ATMOS Systema - cdn.atmosmed.comcdn.atmosmed.com/docs/907/ga_c11systema_gb_2018-03_vers20... · 3 1.0 Introduction 1.1 Notes on Operating Instructions These operating instructions

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ATMOS® C 11 Systema

GA1GB.110300.0

2018-03 Index: 20

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ATMOSMedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 1679853 LenzkirchGermanyPhone: + 49 7653 689-0Fax:+ 49 7653 689-190+ 49 7653 689-292 (Service Centre)E-mail: [email protected]: www.atmosmed.de

4.4 Compressed-air system ......................................154.4.1 Activation ............................................................154.4.2 Adapt / deposit sprayer .......................................164.4.3 Ear irrigation module compressed air (REF 541.1100.0) ................................................164.4.4 Ear irrigation bowl ...............................................164.5 ATMOS® LS 21 LED - quickstart .........................174.5.1 Connection ..........................................................174.5.2 Attaching the application part..............................174.5.3 Autostart function ................................................174.5.4 Intensity control ..................................................174.6 ATMOS® HL 21 LED - quickstart .........................184.6.1 Switching on........................................................184.6.2 Focusing the headlight ........................................184.6.3 Intensity control ..................................................184.7 LED cold light module .........................................184.8 Endoscope management ....................................194.8.1 Overview .............................................................194.8.2 Mirror quick-heater ..............................................194.9 Emptying the deposit for used instruments .........20

5.0 Cleaning and care .............................................215.1 General information on cleaning and disinfection.....................................215.1.1 Cleaning the unit surface ....................................215.1.2 Secretioncanister,bacterialfilterand suction hose ........................................................215.1.3 TestDDSbacterialfilter/ oversuction stop ..................................................215.1.4 Medicament sprayers..........................................225.1.5 Instrument trays ..................................................225.1.6 Endoscope quivers .............................................225.1.7 Ear irrigation bottle and ear rinsing bowl.............225.2 Recommended instrument disinfectants .............235.3 Recommended surface disinfectants ..................245.4 Recommended endoscope disinfectants ............255.5 Cleaning and disinfection plan ............................26

6.0 Maintenance and Service .................................286.1 Sending in the device..........................................28

7.0 Troubleshooting ................................................29

8.0 Options, accessories, and consumables ..............................................31

9.0 Technical data ...................................................33

10.0 Disposal .............................................................35

11.0 Notes on EMC ....................................................36

Content

1.0 Introduction .........................................................31.1 Notes on operating instructions ............................31.2 Intended use .........................................................41.3 Function ................................................................41.4 Explanation of symbols .........................................51.5 Scope of delivery ................................................. 5

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

3.0 Setting up and starting up .................................73.1 Required connections ...........................................73.2 Connection to electrical power line .......................73.3 Overview of complete equipment......................... 83.4 Back view ..............................................................8

4.0 Operation .............................................................94.1 Suction system......................................................94.1.1 Activation ..............................................................94.2 Canister systems ................................................104.2.1 Reusable canister systems .................................104.2.1.1 Bodywork secretion canister ...............................104.2.2 Insert / Remove DDS bacterial filter/oversuctionstop ........................................104.2.3 Using the DDS splash protector..........................104.2.4 Attach / remove DDS secretion canister lid ........114.2.5 Attach / remove DDS secretion canister handle .114.2.6 Close / open DDS secretion canister handle ......114.2.7 Removing / securing DDS secretion canister .....124.2.8 Insert DDS hose adapter ....................................124.2.9 Connecting the hose ...........................................124.2.10 DDS changeover docking station........................124.2.11 Draining of reusable canister system ..................124.3 Disposable canister system ................................134.3.1 Assembling the Receptal® secretioncanister system ...................................................134.3.2 Assembling the Medi-Vac® secretioncanister system ...................................................134.3.3 Assembling the Serres® secretioncanister system ...................................................134.3.4 Bemis® secretion canister system .......................14

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1.0 Introduction

1.1 Notes on Operating Instructions

These operating instructions contain important notes on how to operate the ATMOS® C 11 Systema safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases also the reliability and service-life of your device.These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Reproduction, even partial, is only permitted with written permission from ATMOS.These operating instructions must always be kept available near the device.

Care and period tests in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS® C 11 Systema and are therefore a must besides regular cleaning.Repair work and period tests may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS® C 11 Systema will be preserved.

• The unit ATMOS® C 11 Systema bears CE marking CE 0124 according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive.

• The unit ATMOS® C 11 Systema 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 and our general standard terms and conditions can be obtained on our website at www.atmosmed.com.

• ThequalitymanagementsystemappliedatATMOShasbeencertifiedaccordingtointernationalstandards 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.

These operating instructions are valid for the following devices:

ATMOS® C 11 Systema (sitting) REF 541.0000.0ATMOS® C 11 Systema (standing) REF 542.0000.0

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1.2 Intended use

Name: ATMOS® C 11 Systema

Main function: • Suction• Ear irrigation• Compressed air for medication spraying• Electric power supply for LED light handles and LED headlight• Power supply for optional LED cold light source• Instrument deposit• Mirror quick heater

Medical indications / application:

Standard ENT examination and/or therapy

Specification of the main function:

• Suction at 90 % vacuum / 100 mbar end pressure• Ear irrigation with 37 °C ± 2 °C, max. 500 ml/min• Compressed air for medication spraying, max. 2 bar• Power supply for LED, 700 mA or 1.000 mA • LED cold light source min. 80 kLux ± 10 %, colour temperature 5.600 K

Application organ: Mouth to pharynx, auditory canal to the ear drum and the nasal cavities

Application time: • ENT unit: Short term use (up to 30 days)• Suction / Compressed air / ear irrigation: Temporary application on the patient (less than 60

minutes)

Application site: Application sites are clinics and practices for ENT doctors and phoniatrists. The examination and/or therapy with the ENT unit may only be executed by medically trained persons.

