Variotherm Operating Instructions Index 17 Aug 2014

Table of contents 1.0 1.1 1.2 1.3 1.4

Introduction Notes on operating instructions...3 Intended use...4 Function...4 Explanation of symbols...5

2.0 2.1

Safety advice...6 Advice for the user for maintaining hygienic status...7

3.0 3.1 3.2 3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.4

Installation and start-up Standard delivery...8 Illustrations... 9-10 Connections... 11 Electrical connection...11 Connecting a potential balance...11 Water connection...11 Connecting the irrigation handle...11 Start-up...11

4.0 4.1 4.2 4.3 4.4

Operation Activation of the Variotherm...12 Temperature adjustment... 12 Time setting...12 Thermal nystagmus stimulation ...12

5.0 5.1 5.2 5.4

Cleaning General information on cleaning and disinfection...13 Recommended disinfectants...14 Cleaning method for handle with jet connection for water irrigation tip...14

6.0 6.1 6.2 6.3 6.4

Maintenance and service Functional test...15 Visual inspection...16 Electrical test...16 Cleaning method for handle with jet connection for water irrigation tip and handle...16

7.0

Trouble shooting...17

8.0 8.1 8.2

Accessories and spare parts Accessories...18 Spare parts...18

9.0

Technical Specifications...18

10.0

Disposal...19

11.0

Notes on EMC...19 General Standard Terms and Conditons

2

Page

1.0 Introduction 1.1

Notes on operating instructions

 These operating instructions contain important notes on

how to operate the Variotherm plus safely, correctly and effectively. Therefore, they are intended not only for new operating personnel to be instructed in its use, but also for use as a reference manual. They help to avoid risks, and also to reduce repair costs and down-time. Furthermore, reliability and service-life of the equipment will be increased. For these reasons these operating instructions must always be kept available near the appliance. Prior to first use please peruse the chapter “Safety advice”, in order to be prepared for any possible dangerous situations. It would be too late during in actual use. The basic principles are: Judicious and careful work provides best protection against accidents! Operational safety and readiness for use depend not only on your capabilities, but also on care and maintenance given to the Variotherm plus. For this reason regular cleaning and service work are a must. Major maintenance and repair work may be carried out only by expert personnel authorised by ATMOS. In case of repairs you should insist that only original spare parts are used. You will then have the warranty that operational safety, readiness for work and the value of your appliance will be preserved.

 The product Variotherm bears CE Marking CE-0124

according to the EC Directive of the council for medical products 93/42/EEC and meets the essential requirements of this directive.

 The product Variotherm complies with all applicable re-

quirements 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.

ATMOS

MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch Deutschland / Germany Telefon: + (49) 7653 689-0 Fax: + (49) 7653 689-190 + (49) 7653 689-493 (Service Center) e-mail: [email protected] Internet: http://www.atmosmed.de

 The quality management system applied at ATMOS has

been certified according to international standards EN ISO 9001 and EN ISO 13485.

 Reprints, also in extracts, only with written permission by ATMOS.

Abbreviations / symbols in these operating instructions:

 Indicating a list Subdivision of a list/activity • The recommended sequence must be followed in each case!  Indicating particularly important advice!



Describing the effect of an activity.

3

1.0 Introduction 1.2

Intended use

Name:

ATMOS® Variotherm

Main functions: Device for rinsing the auditory canal and stimulation of the vestibular organ Med. indications/ application: Stimulation of the vestibular organ Specification of the main function: Produces a jet of water for the ear irrigation at body tempera-ture (37°C) with a flowrate of 400 ml/min for the removal of cerumen. Stimulation of the vestibular organ with a defined flow and a fixed temperature for the functional testing. Application organ: Auditory canal to the drumhead Application time: For the short-term application (max. 60 minutes) on patients. Application site: For ENT doctors and phoniatrists in clinics and practices. The therapy with the ATMOS irrigation devices may only be performed by medically trained staff. Contraindications: Do not apply to an infected resp. contaminated auditory canal or to a perforated eardrum. The product is: X active Sterility:

□ not active

Not necessary

Single use product / reprocessing: No single use product

1.3

Function

 When removing the irrigation handle from its holder,

automatic change into the irrigation mode. Here, the auditory canal can be rinsed with water warmed up to 37°C and a flow of at least 400 ml/min.

