ATMOS US 21

MedizinTechnik

ATMOS MedizinTechnikGmbH & Co. KG

Ludwig-Kegel-Straße 1679853 Lenzkirch/Germany

Tel. +49 (0) 7653 / 689-0Fax +49 (0) 7653 / 689-190

[email protected]

ATMOS US 21Ultrasound-Module

Windows versions 98/ 2000 / XP from 11-2005

Ope

ratin

g in

stru

ctio

ns

English

REF 507.1080.B

2012-04 Index: 10

ATMOSMedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 1679853 LenzkirchDeutschland/ Germany

Tel. +49 (0) 76 53 / 689-0Fax: +49 (0) 76 53 / 689-190 +49 (0) 76 53 / 689-493 (Service Center)

[email protected]

33

Table of contents

1.0 Introduction ........................................................................ 4-51.1 Notes on operating instructions ........................................................ 41.2 Proper intended application .............................................................. 41.3 Explanation of pictures and symbols ................................................ 5

2.0 For your safety ....................................................................... 6

3.0 Accessories and System pre-requisites ............................. 73.1 Accessories ...................................................................................... 73.2 Pre-requisites ................................................................................... 7

4.0 Programme installation ................................................... 8-114.1 Installation ultrasound with patient administration ....................... 8-104.2 Now connect your device ............................................................... 114.3 Operating the ATMOS US 21 ......................................................... 11

5.0 Menue navigation ........................................................... 12-175.1 The patient menue ......................................................................... 125.1.1 Defining a new patient in the forms view ................................................... 125.1.2 Calling up a patient .............................................................................. 12-145.1.3 Modification of patient data ....................................................................... 155.1.4 Acceptance of patient data ........................................................................ 155.1.5 Deletion of patient data ............................................................................. 165.1.6 Right mouse button in the patient menu .............................................. 16-17

6.0 Ultrasound measurement ...............................................18-256.1 Operating ......................................................................................... 186.2 Key assignment .............................................................................. 196.3 Analysis ..................................................................................... 19-226.4 Displaying older measurement .................................................. 22-236.5 Right mouse button in the „Ultrasound“ menue ......................... 23-25

7.0 Statutory laws ...................................................................... 26

8.0 Cleaning ............................................................................... 27

9.0 Repair and servicing ...................................................... 28-29

10.0 Trouble shooting .................................................................. 30

11.0 Accessories/Spare parts/Consumables ............................ 31

12.0 Technical specifications ..................................................... 32

13.0 Checking/Disposal .............................................................. 33

14.0 Notes on EMC ................................................................. 34-37

Declaration of conformity ................................................... 38

General Standard Terms and Conditions .......................... 39

44

1.1 Notes on operating instructions

1.2 Proper intended application

In diagnostic chambers of practising doctors and clinics.

In PCs, which are tagged with the CE marking.

By medical persons or medical assistants, who have been trained in the operation of the equipment, or, if applicable, based on the Operating Manual.

On patients of all age groups who are in a position to hold their heads steady for about 30 seconds.

With the accessories listed in the Operating Manual.

Ultrasonic impulses are sent through the sinus frontalis or the sinus maxillaris. The ultrasonic probe is both, sender and receiver of echoes whose consistence depends on the structures in the paranasal sinuses. Echoes are developed when the acoustic impedance changes, at the borders between bone and tissue, bone and fl uid as well as between all solid or fl uid materials and air. It is imperative:

the bigger the impedance difference the stronger the refl exion. For example, in a healthy and air-fi lled maxillary sinus the sound is almost completely refl ected at the frontal septum. There are no late echoes. Mucosal swelling, sec-retion accumulation, cysts or neoplastic changes produce additional, characteristic late echoes. The strongest echo is refl ected by the posterior wall of the maxillary sinus. The quick and easy to perform ultrasound examination is a fully harmless examination method of the paranasal sinuses as an alternative respectively supplement to x-ray diagnostics, especially with children, pregnant women and for follow-up after sinusitis. The ATMOS ultrasound module is characte-rised by the modern technology, the high operating comfort and the ease of maintenance. There are four image memo-ries for comparison of both halves of maxillary and frontal sinus. When switching from maxillary sinus to frontal sinus measuring unit and amplifi cation change automatically. The-re are four amplifi cation processes available for depth regu-lation. The linear amplifi cation is infi nitely digitally variable. All data and graphics are automatically recorded on a hard disk. For printing all Windows printers are available.

These operating instructions contain important notes on how to operate the ATMOS US 21 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. Reprints (also in extracts) only with permission in written form by 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 US 21 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 US 21 will be preserved.

The product ATMOS US 21 bears CE marking according to the EC directive of the council for medical products 93/42/EEC and meets the basic requirements of appendix l. guideline. 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.

