MedizinTechnik

ATMOSPatient chair E 1

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ATMOS MedizinTechnikGmbH & Co. KG

Ludwig-Kegel-Straße 1679853 Lenzkirch/Germany

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

atmos@atmosmed.dewww.atmosmed.de

536.0000.B2015-02 Index: 04

English

Patient chair E 1

2

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)

atmos@atmosmed.dewww.atmosmed.de

Contents

Further information, accessories, consumables andspare parts are available from:

1.0 Introduction ............................................................... 3-51.1 Notes on operating instructions ...................................... 31.2 Intended use .................................................................. 31.3 Function ......................................................................... 31.4 Explanation of pictures and symbols .............................. 41.5 Scope of supply .............................................................. 51.6 Transport and storage .................................................... 5

2.0 For your safety ............................................................. 6 3.0 Setting up and starting up ........................................ 7-83.1 Setting up ...................................................................... 73.2 Starting up ...................................................................... 73.3 Power connection ........................................................... 8

4.0 Operating ................................................................. 9-114.1 Positioning the patient .................................................... 94.2 Adjusting the seat height ................................................ 94.3 Adjusting the backrest .................................................. 104.4 Moving the upper part .................................................. 104.5 Adjusting the arm rests ................................................ 104.6 Adjusting the head rest .................................................114.7 Foot rest ....................................................................... 114.8 Chassis (optional) .........................................................11

5.0 Cleaning ................................................................ 12-135.1 General information on cleaning and disinfection ........ 125.2 Cleaning the unit‘s surfaces and upholstery ................ 125.3 Recommended surface disinfectants ........................... 135.4 Recommended upholstery disinfectants ...................... 13

6.0 Maintenance and service ........................................... 14

7.0 Trouble-shooting ........................................................ 14

8.0 Accessories and Spare Parts .................................... 148.1 Accessories .................................................................. 148.2 Spare parts ................................................................... 14

9.0 Technical specifi cations ............................................ 15

10.0 Disposal ...................................................................... 16

11.0 Notes on EMC ........................................................ 17-19

General tems and conditions

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1.3 Function1.2 Intended useThe electrically height adjustable ATMOS E 1 patient chair has been designed for medical examinations. Height adjustment is achieved by an encapsulated infi nitely variable electric actuator. The removable headrest is also height adjustable. The moving and fold away armrests will maintain a horizontal orientation even if the backrest is being reclined to horizontal. Upper part rotates around 360° via a ball bearing and is equipped with an arrestor each 90°. The chair movement is controlled by a foot switch. The mechanically reclining backrest ranges from +7° (forward lean) to horizontal, the footrest features a fold away foot plate.

Option: chair is moveable to any direction on freely swivelling castors. (see options)

These operating instructions contain important notes on how to operate the ATMOS Patient chair E1 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. 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 Patient chair E1 and are therefore a must besides regular cleaning.Repair work and safety inspections may be carried out only by expert personnel authorised byATMOS. By applying only original spare parts you will have the guarantee that operational safety,readiness for work and the value of your ATMOS Patient chair E1 will be preserved.

● The product ATMOS Patient chair E 1 bears CE marking CE according to the EC Directive of the council for medical products 93/42/EEC, Directive 2007/47/EC dd. 05 September 2007 and meets the basic requirements of annex I of this directive. ● The product ATMOS Patient chair E 1 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 applied at ATMOS has been certifi ed 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

1.1 Notes on operating instructions

Name: ATMOS® Chair E 1Main functions:This patient‘s chair enables the optimum positioning of the patient with regard to height and access.Med. indications/ application:Positioning of the patient during standard ENT examinations and / or therapy.Specifi cation of the main function:• Electrical height adjustment via foot switch from 52.0 cm up to

72.0 cm• Upper part of the chair 360° rotatable and can be arrested at 90°• Infi nitely variable inclination of the backrest from +7° forward to

the horizontal position• Height adjustable and detachable headrest• Armrests can be folded up (individually)• Foot support, synchronous coupling with the backrestApplication organ: Positioning of the patientApplication time: Temporary (max. 60 minutes)Application site:In clinics and practices for ENT doctors and phoniatrists. The application of the doctor’s chair must be executed by medically trained persons only.Contraindications: NoneThe product is: X active □ not activeSterility: Not necessarySingle use product / reprocessing: No single use product

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Symbols of the ATMOS patient chair E 1

REF

1.4 Explanation of pictures and symbols

1.0 Introduction

!

■

●

→

clickclick

Symbols within these operating instructions

Warning, especial diligent notice!

Short cuts / symbols contained in this manual

Please press where the dot indicates

Subnumeration

Numeration

General informationFollow the arrows whilst proceeding, sequence

Checking

Please read, important information

Important notes

Order number

The CE sign shows that this product meets the appropriate requirements of the EC guidelines.