 Possibility to change into the stimulation mode for stimu-

lating the vestibule with a reduced flow of water. The Variotherm plus is equipped with a timer for preselecting the stimulation time.

4

1.0 Introduction

1.4

Explanation of symbols Pay attention to operating instructions! Type B equipment as to IEC 417

°C

Temperature in degree centigrade

s

Timer adjustment in seconds Timer

Cold stimulation 20 - 36°C

Warm stimulation 38 - 47°C Rinsing mode (water temperature 37°C) Setpoint value adjustment possible

Increase of setpoint value Decrease of setpoint value

Handle

{

Low

Reduced flow for stimulation of the vestibule

High High flow for rinsing the auditory canal

5

2.0

Safety advice

 The Variotherm plus unit is produced according to

IEC 601/EN 60601 and listed in the following classes: • VDE Class of protection 1 • Class IIa (EEC 93/42).

 The appliance may be installed and operated only in examination units from ATMOS.

 The Variotherm plus may be used in supervised operation

by qualified personnel only who have been authorised by ATMOS and who have been trained for operating the appliance (IEC 601-1/EN 60601-1).

 The mains voltage specified on the type plate must correspond with the data of the power supply system.

 Prior to every application of the equipment make sure that

 Additional equipment, which is to be connected to the analog and digital interfaces of the appliance, must provably meet the requirements of relevant EN specifications (for inst. EN 60950 for data processing equipment and EN 60601 for electrical medical appliances). Furthermore, all configurations must satisfy system specification EN 606011-1. Whoever connects additional equipment to the signal input or signal output section is a system configuration operator and as such responsible for meeting the requirements of system specification EN 60601-1-1. In case of further questions please contact your local specialist supplier or the technical service.  The irrigation jet must not get into contact with contaminated material.

 Application of the warm water jet only with tube tip put on!

it is technically safe and in proper condition. Damaged leads must be replaced immediately!

 Caution to be paid to avoid injury to eardrum when

 Correct configuration in assembly of country-specific

 For hygienic reasons jet connections must be changed

connections green/yellow: blue: black resp. brown:

protective conductor (PE) neutral conductor (N) phase (L)

 The control panel must be well visible to and in reach of the operator.

  Metal parts can be hot!  Prior to spraying, the water temperature must be checked by the user!



 Switch off main switch of the examination unit after

finishing work in practice and close water cock of water supply.

 The ATMOS Variotherm may be operated only in

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

introducing the jet!

after each patient. This prevents also retrograde germination of the warm water system.

 Use only for irrigation of auditory canal !  ATMOS is not liable for personal injury and damage to

property if • no original ATMOS parts are being used, • the advice for use in these operating instructions is not being observed, • assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS.

 Prior to ear rinsing, the user has to control the output pressure, it may not exceed 2.2 bar.

 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 connected.

 The flow rate has to be checked after switch on or

at least once a day with a measuring cup. The quantity of 500 ml/min may not be exceeded. The water jet has to be straight.

6

2.0

Safety advice

2.1 Important instructions for the maintenance of the hygiene status of warm water irrigation units For loosening cerumen in the auditory meatus and for the stimulation of the labyrinthine system, ATMOS offers the warm water units Hygrotherm plus (37°C) and Variotherm plus (20° - 47°C). These units heat the drinking water which comes from the household connection to the preselected temperature. Should the following operating instructions not be adhered to, this can lead an increased number of germs in the rinsing water at these temperatures which can in turn lead to sensitive patients being subjected an impairment of their health. Requirement for taking into use



The water which is provided by the household connection must at least meet the WHO guidelines or the country-specific guidelines for drinking water.

Connection



Fresh water must flow through the wall connection for a period of approx. 1 minute prior to the ATMOS unit being connected.*



Ensure that the installation is hygienically carried out! Before screwing them into place, disinfect threaded connections with 70 % alcohol.*



When carrying out maintenance work on parts which come into contact with the water, wear disposable gloves.*



Carry out thermal cleaning at least 3 times before commissioning.* * This work is carried out by the ATMOS service technician.