1.0 Introduction

55

1.3 Explanation of pictures and symbols

1.0 Introduction

!

→

Warning, especial diligent notice

Application part type B

Fuse according toIEC 417/5016, DIN 30600/0186

Subnumeration

General information

Numeration

Please read, important information

manufacturing date

Short cuts / symbols contained in this manual

Pictures contained in this manual

~

Controll

Replace

Move, plug ... in this direction

Engage, check correct fi t

Turn, shift ... in this direction

clickclick

Activate the optional foot switch

Off (feed-in, power connection)

On (feed-in, power connection)

Alternating current

66

The equipment may only be used in proper condition and must be subjected to a bi-yearly functional and safety-relevant test by the manufacturer.

A functional test must be performed by an experienced user daily. The maxillary sinus of the user is best suited for this purpose.

A mechanically defective probe may not be used for measurements.

Damaged device!

2.0 For your safety

!

Please note unconditionally!

No warranty rights shall exist in the event of damage or failure caused by the use of non-ATMOS accessories or non- ATMOS consumables.

Pay also attention to the safety information of the attached devices / parts as well as to the safety informations in the following chapters.

General safety information

Danger of injury!

The ATMOS US 21 may only be used under the supervision of skilled staff who have been authorised by ATMOS and trained in its operation (IEC 601-1 / EN 60601-1).

The use of accessories not recommended by ATMOS may lead to fl ickering or image failures.

These operating instructions correspond to the design of the device and the status of basic safety engineering standards on going to print.

Please check the delivery on complete- ness and intactness.

ATMOS will not be liable for damage to people or property if: → Any non-original ATMOS parts are used. → The instructions for use contained in these operating instructions have been disregarded. → Assembly, resetting, alterations, extensions and repairs have not been carried out by people authorised by ATMOS.

To avoid injuries, please note the following details:

Never touch the device´s interfaces and the patient at the same time.

Prior to fi rst starting up, all connecting leads must be checked on damage. Dama- ged cables must be replaced!

To disconnect the device from the mains supply, fi rst remove the plug from the wall outlet. Then separate the connecting cable from the device. Never touch plug or cable with wet hands!

Prior to cleaning, switch off the device and separate it from the mains supply resp. from other devices.

Ambient conditions: The ATMOS US 21 may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards. Explosion hazards may result from the use of combustible anaesthetic agents, skin cleansing agents or disinfectants.

When connecting several devices on one grounding receptacle, the allowed strain and leakage current have to be observed!

77

Sonogel

3.0 Accessories and System Pre-requisites

3.1 Accessories

main cable

USB cable

Module ATMOS US 21 operating

instructions installation CD

measuring probe withsupport

Computer requirements:

Pentium e.g. INTEL® Pentium III 500 or higher with USB 2.0 port

Printer requirements:

Windows®-compatible printer

Operating Systems:

MS-WINDOWS® 98 / 2000 / XP

Programme:

Programme runs under WINDOWS ®

RAM required: 2 MB Hard disk space required: approx. 2 MB without patient data Patient data bank is a paradox-compatible format Hard disk space required for measurement per side: max. approx. 16 kB

3.2 System Pre-requisites

measuring probe withsupport

foot switch

88

4.0 Programme installation

The installation CD is inserted and the following menu appears:

Insert the installation CD in the CD/DVD drive of your PC.The installation wizard starts automatically. If not, then run the fi le setup.exe via the menu Start and Run. The following mask appears.

4.1 Installation ultrasound with patient administration

“next” click

1. You require one USB 2.0!

Important - please perform the installation in the following order1. Install software from the CD.2. Set up and switch on the ultrasound device but do not yet connect it to the PC.3. Connect the USB cable to the PC.4. Start the installation wizard and select „manual installation“! No automatic search.5. Install driver software from „C:\ATMOS\USB\[Betriebssystem]6. Follow the installation wizard.7. Restart computer

99

The setup programme executes till the end and installs symbols and folders.


„Continue Anyway“ click

1010


After successful installation the ATMOS US 21 programme icon appears on the desktop.

1111

4.0 Programmme installation

4.2 Now connect your device:

foot switchsensormains-adapter and cableConnect device PC via USB; use free USB-Port on your PC

4.3 Operating the ATMOS US 21Device switch on 0-1;LED-light switches to green

First of all the language German or English is selected by clicking on the country fl ags and subsequently the button Shell/Patient is clicked to install the patient management package.

