E GA Diagnostic Atmos Cube 2013-08-11

8/20/2019 E GA Diagnostic Atmos Cube 2013-08-11

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ATMOSDiagnostic Cube

O p e r a

t i n g i n s t r u

c t i o n s

English

512.0000.B

2013-08 Index: 11


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Further information, accessories, consumables and

spare parts are available from:

ATMOSMedizinTechnik GmbH & Co. KG

Ludwig-Kegel-Straße 16

79853 Lenzkirch

Germany

Phone +49 7653 689-0

Fax +49 7653 689-190

+49 7653 689-292 (Service Centre)

[email protected]

www.atmosmed.de

Table of Contents

4.0 Operation ...............................................................19-404.1 Starting the diagnostic software ................................... 19

4.2 Patient management ............................................... 20-21

4.3 Application of the software

and execution of the measurements ............................ 20

4.4 Individual measurement parameter settings for the

diagnostic programme ............................................. 21-22

4.5 Measurement ATMOS Rhino 31................................... 23

4.5.1 Measurement with nose olives ..................................... 24

4.5.2 Measurement with nose mask ..................................... 25

4.5.3 Provocation measurement ...................................... 25-26

4.5.4 Illustration of a measurement curve ............................. 27

4.5.4.1 Illustration of a number of

measuring curves ......................................................... 28

4.5.5 Loading saved measurements ATMOS Rhino 31 ........ 29

4.6 Measurement ATMOS Sono 31.................................... 30

4.6.1 To change parameters during a measurement ............ 31

4.6.2 Gain graphs .................................................................. 31

4.6.3 Measurement ............................................................... 32

4.6.4 Loading saved measurements ATMOS Sono 31 ......... 33

4.7 Measurements ATMOS Tymp 31 ................................. 344.7.1 Handling of the clinical impedance meter probe .......... 34

4.7.1.1 Operating and control elements

of the clinical impedance meter probe ......................... 34

4.7.1.2 Handling of the ear plugs ............................................. 34

4.7.2 Functional tests ............................................................ 34

4.7.3 Compliance, peak and stapedius reex measurement 354.7.3.1 Measuring screen and settings .................................... 35

4.7.3.2 Start screen compliance, peak and

stapedius reex measurement ..................................... 35

4.7.3.3 Commencing the measurement ................................... 36

4.7.4 Eustachian tube function test (TFT measurement) ...... 37

4.7.4.1 Measuring screen and adjustments ............................. 37

4.7.4.2 Commencing the measurement ................................... 38

4.7.5 Loading of stored measurements ATMOS Tymp 31..... 39

5.0 Cleaning and disinfection .................................... 40-415.1 General information on cleaning and disinfection ........ 41

5.2 Cleaning the device surface ......................................... 41

5.3 Cleaning and disinfection plan ..................................... 41

6.0 Maintenance and servicing ....................................... 426.1 Basic information .......................................................... 42

7.0 Troubleshooting .................................................... 43-457.1 Permanent power supply of the USB port .................... 43

7.1.1 Windows 7 (32 Bit) ....................................................... 43

7.1.2 Windows XP ................................................................. 45

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

9.0 Technical specifications .......................................48-49

10.0 Disposal ...................................................................... 50

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

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

ATMOS General terms and conditions

1.0 Introduction ...............................................................3-91.1 Notes on operating instructions ...................................... 3

1.2 Intended use .................................................................. 4

1.3 Function ......................................................................... 5

1.4 Explanation of pictures and symbols .............................. 6

1.5 Scope of supply .......................................................... 7-8

1.6 Transport and storage .................................................... 9

2.0 For your safety ........................................................... 10 3.0 Setting up and starting up .................................... 11-223.1 Front view ..................................................................... 11

3.2 Rear view ..................................................................... 11

3.3 Installation and starting up ........................................... 12

3.3.1 Installation of the software ........................................... 12

3.3.2 Connecting the modules .............................................. 13

3.4 Installation of the iHandle (optional accessory) ............ 15

3.4.1 Mounting the probe handle to the iHandle ................... 15

3.4.2 iHandle software conguration ..................................... 16

3.5 Conguration of the system settings ............................ 17

3.5.1 Conguration of the iHandle in the diagnostic programme ........................................ 17

3.5.2 Conguration of the patient management .................................................... 17

3.5.3 Conguration of the system settings without network ............................................................ 18


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1.0 Introduction

1.1 Notes on operating instructions

These operating instructions contain important notes on how to operate the ATMOS Diagnotic Cubesafely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costsand 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 withthe 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 safetyand readiness for use of your ATMOS Diagnostic Cube and are therefore a must besides regularcleaning.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 anydata loss, neither in case of any malfunction.