Contraindications: • May not be used for irrigation of the paranasal sinuses.• May not be used for the Politzer manoeuvre.• The ear irrigation should not be applied to an infected auditory canal or a perforated eardrum.

The product is: active

Sterility: The ENT unit is no sterile product.

Single-use product / reprocessing:

The ENT unit is intended for multiple use. The device and parts of the accessories are reusable. For information on reprocessing, cleaning and disinfection please see the operating instructions.

1.3 Function• Suction system• Compressed-air system• Ear irrigation by means of compressed air• LED light handle ATMOS® LS 21 LED• LED headlight ATMOS® HL 21 LED• LED cold light source• Instrument deposit• Endoscope management• Mirror quick heater

1.0 Introduction

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1.4 Explanation of symbols

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→

Graphic symbols contained in these operating instructions

Warning, special diligent notice

Short cuts / symbols contained in these operating instructions

Please press where dot indicates

Subnumeration

Numeration

General informationFollow the arrows

Replace

Check

Please read, important information

Move, plug... in this direction

Engage, check correctfit

Turn, shift... in this direction

) Important information

Symbols of ATMOS® C 11 Systema

Serial number

Order number

Manufacturing date

This product complies with the relevant requirements of EU Directive

REF

SN

Observe operating instructions!

Professional disposal

1.5 Scope of deliveryThe ATMOS® C 11 Systema was subjected to an extensive functional test and was carefully packed prior to dispatch.Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).

Scope of delivery ATMOS® C 11 Systema (sitting):Basic module with two large drawers, one small drawer, service compartment for secretion canister, safe storage of three clean and three used endoscopes at a time, two connections for LED light handle ATMOS® LS 21 LED and headlight ATMOS® HL 21 LED, support for LED light handle with automatic start-up function by means of light barriers, three supports for medicament sprayers, two supports for rinsing bottles, suction module, suction hose, power cable, operating instructions

Scope of delivery ATMOS® C 11 Systema (standing):Basic module with three large drawers, one small drawer, service compartment for secretion canister, safe storage of three clean and three used endoscopes at a time, two connections for LED light handle ATMOS® LS 21 LED and headlight ATMOS® HL 21 LED, support for LED light handle with automatic start-up function by means of light barriers, three supports for medicament sprayers, two supports for rinsing bottles, suction module, suction hose, power cable, operating instructions

This product is not re-sterilizable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these

components lose their function and there is a high infection risk.

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Suction system

Compressed-air system Potential equalisation

1.0 Introduction

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2.0 For your safety

!For your safety

• The ATMOS® C 11 Systema is produced according to IEC 601 / EN 60601 and listed in the following classes:

- VDE Class of protection 1 - Class IIa (93/42/EEC).

• The device may only be connected to a properly installed safety socket. Correctconfigurationinassemblyofcountry-specificconnections:

- green/yellow: protective conductor (PE) - blue: neutral conductor (N) - black or brown: phase (L)

• The ATMOS® C 11 Systema may be used in supervisedoperationbyqualifiedpersonnelonlywhichhas been authorised by ATMOS and which has been trained for operating the appliance (IEC 60601-1/EN 60601-1).

• The mains voltage indicated on the type plate must correspond to the values of the supply network.

• Valves must be checked for correct function in regular intervals!

• Arrange a sight check every morning for the hoses, secretion canister and cables. Exchange damaged parts immediately! Only proper and undamaged plugs and extension cables may be used.

• Switch off the unit before you open it and separate it from the line voltage.

• Never leave the patient unattended at the treatment unit.

• This product is not re-sterilizable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.

• In case that there is no adapter attached to the light conductor,touchingthelightsourcewitheitherafingeror any tool should be avoided. On the one hand this may damage the lens and on the other hand there is a risk of injury.

• Itisnotallowedtouseflammablesubstanceswiththedevice.

• Switchoffthemainswitchafterfinishingworkinpractice.

• If the device is connected to the mains by means of a mains distributor together with other electrical devices the total leakage current of all connected devices must not exceed 0.5 mA. In case of leakage currents exceeding this value, the devices have to be connected to the mains by means of wall mounted connectors. Alternatively the devices can be operated by using an isolating transformer according to IEC 60601-1 with insulation monitoring or any similar safety device.

• Do not place used contaminated instruments on the ENT unit except on destined places!

• Theambientconditionsspecifiedinthe"Technicaldata"must be strictly observed!

• Care is to be paid in respect to light sources when working with endoscopes. Do not look directly into the light outlets! In case of possible light failure remove the endoscope from the working area.

• The ATMOS® C 11 Systema may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments.

• The ATMOS® C 11 Systema meets the immunity to interference requirements of IEC 60601-1-2 / EN 60601-1-2 „Electromagnetic Compatibility – Medical Electrical Devices“.

• The ATMOS® C 11 Systema may not be operated with devices not complying with the requirements of standard EN 60601-1 „Medical Electrical Equipment“ and EN 60601-1-2 „Electromagnetic Compatibility“ (Medical Electrical Equipment).

• 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.