Running operation



Exchange and disinfection required for contact parts such as the jet connection after each patient (prevention of retrograde germification).



Before use spray off water and check the temperature.

Service



Ensure that the suspended particle filter is hygienically changed (see commissioning) (dispose of filter and carefully clean the filter glass). Ensure that no contact is made with the contaminated parts.



Depending on the quality of the drinking water available, a biofilm growth cannot be excluded (despite our patented thermal process for reducing bacterial count). We, therefore, recommend to test the drinking water quality at regular intervals (acc. to ISO 6222) at the drinking water connection on the unit and on the application part. In case of a significant rise of germs, a biofilm removing process with following disinfection can be carried out.

7

3.0 Installation and start-up

3.1

Standard delivery

Quantity 1 1 3 1 1 1 1 1

8

Variotherm basic unit Irrigation handle with Double-barrelled hose Jet connection short, straight (80 mm) Splash protection Rubber bush for splash protection Three-holes gasket Hose tips for jet connection (30 pcs) Operating instructions

3.0 Installation and start-up 3.2

Illustration

 











 

Fig. 1 Front view

 Arrow keys up resp. down

(for temperature adjustment resp. time settings)

 Stimulation time display (double digits, resolution 1s)  Temperature display (double digits, resolution 1°C), shows actual value

 Start/stop key for stimulation (150 ml/min)  Adjusting key for stimulation time  Key for irrigation mode (37°C)  Key for warm stimulation (e.g. 44°C)  Key for cold stimulation (e.g. 30°C)

11

9

3.0

Installation and start-up 3.2

Illustrations



   



 

 

Fig. 2. Irrigation handle

 Handle  Connection for double-barrelled hose  Three-holes gasket  Adjusting screw  Release lever  Valve plunger  Jet connection  Splash protection  Cap  Double-barrelled hose Set screw

!

The sprayer tube must be exchanged after each patient. Adjusting flow quantity

 Prior to stimulation turn the set screw (11 , fig. 2) upwards and arrest it.

 2 adjusting possibilities: High: Low:

Flow quantity for rinsing the auditory canal Flow quantity for stimulating the vestibular organ

Prior to ear irrigation the set screw is turned downwards, inserted into the handle and then adjusted by turning it downwards again.

 For fine adjustment of the flow the adjusting screw ( 4 , fig. 2) is turned in respectively out.



10

Periodically check the water flow for the stimulation of the vestibular organ and readjust, if necessary.

3.0

Installation and start-up

3.3

Connections

3.3.1 Electrical connection  See operating instructions of the ENT unit. For connection to the mains supply we recommend a residual current circuit breaker!

3.3.2 Connecting a potential balance  See operating instructions of the ENT unit.

3.3.3 Water connection  See operating instructions of the ENT unit.

3.3.4 Connecting the irrigation handle  Insert a "three-holes gasket" (, fig. 2) in the double-

barrelled hose and fix it ( , fig. 2) to the connection on the examination unit.



Only use "three-holes gaskets" as otherwise correct function of the unit is not guaranteed!

 Insert a "three-holes gasket" in the irrigation handle and screw it on the free end of the double-barrelled hose.

 Open the water-tap of the ENT examination unit. Check whether all connections are tight.

3.4

Start-up

 Insert the handle in its holder; the jet must point to reverse side of the unit.

 Switch on the examination unit.  Automatic display test with digital figures " 8 8 " and audible signal.

 Automatic change into energy saving mode.  When the irrigation handle is removed from its holder, the irrigation mode with the last adjusted temperature is activated.

 When the irrigation handle is again inserted in its holder, automatic change into the energy saving mode.

11

4.0

Operating !

■ When the device is switched on, a segment test is performed. Here all LED light up for a short time. During this time please visually inspect perfect function of the LED. ■ Prior to caloric stimulation, checking of the water pressure is essential. The required pressure is 2 bar. Danger of overpressure!

ATTENTION: Please make sure that the water supply module is switched on and that water supply is guaranteed!