● The product ATMOS Diagnostic Cube bears CE marking CE 0124 according to the EC Directiveof 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 tointernational 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 REF 512.1000.0ATMOS Rhino 31 with mask measuring probe REF 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


ATMOS Tymp 31 REF 512.1100.0

Clinical impedance meter module



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1.0 Introduction

1.2 Intended use

ATMOS Rhino 31

Designation: ATMOS Rhinomanometry module

Main function: determination of the nasal flow resistance

Application: for application on human beings and only by trained ENT physicians, audiologists and practise nurses

Specification of themain functions: - determination of the nasal flow resistance

- 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 andtissue status

Application organ: paranasal cavities


Application environment: clinic or practice Contraindication: none

ATMOS Tymp 31

Designation: ATMOS clinical impedance meter module

Main function: determination and display of theeardrum's mobility

Application: for application on human beings and only by trained ENT physicians

and audiologists

Specification of themain functions: - 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


Application environment: clinic or practice Contraindication: inflamed auditory canal inflamed tympanic membrane during recovery after ear surgery injuries and foreign body


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1.0 Introduction

1.3 Function

ATMOS Rhino 31

The ATMOS Rhino 31 is used for determining the respirationow, this is performed by means of an annular diaphragm spiro-ceptor which is connected to the patient by means of a breathingmask or nasal olives. The differential pressure determinationis then taken by means of the anterior method (choana versusmask interior pressure/olive pressure).

Data are shown in real time as a rhinogram and afterwardsas a ow-pressure-diagram, as a value table and bar graph.The data processing is done by the ATMOS Rhino 31 softwareand the obtained values and results are saved. For printing aWindows 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 evaluati-on a comparison of the curves is shown both tabularly and gra-phically. The results of the calculation include a patented dataprocessing system CAR (computer aided rhinomanometry).This process supports the rejection of artefacts. This providesthe examiner with more objective examination results.The results are saved in an individual patient data le out ofwhich they can be printed via a Windows printer. The Rhino31 diagnostic software is network-compatible and can be inte-grated into a patient EDP or a hospital information system.

ATMOS Sono 31

The quick and easy to perform ultrasound examination withthe Sono 31 computer module is a fully harmless examinationmethod for detecting the condition of the maxillary sinuses.For each of the four cavities there is a corresponding graphwhich shows the echo performance of the ultrasound. Echoesdevelop when the acoustic impedance changes, this occurson the border between bones, tissue, liquids (secretion) andair. The bigger the impedance difference, the stronger is thereection. An ultrasound probe is used both as a sender andreceiver for ultrasonic waves.Ultrasonic waves are almost completely reflected on thetransition areas between bones or tissue and air. This fact isused for the diagnostic evaluation. Consequently in a healthyand air-lled frontalis or maxillary sinus only a front wall echocan be seen. Mucosal swelling, secretion accumulation, cysts

or neoplastic changes produce additional characteristic lateechoes.Free text comments can be added to the graphical displayof the examination results, whereby here a dialogue eld foreach individual sinus is available. Furthermore there is alsoa dialogue eld for the overall assessment. All test readingsand evaluations are saved in a database and are availablefor later viewing. For printing a Windows printer connected tothe device can be used. The Sono 31 diagnostic software isnetwork-compatible and can be integrated into a patient EDPor a hospital information system.

ATMOS Tymp 31

The ATMOS Tymp 31 is a diagnostic device for the objectivemeasurement and examination of the eardrum, ossicularchain, stapedius reex and the eustachian tube. Here the earof the test subject is exposed to precise pressure conditionsand is lled with acoustic sound in different frequencies andlevels. The aim of this examination is to determine the exibility(compliance, reciprocal value of the acoustic impedance), thepressure in the middle ear at maximum impedance (peak), theminimum triggering level of the stapedius reex by four differentfrequencies (500, 1000, 2000 and 4000 Hz) and in order todetermine the function of the eustachian tube.

In order to perform this diagnostic investigation a probe isplaced into the entrance of the subject’s auditory canal. It isthen 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 exposedto an increase and decrease in pressure. The reected echoesare determined and calculated by the ATMOS Tymp 31 softwa-re and are shown both as a graph and in tabular form. Accor-ding to the preselected examination method, a result is shownon the monitor. Due to a variety of adjustment possibilities, itcan be adapted to suit the examination on the physiology ofthe test subjects as well as the preferences of the examiner. Inthe everyday clinical life freely selectable standard parameterssimplify the application of the Tymp 31.The results are saved in an individual patient data le out ofwhich they can be printed via a Windows printer. It is easy tointegrate the data into the practice or clinics EDP system.The ATMOS Tymp 31 corresponds with the current require-

ments for correct accounting with the insurance companies,all data is available for assessment and is documented elec-tronically for verication.The ATMOS Tymp 31 diagnostic software is network-compa-tible and can be integrated into a patient EDP or a hospitalinformation system.


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!

■

●

→

click

1.4 Explanation of pictures and symbols

Pictures contained in this manual

Warning,especial diligent notice !

1.0 Introduction

Short cuts / symbols contained in this manual

Important information

Symbols of the ATMOS Diagnostic Cube

Serial number

Order number

Manufacturing date

The CE sign shows that this productmeets the appropriate requirementsof the EC guidelines.

Fuse

Protection class II

Application part type B

REF

SN

Please observe operating instruction!