• Do not restrict the air supply at the rear of the unit!• Payattentiontothecorrectfitofthelightsource

ATMOS® LS 21 LED in the holder. • With every light source a warming of tissue due to

radiation and absorption could occur. This could result in damage to the biological tissue.

• Please make sure to reduce duration of use to a minimum, to switch off the light source when not in use and to check heat development if necessary.

• Avoid looking directly into the light source.• Never touch the connection of the LED light source or

the metal parts of the bottle warmer and the patient simultaneously (700 mA & 1000 mA).

• In order to avoid the danger of an electric shock this device should only be connected to an earthed power connection.

• Warning: Do not modify the device without permission of the manufacturer.

• Caution: The light handles become warm during use.• The potential equalization module must be connected

according to EN 60601-1 3. edition chapter 8.6.7. This is required in order to equalize all the wiring from the various medical devices which are used together.

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3.2 Connection to electrical power line

• According to the directions of VDE 0107 and VDE 0100, medically used rooms have to be equipped with a leakage current protective circuit (FI protective circuit) with a nominal leakage current of < 0.03 A. The installation must correspond with VDE 0107.

• The power cable of the ATMOS® C 11 Systema is connected to an earthing contact socket which is to be mounted near the unit(max.5m,seefig.).Thismayonlybecarriedoutbyauthorizedqualifiedpersonnel.

• The power consumption comes to 270 W max. • For the connection of further electrical devices, please allow for extra plugs (installation of an electrically operated patient

chair, etc.).• Inordertoswitchontheunitbringtheon/offswitchinto"on"position.• Inordertoswitchofftheunitbringtheon/offswitchinto"off"position.Inthispositiontheunitisdisconnectedfromthepower

supply.

Unit / Device Maximum required connectionsATMOS® C 11 Systema 1x earthing contact socket outletOptional:Monitor 1x earthing contact socket outletMicroscope ATMOS® i View 1x earthing contact socket outletPatient chair 1x earthing contact socket outlet

3.1 Required connections (power supply)

15002260

552

1100 9601160

532

640

1600

8001519

3.0 Setting up and starting up

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3.0 Setting up and starting up

3.3 Overview of complete equipment

3.4 Rear view

Microscope, monitor and table are not shown.

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1 Hook for headlight with automatic switching (optional)

2 Endoscopemanagementforrigidorflexible,cleanoptics (optional)

3 Mirror quick heater (optional)

4 Disinfectant quiver for used endoscopes (optional)

5 LED light handle (optional)

6 Brightness controller

7 Connection for LED light source and LED headlight (optional)

8 1-channel cold light source (optional)

9 Deposit for used instruments (optional)

10 On / Off switch

11 Service compartment

12 Compartment for secretion canister

13 Drawers

14 Automatic suction equipment

15 Compressed air (optional)

16 Nebulization of medications (optional)

17 Ear irrigation module compressed air (optional)

18 Instrument deposit (optional)

19 Storage shelf (optional)

1 Mains supply

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4.1 Suction system

4.1.1 Activation

Take handle from holder. By the installed light barrier the suction system activates automatically.Thebacterialfilter/oversuctionstopoftheDDSreusablesystemandtheoverflowprotectionsinthesingle-usesecretioncanisters safely prevent from oversuction.Ifthecanistersarefilled,theoverflowprotectionsseparatethecanisterfromthevacuum.Thisisrecognizableduetothedecreasing suction capacity at the handle. In this case please exchange the disposable bag in the single-use system respectively remove, empty, clean and disinfect the reusable canister system as described in chapter 5 and insert a new bacterialfilter.

Donotoperatethesuctionsystemwithoutabacterialfilter.Alwaysusethesplashguardforextensionoftheutilizationofthebacterialfilter.ATMOSdoesnotassumeanyliabilityformalfunctionscausedbyoperatingthedevicewithoutbacterialfilter.Exchangethebacterialfilterregularly.Advicesinchapter4.2.2.The hose attachment must be exchanged after each patient.Please note that the tube set can be cleaned and disinfected mechanically by 70°C.

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!

4.0 Operation

Prior to application please check suction performance and leak tightness of the suction system.Pleaseremovethehosefromthesupport,sealthehoseendwithyourfinger.Checkwhethervacuumisbuiltup.In case of any leakage (no vacuum build up, hissing sound) please contact the service engineer (see chapter 4.2.10 DDS changeover docking station and chapter 6.0 Maintenance and Service).Please take care to insert the suction hose into the left support, mark with this symbol ,only(seefigurebelow).

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DDS canister handle340.0055.0

DDS canister lid with gaskets340.0053.0

DDSbacterialfilter340.0054.0

DDS splash protection340.0056.0

DDS secretion collection canister1,5 l 340.0050.0 resp. 3,0 l 340.0051.0

DDS hose adaptor set 340.0057.0

4.2 Canister systems

4.2.1 Reusable canister system

4.2.1.1 Bodywork secretion canister

4.2.2 Insert / Remove DDS bacterial filter / oversuction stop

) Please wear gloves for inserting resp. removing the DDS bacterialfilter!

4.2.3 Using the DDS splash protector

4.0 Operation

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4.2.4 Attach / remove DDS secretion canister lid

• PlacetheDDSsecretioncanisteronafirmsurface,position the lid horizontally on top (the lid may not be twisted!).

• Press it tightly with both hands as far as it will go onto the canister.

• With one hand on the canister handle lift the complete canister upwards. With the other hand on the canister base guide the canister in order to prevent it from tilting when lifting it out.

• Unhinge the snap-in hook of the canister handle at the canister. Pull out the snap-in hook with both hands and remove the canister handle upwards. Remove bacterial filter/oversuctionstopfromthecanisterhandle.