1234

1 243

1212

5.0 Menue navigation

5.1 The patient menue

5.1.1 Defi ning a new patient in the forms view

Click on the right mouse button and select „patient administration.“ Click on the button „New“ or press „F4“

Filling up the fi elds :

a. Enter the patient number (as per the EDP or the record card system) maximum 8 char. Switch between input fi elds using the „TAB“ key b. Family name c. First name d. Date of Birth. (The points dots will be set automatically. The year 4-digit, please) e. Sex ( M or F) f. Street g. Postcode h. Place

1313


If all inputs are correct, confi rm by pressing OK twice.

The patients can also be displayed in the View List:

1414


In order to facilitate a search, one can sort the list by the „No“ or „Name“ of the patients by clicking on the appropriate „No“ or „Name“ fi eld.

One can page within the forms by means of the inner arrow keys, while the outer arrow keys display the fi rst or the last patient.

1515


A list of patients is displayed and the fi rst entry found is displayed. One can now once again enter the patient number or the name or use the arrow keys and select the desired patient with the „Enter“ key, or click with the mouse cursor on the patient.

By clicking on „OK“ one returns to the main menu.

5.1.3 Modifi cation of patient data By clicking on „Change“ or „F5“ the individual entries in the fi elds can be modifi ed, other than the patient number.

5.1.4 Acceptance of patient data

If an EDP system with medical software is integrated in the computer or in the network, then one has the option to accept the current patient with many programmes. In this manner, one can accept the current patient from the EDP system by clicking on „Import“ or „F2“.

5.1.2 Calling up a patient

Enter the patient number in the fi eld „Number“, or go to the fi eld „Name“ with the Tab key or the mouse cursor and enter the fi rst alphabet of the patient name.

1616


5.1.5 Deletion of patient data

By clicking on „Delete“ or „F8“ the current patient displayed is deleted. ATTENTION! Patient numbers that have been deleted may not be used subsequently for another patient.

5.1.6 Right mouse button in the patient menue

If the right mouse button is pressed in the patient menue, the following fi eld is displayed:

After clicking on Options the next menu appears:

1717


The name and the folder can be selected for the patient data bank, or a new data bank can be created here. Furthermore, it can be set up whether the forms view or the list view appears after invoking the patient management system. The import fi le can be selected when accepting data of the patient from an EDP system. The settings are confi rmed by pressing the „OK“ key.

1818

6.1 Operation

The ultrasound probe is connected to the ultrasound connector at the front of the equipment, and the foot switch at the back. In the main menue (Shell) the key “F2“ is pressed or the „Ultrasound“ button clicked. On doing so, an ultrasound diagram appears with a data section and a menu bar. If the curves need to be archived sub-sequently in the data memory, then the patient data must fi rst be called up and displayed.

6.0 Ultrasound measurements

Function Key Button Function

Esc Return to the main menue (Shell) F3 Sine Switching between individual cavities (max.- front.) F4 Magnifi cation Selection of 4 magnifi c curves (depth compensation) F5 Print Print the measurements F6 Load Select previous measurements for comparison F7 Zoom Increasing the scale (8 cm or 4 cm) F8 Save Store the measurement data F9 4 Picture Comparative display of all four curves for better overview in one diagram

6.1.1 Function of the front LED

LED Device StatusLED is not illuminated device is not ready for measuringLED is green device is ready for measuringLED is red device is measuring

1919

6.0 Ultrasound Measurements

6.2 Key assignment

+ Magnifi cation is higher (from +00 to +30) - Magnifi cation is smaller (The value is blended below the magnifi cation) Default value at the time of delivery is +10

6.3 Analysis

First, the cavity to be measured is selected using the “F3“ key or by clicking the button in the Sinus selection. „Frontalis“ right and left, as also „Maxillaris“ right and left. The button of the current measurement is inverted respectively.

Four different magnifi cation curves can be called up for display using the “F4“ key or by clicking on „Magnifi cation“, which respectively have a particular depth compensation and facilitate very quick diffe-rentiated diagnosis.

1 = Normal magnifi cation Maxillaris 2 = Normal magnifi cation Frontalis 3 = Medium emphasis for cysts, growths etc. (Bell curve) 4 = High magnifi cation over the entire depth. (e.g. in case of completely fi lled cavity for better location of the rear wall echo)

As a rule, only the magnifi cation curves 1 and 2 are required, and in critical cases, one can switch to curve 3 or 4.

When measuring “Maxillaris“ or “Frontalis“ the magnifi cation curve changes automatically, in order to use the depth compensation.

2020


The gel is applied on the probe and the cavity is investigated. On fi nding a clear measurement curve the foot switch is activated and the measurement curve is saved and displayed as a still picture (Still picture memory).