This product is not re-sterilisable.Repeated reuse of componentswhich are marked with a isforbidden. In case of repeated reusethese components lose their functionand there is a high infection risk.

2

~

Foot switch

Alternating current

2

Please press wherethe dot indicates

Subnumeration

Numeration

General informationFollow the arrowswhilst proceeding,sequence

Replace

Check

Please read,important information

Move, plug ... in thisdirection

Engage, check correctt

Turn, shift ... in thisdirection

Please observehygiene requirements!

DC connection


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1.5 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).

1.0 Introduction

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

Foot switch (optional accessory)

iHandle (intelligent probe support, optional accessory) for automatic starting of diagnostics by removing the measuring

probe from the support (gure shows maximum equipment).

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

cable and USB cable


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1.0 Introduction

or

Measuring probe with olives in 3 sizes,50 lter plates and test block

A T M O S R h i n o 3 1

A T M O S S o n o 3 1

A T M O S T y m p 3 1

Alternatively supplied with

Measuring probe with nose mask, 50 lter plates

3 sets nose adapters á 50 pieces and test block

Ultrasonic probe with connecting cable Ultrasonic gel US tester coupler 2 cm (test piece)

clinical impedance meter probe Set of ear plugs (2x size 6, 5x size 5, Contra headphone (optional accessory)with connecting cable 5x size 4, 5x size 3, 5x size 2, 2x size 1)


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● 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

1.6 Transport and storage

● The transport of the device may be effected only in a

dispatch carton upholstered and offering sufcient pro-

tection.

● Please document and report damages in transit imme-

diately.

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

1.0 Introduction


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!Importantsafety instructions

2.0 For your Safety

Dispose of the packing material in a proper manner.

Before the device is connected a check must be madeto see that the mains voltage and mains frequency

given on the device agree with the values of the supplysystem.

Only regular and undamaged mains connection and extension cables must be used.

To disconnect the device from the mains rst pull outthe plug from the wall socket. Only then disconnect theconnection cable from the device. Never touch the plugor cable with wet hands.

The ambient conditions specied in section 9.0 mustbe strictly observed.

The control panel should always be clearly in view forthe 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 electricaldevices“.

No guarantee claims can be accepted for damage whichis produced by using third party accessories or thirdparty consumable materials.

ATMOS cannot guarantee perfect functioning neither willit 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 follo-

wed exactly or are disregarded,

• Assembly, resetting, alterations,extensions andrepairs are not carried out by people authorised by ATMOS.

These operating instructions correspond to the designof the device and the situation of the safety standardson which they are based when they were printed. Thecircuits, processes, names, software programmes anddevices are all covered by patents.

This product is not re-sterilisable. Repeated reuse of components which are marked with a 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 withmatching earplugs. Please check the earplugs on anydamage!

The ATMOS Diagnostic Cube may be operated only inrooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen richenvironments.

Warning: ultrasonic devices should not be used in HF-surgery if possible. Thus the risks of burnings can beexcluded

The ATMOS Diagnostic Cube is designed in accordancewith IEC 60601-1/EN 60601-1. It is a device whichmeets the VDE protection class II. It may be connectedto a properly installed wall power point socket.

Before commissioning the device, mains cables,accessories, connecting leads and hoses should bechecked for any damage. Damaged leads and hoses

must be replaced immediately. The function of the deviceshould be checked prior to use.

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

No liquid may enter the device. If liquid has entered the device it must be checked by the customer service be-

fore it is used again.

The user has to check correct function of optical andacoustic indicators prior to use.

Mechanically defective probes may not be used.

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

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

The Rhino twin tube contains phthalates which arecategorised as toxic for reproduction in category 2. Thisapplies particularly to children, pregnant andbreastfeeding women. As a preventive measure werecommend avoiding direct contact with the skin. Theresidual risk, which may arise through possible exposure

and due to the short term application, can be valued asinsignicant compared to the benet of the product.

2


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3.0 Setting up and starting up

Always set up the device on a level, rm 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 pun-

chings indicate year and month.


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● Copying the USB driver into the folder C:/AGHDiag\USB (resp. C:\AGHDiag\Driver)

2. 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 inthe folder C:\AGHDiag\Tymp 31

● Installation of the measuring value data base for theindividual 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 thepatient administration in the network.

3.3 Installation and starting up

For the operation of the ATMOS Diagnostic Cube the priorinstallation of drivers and software is required. You will findthem on the supplied installation CD.

Prior to the device installation the system requirements (Win-

dows version WinXP / Win7 Prof 32 Bit / Win8 64 Bit) of thecomputer system and the installation location of the ATMOSDiagnostic Cube must be checked. They have to comply withthe information in accordance with the technical data (chapter9.0).

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 Installation of the software

Important: Do not connect the ATMOS Diagnostic Cubeuntil the installation of the software is completed! Theinstallation may only be performed with the help of theservice department (manufacturer) or a qualified dealer!

Detailed instructions on how to install drivers and software youwill find in the separate installation instructions.

You must have the full administration authorisation for yourcomputer and for the partition “C:\” write and read protectmust be inactive.