Temperature and time to be selected

 

Handle for thermal nystagmus stimulation

On / Off switch for nystagmus binoculars

Fig. 3 irrigation handle

Connection nystagmus binoculars

 set screw  adjusting screw

4.1 Activation of the Variotherm Remove the handle from the support. Due to the built in light barrier, the ear irrigation module starts up automatically. After taking out the handle the control of the Variotherm requires approx. 20 s until the requested temperature is reached. Check the temperature display! As long as the actual temperature deviates from the requested temperature, the LED of the "set button" is blinking. As soon as the requested temperature is reached, the LED is continuously illuminated. Only then start to rinse the auditory canal.

4.2 Temperature adjustment You may use the Variothem at temperatures betweeen 20°C up to 47°C. In order to change the set temperature the set button must be kept pressed*. With the arrow keys  the set temperature can be selected within 20-47°C. After release of the "set" button the new set temperature is adjusted and on the temperature display the actual temperature is displayed. 3

4.3 Time setting (1-99 sec.) Keep  pressed and adjust the requested stimulation time with . Next time when the relevant temperature is selected again, the previous time setting is taken over automatically.

1

2

4

5

6

Please check the time setting of the timer once in a while.

4.4 Thermal nystagmus stimulation Remove the handle  select- and if need be, adjust the temperature (s. 4.3)  if required adjust the time  press  (is blinking approx. 10 sec.)  as soon as the Variotherm is ready a beep is audible  perform the nystagmus stimulation  after lapse of time a beep is audible again. * On the temperature display the desired value is shown.

12

5.0

Cleaning 5.1

General information on cleaning and disinfection

The jet connection which comes into contact with the patient must be disinfected after each use. The hose tips must be exchanged after each use. The surfaces of the Variotherm plus resist most of the common surface disinfectants. However, 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 plastic material used for the housing of the unit.

For cleaning and disinfection, you may also use disinfectant sprays or disinfectant tissues.



Switch off the ENT unit by the main switch before starting cleaning and disinfection.

Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution. Make sure that no liquid penetrates the unit. You may use all cleansers and disinfectants listed in section 5.3.



Spilled liquid must immediately be dry wiped.



Always observe the instructions for use by the manufacturer of the disinfectants, above all, concentration specifications.



The above measures for cleaning and disinfecting do not replace the respective precautions for operating the unit.

13

5.0 5.2

Cleaning Recommended disinfectants

Recommended instrument disinfectants Ingredients

(in 100 g)

Korsolex basic Glutaral (Application concentrate) (ethylene-dioxy)dimethanol tensides, salts, corrosion inhibitors

15.2 g 19.7 g

Sekusept aktiv sodiumpercarbonate, phosphonates (Application concentrate) non-ionic tensides 11.0 g 3.0 g

Instruments, automatic Neodisher MediClean NTA forte non-ionic tensides (Application concentrate)enzymes preserving agents

5-15 g < 5g

Ingredients

(in 100 g)

Dismozon pur magnesium monoperoxyphthalate (Application concentrate) hexahydrate

80 g

Green & Clean SK alkyl-dimethyl-benzyl-ammonium chloride (Application concentrate) dialkyl-dimethyl-ammonium chloride Alkyldimethylethylbenzylammoniumchlorid Perform

Bode Chemie, Hamburg

Ecolab, Düsseldorf

Gigasept FF new succinic acid dialdehyde (Application concentrate) dimethoxy tetrahydrofurane corrosion inhibitors

Machine disinfection

Manufacturer

Pentakalium bis(peroxymonosulfate)bis(sulfate)

<1 g

45.0 g

Schülke & Mayr, Norderstedt

Dr. Weigert, Hamburg

Manufacturer Bode Chemie, Hamburg Metasys, Rum (Austria)

Schülke & Mayr, Norderstedt

If using aldehyde-containing or amine-containing disinfectants at the same object, this may result in discolourations.

5.3

Cleaning method for handle with jet connection for water irrigation tip

The ATMOS appliances Variotherm and ATMOS Hygrotherm are used, according to the rules, with disposable hose tips (disposables). These tips must be disposed off after each application to the patient. When using the hose tips ATMOS recommends a reprocessing in line with the below cleaning and disinfection plan.