Application part type B

Move, plug ... in this direction

Turn, shift ...in this direction

Exchange

Engage,then check correct fi t

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Basic device

Operatinginstructions

1.0 Introduction

1.4 Scope of supply

● Prior to dispatch, the ATMOS patient chair E1 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).

1.5 Transport and storage● The transport of the device may be effected only in a dispatch

carton upholstered and offering suffi cient protection.

● Please document and report damages in transit immediately. For complaints or return deliveries, please use the enclosed form QD 434.

● The unit must be allowed to stand for up to six hours at room temperature prior to starting up for the fi rst time following transport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage the motor.

● Ambient conditions: Transport/Storage: -10...+50°C; 30...95 % air humidity non-condensing at air pressure 500...1060 hPa

Operation: +10...+35°C; 30...95 % air humidity non-condensing at air pressure 700...1060 hPa

Netzkabel

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!For your safety

2.0 For your safety

• The ATMOS patient chair E1 is designed in accordance with IEC 601/EN 60601-1. The chair conforms to VDE protection class I. It may only be connected to a correctly installed shockproof socket.

• The chair may only be operated under constant supervision (IEC 60601-2/EN 60601-1).

• Prior to starting the chair for the fi rst time, check whether the supply voltage indicated on the line voltage selector corresponds to the value of your local mains supply.

• The power cable supplied with the chair (or an equivalent one) must be used exclusively for connection to the mains supply.

• Observe correct wiring when installing plugs specifi c to foreign countries:

green/yellow: ground conductor blue: neutral conductor black or brown: phase

• Prior to starting the chair, check whether connecting cables show signs of damages. Damaged cables must be re-placed.

• For the purpose of separating the chair from the mains, the mains plug must always be pulled out of the wall socket fi rst before unplugging the power cable from the chair. Never touch power cord or plugs with wet hands.

• The ambient conditions specifi ed in section 9.0 "Technical specifi cations" must be strictly observed.

• The ATMOS patient chair E1 is not intended for operation in areas of medical rooms subject to danger of explosion. Areas subject to explosion hazards may be created by the use of infl ammable anaesthetics, skin cleansers and disin-fectants.

• Ensure that your patients sit in the middle of the seat. A constant unilateral strain on the seat can damage the surface.

• The user must be familiar with the operation of the chair.

• ATMOS cannot be held liable for injury to persons ordamage to property if- the parts used are not original ATMOS parts,- the user instructions given in this manual are dis-

regarded.

• Before using the ATMOS patient chair E1, please carefully read and observe the safety instructions and recommendations listed in this manual.

• The electric motor is protected by an integrated thermo protection switch. After 1.5 minutes of continued opera-tion, the motor needs a cool down period of approx. 8.5 minutes. If the thermo protection switch activates, the motor needs a cool down period of approx. 20 minutes

• The device may not be operated in: - explosion-hazardous areas - humid areas.

• In case of malfunction or abnormal noises, please imme-diately disconnect the chair from the mains supply. Please contact service technician.

• The device may only be used for the purpose described in these instructions.

• Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1

is required, if several devices are connected over one common power supply. The transformer must correspond to the power consumption of all the devices to be connec-ted.

• The maximum continues duty cycle of the actuator is lime limited, i. e. after 2 minutes of continues load an 8 minute cool off period is required.

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3.0 Setting up and starting up

3.1 Setting up

Make sure, product is set up on level, solid fl oor.

Line power and fuses

Line power : 230V / 50Hz (120V / 60Hz)

Fuses: 3.15 A T

3.2 Starting up

● Set up product at desired spot, make sure fl oor is even and level.

● Make sure, suffi cient space is available for proper rotation of the upper part of the chair

● Before fi rst operation of chair, read and observe the safety instructions in section 2.0.

● Finally, connect power cord.

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3.3 Power connection

Connect the ATMOS E 1 chair to line power using the included IEC power cord. Insert the power cord to the IEC socket at the back side of the chair base and the wall mounted power outlet. Make sure, power outlet features a proper ground connection. Find all relevant electrical data (voltage and nominal frequen-cy) as well as the data for fuses on the label located over the socket.

To disconnect the device from the mains supply, pull the power cord out of out let socket.

There is no indication, that product is hooked up to line power.

Disconnect chair, if not in use, during service and repair work and for cleaning.

3.0 Installation and start-up

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4.0 Operating

To adjust the chair height, press the left foot switch for up, and the right foot switch for down movements.

The arm rests fold away backwards, which will assist incapacitated people to shift from a wheelchair into the examination chair.

The infi nitely adjustable backrest is locked / unlocked by a release lever on either side of the backrest.

The arm rests, foot rest and back rest are mechanically interlocked and move synchronized.

The maximum continues duty cycle of the actuator is lime limited, i. e. after 2 minutes of continues load an 8 minute cool off period is required.