Installation of drivers and software is performed in severalsteps:

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



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3.3.2 Connecting the module

Prior to assembling and connecting the module to the compu-

ter, check whether the parts provided show any signs of dama-ge (transport damage). If damage is visible please contact ourservice department for information on how to proceed.Usually the installation of diagnostic devices is performed byour service technicians or competent contracting party. Theyare also responsible for the installation of the driver for theUSB-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 thefront side of the device. This is done by pressing down themetal lever on the connector of the rhino module.

By pressing down on the metal lever the probe-hose is theneasily connected to the module. When the catch has clickedin, you may then test for the correct fit by pulling gently on thehose. In order to obtain a correct fit, the connector must sitfirmly in the socket.

ATMOS Sono 31

Press the connector to the socket with the guide pin turnto the right as far as it will go then the connector clicks intothe socket. When the catch has clicked in the correct fit canbe tested by gently pulling on the connector. In order to obtaina correct fit the connector must sit firmly in the socket. In thesame way press the ultrasound head and ultrasound cableuntil 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 bypulling gently on the hose. The connector must sit firmly inthe socket

ATMOS Rhino 31

ATMOS Sono 31

ATMOS Tymp 31



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Rear side

Rear side

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 connectionsto the PC and the iHandle resp. to the foot switch, so that thewires do not get mixed up. This cannot happen if the suppliedaccessories are used (each connector has a different shape). A USB-B connector is used for the connection to the PC oriHandle, for the connection of the footswitch a USB-A con-nector is required. Please also pay attention to the letteringinstructions on the rear side of the module. Finally the powersupply connector is fitted to the module. After the driver in-

stallation and system configuration (chapter 3.4) the ATMOSDiagnostic Cube is ready for use.

The functionality of the device is indicated when the greenlight on the front is illuminated. When the light is red then themodule is in the measuring mode.iHandle, connection USB to the PC



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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 conguration 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 tothe 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.

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 ofthe iHandle.

5. Open the cover of the iHandle.

12. Fix the iHandle to the Diagnostic Cube housing


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3.4.2 iHandle-Software configuration

Usually our service technicians or competent contracting partycarry out the rst installation of the iHandle. They also install the

driver for the USB interface.

After the manual start with the iHandle software the congurationoptions can be executed. Subsequently the iHandle software isinstalled 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 isa path dened to the programs to be started when a probe isremoved from the support. In the line “other modules” furtherdiagnostic modules can be integrated into the handle button. The-se can be called up by a mouse click. In the line “pictures” icons are dened for the control elements of the software.

In the tab “system” the user language is defined and the IDnumber of the port of the iHandle for the Windows-system isspecified.

In the system settings for the iHandle software, on the one handthe language file is defined and on the other hand the joystickport for the iHandle sensor. When no control unit e.g. joystick,gamepad or iHandle are connected to the PC the software showsno entries in the ID and status bar (see fig. above).

The menu language is realised by means of special lanugagefiles. According to the selected language the path to the associa-ted language file is shown in the option menu "system". Therefo-

re, it is possible to change the menu language later, in case anyother language file is available.

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


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3.5 Configuration of the system settings

3.5.1 Configuration of the iHandle in the diagnostic programme

The port settings for the iHandle have to be made additi-

onally and separately in every diagnostic programme. Forfurther 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 op-tions.

During the installation all directory folders and settings for asingle-user operation are automatically set and the databaseis installed on your local computer. Modifications in thesesettings should only be conducted by a qualified administra-tor.

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 beconfirmed with the “ok button” .


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3.5.3 Configuration of the system settings without network

Must be conducted on each module!During the installation all directory folders and settings for asingle-user operation are automatically programmed and thedatabase is installed on your local computer. Modifications inthe settings should only be conducted by a qualified admini-strator.

The import and export paths must be left blank.

As a user of diagnostics you are responsible for the data pro-tection. We assume no liability in the case of data loss! For theintegration in the practice software there is usually a partitionavailable on the server for this purpose. Here the diagnosticsdata is saved and the practice software is integrated in the

routine back-up. Please ask your service software supplier forinformation regarding this.

Network settings and GDT settings have to be made by atrained technician.

!


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4.0 Operation

4.1 Starting the diagnostic software

Depending on the level of integration into the practice EDPor which device conguration 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.

Measuring stationwithout the iHandle

Measuring stationwith the iHandle

Viewer station(without diagnostics)

Single-user without EDP integration

Diagnostic icon on the desktop

or selection over the Windows

programme option.

Patient management will be

started.

Remove the probe.


started.

Networkwithout EDP integration



programme option.


started

Remove the probe.


started.



programme option.


started.

Network

with EDP integration

Diagnostic icon in the practice

software or command via keycombination.

Diagnostics will be started.

Remove the probe.


Click the entry in the patient

sheet of the practice softwareor command via key combina-

tion.



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4.0 Operation

4.2 Patient management

When the Diagnostic Cube software is not integrated into thepractice EDP, then the patients data e.g. number, rst name, sur-

name, 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 compul-

sory 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 (GDTinterface) access to the patient management is blocked be-cause all patient-related data is automatically adopted.

