Please store this document near the device for later use!

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2014-07 Index: 08

MedizinTechnik

507.4500.B507.4507.B530.4020.B506.7551.B507.4760.B507.4505.B507.4506.B

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1.0 Introduction ......................................................................................31.1 Notes on operating instructions ..........................................................31.2 Explanation of symbols ......................................................................4

2.0 Notes on safety ................................................................................53.0 Intended use .....................................................................................6

4.0 Setting up and starting up ...............................................................7 - 104.1 Einzelkomponenten der Stirnleuchte .................................................74.2 Adjustment to head measurement .....................................................8 - 94.3 Functionality of rechargeable LED battery .........................................10

5.0 Operation ..........................................................................................11 - 125.1 Variants of the headlight ATMOS HL 21 LED .....................................115.2 Switching on .......................................................................................125.3 Focusing the headlight ATMOS HL 21 LED .......................................12

6.0 Notes on cleaning and care ............................................................13 - 146.1 Recommended surface disinfectants .................................................14

7.0 Maintenance and servicing .............................................................15

8.0 Trouble-shooting ..............................................................................16

9.0 Accessories, spare parts, consumables ........................................17

10.0 Technical specifi cations ..................................................................18

11.0 Disposal ............................................................................................19

12.0 Annex ................................................................................................20 - 2612.1 Notes on Electromagnetic Compatibility (EMC) .................................20 - 25

General Standard Terms and Conditions

Table of contents

ATMOS MedizinTechnik GmbH & Co. KGLudwig-Kegel-Str. 16 – 79853 Lenzkirch / Germany –

Tel: +49 7653 689-0 - Fax: +49 7653 689-392 (Vertrieb Inland) – Fax: +49 7653 689-391 (Export) E-Mail: atmos@atmosmed.de – www.atmosmed.de

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1.0 Introduction1.1 Notes on operating instructions

Maintenance and repairs may only be carried out by a skilled person authorised by ATMOS. Only original spare parts may be used for repairs. This will guarantee that the safety, readiness for operation and value of your device will be maintained.

The ATMOS HL 21 LED bears the CE identifi cation symbol CE in accordance with the EU Medical Devices Directive (MDD) - Directive 93/42/EEC and meets the basic requirements of Annex I to this Directive. The product ATMOS HL 21 LED complies with all applicable requirements of the directive 2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”). The declaration of conformity can be obtained on our website at www.atmosmed.com. The quality management system used at ATMOS has been certifi ed for quality management in accordance with the relevant international standards.

These operating instructions correspond to the design of the device and the status of basic safety engineering stan-dards on going to press. Reproduction of these instructions - even in part - only with the written permission of ATMOS.

Abbreviations / symbols in these operating instructions: Identifi es a list • Subdivision of a list/activity. The recommended sequence must be adhered to in each case!

Important Notes!

These operating instructions are valid for following devices:

• ATMOS HL 21 LED REF 507.4505.0 Examination set

• ATMOS HL 21 LED REF 507.4506.0 OT set

• ATMOS HL 21 LED REF 507.4507.0 Unit set

in connection with the accessories mentioned in chapter 9.0.

These operating instructions contain important information on how to operate the ATMOS HL 21 LED safely, correctly and effi ciently. ALWAYS STORE THESE OPERATING INSTRUCTIONS CLOSE TO THE DEVICE !

The device’s operating safety and its readiness for use depend not only on your competence but also on care and maintenance of the ATMOS HL 21 LED. Regular cleaning and preventive maintenance work is, therefore, essential.

1.0 Introduction ......................................................................................31.1 Notes on operating instructions ..........................................................31.2 Explanation of symbols ......................................................................4

2.0 Notes on safety ................................................................................53.0 Intended use .....................................................................................6

4.0 Setting up and starting up ...............................................................7 - 104.1 Einzelkomponenten der Stirnleuchte .................................................74.2 Adjustment to head measurement .....................................................8 - 94.3 Functionality of rechargeable LED battery .........................................10

5.0 Operation ..........................................................................................11 - 125.1 Variants of the headlight ATMOS HL 21 LED .....................................115.2 Switching on .......................................................................................125.3 Focusing the headlight ATMOS HL 21 LED .......................................12

6.0 Notes on cleaning and care ............................................................13 - 146.1 Recommended surface disinfectants .................................................14