If more than one curve is to be saved, then fi rst the foot switch is used to enter the „Measure-ment“ mode, and then the next cavity is selected with the „F3“ key. If automatic sine has been set up (right mouse button in the measurements menue, click Options and set „Yes“ for Automa-tic Sine) switchover to the next cavity is done automatically. Thus, in this manner, four curves can be saved.

2121


All four curves can be observed with the help of the “F3“ key or by clicking on the „Sine“ button. If a particu-lar curve is not adequately clear then it can be overwritten by pressing the foot switch and returning to the „Measurement“ mode, in which the measurements are made and saved.

2222


With the help of the „F9“ key or by clicking on the „ 4-image“ button an overview display of all four curves can be displayed for ease of comparison.

This overview display can be printed out with the help of “F5“ or by clicking on „Print“.

If the curves should be archived in the patient fi le then the „F8“ key must be pressed or the button „Save“ must be clicked. (For this purpose, the data pertaining to this patient must have been cal-led up for display fi rst). The curves are now assigned to the patient as documentation in the data memory.

All curves saved can be printed automatically using the „F5“ key or by clicking on the „Print“ button.

6.4 Displaying older measurement curves

While taking measurements of a patient, the older curves pertaining to the same patient can be displayed for the purpose of comparison.

1. The cavity ( e.g. max. right ) is investigated. As long as the display is not stopped with the foot switch, the key “ F6 = BACK “ can be used to display and assess all previous investigations for “ max. right “. In this case, even the comments and the date of investigation can be seen on the screen.

2323


Attention: If the equipment does not respond when a key is pressed, please check if the US picture is in the „Stop“ mode. If yes, then please step on the foot switch so that the equipment switches to the „Measurement“ mode.

The desired measurement can be clicked and called up for display by mouse click or with the help of the arrow buttons.

6.5 Right mouse button in the „Ultrasound“ menue

A window displaying options appears in the ultrasound measurement menu on pressing theright mouse button.

2424


Clicking on „Options“ displays the „Options“ menu

2525


The following can be selected on the left side of the screen: a. Whether the sine switching should take place automatically - „Off“ / „On“. b. Whether the printout should be in A5 portrait or A4 landscape - „A5 portrait“ / „A4 landcape“ c. The name of the clinic can be entered in the fi eld, which then appears on the printout. d. Whether the Show mode software is activated at the workplace. e. Whether an internal interface or the USB is used. f. Whether the connection is at the foot switch at the game port or externally on the module.

Right side:

a. The folder, in which the patient data should be saved. Many folders can be created for this purpose. b. The name of the fi le, in which the patient data should be saved. Many fi les can be created for this purpose. c. The directory of external modules of the patient management system. d. The language in which the ultrasound measurement menu is displayed. e. A fi le name can be entered here if a fi le needs to be exported i. The patient fi le.

2626

7.0 Statutory laws

As a result of the guideline 93/42 EEC and the medical products act MPG, both the manufacturer and the operator of medical products, in our case, diagnostic equipment, are obliged to comply with a series of rules. The rules, for the operator, that is to say, the doctor, are derived primarily from the medical products operation act (MPBetreibV).

1. The Inventory Register All medical products must be listed in an inventory register. The inventory register must contain the following:

a. Description, serial number and year of acquisition of the equipment. b. Name of the person responsible for the product (nominated by the clinic). c. The number of the notifi ed body named in the CE marking. d. Clinic-specifi c inventory number (if available). e. Location of the equipment and the operational allocation. f. The intervals prescribed by the manufacturer for safety-relevant and measurement-related test

2. Regular tests please see 9.2 Regular Safety relevant tests on page 29

Other applications need the consent of the manufacturer

2727

1

+

+

8.1 General information on cleaning and disinfection

8.4 Chemical disinfection

8.3 Sensor

8.2 Unit surface

Do not use: Disinfectants containing concentrated organic or inorganic acids or bases, as these may cause corrosion damages. Disinfectants containing chloramides, phenol derivatives or anionic tensides, as these may cause stress cracks in the material used for the housing of the unit.

Prior to cleaning

...and all connected devices

→ Always observe the concentration specifi cations and instructions by the respective manufacturer.

→ Disinfection: All parts, which come in physical contact with the patient, must be disinfected with the customary disinfectants after taking measurements. This applies particularly to the Ultrasound probe

Prior to cleaning Basic cleaning

→ Upon drying, avoid liquid residues and spots on the lense of the sensor.→ All surfaces may be cleaned with the disinfectants.

→ For cleaning / disinfecting the sensor, please pay attention to the respective cleaning instructions.

8.0 Cleaning

Basic cleaning

+1 2

...

A

...