How to use the patient management

When opening the diagnostics with the desktop icon or the Win-dows programme list, then the patient software is automatically

started.

The patient management can be opened by clicking the “hands-

hake” button on the measuring screen.

Form view of the patient management

Patient search by rst name, name or number

Patient data - patient number is a “mandatory eld”, the rest of

the information should be lled in at one’s own discretion.

Conrmation 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 bemodied or added.

Without patient data.


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4.0 Operation

Diagnostics may only be conducted by medically specialiedpersonnel who have been trained in advance on the use ofthis diagnostic device. Please pay attention to the Medical

Device Act and only use this device after previous trainingaccording to the Medical Device Act.

4.3 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 ma-

nufacturer is not liable for any errors which could occur as aresult of differences from other versions of operating instruc-

tions 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 processit is recommended that the measurement parameters in thesoftware settings are individualised. Click the “tool button” toopen the settings on the measurement screen.

These settings are only related to the relevant diagnosticprogramme and must be adapted for all the diagnostic pro-grammes.

In the register card ”user” you can enter a practice name orthe name of the attending doctor. This appears on the print-out of the measurement. In addition up to 8 user-codes canbe dened here, these may be chosen prior to a measure-ment via the pull-down menu. This serves for the completedocumentation of a measurement.

The register card “output” gives you the possibility to denethe print-out or the output format of an electronic image le.The latter is an advantage for the integration into a clinicsoftware.

!

Entering examiner

Selecting examiner


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ATMOS Rhino 31

4.0 Operation

ATMOS Rhino 31

In the register card “measurement” the type of probe used forthe software is dened. In addition the analysis results (print

parameters) for the evaluation can be adopted. The defaultvalue 75,150 and 300 pa complies with the standard Germannorm.

ATMOS Sono 31

In the register card "measurements" the standard adjustmentsof the gain can be adjusted.

ATMOS Tymp 31

In the register card “measurement” the age control for theautomatic parameter settings can be dened. In addition thepressure values as well as the probe frequencies for certainage groups are adjusted. There are three age groups availa-ble these are dened 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

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

ATMOS Sono 31

ATMOS Tymp 31


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!

!

4.5 Measurement ATMOS Rhino 31

The lters and nose adapters should only be used once foreach patient. Failure to comply could result in a danger ofinfection. The lters cannot be reprocessed!

All parts which come into contact with the patient must bedisinfected.

Attention when using the applied parts! There is danger ofinjury to the patient when applying the olives and nose adap-ters.

Function test:

Test block

Connection for measuring hose

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 outthrough 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 valuesmust be identical for the right and the left side. The diffe-

rence 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 lter plates must be renewed.

MeasurementBefore you begin the measurements the size of the nosemask resp. the olives must be chosen in accordance withthe anatomy of the person. The probe must have an air-tightt. In order to achieve a premium measurement the personmust be informed regarding the measurement procedure.

Their collaboration could have a positive inuence on themeasurement and avoid repetition. The Diagnostic Cubesoftware always starts automatically on the right side of thenose. A manual changeover can be conducted by clicking on

the respective button. (L,R)

Each time the Rhino 31 software is started an automaticpressure balance is performed. In the case of air pressurevariations due to extreme weather conditions, a secondcomparison should be initiated manually. To do this click the“adjustment” button on the “measurement” tab.

4.0 Operation

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Handpiece

test block

2


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It is recommended that when the probe is placed on theperson they should breathe in and out several times. Thiswill help them get used to the slightly increased breathing re-sistance. When you feel the person has a normal breathing

rate and a normal breathing intensity then the measurementcan be started by pressing the foot switch.It is recommended that the measurement is conducted forat least the duration of the recording of the ow-process. Byrenewed pressing of the footswitch all measurements areheld, the measuring values are adopted in the value tableand an automatic change of sides can be initiated.

After the person is prepared for the measurement on theother side (usually the left) the footswitch is pressed and therecording of the nasal breathing is restarted. The mea-surement is saved only after the second measurement iscompleted and if applicable an annotation in the dialogueeld was made.

4.5.1 Measurement with nose olives

If the rhinomanometry measurement is performed with noseolives then attention should be paid to the following:

1. The size of the olive must be chosen so that thenostril is sealed. No air should pass through theolive.

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 attachmentshould be held to the nostrile which is to be

measured. The olive at the end of the hose sealsthe 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 lter

should be renewed.

To exchange the lter, screw the one olive from the support

and with the help of the bayonet catch pull the other olive

from the probe body. The lter can be removed with the help

of tweezers.

Attention: When exchanging the lter of the probe the new

lter should be inserted no deeper than to the sealing ring

(rubber ring)!

Please pay attention to the chapter 5.3 cleaning and

disinfection!

4.0 Operation

Contra olive

Handpiece


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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 anddisinfected (ATMOS Green & Clean SK) and the lter int

he handpiece should be renewed.

Attention: When exchanging the probe pad of the mea-

suring 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.