S

Recommendations

Who Monthly

D

Reinigung Desinfektion Sterilisation

Weekly

R

When

Daily

Aufzubereitende Teile

How NAfter each procedure

What

Ear irrigation / Thermal nystagmus stimulation Ear irrigation bowl

X

X

Manual cleaning and disinfection

Handle

X

X

Wipe cleaning and wipe disinfection

Jet connection

X

X

Wipe cleaning and wipe disinfection

X

Splash protection

X

X

Wipe cleaning and wipe disinfection

X

Hose tip (disposable)

Exchange after each application

X

Rinsing attachment

X

Exchange after each application Manual cleaning and disinfection

X

Hygiene fi lter

14

X

See operating instructions for hygiene fi lter

X X

X

Qualifi ed and trained staff who are familiar with reprocessing. (Please fi ll in the responsible person -> use a water-based overhead marker)

6.0

Maintenance and service

Decalcification and change of filter (see sections 6.4, 6.5) should be carried out immediately by the user when required.

Safety-related inspection

The safety-related inspection must be performed according to §4 clause (4) of the Medical Device Operator Ordinance, after each maintenance measure. The safety-related inspection must be performed to guarantee safety and operational reliability of the most important constructive and functional features, as far as they can be influenced by maintenance measures. However, according to §6 clause (1) of the Medical Device Operator Ordinance, the inspection must be performed at the leat once a year.

6.1

Safety-related inspection Test

  Shut-off main water tap and observe temperature indication.  After a few seconds error signal will appear "E1" (= no water).   Testing the displays.  All optical and audible indicators issue their signal during the first second after switching on (in particular segmental test "8 8 "). 

 Set all temperature setting switches on 40°C and test consecutively by touching the corresponding keys

whether in all ranges 40°C is reached in ACTUAL temperature indication. • Spray off and check water temperature by hand. • Carry out the same test with temperatures 37°C and 28°C.

  Measure temperature of water splashed off at standard settings: 30°, 37° and 44°C.  The value may not deviate more than ± 0,5° ± 1/2 digit, i.e. 1°C in total. Typically, however, values are better than ± 0,5°C. This measurement is critical! Measuring probes or thermometers which are too large may cause faulty measurements because of substantial heat removal, inertia, and because their temperature sensitivity is not localised on a point but spread over a larger surface. Instruments whith an immersion probe, a precision of 0.3°C and a resolution of 0.1°C or better are suitable.

After setting the temperature, at least 1 minute should be waited in order that the double-barrelled hose to the handle attains correct temperature.

See also chapter 4.0!

15

6.0 6.2

Maintenance and service Visual inspection Test





Check unit for external damage (damage to cables, hoses, filter and irrigation handle).





Check hose system for external indications for leaks (drops, water spots, corrosion deposits etc.).





Inspect unit, insulated from power supply and with open housing, for internal damage, leaks, corrosion, and deposits (mineral scale). Close housing again and tighten screws, connect mains cable again.





Check sign plates and inscriptions for completeness and readability.

6.3

Electrical test Test



Measure protective conductor resistance according to VDE 0751 (max. 0.3 Ohm).



  Measurement and comparison with "first value measured" of unit leakage current according to VDE 0751 (measured during operation).  The "value measured first" may not be exceeded by more than 50%. 

6.4 

Documentation and recording of evaluation and tests according to VDE 0751.



Decalcification  If the tap water in the area, where the unit is used, is known for mineral precipitation, preventive decalcification should

be carried out:

• • • • • •

Close water tap. Unscrew screwed glass of filter. Fill screwed glass with approx. 100 ml of decalcifier on acetic / citric, or lactic acid base (for inst. Citrosteril, by Fresenius). Screw glass on again. Open water tap again. Switch on the unit.  Decalcification now takes place automatically in the thermal process for reducing bacterial count. If after switching-on the unit has been in the thermal process for reducing bacterial count for 5 minutes the water passages have been decalcified and cleaned, and also sufficiently flushed. The Variotherm plus is again fully ready for operation. When water passages are heavily calcified, a modified procedure may become necessary, with a prolonged reaction period for the decalcifier.

 Recommendation: Calcification protection device, REF 502.0995.0.