• Remove the canister lid from the canister with both hands. Remove the splash protection.

4.2.5 Attach / remove DDS secretion canister handle

• Fix the secretion canister handle into the guiding of the lid with opened snap-in hook .

• Fix the snap-in hook below the canister edge and press at the upper part towards the centre of the canister until the handle snaps in.

4.2.6 Close / open DDS secretion canister handle

• To close, secure the snap-in hooks under the edge of the secretion canister, and then press the clips downwards until they lock into place.

• To open, pull the clips upwards to release the snap-in hooks and remove from under the edge of the secretion canister.

4.0 Operation

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4.2.7 Removing / securing DDS secretion canister

• Open the storage compartment for the secretion canister (see page 8), remove the canister in lifting it vertically upwards; for reinserting it, allow it to slide vertically downwards into the securing device.

4.2.8 Insert DDS hose adapter

• Press the required DDS hose adapter with 6 mm or 10 mm diameter into the opening “patient” on the DDS secretioncanisterlidtwistingslightlytoensureatightfit.

• Twist slightly in the same manner when removing.

4.2.9 Connecting the hose

Please put the hose on the hose adapter.

4.2.10 DDS changeover docking station

Maximum load of the station: 15 kg!• The DDS changeover docking station for 2 canisters with

changeover switch and direct docking may be used on the ATMOS® C 11 Systema.

• The changeover lever serves to switch the vacuum to the canister towards which the lever points.

• To remove or insert a canister, switch the changeover lever towards the canister that is not being replaced.

4.2.11 Draining of reusable canister system

The canister system has to be cleansed and disinfected regularly. Read more in chapter “5.0 Cleaning”.Openthesidedrawerregularlytocheckthefillinglevel.Drain the secretion canister manually at approx. half level.Pull the secretion canister horizontal out of the holder in the service compartment and remove the suction hose.

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4.0 Operation

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4.3.2 Assembling the Medi-Vac® secretion canister system

Insert the Medi-Vac® bag into the Medi-Vac® canister.Close the canister tightly at all sides.Check again for density, otherwise no vacuum can be built up.

Plug in the vacuum hose of the pump and connect the suction hose to the „patient“ connection.

Onlybagswithintegratedbacterialfiltermaybeused!!

Receptal® bag

MediVac® bag

4.3 Disposable canister system

4.3.1 Assembling the Receptal® secretion canister system

Insert the Receptal® bag into the Receptal® canister.Close the canister tightly at all sides.Check again for density, otherwise no vacuum can be built up.



4.3.3 Assembling the Serres® secretion canister system

Insert the Serres® bag into the Serres® canister.Close the canister tightly at all sides.Check again for density, otherwise no vacuum can be built up.



-0,2+0,2

MedizinTechnik

Tolerierungsgrundsatz ISO 8015 Schu

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IN IS

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6016

Ers.d.:

Zeichnungs/Artikel-Nr.(part no.)

Benennung (designation)

Werksto (material)

Konstr.-Nr.:

Bl.

Blatt(sheet)

Zust.(index)

Änderung(revision)

Datum(date)

Name(name)

Gepr.

Bearb.

NameDatum

Maßstab (scale)

Serres-Behälter 1 L

05.312.01.04

1:10

PC

1/1

1

02.08.2011

Ers.f.:

ATMOS MedizinTechnik GmbH & Co. KGLudwig-Kegel-Str. 12,14-16, 1879853 Lenzkirch / GermanyTel: +49 7653 689 -0Fax: +49 7653 689 [email protected]

Erstellt Baer

Alle Maße in mmall dimensions in mmAllgemeintoleranzen/General tolerancesISO 2768-mK

Serres® bag

Patient

Pump

Patient

Pump

PatientPump

4.0 Operation

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4.3.4 Bemis® secretion canister system

Insert the Bemis® bag into the Bemis® canister.Close the canister tightly at all sides.Check again for density, otherwise no vacuum can be built up.



4.0 Operation

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4.4 Compressed-air systemPrior to application check the leak tightness of the compressed air system.Remove the handle and see if any air is escaping. If there is any leakage contact the service technician (see chapter 6.0 Maintenance and Service).

Nebulization of medications (compressed air)

Handle for compressed air (optional)

• For security reasons you should avoid repeated activation of the handle of compressed air in a rapid sequence.• Makesureequipmentandhosesarefirmlyconnectedinordertobuildupasufficientpressure.• Pay note, insert the compressed air handle into the right support, marked with this symbol .

• There should be no Politzer manoeuvre performed with the compressed-air system!

4.4.1 Activation

Take handle from holder. By the installed light barrier the compressed-air system activates automatically.

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Bent sheet of metal with integrated support for correct sprayer-alignment

Ear irrigation module compressed air (optional)

4.0 Operation

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1

2 Prior to application, please check water pressure and water temperature on the back of the hand.In order to start the ear irrigation, please close the vent valve () and press the adjusting lever (). You stop ear irrigation in releasing the adjusting lever () and the vent valve (). Ear irrigation stops.Change the jet connection after each patient. Only use reprocessed jet connections, in order to prevent spreading germs.The glass vials have to be checked for intactness prior to every use (cracks, chippings on the winding, etc.). Broken glass vials may not be used for ear irrigation.

!

Adjusting leverVent valve

Adapt:

Stick () handle onto the medication bottle.Let snap, then lift medication bottle with handle out of the attachment ().By pulling the trigger, compressed-air will be applied into the sprayer ().