7.0 Maintenance and servicing .............................................................15

8.0 Trouble-shooting ..............................................................................16

9.0 Accessories, spare parts, consumables ........................................17

10.0 Technical specifi cations ..................................................................18

11.0 Disposal ............................................................................................19

12.0 Annex ................................................................................................20 - 2612.1 Notes on Electromagnetic Compatibility (EMC) .................................20 - 25

General Standard Terms and Conditions

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ECO Half performance

O Lamp switched off

POWER Full performance

Test button for battery test

Connection for lamp to rechargeable LED battery

Connection for charging power pack with identifi cation of the polarity

1.2 Explanation of symbols

The following symbols are at the ATMOS HL 21 LED, at the rechargeable LED battery or at the charging power pack. Please remember their meaning.

Symbol"Pay attention to operating instructions". This symbol shall draw your attention to the safety information contained in the operating instructions. It serves as a reference to particular notes which are important for the application of the headlight.

The CE identifi cation symbol shows that this device complies with the appropriate requirements of the EU guidelines.

Class II equipment

Type B device

SN Serial number

REF Order number

1.0 Introduction

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2.0 Notes on safety

Prior to starting up the headlight ATMOS HL 21 LED, read these operating instructions carefully.

ATMOS cannot guarantee perfect functioning neither will it be liable for damage to people or property if: • Any non-original ATMOS parts are used. • The instructions for use contained in these operating instructions are disregarded. • Assembly, resetting, alterations, extensions and repairs are not carried out by people authorised by ATMOS.

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

Please make sure that the ATMOS HL 21 LED is used in the EMC area described in the Annex.

Only use the charging power pack supplied by ATMOS.

Exclusively use the headlight ATMOS HL 21 LED in connection with the rechargeable ATMOS LED battery or ATMOS current sources.

Separation of the charging power pack from the supply is only guaranteed with the charging power pack being discon-nected from the power socket.

Prior to each application, check the device's functions and its proper condition. Damaged cables must be replaced immediately!

During each application, pay attention to proper seat of the headlight ATMOS HL 21 LED.

Note: The headlight ATMOS HL 21 LED is not sterile! This fact might be important for medical operations.

Always make sure that you do not shine in patient's eyes resp. that the patient does not look direct into the light exit as, otherwise,

EYE INJURIES MIGHT BE THE CONSEQUENCE.

Charging of the LED battery must be checked regularly as the light expires very fast when the battery gets fl at.

When the headlight ATMOS HL 21 LED is applied by several users, regular cleaning and disinfection is necessary.

When not in use, switch off the headlight ATMOS HL 21 LED.

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3.0 Intended use

Name: ATMOS® HL 21 LED

Main functions: Headlight for medical examination: Illumination of orifi ces for the examination in the ENT fi eld.

OT-headlight: Illumination of the operating fi eld, natural body orifi ces.

Med. indications/ application: Illumination of body orifi ces.

Specifi cation of the main function: Due to the long-life light source with power-white light LED (service

life approx. 50.000h) in combination with a high-end-battery system the ATMOS® HL 21 LED enables a homogenous illumination of the examination resp. operating fi eld.

Application organ: Ear, nose, throat

Application time: Headlight for medical examination: Temporary application – the operation and application of the headlight may only be performed by trained staff. OT-headlight: For short-term application (max. 4 hours) – the operation and application of the headlight may only be performed by trained staff.

Application site: Headlight for medical examination: Application environment are ENT clinics and practices.

OT-headlight: Application environment are operating rooms.

Contraindications: None

The product is: X active □ not active

Sterility: Not necessary

Single use product / reprocessing: No single use product

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4.0 Setting up and starting up

4.1 Individual components of the headlight Headlight ATMOS HL 21 LED Charging power pack 12 V DC Rechargeable LED battery Connecting cable; length: 40 cm, 140 cm and 200 cm Different mains plugs for charging power pack (Euro/UK/US/Aus) Cable holder on headlight rack Adjusting instruments on the headlight rack.

Extent of supply Extent of supply Extent of supplyof Examination Set of OT Set of Unit SetREF 507.4505.0 REF 507.4506.0 REF 507.4507.01 Headlight 1 Headlight 1 Headlight ATMOS HL 21 LED ATMOS HL 21 LED ATMOS HL 21 LED1 Charging power pack 1 Charging power pack 1 Cable 200 cm (Euro/UK/US/Aus) (Euro/UK/US/Aus) 1 Cable clip1 Rechargeable LED batteries 2 Rechargeable LED batteries 1 Cable 40 cm 1 Cable 40 cm1 Akkuhalterung 1 Cable 140 cm 1 Cable clip 1 Battery holder

Prior to dispatch, this ATMOS device 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 following extents of supply).