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4.1 Positioning the patient

Ensure that your patients sit in the middle of the seat. A constant unilateral strain on the seat can damage the surface.

4.2 Adjusting the seat height

The seat height is adjusted with the foot switch (fi g. 1.):

= upwards = downwards

Furthermore, the ATMOS patient chair features an “Auto – Down (homing)” function, driving the seat down to its lowest level after a short tap of the foot switch. Pressing the right foot switch for less than 0, 5 seconds will move the chair to home position. To stop the movement, just briefl y tap the switch again.

Fig. 1

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4.0 Operating

Fig. 3 Arm rests

4.5 Adjusting the arm rests

The arm rests (fi g. 3) can be individually swivelled off backwards.

4.4 Adjusting the backrest

– Press lever element (, fi g. 2) downwards,– adjust backrest to the desired position,– release lever element which will then return to its initial position,– backrest and foot support are arrested.

Arm rests, foot section and backrest are coupled and change their positions synchronously.

Fig. 2 Lever element

4.3 Moving the upper part

Upper part rotates around 360° via a ball bearing and is equipped with an arrestor each 90°.The patient can be rotated with the upper part in the desired direction..

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4.0 Operating

4.6 Adjusting the head rest

The headrest can be adjusted to a lower position by simply pulling out the retaining band; a higher position is reached by pushing the band in. For removing the headrest, pull the retaining band completely out of the backrest.

Fig 4 Head rest

4.7 Foot rest

If required, the foot rest can be folded down (fi g. 5).

4.8 Chassis (optional)

Do not transport any weights or persons on the chair.

The chair may be moved as soon as the red light illuminates.Clearance height: ca. 15mm.

Extend the chassis:• Move the chair upwards until the green light illumi-

nates (, fi g 6).• Push the lever to the left (, fi g. 8) to extent the chas-

sis.• Move the chair downwards until the red light illumi-

nates (, fi g. 6).The chair can now be moved.

Retract the chassis:• Move the chair upwards until the green light illumi-

nates (, fi g. 6).• Push the lever forward (, fi g. 7) to retract the chas-

sis.• Move the chair to the desired position / .

LEDs (fi g. 6) Red: extend the chassis, chair can be moved Green: lever can be adjusted

Lever position (fi g. 7 + 8):Only adjust the lever when the green LED is illuminated otherwise the chair can get damaged. Forward: retract the chassis Left: extend the chassis

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Fig. 5 Foot rest

!Fig. 7 Fig. 8

Fig. 6

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Do not use any abrasive cleaning agents. For the upholstery usual dry foam may be used.Treatment with a commonly used care product for artifi cial leather is recommended once a week in order to keep the upholstery soft and smooth.

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5.2 Cleaning the unit's surfaces and upholstery

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

● The surfaces of the ATMOS Patient chair E 1 are resistant against all the recommended surface disinfectants stated in chap-ter 5.3 and 5.4. Nevertheless after any length of time discolourations could possibly develop. Polar solvents (e.g. acetone or chlorinated hydrocarbons (CCs)) may not be used for cleaning and disinfecting.

Prior to cleaning and surface disinfection, please disconnect the chair from the mains supply.

● The unit itself can be wiped off with a moist (not wet) cloth.

● Substances such as blood need to be removed immediately to prevent stains on the cover material of the upholstery.

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The described measures to clean and to disinfect or sterilize do not rule out regulations valid for theparticular company!

In chapter 5.3 Recommended disinfectants“ all surface and instrument disintectants are stated which are suitable for disinfection.

Always observe the concentration specifi cationsand instructions by the respective manufacturer

Do NOT use

- disinfectants containing concentrated organic or anorganic acids or bases, since these may cause corrosion damages.

- disinfectants containing chloramides, phenol derivatives or anionic tensides, since these may cause stress cracks in the plastics used.

5.1 General information on cleaning and disinfection

5.0 Cleaning

Before cleaning

Medical devices must always offer a maximum in safety and function. We therefore recommend:

Prior to each application:

if

necessary

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5.0 Cleaning

5.3 Recommended surface disinfectant

● The surfaces of the ATMOS patient chair E2 can be cleaned/wiped with disinfectants containing the following active ingredients: • QAV (quarternary ammonium compounds)

5.4 Recommended disinfectants for the upholstery

Disinfectant Ingredients (in 100 g) ManufacturerATMOS Green & Clean SK Alkyldimethylbenzylammoniumchloride < 1 g Metasys, Rum (Austria)(application solutionungslösung) Dialkyldimehtylammoniumchloride < 1 g Alkyldimethylethylbenzylammoniumchloride < 1 g

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7.0 Trouble-shooting

6.0 Maintenance and service

The chair does not require any maintenance. However, a blown out fuse may occur and require replacement (ref. to Sect. 6.1).In case of malfunctions, please contact your local authorized ATMOS service technician.

Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts.

Please comply with the country specifi c guidelines regarding regular testing especially for the electrical safety.ATMOS recommends a test every 24 months.

6.1 Fuse exchange

Before commencing this job, make sure to disconnect the device from line power.

● To open the fuse socket rotate top ccw.

● exchange fuse,

● To close fuse socket, rotate top cw.

Malfunction Possible cause Solution

● Chair does not start up – Mains plug is not connected correctly – Check connection at the socket

– No mains voltage – Check house fuse

– Check mains plug on perfect fi t at the device

– Defective fuse – Exchange the fuse

In the case that any malfunction, please immediately inform your authorised ATMOS service.

REF

8.1 AccessoriesChild seat on request

8.2 Spare parts

8.0 Accessories and Spare Parts

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9.0 Technical specifi cations

Last update: 24.02.2015

Voltage 230 V~ ± 10 %; 50 HzSpecial voltage:120 V~ ± 10 %; 60 Hz

Current input max. 2.5 A

Power consumption 550 VA

Fuses 3.15 A T

Operating time Max. 8,5 min continuous operation afterwards cool down period 11 min

Seat depth 470 mm, wide, 500 mmm long

Seat height 520-720 mm

Vertical lift 200 mm

Vertical speed 13 mm/s

Lifting capacity / load 150 kg

Height adjustment 200 mm, mit 12 mm/s

Rotation 360°, detent every 90°

Height of back rest 900 mm

Back rest inclination + 7° bis –90° (horizontal position)

Protective earth conductor resistanceEarth leakage currentEnclosure leakage currentPatient leakage current

——N.C. < 0,1 mA—

Ambient conditionsTransport/storage

Operation

-10...+50°C30...95 % humidity without condensing,air pressure 500...1060 hPa

+10...+35°C30...95 % humidity without condensing,air pressure 500...1060 hPa

Dimensions HxWxD 1420 mm x 630 mm x 920 mm

Weight 92 kg

Weight with the base plate is movable 100 kg

Protection class (EN 60601-1) I

Period Tests Recommended: Testing every 24 months.

Circular safety controls According to accident prevention regulations a circular safety control has to be enforced every 2 years.

Degree of protectionType B

Protection category IP 20

Classifi cation acc. to Annex IXEC Directive 93/42/EEC

I

CE marking CE

Rules applied EN 60601-1EN 60601-2

UMDNS-Code 10-794

GMDN-Code 38447

REF 536.0000.0536.0000.4 (Special voltage)

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● The ATMOS patient chair E1 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 directly 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.

10.0 Disposal

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12.0 Notes on EMC

12.1 Guidelines and Manufacturer´s Declaration - EmissionsThe ATMOS Patient chair E1 is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS Patient chair E1 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 - GuidanceHarmonics IEC 61000-3-2 Class A The ATMOS Patient chair E1 is suitable for use in

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

Flicker IEC 61000-3-3

Inapplicable

12.2 Guidelines and Manufacturer´s Declaration - Immunity for ATMOS Patient chair E1

The ATMOS Patient chair E1 is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS Patient chair E1 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 ceramics tile. If fl oors are syn-thetic, 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.

Power Frequency 50/60 HzMagnetic fi eld IEC 61000-4-8

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

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.

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Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic

Environment - GuidanceVoltage 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 Patient chair E1 demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS Patient chair E1 from an uninterruptible current supply or a battery.

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

12.0 Notes on EMC

12.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS Patient chair E1 is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS Patient chair E1 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 up to 80 MHz

3 VPortable and mobile communications equipment should be separated from the Patient chair E1 incl. the cables by no less than the distances calculated/listed below.

Recommended distances:

d = 3,5/3 √ Pd = 3,5/10 √ P d = 7/10 für √ P

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 up to 2,5 GHz 10 V/m

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12.0 Notes on EMC

12.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS Patient chair E1

Recommended separations between portable and mobile RF Communicationsequipment and the ATMOS Patient chair E1

The ATMOS Patient chair E1 is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS Patient chair E1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS Patient chair E1 as recommended below, according to the maximum output power of the communications equipment.

Separation distance, depending on transmit-frequency mNominal output of the

transmitter

W

150 kHz bis 80 MHz

d = 3,5/3 √ P

80 MHz bis 800 MHz

d =3,5/10 √ P

800 MHz bis 2,5 GHz

d = 7/10 √ P

0,01 0,12 0,035 0,070,1 0,37 0,11 0,221 1,17 0,35 0,710 3,7 1,1 2,2100 11,7 3,5 7

For transmitters for which the maximum nominal output is not indicated in the above table, the recommended separation distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specification.

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

NOTE 2 These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.

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

NOTE 2 These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.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 Patient chair E1 is used exceeds the above compliance level, the ATMOS Patient chair E1 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.

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