4.0 Operation


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Measuring screen after programme start-up / withoutmeasurement

Graph for the ow 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 eld for documentation

Calling up already recorded measurements

Selection of the side to be measured

Printing according to printer settings

Recording the performed measurement

The performed measurements can be recorded either in put-

ting the measuring probe back into the iHandle, clicking on the"save" button or conrming the security query with "yes" when

the Rhino 31 software is closed down.

4.0 Operation

11

12

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4.0 Operation

4.5.4 Illustration of a measurement curve

Recorded ow 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 coefcient of

resistance.

The value table of the rhinogram contains the following

measuring values:

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

75, 150 and 300 Pa

Fl . R = ow right nostril determined at a pressure differenceof 75, 150 and 300 Pa

Fl . L+R = in case that the ow values for both nostrils areavailable, then the sum of the ow values is shown at 75, 150

and 300 Pa: Fl .L+R = ow left nostril + ow 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 ow value of left nostril

Fl inc R = percentage increase of the ow value of right nostrilfrom 75 to 150 resp. 150 and 300 Pa

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

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

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 theright nostril

The register card "graphic" makes a visual

registration easier and is helpful for diagnostic

analysis.


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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 rst curve according to the

legend.

The value table of the rhinogram contains the following

measuring values:

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

75, 150 and 300 Pa

Fl . R = ow right nostril determined at a pressure differenceof 75, 150 and 300 Pa

Fl . L+R = in case that the ow values for both nostrils areavailable, then the sum of the ow values is shown at 75, 150

and 300 Pa: Fl .L+R = ow left nostril + ow 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 ow value of left nostril

Fl inc R = percentage increase of the ow value of right nostrilfrom 75 to 150 resp. 150 and 300 Pa

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

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

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 theright nostril

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.


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4.0 Operation

4.5.5 Loading saved measurements ATMOS Rhino 31

Depending on the equipment and the system conguration 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 le 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 dis-played in chronological order. Up to three measurements can

be chosen from this list. These measurements will be displa-

yed 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.


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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: maxilaris, right

Gain factor: 12

Gain graph: A

Scaling: frontalis to 4 cm, maxilaris to 8 cm

Zoom: deactivated

By clicking on the control elements shown on the measuring

screen the measuring parameters can be modied. 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 programmestart-up / without measurement

Graph for frontalis right and left

Graph for maxilaris right and left

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 eld for documentation

Saving the performed measurement

Printing according to printer settings

Calling up already recorded measurements

Function test: Apply ultrasonic gel onto the ultrasonic probe and put the "US-tester-coupler-2 cmm" onto the probe (see gure on the left).

The peak of the curve must be at 2 cm.

4.0 Operation

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4.6.1 To change parameters during ameasurement

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 inaccordance with the maxilaris.

After changing to the frontalis sinus level, the measurement

parameters are set as shown on the left. These are the stan-

dard values for a frontalis measurement. By clicking on the +and - symbols the overall gain can be changed. The gain curveis 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 amplication for cysts, inclusions (bell-shaped curve)

4.0 Operation


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4.0 Operation

4.6.3 Measurement

Please handle the Sono probe with special care! It is a sensi-

tive measuring instrument which may be destroyed in case of

any vibration, shock or any other mechanical impact.

A sufcient 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 getthrough 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 exami-

nation of the right maxillaris. The picture can either be recordedby 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 furtherclick on the “start/stop” button or using the foot switch is neces-

sary 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.

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

!


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4.0 Operation

4.6.4 Loading saved measurements ATMOS Sono 31



into the practice PC system has been done, a measurement

can be opened in the patient le by a “click” on the entry.


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.


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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 in- jured/perforated tympanic membrane, inamed 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 impedancemeter probe

Prior to the measurement the choice of the earplug which isconnected 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 cor-

rect 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 togreen (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 thissignalises 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 modulerecognises a leaky system or a probe blocking, then the LED-changes 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 Functional tests

Prior to each use the user must check the functional safetyand 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

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4.7.3 Compliance, peak and

stapedius reflex measurementThis 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 themodule 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 thestapedius reex is automatically activated as a standard.

4.7.3.1 Measuring screen and settings

When you open the clinical impedance meter software anda module is connected, the system is automatically ready tomeasure. The settings and the parameters are set accordingto the conguration.

In case that other measuring parameters are requested for apatient it is possible to adjust them manually directly on themeasuring screen. These settings are not saved and for anyfurther measurement the in the conguration preset valuesare reused.

4.7.3.2 Start screen compliance, peak andstapedius reflex measurement

In case that other values for the measuring parameters or anyother stapedius reex mode are requested it is necessary toadjust these settings prior to start measurements. As soonas the measurement has started (probe in the ear conrmedtightness and system started measurement) it is no longerpossible 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 reex measurements

Settings, patient administration, help menu and

system information

Results of the stapedius reflex measurement

4.0 Operation


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!

4.0 Operation

4.7.3.3 Commencing the measurement

For commencing the measurement, place the probe into

the person’s ear. As soon as the probe recognises a closed

system (sealed ear) the measurement commences automati-cally. When the LED is green then the measurement is com-

pleted. 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 reex 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.