Servicing

Prior to a service the device must be disconnected from the mains supply. Please let the inside of the device clea-ned every three years by a qualifi ed expert. Dust and longer periods without cleaning may lead to fi ring or failure. Before cleaning please make sure that the device is switched off and was disconnected from the mains supply. Clean the device with a soft cloth. Do not use any solvents like alcohol or paint thinner as this may result in damage of the housing. Dust can be removed with a vacuum cleaner.

Cleanser

The casing may be wiped off with a damp cloth. In no case moisture may enter the interior of the device. The probe may be disinfected with standard disinfectants

+

2828

9.0 Repairs and servicing

9.2 Regular safety-relevant tests:

Medical devices must always offer a maximum in safety and function. Therefore, please observe the following instructions

Further regular maintenance work is not required.

9.1 Replacing the fuse

Prior to each application:

if

necessary

All equipment in a given clinic must be in proper condition, and there may be no possibility of any hazard for the patient or the operator for any medical product. The sound condition and also the proper functioning of the equipment must be checked regularly by the operator or any other person appointed by the clinic for this purpose.

Regular safety-relevant tests (SRT) have to be performed in line with the § 6 MPBetreibV and carried out every two years. The operator, that is to say, the doctor, is obliged to have these tests performed. The result of these tests must be recorded in the respective medical product register. A sticker must be affi xed to the equipment in such a manner that it is visible, and containing information regarding the due date for the next SRT and also the test centre.

Maintenance

In the following cases the device should only be maintained by a qualifi ed expert who is authorised by ATMOS:

a. Damaged mains cable respectively a damaged mains plug.b. Permeated foreign substances or liquids.c. The device was exposed to rain.d. The device had a failure.e. The device was dropped or the housing is damaged.

clickclick

+...

+...

Modifi cations should be carried out only by authorized competent personnel.

2929

9.0 Repairs and servicing

In the case you need maintenance and/or service, please contact:

ATMOS

MedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 1679853 LenzkirchDeutschlandTelefon: +49 7653 689-222Fax: +49 7653 689-292

e-mail: [email protected]

30

10.0 Trouble shooting

Description Possible causes of error and measures

LED light is illuminated in green programme starts but the probe does not work

~ programme is possibly in the show mode click the right mouse button settings close the show mode close the programme and restart it

LED light is illuminated in red no record although the device is ready to operate

~ check the plug and socket connections whether they are fixed correctly~ measuring probe is defective~ device is defective

31

11.0 Accessories and spare parts

REFAccessories

ATMOS Medical PC Network Medical workplace with 17’’ TFT monitor and network interface card

507.3201.0

Spare parts

Mains cable on request

USB cable on request

Measuring probe with support on requestConsumables

Sonogel on request

3232

12.0 Technical specifi cations

update of technical data: 19th July 2010

Technical Data ATMOS US 21

Voltage 230 V ~ ‡ 10%; 50/60 HzPlease also observe the technical date of the provided power supply unit: Voltage 100-240 V ACCurrent consumption: max. 900 mAPower consumption max. 30WFuse: 13.2 V T 1.25 AUltrasonic frequency: 3.5 MhzImpulse frequency: 120 Hz Probe power: 50 mW / cm2

Amplifi cation: 80 dBDepth regulation: 20 dBSystem: PC module with USB 2.0 connectionMethod: A- modeProbe: focussed, 14 mm diameterMeasuring range: sinus frontalis 0- 3.5 cm sinus maxillaris 0- 7,.cmSwitching: automatic or manually with foot switchCompensation curves: 1. for maxillaris 2. for frontalis 3. for cysts 4. for small signalsComment line: for each data setPatient Data: data base in paradox formatStorage keep dryTransport in the original packing, keep dry and do not throwFrequency: 50/60 Hz Operation Continuous: Continuous Operation

Protective earth conductor resistance max. 0.1 ΩEarth leakage current max. 0.5 mAEnclosure leakage current max. 0.1 mAPatient leakage current max. 0.1 mA

Ambient conditions:Transport/storage: -20...+50°C 30...95 % air humidity without condensation at an air pressure of 500...1060 hPa Operation +10...+35°C 30...95 % air humidity without condensation at an air pressure 700...1060 hPaDimensions W=320 mm D= 270mm/370mm H=70mm/100mmWeight 2,5 KgSafety related controls: Due to accident prevention regulation a safety related control has to be accomplished each 2 years. ATMOS recommends a yearly maintenance.

Protection class IIApplication part: Typ BFClassifi cation acc. to Medical Product Law: II aCE marking: CE 0124Standards: EN 60601 -1 / 1-1 / 1-2 / IEC 1157 / MPG UMDNS Code: 16-272REF 507.1080.0

33

13.0 Checking / Disposal

13.1 Checking ATMOS devices

The ATMOS devices are maintenance-free in the case they are used according to the operating instructions. However, regular safety-relevant checks have to be performed in line with the BGV A3/GUV 2.10 (MPBetreibV §2 Abs. 8) at least every two years.