Please document and report damages in transit immedia-tely. For complaints or return deliveries, please use enclosed form QD 434.

Fig. 1. Single components

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4.2 Adjustment to head measurement

At fi rst, take the headlight rack incl. headlight (, fi g. 2) and put it on a table in front of you.

Adjusting the headlight rack:Depending on your head measurement, adjust the headlight rack gradually to a comfortable and correct position by means of the turning knob (, fi g. 2).The level of the headlight rack is adjusted by means of a strap (, fi g. 2).

The lower edge of the headlight rack is to be positioned directly above the ears.

Fig. 2. Headlight ATMOS HL 21 LED Headlight rack Turning knob for adjusting the measurement Strap for adjusting the level

The lower edge of the headlight rack is to be positioned directly above the ears.

Prior to fi rst operation, pay attention to the safety information in chapter 2.0.

Prior to fi rst use of the headlight, charge the LED battery by means of the supplied charging power pack. Prior to fi rst use of the headlight, charge the LED battery by means of the supplied charging power pack.

4.0 Setting up and starting up

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Fig. 3. Cable holder Cable clip Front pad headlight connection

Fig. 4. Connection of LED battery

4.2 Adjustment to head measurement (contin.)

Take one of the enclosed connecting cables and join it with the headlight connection (, fi g. 3).

Use the short connecting cable if you want to carry the LED battery on the headband. (fi g. 8, page 11).

Use the long connecting cable if you want to carry the LED battery in your coat pocket, in your trouser pocket or on your belt. This cable is also to be used if the headlight is to be

supplied from an ATMOS current source. If necessary, lead the cable under the front pad and through the cable holders in the joint of the headlight ATMOS HL 21 LED.

Use the enclosed cable clip (, fi g. 3) to fi x the long cable on your clothes.

Join the other end of the connecting cable with the socket on the rechargeable LED battery (fi g. 4) or with the current source in your ATMOS ENT examination unit.

Note: By means of its rear cable clip, the rechargeable LED battery can be fi xed to your coat pocket, to your belt or to the battery holder on the headlight ATMOS HL 21 LED.

4.0 Setting up and starting up

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4.3 Functionality of the rechargeable LED battery

4.3.1 Capacity indication

Charging of the LED battery must be checked regularly as the light expires very fast when the battery gets fl at. We recommend to change resp. charge the battery when the capacity is <50%.

As long as the test button (, fi g. 5) of the rechargeable LED battery is pressed, the battery capacity is shown for about 3 seconds (, fi g. 5, green LEDs for levels 1 ... 5).

4.3.2 Charging the LED battery

Use the primary adapter fi tting your power supply (Euro/US/ UK/Aus). See information enclosed to the charging power pack.

To charge the LED battery, separate it from the headlight ATMOS HL 21 LED.

Join round connector of the power pack cable with the socket (, fi g. 6) on the LED battery.

During the charging process, the current battery capacity is indicated (, fi g. 5, LEDs for levels 1 ... 5). The battery is fully charged when all 5 LEDs expire again.

During charging, operation of the headlight is impossible!

Fig. 6. Connecting socket for headlight Charging socket on LED battery

Fig. 5. Test button Indication of battery capacity (green LED)

Charging of the LED battery must be checked regularly as the light expires very fast when the battery gets fl at. We recommend to change resp. charge the battery when the capacity is <50%.

During charging, operation of the headlight is impossible!

4.0 Setting up and starting up

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5.0 Operation

5.1 Different variants of the headlight ATMOS HL 21 LED

Fig. 7: Headlight ATMOS HL 21 LED with long cable, supply from the LED battery in the coat pocket or from a suitable ATMOS current source in an ENT examination unit.

Pay also attention to the respective operating instructions of the ATMOS ENT examination unit.

Fig. 8: Headlight ATMOS HL 21 LED with short cable, LED battery in battery holder on the headlight.