Prior to starting the measurement please warn the patient

against loud tones and uncomfortable pressure/vacuum.


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4.0 Operation

When all the measurements are completed the curve of the

tympanogram and the stapedius reex measurement are

shown and the compliance, peak and the volume are dia-

grammed.

Table view of the measuring values

Tympanogram

Stapedius reex measurement

Saving the measurement

Print out on the printer preselected

A form for comments or ndings 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 procedu-

re 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 anyother stapedius reex mode are requested it is necessary toadjust these settings prior to start measurements. As soonas the measurement has started (probe in the ear conrmedtightness and system started measurement) it is no longerpossible to make any adjustments.


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4.0 Operation

4.7.4.2 Commencing the measurement

The measurement starts with a normal clinical impedance

meter without any reex 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 overfrom "Tymp" to "Valsalva" and nally 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 andthe 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.


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4.0 Operation

4.7.5 Loading of stored measurements ATMOS Tymp 31



into the practice PC system has been done, a measurementcan be opened in the patient le by a “click” on the entry.


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 thespecic selection of saved measurements.


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5.1 General information on cleaning and disinfection

5.0 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 disinfector sterilise do not replace the instructions given inthe particular company!

All disinfects used to disinfect ATMOS DignosticCube have to be legally marketed disinfectants.

Always observe the concentration specicationsand instructions by the respective manufacturer!

During cleaning and disinfection there is a risk ofunpleasant or dangerous vapours. Therefore,

please observe the manufacturer's instructions for use.

■ 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 anddisinfected (ATMOS Green & Clean MK or ATMOS Green & Clean SK). In addition the lters in the adapters for therhinomanometry must be exchanged. All parts which are marked as single-use products (lter) may not be reused (seechapter 5.3 "Cleaning and disinfection plan")!

After reporcessing all parts have to pass through visual inspection with regard to any residues or any contamination.

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.

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5.0 Cleaning and disinfection

5.3 Cleaning and disinfection plan

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.

Denition 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 cate-gorised 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 operator‘s discretion.

All the recommended disinfectants which are stated herein are listed disinfectants (VAH/RKI) and have been tested on their suitability of use on the ATMOS 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 certied 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.

Wrong concentration of disinfectants may lead to damage!

Recommended disinfectants

Surface disinfection

for coated surfaces:

Tested:

Green & Clean SK (ATMOS)

Experience with:

Dismozon® pur (Bode Chemie)

Kohrsolin® FF (Bode Chemie)

Perform® (Schülke & Mayr)

Terralin® Protect (Schülke & Mayr)

Other surfaces: Dismozon® pur (Bode Chemie)

Kohrsolin® FF (Bode Chemie)

Bacillocid® rasant (Bode Chemie)

Mikrobac® forte (Bode Chemie)

Perform® (Schülke & Mayr)

Terralin® Protect (Schülke & Mayr)

Surface disinfectant FD 312 (Dürr Dental)

Quick disinfection B 30 (Orochemie)

Manual instruments disinfection: Machine disinfection of instruments:

Korsolex® extra (Bode Chemie)

Sekusept® aktiv (Ecolab)

Gigasept FF neu (Schülke & Mayr)

Dismoclean® 28 alka one (Bode Chemie)

Dismoclean® twin basic/twin zyme (Bode Chemie)

Thermosept® alka clean forte (Schülke & Mayr)

Thermosept® RKN-zym (Schülke & Mayr)

For concentrations, contact time, temperature, material compatibility, please see the relevant information from the

manufacturer.

What How

Recommendations

When Who

Parts to be reprocessedC

CleaningD

Disinfection

A f t e r e a c h

p r o c e d u r e

D a i l y

W e e k l y

M o n t h l y

Qualified and trai-

ned staff who arefamiliar with repro-

cessing. (Please fillin the responsible

person -> use a

water-based over-head marker)

ATMOS Rhino 31

Test block X X manual cleaning and disinfection X

Measuring oliveX X

manual cleaning and disinfection,

exchange of olives after each patientX

X Xmachine reprocessing, 85°C, with recommended agents

(see below)X

Pressure probe and hose X

manual cleaning and disinfection,

exchange of olives after each patientX


(see below)X

Measuring probe mask

X X wipe cleaning and disinfection X


(see below)X

Nose adapter single-use product X

Annular diaphragm

spiroceptor

X wipe cleaning and disinfection X


(see below)X

Hose system X wipe cleaning and disinfection X

Filter hygiene pad single-use product X

ATMOS Sono 31

Ultrasonic probe X X wipe cleaning and disinfection X

ATMOS Tymp 31

Handle X X wipe cleaning and disinfection X

Ear plugs

X Xmanual cleaning and disinfection with Orliclean,

exchange of ear plugs after each patientX

Xmachine reprocessing, 85°C, with recommended agents

(see below)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.


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6.0 Maintenance and servicing

6.1 Basic information

● Carry out a visual inspection of the unit prior to each useincluding hoses and connection cable. Damaged cables

and hoses must be replaced immediately.