Regular, thoroughly cleaning and disinfection of the hoses and the application parts respectively the operation in line with theoperating instructions are assumed.

13.2 Disposal

The ATMOS US 21 does not contain any hazardous materials.

The housing is recyclable.

Device and accessories must be decontaminated prior to disposal.

Please take care on a careful separation of the different materials.

Please observe national disposal regulations (e.g. waste incineration).

Disposal within the EC

The device described above 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. 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 direct-ly to ATMOS MedizinTechnik for a professional disposal.

Before disposal respectively before transport all parts, which came into contact with the patient must be thoroughly cleaned, disinfected/sterilised. The device surface must be disinfected.

34

14.0 Notes on EMC

14.1 Guidelines and Manufacturer´s Declaration - EmissionsThe ATMOS US 21 is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS US 21 should ensure that it is used in such an environment.

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.

Emissions Test Compliance Electromagnetic Environment - GuidanceRF Emissions CISPR 11

Group 1 The ATMOS US 21 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 The ATMOS US 21 is suitable for use in all esta-blishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonics IEC 61000-3-2 Class AFlicker IEC 61000-3-3

Inapplicable

35

14.0 Notes on EMC

14.2 Guidelines and Manufaturer´s Declaration - Immunity for ATMOS US 21

The ATMOS US 21 is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS US 21 should ensure that it is used in such an environment..

Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environ-

ment - GuidanceESD IEC 61000-4-2

± 6 kV Contact

± 8 kV Air

± 6 kV Contact

± 8 kV Air

Floors should be wood, concrete, or ceramis tile. If floors are synthe-tic, the relative humidity should be at least 30%.

EFTIEC 61000-4-4

± 2 kV Mains

± 1 kV I/Os

± 2 kV Mains

± 1 kV I/Os

Mains power quality should be that of a typical commercial or hospital environment.

SurgesIEC 61000-4-5

± 1 kVsymmetric

± 2 kVsymmetric

± 1 kVsymmetric

± 2 kVsymmetric

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips / DropoutIEC 61000-4-11

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

40 % UT(60% Dip of the UT) for 5 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 0.5 Cycle

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

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

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

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS US 21 demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS US 21 from an uninterrup-tible current supply or a battery..

Power Frequency 50/60 HzMagnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be that of a typical com-mercial or hospital environment.

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

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

36

14.0 Notes on EMC

14.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS US 21 is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS US 21 should ensure that it is used in such an environment.

Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environment

- Guidance

Conducted RFIEC 61000-4-6

3 Veff150 kHz bis 80 MHz 3 V

Portable and mobile communications equipment should be separated from the ATMOS US 21 incl. the cables by no less than the distances calculated/listed below.

Recommended distances:

d = 1.17 √ P

d = 1.17 √ P 80 MHz bis 800 MHz

d = 2.33 √ P800 MHz bis 2,5 GHz

where „P“ is the max. power in watts (W) and D is the recommended separation distance in meters (m).

Field strengths from fixed transmitters, as determined by an electromagnetic site (a) survey, should be less than the compli-ance level (b). Interference may occur in the vicinity of equipment containing following symbol

Radiated RFIEC 61000-4-3

3 V/m80 MHz bis 2,5 GHz 3 V/m

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

NOTE 2 These guidelines don´t like to be applicable in any case. The propagation of electromangetic sizes is influenced by absorptions and reflections of buildings, objects and people.a The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered. If the measured field strength at the location where the ATMOS US 21 is used exceeds the above compliance level, the ATMOS US 21 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.

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

37

14.0 Notes on EMC

14.4 Other Notes on EMC (electromagnetic compatibility)

The ATMOS US 21 is a so-called PC modules which is only operated in connection with a computer via USB interface. The ATMOS US 21 was tested and certified by an accredited EMC test institution. The tests of the diagnostic modules was performed with a medical computer which fulfils all require-ments with regard to safety and EMC.

The EMC test is based on an interference resistance level of 3V/m. Therefore, the device should not be operated in an ambient with a higher level. An operation near to high voltage equipment should be avoided. High-performance transmitters may not be operated near to the device.

In the case of too high irradiation of electromagnetic fields the accuracy of measuring results may be influenced.

Sometimes ATMOS does not know the final configuration of computer, network, printer, etc. where the diagnostic module is included, in these cases the user has the final responsibility regarding the electromagnetic compatibility (EMC).