For removing the battery holder, proceed as follows: • Use the turning knob to adjust the headlight rack quite tight. • Remove the centric cover in the turning knob and then take a Philips head screwdriver to remove the screw. • Remove the turning knob. • Remove the battery holder. • Add the turning knob again. Make sure that the tight adjustment of the headlight rack

has not changed. Otherwise, the headlight rack is to be pushed toghether again. • Add screw and cover again.

Fig. 7. Headlight without battery holder Fig. 8. Headlight with battery holder

Pay also attention to the respective operating instructions of the ATMOS ENT examination unit.

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Fig. 9. Focusing Headlight rack Focusing ring

5.2 Switching on

Adjust the lateral switch on the LED battery to the desired position:

ECO mode: operation for about 4 hours.

POWER mode: operation for about 2 hours.

5.3 Focusing the headlight

The size of the light spot can be adjusted by turning the focusing ring (, fi g. 9).

5.0 Operation

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6.0 Cleaning

The measures described for cleaning and disinfection are not intended to replace the regulations applicable for the respective operation!

Always comply on principle with the relevant manufacturer’s information regarding concentration and material compatibility!

Do not use any: • Disinfectants containing organic or inorganic acids or bases since these may cause corrosion damage. • Disinfectants containing chloramines, phenol derivatives or anionic tensides since these may cause stress cracks in the plastics used.

When the headlight ATMOS HL 21 LED is applied by several users, regular cleaning and disinfection is necessary.

Do not touch the lens in the light object.

Fingerprints can be wiped down with a soft cloth. If necessary, you may use ethanol.

The surfaces can be cleaned with a moist cloth. If necessary, you may use ethanol.

5.2 Switching on

Adjust the lateral switch on the LED battery to the desired position:

ECO mode: operation for about 4 hours.

POWER mode: operation for about 2 hours.

5.3 Focusing the headlight

The size of the light spot can be adjusted by turning the focusing ring (, fi g. 9).

Always comply on principle with the relevant manufacturer’s information regarding concentration and material compatibility!

When the headlight ATMOS HL 21 LED is applied by several users, regular

regulations applicable for the respective operation!

The headlight ATMOS HL 21 LED cannot be sterilised.

The light body and the rigid headlight rack can be wiped down with a cloth moistened with a surface disinfectant (see page 14).

The front pad can be cleaned using a brush, clear water and soap. If necessary, you may use a 70%-ethanol solution. The cleaning agent must not contain tuluol. The front pad may also be cleaned in the washing machine (30°). Nevertheless, it may not be spin-dried or be put in the tumbledrier.

Do not touch the lens in the light object.

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6.1 Recommended surface disinfectants

Disinfectant Ingredients (in 100 g) Manufacturer

Incidin Plus Glucoprotamin 26,0 g Henkel, Düsseldorf(Application concentrate) Nonionic tensides Solvents, complexing agents

Dismozon pur magnesium monoperoxyphthalate Bode Chemie, Hamburg(Application concentrate) hexahydrate 80 g

Green & Clean SK alkyl-dimethyl-benzyl-ammonium (Application concentrate) chloride dialkyl-dimethyl-ammonium <1 g Metasys, Rum (Austria) chloride

6.0 Cleaning

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6.1 Recommended surface disinfectants

Disinfectant Ingredients (in 100 g) Manufacturer

Incidin Plus Glucoprotamin 26,0 g Henkel, Düsseldorf(Application concentrate) Nonionic tensides Solvents, complexing agents

Dismozon pur magnesium monoperoxyphthalate Bode Chemie, Hamburg(Application concentrate) hexahydrate 80 g

Green & Clean SK alkyl-dimethyl-benzyl-ammonium (Application concentrate) chloride dialkyl-dimethyl-ammonium <1 g Metasys, Rum (Austria) chloride

Prior to each application, check the device's functions and its proper condition. Damaged cables must be replaced immediately!

The headlight ATMOS HL 21 is low-maintenance. However, the regulations and instructions applying to the respective fi eld of application have to be taken into account.

Maintenance or opening and repair of the ATMOS HL 21 LED (with exception of the cleaning work described in these operating instructions) may only be carried out by ATMOS or a specialist authorised by ATMOS. In this case, attention should be paid to the protective technical and hygiene measures plus the safety information in chapter 2.0.

For repair, this device can be returned to ATMOS.

Prior to effecting a return shipment, clean and disinfect the device.