16

7.0 Trouble shooting

Error in temperature display

"E0"

not used

"E1"

no water (water pressure <0.5 bar)

• Check, whether the water supply delivers a pressure of at least 2 bar (Did you open the water-tap?).

• Filter clogged? "E2"

-5V is missing (supply voltage on the control board)

"E3"

break of the safety NTC

"E4"

break of the safety NTC

"E5"

break of the regulating NTC

"E6"

not used

"E7"

temperature too high (>48°C), display only in the stimulation and irrigation mode, but not in the thermal process for reducing bacterial count

"E8"

short-circuit of the regulating NTC

• Inform service staff.

• Inform service staff. • Inform service staff.

• Inform service staff.

• Check, whether temperature setting is too high.

If necessary, adjust desired temperature to a value of <48°C by means of the coding switches.

• Inform service staff. • Have temperature feeler of the regulating NTC checked by the service staff.

"E9"



not used

If, nevertheless, the errors cannot be removed, inform the ATMOS service staff. Do not start any attempts to repair the unit yourself!

17

8.0 8.1

Accessories and spare parts Accessories Description

REF

Calcification protection device...502.0995.0 Jet connection, extra long, straight (110 mm)...508.0429.0 Rinsing connection (Teflon) for stimulating the vestibular organ...501.0355.0

8.2

Spare parts REF

Description

Irrigation handle...530.1190.0 Jet connection, short, straight (80 mm)...508.0427.0 Splash protection...501.0331.0 Rubber bush for splash protection...501.0331.1 Three-holes gasket device side...501.0320.0 Three-holes gasket handle side...530.1186.0 Hose double barrel for irrigation handle...530.1181.0 Jet connection for water irrigation handle 40 mm...502.0984.0 Hygiene filter for water irrigation...000.0918.0 Hose tips for jet connection (30 pcs.)...502.0844.0 Front foil Hygrotherm ...060.0514.0 Operating instructions...503.2030.B

9.0 Technical Specifications Voltage range

220 - 240 V~ ± 10 % 50/60 Hz Special voltage: 100 - 127 V~ ± 10 % 50/60 Hz

Current input

6.8 A (220 - 240 V~); 14.8 A (100 - 127 V~)

Power consumption

1500 W

Operating modes

0-450 ml/min at 37°C; Stimulation mode; Heating off (energy saving mode)

Stimulation time Timer indication Water temperature Temperature indication Feed temperature of the water Water quality

adjustable by timer from 1 up to 99 sec. Accuracy ± 0.5 s ± ½ digit 20°C - 47°C Accuracy ± 0.8 °C ± ½ digit (can only be guaranteed with unchanged ambient conditions) +7...+19.5°C Drinking-water

Operating pressure

at least: +2000 hPa (2 bar); max: +6000 hPa (6 bar)

Connections

Power connection Water supply Water drainage Connection for double-barrelled hose

Operating time

Continuous operation

Protective earth conductor resistance Earth leakage current Enclosure leakage current Patient leakage current

0,1 Ω max. 0.5 mA max. 0.1 mA max. 0.1 mA max.

18

9.0

Technical Specifications

Ambient conditions Transport/storage Operation

-20...+50°C; 5...90 % humidity without condensing, air pressure 700...1060 hPa +10...+35°C; 20...80 % humidity without condensing, air pressure 700...1060 hPa

Weight

approx. 5.5 kg

Protection class (EN 60601-1)

I

Degree of protection

Type B

Protection category

IPX0

Classification acc. to Annex IX EEC directions 93/42/EEC

IIa

CE marking

CE 0124

Rules applied

EN 60601-1: 1990 + A1:1993 + A2:1995 EN 60601-1-2: 1993 (EMV / EMC)

UMDNS-Code

10-548

GMDN-Code

34891

Reference-No.

502.0401.0 506.6002.0 510.2002.0 Issue of the Technical Specifications: Jan 2007

10.0 Disposal ● The ATMOS Variotherm 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. The device surface must be disinfected.