MedizinTechnik

This Operating instructions is copyrighted. Duplication, translations, microfilming and savings on electronic systems, particularly for commercialpurposesare illegal without prior agreement of the manufacturer. All compiled data are based on manufacturers instructions. All logos,product names and designations used in this catalogue are property of the respective manufacturer.We do not take over any warranty and liability in the case of missing inscriptions. Subject to modifications and amendments.

1. General:Our General Standard Terms and Conditions apply exclusively. Client’s terms and conditions which are contrary to or deviate from our General Standard Terms and Conditions are not recognised unless their validity is explicitly confirmed in writing. Our General Standard Terms and Conditions also apply even if we deliver to clients without reservation, in the knowledge of the client’s contrary terms and conditions. Our General Standard Terms and Conditions also apply to all future business with that client.

2. Proposal - Order Confirmation Our proposals are subject to change without notice unless otherwise stated in our order confirmation. Each order is only accepted by us following our written order confirmation.

3. Orders Every order requires an exact description of all of our product’s details. We assume no liability for errors and damage caused by inaccurate or incomplete ordering details.

4. Prices Unless otherwise stated in the order confirmation, our prices in the order confirmation are ex factory prices and exclude packaging and value added tax. Packaging is charged separately at cost price in the invoice. Value added tax is charged separately in the invoice according to the legal rate on the invoice date. We reserve the right to change prices appropriately should price reductions or increases, especially due to wage settlements, changes in the price of materials or currency fluctuations, be incurred. Proof of such changes will be provided for the client on request.

5. Payment Conditions - Balancing Unless otherwise stated in the order confirmation, our invoices 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; 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 basic interest rate of the German Federal Bank. Should the client have payment arrears, we are entitled to charge interest on arrears at a rate 5% above the relevant basic interest rate of the German Federal Bank. Should we be able to prove higher damages due to arrears, we are also entitled to claim these. The client only has the right to balance invoices against its own claims should such claims be confirmed in a court of law or recognised by us. The client does not have the right of retention due to disputed counterclaims.

6. Delivery Periods Fulfilment of our delivery duties requires the punctual and proper fulfilment of the client’s duties. The right to defense on the grounds of an unfulfilled contract is reserved.Should the client default in accepting the goods delivery or breach other cooperation duties, we are entitled either to withdraw from the contract or claim compensation for any increased 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 of coin-cidental destruction or a coincidental deterioration in the quality of the delivered goods is transferred to the client in the case of default in accepting such goods or payment arrears. Acts of God or stoppages (due to insufficient supplies of material, industrial disputes etc.) entitle us either to demand an appropriate extension of delivery periods or to partly or entirely dissolve the delivery contract. This does not give the client the right to claim damages. We have fulfilled delivery periods if the delivery goods have left our factory or the client has been informed of the goods’ readiness for delivery within such delivery periods. Delivery periods stipulated by the client are not recognisedby us unless they form part of our order confirmation. We adhere to legal terms and conditions in cases where, as a result of an undue delay in the delivery for which we are liable, the client is entitled to claim that his interests in a continued fulfilment of the contract have ceased. We also adhere to legal terms and conditions should a delay in delivery be caused by deliberate or grossly negligent action by us or our representatives for which we are responsible. We are also responsible for such actions by our representatives or agents. Should the delivery delay not be caused by our deliberate infringement of contractual duties for which we are 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 and in so far as the delivery delay for which we are responsible is caused by an infringement of a substantial contractual duty. In such cases, our liability is also limited to damage which is regardedas typical for that

case. Should the delivery delay be caused by a culpable infringement of non-substantial contractual duties, our client is also entitled to claim a one-off damage compen-sation worth 3 percentage points of the delivery value of the goods for each week’s delay, up to a maximum which is no higher than 15 percentage points of the delivery value of the goods

7. Delivery - Familiarisation In the case of the delivery of devices for the medico-technical industry which require assembly and/or familiarisation for the final customer using specialist trade personnel (such as Ear, Nose and Throat Apparatus and Suction Units), we reserve the right to deliver the goods exclusively to the relevant specialist traders. Should the trader not carry out assembly and/or familiarisation for the final customer, this is carried out by us. In such cases, we reserve the right to charge the client for the additionally created costs. Our specialist traders operate a recording system so that, if necessary, our products can be traced to the final customer. The specialist trader undertakes to immediately report to us all events and risks which must be reported in connection with our products.

8. Passage of Risk - Packaging Unless otherwise stated in our order confirmation, delivery is agreed ex factory. The risk of the goods’ damage or loss is therefore transferred to the client as soon as the goods leave the factory or the client is in default of acceptance of the goods. This also applies to cases where we confirm prepaid carriage. Transport packaging and all other packaging according to the packaging regulations is not returnable. Our client is responsible for disposing the packaging at its own cost. Our deliveries are insured by us at the client’s expense unless explicitly otherwise agreed. No insurance is arranged in the case of goods which are collected by our clients. In the case of transport damage, claims are only handled if the client receives confirmation of any damage, reduced weight or loss by the shipping company before accepting the delivery.