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Deposit:

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2

Adapt medication bottle top down into in the attachment.Press activator () and pull handle () backwards.

• Handle carefully when using a sprayer to avoid injuries.• Before using the sprayer bottle, check the defensibility of the included medications.• Clean all parts of the sprayer regularly! Read more in chapter 5.0 “Cleaning”.

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4.4.2 Adapt / deposit sprayer

4.4.3 Ear irrigation module compressed air (REF 541.1100.0)

4.4.4 Ear irrigation bowl

• Purpose: To collect the water during ear irrigation.

• The ear irrigation bowl is connected to the adapter of the suction system and is then held under the patient`s ear.

4.0 Operation

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4.5 ATMOS® LS 21 LED - quickstart

4.5.2 Attaching the application part

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4.5.1 Connection

ATMOS® LS 21 LED for ATMOS® C 11 SystemaREF 541.4300.0 white lightREF 541.4400.0 warm white

Endoscope adaptor WolfREF 507.4657.0

Endoscope* Endoscope with integrated light conducting cable*

Light conducting adaptor Storz*REF 507.4611.0 with detentREF 507.4612.0 for screwing

! Danger to the device!

CAUTION!• If the light source is used with unsuitable adaptors, the lens could be badly damaged!• Use optics only with the supplied and/or optional adaptors!• Make sure, the endoscopes with adaptor engage in the light source!

or

Light conducting adaptor Olympus*REF 507.0949.0

The integrated ATMOS® LS 21 LED features separate operating instructions.Please note:Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions! Never look directly into the light source!!

4.5.3 Autostart function

The light source is automatically activated when removing the light handle.

4.5.4 Intensity control

• Switch on the light source.• Turn the brightness controller anti-clockwise to reduce the brightness or clockwise to increase it.

) When the device is switched off the last adjustment will be kept.

*Not contained in scope of delivery. Optionally available.

Connection ATMOS® LS 21 LED

4.0 Operation

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The ATMOS® HL 21 LED features separate operating instructions.Please note:Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions!

Please note to use the right power connection, marked with 700 mA, for the headlight ATMOS® HL 21 LED.

4.6.1 Switching on

a)When the headlight is connected to the power supply of the ENT workstation, the headlight is automatically activated when removed from the headlight hook.b)For the connection of the headlight to the battery• Adjust the lateral switch on the LED battery to the desired

position: - ECO mode: Operation for approx. 4 hours. - POWER mode: Operation for approx. 2 hours.

4.6.2 Focusing the headlight

• The size of the light spot can be adjusted by turning the focusing ring.

4.6.3 Intensity control

• Switch on the light source.• Turn the brightness controller anti-

clockwise to reduce the brightness or clockwise to increase it.


!

!

4.6 ATMOS® HL 21 LED - quickstart 4.7 LED cold light module

Headlight rack

Focusing ring

The one-channel LED cold light module is delivered with an ATMOS/Storz adapter.The light conducting cable can be connected to the ATMOS/Storz adapter.When removing the light conductor the light source switches on automatically due to the built in light barrier.In case you use a light conducting cable from another manufacturer you will then require a suitable adapter.

Adapter exchangeIn order to release the adapter turn it to the left and then pull it out.Insertthenewadapterandturnittotherightuntilitisfirmlyin place.

Care is to be paid in respect to light sources when working with endoscopes. Do not look directly into the light outlets! In case of possible light failure remove the endoscope from the working area.

Intensity control

• Switch on the light source.• Turn the brightness controller anti-

clockwise to reduce the brightness or clockwise to increase it.


!

4.0 Operation

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Press the power-on button in order to activate the mirror quick heater. After 10 seconds it switches off automatically.

Fire hazard! Prior to each use on your patient check your instruments´ temperature (on the back of your hand or similar).

Only store and heat clean instruments!

Assoonasthemirrorheaterisactivatedallotherelectricaldevicesareswitchedoffautomaticallyuntilmirrorheatingisfinished.In case that the suction system is required simultaneously, it is activated when the suction hose is removed from the support and the mirror quick heater is switched off.

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4.8 Endoscope management

4.8.1 Overview

Plastic quivers for storage of clean optics (removable)

Plasticsquiverforstorageofusedopticsandfillingwithdisinfectantdilution(removable)

4.8.2 Mirror quick-heater

• Please treat the instruments carefully, when inserting resp. removing.• Please put used contaminated endoscopes only into the appropriate quivers.• Please take care to strictly separate clean from contaminated instruments.• Please observe the manufacturer's instructions when reprocessing endoscopes and in addition general rules and instructions

valid for reprocessing.• Reprocessing of endoscopes for reuse may not be performed at the workstation! Furthermore please observe existing

directives and rules.• Clean and disinfect the storage quivers regularly! Therefore please note the instructions in chapter “5.0 Cleaning”.

Power-on button

Danger of burning - Do never touch the cover of the mirror quick heater. The cover is hot!!

4.0 Operation

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Deposit for used instrumentsTobefilled/emptied

4.9 Emptying the deposit for used instruments

Please put the used instruments into the deposit for used instruments.

To empty the deposit for used instruments open the drawer and remove the closed plastic container. The lid can be removed and emptied.

Put a new or the reprocessed plastic container back into the drawer and close it.

4.0 Operation

21

5.1 General information on cleaning and disinfection

• Switch all devices off prior to cleaning and disinfection!• The described action relating to cleaning and disinfection

resp. sterilisation do not substitute the relevant instructions which must be adhered to prior to operation!

• For disinfection, you may use all listed surface and instrument disinfectants.