7.0 Maintenance and servicing

ATMOS cannot guarantee perfect functioning neither will it be liable for damage to people or property if: • Any non-original ATMOS parts are used. • The instructions for use contained in these operating instructions are disregarded. • Assembly, resetting, alterations, extensions and repairs are not carried out by people authorised by ATMOS.

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

● Rechargeable batteries are wearing parts and therefore excluded from the 2 years‘ product liability!

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8.0 Trouble-shooting

Symptom

No light

LED battery cannot be charged

Cause Remedy

LED battery is fl at

Cable is not correctly connected

Cable is defective

LED battery is defective

Charging power pack is defective

Charge LED battery

Connect cable

New cable is required

New LED battery is required

New charging power pack is required

Prior to dispatch, the headlight ATMOS HL 21 LED was subjected to an extensive functional test. If, nevertheless, a failure should appear, you may possibly clear it yourself if you follow these notes:

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9.0 Accessories, spare parts, consumables

9.1 Accessories

Description REF

Connecting cable for LED battery, 40 cm.................. 507.4542.0

Connecting cable for LED battery, 140 cm................ 507.4541.0

Connecting cable for LED battery, 200 cm................ 507.4545.0

Clip - for fixing the cable to clothes .......................... 507.4543.0

9.2 Spare parts

Description REF

Light body complete.................................................. 507.4537.0

Headlight rack........................................................... 507.4530.0

Universal battery quick-charging power pack ........... 011.1199.0with primary adapters assortment(Euro/UK/US/Aus)

Cable holder.............................................................. 507.4536.0

9.3 Consumables

Description REF

Replacement LED battery (lithium-ionic)................... ..........507.4510.0

Front pad .............................................................................507.4535.0

Nape pad .............................................................................507.4533.0

Remedy

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10.0 Technische DatenCharging power pack, 100...240 V~ 50/60 Hz; exchangeable primary adapters (Euro/UK/ US/Aus); secondary 12 V DC; 0.8 A via non-medical 1.8 m cable with DC plug 5.5 x 2.5 mm; protection class II; only for dry rooms

Rechargeable battery Charging with 12 V DC; approx. 120 min charging time after complete discharge; automatic switchover battery to compensation charging; capacity indication by 5 LEDs at the touch of a button and during the charging process; lithium-ionic battery with 3.7 V nominal voltage and a 1950 mAh capacity; at least 500 charging cycles possible; switch with 2 operating modes (Power and ECO): 120 min operation with full light performance and at least 240 min with reduced light performance; weight approx. 80 g

Light emitter White high-performance LED; Type 5500K; 2 watts; light spot focusing with a diameter of 25 to 55 mm in 25 cm distance to the eye

Headlight rack Head measurement adjustable from 50...64 cm, level 92...115 mm, weight with emitter: approx. 200 g

Connecting cable 40 cm, 140 cm and 200 cm long

Ambient conditions

Transport/storage -30 ...+50°C, 5...90 % humidity without condensing, air pressure 700...1060 hPa

Operation +10...+35°C, 20...80 % humidity without condensing, air pressure 700...1060 hPa

Regular safety Not necessarytechnical controls

Classifi cation acc. to IAnnex IX EEC directions93/42/EWG

Protection class II (charging power pack)(EN60601-1)

Protection category IP X0

Degree of protection Device / application part: Type B

CE identifi cation CE

UMDNS-Code 11-963

GMDN-Code 11963

Issue of Technical Speifi cations: 29.06.2011

Canadian Classifi cationDevice group: OphthalmologyPNC 86KAFRisk Class 1Description

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11.0 Disposal

The headlight ATMOS HL 21 LED does not contain any hazardous goods.

The LED battery (lithium-ionic) must be disposed of correctly.

Prior to disposal, device and accessories must be de-contaminated.

Make sure that materials are separated carefully.

Pay attention to country-specifi c regulations regarding the disposal.

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12.1 Notes on EMC

Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC notes.

Portable and mobile HF communication facilities can infl uence 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.

12.0 Annex

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.

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The device may not be used when being set up directly besides another equipment resp. when being stacked with other equipment. If, nevertheless, one of these arrangements is necessary, the device is to be observed to check its intended use.

12.0 Annex

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12.0 Annex

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P√

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12.0 Annex

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12.0 Annex

25

P√ P√P√

12.0 Annex

26

For your notes

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For your notes

MedizinTechnik

This document 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 document 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 operating instructions 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