● Maintenance or opening and repair of the ATMOSDiagnostic Cube may only be carried out by ATMOSor a specialist authorised by ATMOS. In this case,attention should be paid to the protective technical andhygiene measures, the notes on safety plus the de-scriptions in the servicing instructions for the ATMOSDiagnostic Cube.

● For repair, this device can be returned to ATMOS.

● Prior to sending in the device it must be thoroughlycleaned and the surface must be disinfected.

● Send in the device including all the accessories butwithout any consumables!

● ATMOS cannot guarantee perfect functioning neitherwill 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 authorisedby ATMOS.

● No warranty rights shall exist in the event of damage orfailure caused by the use of non-ATMOS accessories or

non-ATMOS consumables.

● When the operating instructions stated in this manualare observed there is no health hazard. Nevertheless,we recommend at least every 2 years, depending onthe type of application, the hygienic reprocessing of thedevice within the scope of the safety-related inspectionand the checking of the measuring accuracy.

● Pay attention to regulations and instructions valid for therespective application range.

● According to the Medical Devices Act maintenance isrequired for the Diagnostic Cube at least every 2 years

(safety-related control and medical technical check).Please get in touch with the manufacturer prior toexpiration of this deadline in order to x a date. A pres-sure calibration is performed automatically during eachsoftware start. Only in certain cases when the weatherchanges drastically (change from high pressure to lowpressure) a manual calibration might be required. In thiscase please go to the tab "measurement" and click onthe button "calibration".

!


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7.0 Troubleshooting

Description Possible reasons Measures

Measurement does not start-up

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

Socket and probes must be connected acc.

to the regulations, should the failure stillexists please contact the customer service

of the manufacturer.

No USB connection between Diagnostic

Cube and Computer, USB device entry

within the device control of the Windowssoftware (system control – device ma-

nager – USB controller, entry AGH USB

2.0 must exist twice.

Probe is not connected to the right

Diagnostic Cube connection, removing

probe should not be able without relea-

sing the holder equipment.

USB port is switched-off because of theenergy-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 bot-

tom of the ear canal or the upper part of

the ear canal.

Check position of the probe and repeat the

measurement.

Error message via software:data base error

No network connection to the server

(if necessary through the network admi-nistrator)

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

a network inclusion, if the failure still existsplease contact the customer service of the

manufacturer.Insufcient user permissions of the user

(user must have local administrator

permission).

Measurements starts but no

graphic is recorded

ATMOS Rhino 31 and ATMOS Tymp 31Probe tube has no correct connection to

the probe and to the Diagnostic CubeProvide correct connection of the probetube, if necessary clean probe and probe

tube, if the failure still exists please contact

the customer service of the manufacturer. ATMOS Rhino 31 and ATMOS Tymp 31

Probe and probe tubes are

contaminated or blocked

Print function does not work Incomplete measurement Complete measurement and print.

No reaction of the programmesurface

Window of the patient menu is still ope-ned in the background.

Bring the window for patient administrationto the front by means of the alt and tab key.

System crash of the measuring

programme

The already opened measuring pro-

gramme 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 measure-

ment with the ATMOS Rhino 31are 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 immediatelyfrom the power supply. Contact the Customer service of the manufacturer.


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7.0 Troubleshooting

7.1 Permanent power supply of theUSB 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 theoption “Power Options”, please select there “USB settings” and

switch it off.

USB energy options settings


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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”.


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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





ATMOS Rhino 31 with mask measurement

Nose mask, large, for adults 105.2014.5

Nose mask, small, for children 105.2012.5

ATMOS Tymp 31Contra lateral headset

Included in delivery:

Headset and connection set

512.1120.0

Integration accessories diagnostic room / treatment unit

iHandle – support for handle with automatic switchingSpecification:

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

512.0500.0

Medical Touch Screen PC

Windows PC with touchscreen

Included in delivery:

Touch Screen PC 17", power supply, IEC mains cable, operating instructions

Technical data:

100…240 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

512.1400.0

Integration in the existing practice software

via GDT interface

512.1500.0

Support arm for integration into ATMOS S 61 ServantSupport arm for monitor/PC via VESA adapter

Technical data:

Maximum load-bearing capacity 25 kg

512.1300.0

Support arm for integration into ATMOS C 21 /C 31/ Servant 5Support arm for monitor/PC via VESA adapter

Technical data:

Maximum load-bearing capacity 25 kg

512.1350.0


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Consumables

ATMOS Rhino 31

Filter for olive measurementset 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, Ø 12 mm (50 pieces) 512.1061.0



ATMOS Sono 31

Ultrasonic contact gel

bottle 250 ml

507.0603.1

ATMOS Tymp 31

Set of earplugs

24 different earplugs

(5 pieces of size 2, 3, 4, 5 plus 2 pieces of size 1 and 6)

1 x cleaning filament

512.1120.0

312.1031.0

Spare parts

Documents

E GA Diagnostic Atmos Cube 2013-08-11