9. Warranty The client is responsible for examining the delivered goods immediately after receiving them to determine any eventual deficiencies or delivery errors, and to report these immediately. Should the client fulfil this examining and reporting responsibility, and should payment conditions be fulfilled, we shall be liable to the client within the scope of legal regulations. Our period of warranty shall in all cases be two years. Our client can make use of the warranty as follows, so long as he can provide first buyer proof (in the form of an invoice or delivery note) and provided that the product still has the original, unchanged serial number: a. We choose whether to fulfil our guarantee by providing repair

services free of charge - either on the client’s premises or in our factory - or replacing the product. We can also provide these guarantee services through an authorised company;

b. Should a product be returned to us, the client agrees to send the product in its original or similar packaging, offering the same protection as the original packaging, to our address or any address notified by us.

c. Our guarantee ceases to apply if changes of any kind have been made to our product, unless such changes have been made by us or a company authorised by us, or have been previously agreed upon in writing by us. Our guarantee also ceases to apply if third parties have carried out repairs to our products or replaced parts thereof. This applies regardless of the fact whether these measures individually or collectively led to a deficiency of the product;

d. We accept no responsibility for damage defects caused by - operational wear and tear; - incorrect installation or incorrect or insufficient maintenance; - incorrect operation of the product (in contradiction to the handbook delivered with the product); - improper use or operating faults; - inappropriate or negligent handling and care, especially with respect to dirt, lime, suction of fluids, inappropriate cleaning and sterilisation;

- using accessories and/or replacementpartswhich are not explicitly approved; - incorrect assembly and/or initial operation by the client or third parties; - the client’s negligence in handling the product; - unacceptable operating conditions, such as humidity, temperatures, the power supply, vibrations. - accidents, acts of God, especially lightening, water, fire, public unrest and insufficient ventilation. We are not liable for damage to other objects apart from our product itself, except in thecase of any deliberate or grossly negligent actions by us or our representatives or agents. Should no deliberate breach of contract be claimed, our liability

is limited to damage which is regarded as typical for tthat case. This also applies in the case of our culpable infringement of substantial contractual duties The indispensable conditions of German Liability Law remain unaffected thereby. - For second-hand equipment, the period of warranty shall be reduced to a period of twelve months.

10. Reservation of Ownership We retain ownership of our goods until the receipt of all payments arising from the business relationship, including all demands arisingfrom installation orders, subsequent orders, repairs, accessory deliveries and replacement orders. Should we have agreed upon payment on the basis of cheque and bill transactions, the ownership reservation applies until the cheque received byus has been paid in, and does not expire through our credit upon receiving the client’s cheque. In the case of a breach of contract by the client, especially payment arrears, we are entitled to repossess our goods. Repossession of our goods repre-sents a withdrawal from the contract, unless explicitly declared in writing by us. We have the right to utilise the product after its repossession, whilst the income form such use is balanced against the client’s arrears, after deducting appropriate utilisation costs.The client is responsible for handling the goods with care. Should maintenance and inspection work be necessary, the client must carry these out punctually at his own cost. Our client is entitled to sell the goods he has bought from us in a proper sale transaction. However, he must immediately assign all outstanding claims to the value of the final invoice sum (including value added tax) of our claims to his customers or third parties. The client is entitled to collect this claim even after such assignment. Our right to collect the claim ourselves remains unaffected thereby.We undertake to release the securities to which we are entitled if requested to do so by the client should the realisable value of the our securities be more than 10 percentage points higher than the outstanding claims. We reserve the right to choose the securities to be released.

11. Plans and Illustrations We retain ownership of and copyrights to all plans, illustrations, calculations and other documents which are attached to our proposals. The client must receive explicit written permission before passing these on to third parties. Imitating our legally patented products is forbidden and will be prosecuted.

12. Jurisdiction and Place of Performance Our central office is the place of performance for all disputes in connection with these General Standard Terms and Conditions and the contracts closed with clients under them. This jurisdiction excludes other jurisdiction relating to persons or subject-matter. Furthermore, our client is not entitled to bring charges against us in another court should he file counter-charges, carry out counterbalancing or declare retention. We, however, are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recognised by German or foreign law.Unless otherwise stated in the order confirmation, our central office is the place of performance.

Lenzkirch, September 2008ATMOS MedizinTechnik GmbH & Co. KG79853 Lenzkirch/Germany

ATMOS General terms and conditions

Documents

ATMOS US 21