• Alwaysobservetheconcentrationspecificationsandinstructions by the respective manufacturer!

Do not use• Disinfectants which contain organic or inorganic acids or

bases as they could cause corrosion damage.• Disinfectants containing chloramides or phenol

derivatives, since these may cause stress cracks in the material used for the housing of the unit.

5.1.1 Cleaning the unit surface

• The surfaces of the ATMOS® C 11 Systema are resistant against all surface disinfectants listed on page 24.

• Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution.

• You may also use disinfectant sprays or disinfectant tissues for cleaning and disinfection.

ª Please note that the alcohol contained in these agents could corrode or cloud the protective covers if employed on a long term basis.

• All application parts which are exposed to direct contact with the patient during treatment must be exchanged or cleaned and disinfected immediately for hygienic reasons.

• Only deposit clean instruments on the board!• Clean and disinfect the instruments regularly!• Do not use any organic solvents (benzine, etc.) and no

abrasive cleaning agents.

5.0 Cleaning and care

5.1.2 Secretion canister, bacterial filter and suction hose

At the end of every working-day, following parts must be cleaned and disinfected:• Reusable secretion canister with lid system and bacterial

filter: - Detach all hose connections carefully on the lid

system and take secretion canister out carefully to prevent spills and contamination of the area. Dispose of the suction material correctly (also see chapter 4.2.7).

- Griplidsystemfirmly,openlidoffilterhousingbyturninginanti-clockwisedirectionandremovefilter.Rinse all parts thoroughly under running water. A detergent or cleaning agent may also be used if required. For disinfection, immerse the parts into disinfectants, observing the manufacturer's instructions regarding the residence time.

- Thebacterialfiltersaredisposablesandmustbedisposed of.

- It can also be cleaned in a washer-disinfector (with neodisher MediClean forte) and thermally disinfected at 93 °C.

- Max. cycles of reprocessing: DDS secretion canister system, silicone hose: 60 cycles

) Suction capacity is limited by the 1.5 l secretion canister. Therefore, do not use more than 1 l rinsing liquid and subsequently evacuate the canister.

) Insertanewfilter!

5.1.3 Test DDS bacterial filter / oversuction stop

TheDDSbacterialfilter/oversuctionstopisdisposable.Prior to each use please check whether the DDS bacterial filterisdryandclean.WetordirtyDDSbacterialfiltersmustbe replaced with new ones.When the vacuum is adjusted to “max” and the suction hose showsmorethan-0,3barthentheDDSbacterialfiltermustbe replaced.ReplacetheDDSbacterialfilteratleastonceaday.UseonlyoriginalATMOSbacterialfilters.The device may never be operated without DDS bacterial filter/oversuctionstop.

22


5.1.4 Medicament sprayers

• The sprayer tube must be exchanged after each patient. • Dismount the medication sprayer and thoroughly rinse all

parts under running water. A detergent or cleaning agent may also be used if required.

- Use water to thoroughly rinse all residues of these substances.

) Make sure that the air opening is not closed!• It can also be cleaned automatically and thermally

disinfected (preferred).• The sprayer nozzles can be cleaned by rinsing them with

a neutral detergent. It is advantageous to have a sprayer bottle (REF 000.0577.0) which is exclusively used for cleaning and disinfection.

) Whenfixingthetwintubenozzleagain,makesurethat the mark (0,X or milling area) on the nozzle shows upwards!

) Sprayer tubes are available as spare parts at ATMOS.

!

5.1.5 Instrument trays

• Before disinfection, thoroughly rinse the trays under running water. A detergent may also be used if required.

- Use water to thoroughly rinse all residues of these substances.

• It can also be cleaned in a washer-disinfector (with neodisher MediClean forte) and thermally disinfected at 93 °C.

5.1.6 Endoscope quivers

• The narrow plastic quivers of the endoscope holder are to be used solely for holding the endoscopes, these first having been cleaned and disinfected. The quivers are to be cleaned daily and subsequently disinfected.

• Plastic quivers are not autoclavable. Clean and disinfect manually. Machine cleaning up to max. 78°C.

5.1.7 Ear irrigation bottle and ear rinsing bowl

• The sprayer tube must be exchanged after each patient.• Dismount the ear irrigation bottle and thoroughly clean

all parts under running water. A detergent or cleaning agent may also be used if required. Residues of any cleaning agents must be removed completely. Afterwards disinfection is required.

• The ear irrigation bowl is not autoclavable! Cleaning and disinfection (also machine cleaning) up to 93°C.

) Sprayer tubes are available as spare parts at ATMOS.

23


5.2 Recommended instrument disinfectants

Manual disinfection of instrumentsDisinfectant Ingredients in 100 g ManufacturerKorsolex® med AF (Application concentrate)

N-dodecylpropane-1,3-diamineN-(3-aminopropyl)-N-dodecylpropane-1,3-diaminesurfactants, corrosion inhibitorsph-value regulators, foam inhibitors

15.6 g5.1 g

Bode Chemie, Ham-burg

Korsolex® basic(Application concentrate)

glutaral(ethylenedioxy)dimethanolsurfactants, salts, corrosion inhibitors

15.2 g19.7 g


Korsolex® plus(Application concentrate)

N-(3-aminopropyl)-N-dodecylpropane-1,3-diaminedidecyldimethylammonium chloridesurfactants, corrosion inhibitorscomplexing agents, ph-inhibitors

9.2 g13.0 g


Korsolex® extra(Application concentrate)

(ethylenedioxy)dimethanolglutaralbenzyl-C12-18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloridesurfactants, foam inhibitors, corrosion inhibitors

