,0 / E1 ] P
800 MHz to 2500 MHz
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.

52

11.0 Notes on EMC


NOTE 1

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

NOTE 2

These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.

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 measured field strength at the location where the ATMOS Diagnostic Cube is used
exceeds the above compliance level, the ATMOS Diagnostic Cube is to be observed to verify the intended
use.
If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed
arrangement or another location for the device.

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

11.4 Recommended separations between portable and mobile RF Communications


equipment and the ATMOS Diagnostic Cube
Recommended separations between portable and mobile RF Communications
equipment and the ATMOS Diagnostic Cube
The ATMOS Diagnostic Cube is intended for use in electromagnetic environment in which radiated disturbances
are controlled. The customer or user of the ATMOS Diagnostic Cube can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS
Diagnostic Cube as recommended below, according to the maximum output power of the communications equipment.

Separation distance, depending on transmit-frequency m


Nominal output of the
transmitter

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = [ 3,5 / 3] P

d = [ 3,5 / 3] P

d = [ 7,0 / 3] P

0.01

0.12

0.12

0.233

0.1

0.37

0.37

0.74

1.16

1.16

2.33

10

3.69

3.69

7.38

100

11.66

11.66

23.33

For transmitters for which the maximum nominal output is not indicated in the above table, the recommended
separation 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 manufacturers specification.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.

53

ATMOS General terms and conditions

MedizinTechnik

1. General:

case. Should the delivery delay be caused by a culpable infringement

is limited to damage which is regarded as typical for tthat case. This

Our General Standard Terms and Conditions apply exclusively. Clients

of non-substantial contractual duties, our client is also entitled to claim

also applies in the case of our culpable infringement of substantial


contractual duties The indispensable conditions of German Liability

terms and conditions which are contrary to or deviate from our General

a one-off damage compen-sation

Standard Terms and Conditions are not recognised unless their validity

delivery value of the goods for each weeks delay, up to a maximum

worth 3 percentage points of the

Law remain unaffected thereby.

is explicitly confirmed in writing. Our General Standard Terms and

which is no higher than 15 percentage points of the delivery value of

Conditions also apply even if we deliver to clients without reservation,

the goods

to a period of twelve months.

- For second-hand equipment, the period of warranty shall be reduced

in the knowledge of the clients contrary terms and conditions. Our


General Standard Terms and Conditions also apply to all future business

7. Delivery - Familiarisation

10. Reservation of Ownership

with that client.

In the case of the delivery of devices for the medico-technical industry

We retain ownership of our goods until the receipt of all payments

which require assembly and/or familiarisation for the final customer using

arising from the business relationship, including all demands arising

2. Proposal - Order Confirmation

specialist trade personnel (such as Ear, Nose and Throat Apparatus and

from installation orders, subsequent orders, repairs, accessory deliveries

Our proposals are subject to change without notice unless otherwise

Suction Units), we reserve the right to deliver the goods exclusively to

and replacement orders. Should we have agreed upon payment on the

stated in our order confirmation. Each order is only accepted by us

the relevant specialist traders. Should the trader not carry out assembly

basis of cheque and bill transactions, the ownership reservation applies

following our written order confirmation.

and/or familiarisation for the final customer, this is carried out by us. In

until the cheque received by us has been paid in, and does not expire

such cases, we reserve the right to charge the client for the additionally

through our credit upon receiving the clients cheque. In the case of

3. Orders

created costs. Our specialist traders operate a recording system so

a breach of contract by the client, especially payment arrears, we are

Every order requires an exact description of all of our products details.

that, if necessary, our products can be traced to the final customer. The

entitled to repossess our goods. Repossession of our goods repre-sents

We assume no liability for errors and damage caused by inaccurate or

specialist trader undertakes to immediately report to us all events and

a withdrawal from the contract, unless explicitly declared in writing by

incomplete ordering details.

risks which must be reported in connection with our products.

us. We have the right to utilise the product after its repossession, whilst

4. Prices

8. Passage of Risk - Packaging

deducting appropriate utilisation costs.The client is responsible for

handling the goods with care. Should maintenance and inspection work

the income form such use is balanced against the clients arrears, after
Unless otherwise stated in the order confirmation, our prices in the

Unless otherwise stated in our order confirmation, delivery is agreed

order confirmation are ex factory prices and exclude packaging and

ex factory. The risk of the goods damage or loss is therefore transferred

be necessary, the client must carry these out punctually at his own cost.

value added tax. Packaging is charged separately at cost price in the

to the client as soon as the goods leave the factory or the client is in

Our client is entitled to sell the goods he has bought from us in a proper

invoice. Value added tax is charged separately in the invoice according

default of acceptance of the goods. This also applies to cases where we

sale transaction. However, he must immediately assign all outstanding

to the legal rate on the invoice date. We reserve the right to change

confirm prepaid carriage. Transport packaging and all other packaging

claims to the value of the final invoice sum (including value added tax)

prices appropriately should price reductions or increases, especially

according to the packaging regulations is not returnable. Our client is

of our claims to his customers or third parties. The client is entitled to

due to wage settlements, changes in the price of materials or currency

responsible for disposing the packaging at its own cost. Our deliveries are

collect this claim even after such assignment. Our right to collect the

fluctuations, be incurred. Proof of such changes will be provided for the

insured by us at the clients expense unless explicitly otherwise agreed.

claim ourselves remains unaffected thereby.We undertake to release

client on request.