11.0 EMC notes The EMC notes are described in the operating instructions of the ATMOS S 61 Servant ENT workstation.

19

ATMOS General terms and conditions

MedizinTechnik

1. General:

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

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

Our General Standard Terms and Conditions apply exclusively. Client’s

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

also applies in the case of our culpable infringement of substantial contractual duties The indispensable conditions of German Liability

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

a one-off damage compen-sation

Standard Terms and Conditions are not recognised unless their validity

delivery value of the goods for each week’s delay, up to a maximum

worth 3 percentage points of the

is explicitly confirmed in writing. Our General Standard Terms and

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

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

the goods

to a period of twelve months.

7. Delivery - Familiarisation

10. Reservation of Ownership

Law remain unaffected thereby. - For second-hand equipment, the period of warranty shall be reduced

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

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

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

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

arising from the business relationship, including all demands arising

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

from installation orders, subsequent orders, repairs, accessory deliveries

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

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

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

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

basis of cheque and bill transactions, the ownership reservation applies

following our written order confirmation.

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

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

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

through our credit upon receiving the client’s cheque. In the case of

3. Orders

created costs. Our specialist traders operate a recording system so

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

Every order requires an exact description of all of our product’s details.

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

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

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

specialist trader undertakes to immediately report to us all events and

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

incomplete ordering details.

risks which must be reported in connection with our products.

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

4. Prices

8. Passage of Risk - Packaging

deducting appropriate utilisation costs.The client is responsible for

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

Unless otherwise stated in our order confirmation, delivery is agreed

order confirmation are ex factory prices and exclude packaging and

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

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

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

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

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

handling the goods with care. Should maintenance and inspection work

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

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

sale transaction. However, he must immediately assign all outstanding

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

confirm prepaid carriage. Transport packaging and all other packaging

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

prices appropriately should price reductions or increases, especially

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

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

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

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

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

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

insured by us at the client’s expense unless explicitly otherwise agreed.

claim ourselves remains unaffected thereby.We undertake to release

client on request.

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

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

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

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

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

percentage points higher than the outstanding claims. We reserve the

by the shipping company before accepting the delivery.

right to choose the securities to be released.

9. Warranty

11. Plans and Illustrations

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

The client is responsible for examining the delivered goods

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

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

immediately after receiving them to determine any eventual deficiencies

calculations and other documents which are attached to our proposals.

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

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

The client must receive explicit written permission before passing these

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

fulfil this examining and reporting responsibility, and should payment

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

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

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

and will be prosecuted.

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

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

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

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

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

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

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

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

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

connection with these General Standard Terms and Conditions and

due to disputed counterclaims.

serial number:

6. Delivery Periods Fulfilment of our delivery duties requires the punctual and proper

12. Jurisdiction and Place of Performance

the contracts closed with clients under them. This jurisdiction excludes

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

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

services free of charge - either on the client’s premises or in our factory

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

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

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

fulfilment of the client’s duties. The right to defense on the grounds of an

services through an authorised company;

We, however, are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recognised by

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

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

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

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

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

to withdraw from the contract or claim compensation for any increased

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

our central office is the place of performance.

costs incurred up to that time without setting a further deadline. The right

notified by us.

to make further claims is reserved. Furthermore, in such cases, the risk

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

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

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

Lenzkirch, September 2008

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

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

ATMOS MedizinTechnik GmbH & Co. KG

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

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

79853 Lenzkirch/Germany

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

parties have carried out repairs to our products or replaced parts

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

thereof. This applies regardless of the fact whether these measures

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

individually or collectively led to a deficiency of the product;

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

d. We accept no responsibility for damage defects caused by

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

- operational wear and tear;

the goods’ readiness for delivery within such delivery periods. Delivery

- incorrect installation or incorrect or insufficient maintenance;

periods stipulated by the client are not recognised

by us unless they

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

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

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

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

inappropriate or negligent handling and care, especially with respect

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

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

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

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

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

approved;

deliberate or grossly negligent action by us or our representatives for

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

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

parties; - the client’s negligence in handling the product; - unacceptable

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

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

by our deliberate infringement of contractual duties for which we are

vibrations.

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

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

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

unrest and insufficient ventilation. We are

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

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

not liable for damage to

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

deliberate or grossly negligent actions by us or our representatives or

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

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

This document is copyrighted. Duplication, translations, microfilming and savings on electronic systems, particularly for commercialpurposes are 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.