15.3 g7.5 g1.0 g1.0 g


neodisher® Septo MED(Application concentrate)

N-(3-aminopropyl)-N-dodecylpropane-1,3-diaminedidecyldimethylammonium chloridenon-ionic surfactants, perfumes

9.2 g13.0 g

Dr. Weigert, Hamburg

neodisher® Septo 3000(Application concentrate)

glutaral(ethylenedioxy)dimethanol

15.2 g19.7 g

Dr. Weigert, Hamburg

Sekusept® PLUS(Application concentrate)

glucoprotamin 25 g Ecolab, Düsseldorf

Sekusept® aktiv(Application concentrate)

Soduim percarbonate, non-ionic surfactants, phosphonate Ecolab, Düsseldorf

Gigasept® Instru AF(Application concentrate)

CocospropylendiaminguanidindiacetatePhenoxypropanolsBenzalkonium chloridenon-ionic surfactants, ph-value regulators, corrosion inhibitors

14 g35 g2.5 g

Schülke & Mayr, Norderstedt

Gigasept® FF (neu)(Application concentrate)

succindialdehydedimethoxytetrahydrofuraneanionic and non-ionic surfactants, perfumes, methylisothi-azolinone

11.9 g3.2 g


Gigazyme®

(Application concentrate)non-ionic surfactantsenzymes, corrosion inhibitors

5 - 15 g Schülke & Mayr, Norderstedt

Automatic disinfection of instrumentsDisinfectant Ingredients in 100 g ManufacturerDismoclean® 24 Vario(Application concentrate)

surfactants, micro-encapsulated enzymes, corrosion inhibi-tors, complexing agents


Dismoclean® 28 alka med(Application concentrate)

alkali dispenser, complexing agents, corrosion inhibitors, surface active materials


Dismoclean® twin basic / twin zyme


Dismoclean® twin basic alkali dispenser, complexing agents, corrosion inhibitorsDismoclean® twin zyme surface active materials, enzymes, stabilisers, corrosion

inhibitorsneodisher® FA Phosphates 15 - 30 g Dr. Weigert, Hamburgneodisher® MediClean forte(Application concentrate)

non-ionic and anionic surfactantsenzymes

< 5 g Dr. Weigert, Hamburg

Thermosept® alka clean forte(Application concentrate)

non-ionic surfactantsanionic surfactantsNTA (nitrilotriacetic acid) and its saltsenzymes, poly carboxylatescorrosion inhibitors

< 5 g< 5 g< 5 g< 5 g


Thermosept® RKN-zym non-ionic surfactants,enzymes, corrosion inhibitors, glycols

5 - 15 g Schülke & Mayr, Norderstedt

When using disinfectants containing aldehyde and amine at the same object colour changes may occur.

24

5.3 Recommended surface disinfectants

Coated surfacesDisinfectant Ingredients in 100 g ManufacturerGreen & Clean SK Di alkyl dimethyl ammonium chloride

Alkyl dimethyl ethyl benzyl ammonium chlorideAlkyl dimethyl benzyl ammonium chloride

< 1 g< 1 g< 1 g

Metasys, Rum (Aus-tria)

Dismozon® pur(Granulate)End of product 12/2014

magnesium monoperoxyphthalate hexahydrate 80.0 g Bode Chemie, Ham-burg

Dismozon® plus(Granulate)


Kohrsolin® FF(Application concentrate)

glutaralbenzyl-C12-C18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloride

5 g3 g3 g


Perform® Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt

Terralin® Protect(Application concentrate)

benzyl-C12-16 alkyldimethyl-, chloride2-phenoxyethanolaminoalkylglycinenon-ionic surfactants, perfumes

22 g

17 g0.9 g


Other surfacesDisinfectant Ingredients in 100 g ManufacturerDismozon® pur(Granulate)End of product 12/2014


Dismozon® plus(Granulate)


Kohrsolin® FF(Application concentrate)

glutaralbenzyl-C12-18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloride

5 g3 g3 g


Bacillocid® rasantEnd of product

glutaralbenzyl-C12-18-alkyldimethyl-ammonium chloridesdidecyldimethylammonium chloride

10 g6 g6 g


Mikrobac® forte(Application concentrate)

benzyl-C12-18-alkyldimethyl-ammonium chloridesN-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

19.9 g5 g


Perform® Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt

Terralin® Protect(Application concentrate)

benzyl-C12-16 alkyldimethyl-, chloride2-phenoxyethanolaminoalkylglycinenon-ionic surfactants, perfumes

22 g17 g0.9 g


Surface disinfection F 312 alkyl-benzyl-dimethyl-ammonium chloridenon-ionic surfactants, complexing agents, hexyl cinnamal, butyl phenyl proionale, linalool

13 g Dürr Dental, Bi-etigheim-Bissingen


25

5.4 Recommended endoscope disinfectants

Manual disinfection of endoscopesDisinfectant Ingredients in 100 g ManufacturerHelipur® H plus N glutaral

2-propanolethyl hexanolsurfactants, complexing agents, corrosion inhibitors, color-ants, perfumes

12 g,7.5 g0.5 g

BBraun, Melsungen

Helix® Ultra peracetic acid BBraun, MelsungenKorsolex® basic glutaral

(ethylenedioxy)dimethanolSurfactants, corrosion inhibitors, salts, perfumes

15.2 g19.7 g


neodisher® MediClean forte(Application concentrate)



Sekusept® aktiv(Application concentrate)