No insurance is arranged in the case of goods which are collected by

the securities to which we are entitled if requested to do so by the

our clients. In the case of transport damage, claims are only handled if

client should the realisable value of the our securities be more than 10

5. Payment Conditions - Balancing

the client receives confirmation of any damage, reduced weight or loss

percentage points higher than the outstanding claims. We reserve the

Unless otherwise stated in the order confirmation, our invoices

by the shipping company before accepting the delivery.

right to choose the securities to be released.

are payable with a 3% discount within 10 days (except for repair and
assembly services) or within 21 days from the invoice date net cash;

9. Warranty

11. Plans and Illustrations

money receipts is decisive for complying with this term. We are entitled

to charge interest after the due date at a rate 2% above the relevant

immediately after receiving them to determine any eventual deficiencies

calculations and other documents which are attached to our proposals.

The client is responsible for examining the delivered goods

We retain ownership of and copyrights to all plans, illustrations,

basic interest rate of the German Federal Bank. Should the client have

or delivery errors, and to report these immediately. Should the client

The client must receive explicit written permission before passing these

payment arrears, we are entitled to charge interest on arrears at a rate

fulfil this examining and reporting responsibility, and should payment

on to third parties. Imitating our legally patented products is forbidden

5% above the relevant basic interest rate of the German Federal Bank.

conditions be fulfilled, we shall be liable to the client within the scope

and will be prosecuted.

Should we be able to prove higher damages due to arrears, we are also

of legal regulations. Our period of warranty shall in all cases be two

entitled to claim these. The client only has the right to balance invoices

years. Our client can make use of the warranty as follows, so long as

12. Jurisdiction and Place of Performance

against its own claims should such claims be confirmed in a court of

he can provide first buyer proof (in the form of an invoice or delivery

law or recognised by us. The client does not have the right of retention

note) and provided that the product still has the original, unchanged

connection with these General Standard Terms and Conditions and

serial number:

due to disputed counterclaims.


6. Delivery Periods

Fulfilment of our delivery duties requires the punctual and proper

unfulfilled contract is reserved.Should the client default in accepting the

the contracts closed with clients under them. This jurisdiction excludes

a. We choose whether to fulfil our guarantee by providing repair

other jurisdiction relating to persons or subject-matter. Furthermore, our

services free of charge - either on the clients premises or in our factory

client is not entitled to bring charges against us in another court should

- or replacing the product. We can also provide these guarantee

fulfilment of the clients duties. The right to defense on the grounds of an


Our central office is the place of performance for all disputes in

he file counter-charges, carry out counterbalancing or declare retention.

services through an authorised company;

We, however, are entitled to bring charges against our client at their

b. Should a product be returned to us, the client agrees to send

general place of jurisdiction or at another relevant court recognised by

goods delivery or breach other cooperation duties, we are entitled either

the product in its original or similar packaging, offering the same

German or foreign law.Unless otherwise stated in the order confirmation,

to withdraw from the contract or claim compensation for any increased

protection as the original packaging, to our address or any address

our central office is the place of performance.

notified by us.

costs incurred up to that time without setting a further deadline. The right
to make further claims is reserved. Furthermore, in such cases, the risk

c. Our guarantee ceases to apply if changes of any kind have been

of coin-cidental destruction or a coincidental deterioration in the quality

made to our product, unless such changes have been made by us

Lenzkirch, September 2008

of the delivered goods is transferred to the client in the case of default

or a company authorised by us, or have been previously agreed

ATMOS MedizinTechnik GmbH & Co. KG

in accepting such goods or payment arrears. Acts of God or stoppages

upon in writing by us. Our guarantee also ceases to apply if third

79853 Lenzkirch/Germany

(due to insufficient supplies of material, industrial disputes etc.) entitle

parties have carried out repairs to our products or replaced parts

us either to demand an appropriate extension of delivery periods or to

thereof. This applies regardless of the fact whether these measures

partly or entirely dissolve the delivery contract. This does not give the

individually or collectively led to a deficiency of the product;

client the right to claim damages. We have fulfilled delivery periods if the

d. We accept no responsibility for damage defects caused by

delivery goods have left our factory or the client has been informed of

- operational wear and tear;

the goods readiness for delivery within such delivery periods. Delivery

- incorrect installation or incorrect or insufficient maintenance;

periods stipulated by the client are not recognised

- incorrect operation of the product (in contradiction to the operating instructions

by us unless they

form part of our order confirmation. We adhere to legal terms and

delivered with the product); - improper use or operating faults; -

conditions in cases where, as a result of an undue delay in the delivery

inappropriate or negligent handling and care, especially with respect

for which we are liable, the client is entitled to claim that his interests

to dirt, lime, suction of fluids, inappropriate cleaning and sterilisation;

in a continued fulfilment of the contract have ceased. We also adhere

- using accessories and/or replacement parts which are not explicitly

to legal terms and conditions should a delay in delivery be caused by

approved;

deliberate or grossly negligent action by us or our representatives for

which we are responsible. We are also responsible for such actions by

parties; - the clients negligence in handling the product; - unacceptable

our representatives or agents. Should the delivery delay not be caused

operating conditions, such as humidity, temperatures, the power supply,

- incorrect assembly and/or initial operation by the client or third

by our deliberate infringement of contractual duties for which we are

vibrations.

responsible, our liability is limited to damage which is regarded as typical

for that case. We are liable according to the legal terms and conditions if

unrest and insufficient ventilation. We are

and in so far as the delivery delay for which we are responsible is caused

other objects apart from our product itself, except in the case of any

- accidents, acts of God, especially lightening, water, fire, public


not liable for damage to

by an infringement of a substantial contractual duty. In such cases, our

deliberate or grossly negligent actions by us or our representatives or

liability is also limited to damage which is regarded as typical for that

agents. Should no deliberate breach of contract be claimed, our liability

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