Soduim percarbonate, non-ionic surfactants, phosphonate Ecolab, Düsseldorf

Automatic disinfection of endoscopesDisinfectant Ingredients in 100 g ManufacturerKorsolex® basic glutaral

(ethylenedioxy)dimethanolSurfactants, corrosion inhibitors, salts, perfumes

15.2 g19.7 g


neodisher® MediClean forte(Application concentrate)



Gigasept® FF (neu)(Granulate)

succindialdehydedimethoxytetrahydrofuraneanionic and non-ionic surfactants, perfumes methylisothiazolinone

11.9 g3.2 g


Endozime® AW Plus 2-propanol Ruhof, Mineola (USA)AdaptacleanTM Potassium hydroxide, surfactants ASP, Norderstedt


26

What How

Recommendations

When Who

Reusable partsC

CleaningD

DisinfectionS

Sterilisation

Afte

r eac

h pr

oced

ure

Wee

kly

Mon

thly

Qualifi ed and trained staff who are familiar

with reprocessing. (Please fi ll in the

responsible person -> use a water-based

overhead marker)Dai

ly

Secretion canister

Hose connection (nozzle) X X2,4,5 Manual or automatic cleaning and disinfection X

Canister lid X X2,4,5 Manual or automatic cleaning and disinfection X

Canister holder X X2,4,5 Manual or automatic cleaning and disinfection X

Bacterial fi lter Daily exchange or when fi lter is blocked X

Splash protection X X2,4,5 Manual or automatic cleaning and disinfection X

Secretion collectioncanister X X2,4,5 Empty when the canister is full X

Disposable canistersystem Exchange and disposal of full canister

Ear irrigation / Medication nebulisation

Ear irrigation bowl X X2,4,5 Manual or automatic cleaning and disinfection X

Jet connection X X2,4,5,6 Manual or automatic cleaning and disinfection X

Splash protection X X2,4,5 Wipe cleaning and wipe disinfection X

Hose tip (disposable) Exchange after each procedure X

Rinsing lid with rinsing hose X X2,4,5 Manual or automatic cleaning and disinfection X

Rinsing bottle X X2,4,5,6Manual or automatic cleaning and disinfection; cleaning in the dishwasher with the glass care programme

X

Handle for compressed air X X Manual Wipe cleaning and wipe disinfection X

Sprayer jetX Cleaning after each application X

X2,4,5,6 Manual or automatic cleaning and disinfection X

Sprayer head X X2,4,5 Multiple rinsing of the sprayer head with water X

Hose at sprayer head X X Weekly exchange of the hose or when changing the medication X

Sprayer bottle X X2,4,5,6Cleaning in a cleaning and disinfection device; week-ly orwhen changing the medication

X

Endoscope management

Plastic quiver X X2,4,5 Cleaning with a brush; afterwards disinfection X

Metal quiver X X2,4,5,6 Cleaning with a brush; afterwards disinfection X

Protective sleeve (tefl on ele-ment for metal quiver) X X2,4,5 Manual or automatic cleaning and disinfection X

Cleaning and disinfection planATMOS® C 11 Systema


27

What How

Recommendations

When Who

Reusable partsC

CleaningD

DisinfectionS

Sterilisation

Afte

r eac

h pr

oced

ure

Wee

kly

Mon

thly

Qualifi ed and trained staff who are familiar

with reprocessing. (Please fi ll in the re-sponsible person -> use a water-based overhead marker)D

aily

Instrument management

ENT instruments X X2,4,5 X

Immerse instruments into solution immediately after use, complete wetting is required, air must be removed from any cavities, after the contact time instruments must be rinsed with water, have to be dried and sterilised after-wards. Please also observe the ATMOS operatinginstructions for ENT instruments.

X

Instrument bowl with cover X X4 Cleaning with a brush;

afterwards disinfection (manual) X

Visualisation

Flexible scope X X1,7,8 x1 Immediate pre-cleaning after the procedure(wipe disinfection) X

Rigid scope X X1,7,8 x1 Immediate pre-cleaning after the procedure(wipe disinfection) X

Laryngoscope X X1,7,8 x1 Immediate pre-cleaning after the procedure(wipe disinfection) X

Light conductor X X3 Wipe cleaning and wipe disinfection X

Light source X X3 Wipe cleaning and wipe disinfection X

Microscope X X3 Wipe cleaning and wipe disinfection X

Headlight X X3 Wipe cleaning and wipe disinfection X

SurfacesHousing X X3 Wipe cleaning and wipe disinfection X

Cover lid X X3 Wipe cleaning and wipe disinfection X

Drawer X X3 Wipe cleaning and wipe disinfection X

Instrument deposit X X3 Wipe cleaning and wipe disinfection X

Mirror quick heater X X3 Wipe cleaning and wipe disinfection X

Instrument tray X X3 Wipe cleaning and wipe disinfection, daily when repla-cing with new instruments X

The above stated hygiene requirements are based on the regulations according to the Medical Devices Act, the Medical Devices Operator Ordinance, §18 IfSG and the recommendations of the Robert Koch Institute.Defi nition of the required reprocessing steps result from the recommendations of the Robert Koch Insti-tute: „Requirements for the reprocessing of medical products“. The medical products were categorised in the risk groups uncritical, semicritical and criti-cal. The reprocessing measures mentioned in this cleaningand disinfection plan are a recommendation of ATMOS MedizinTechnik. Any additional reproces-sing measures are at the operator‘s discretion.All the recommended disinfectants which are stated herein are listed disinfectants (VAH/RKI) and have been tested on their suitability of use on the ATMOS® C 11. ATMOS MedizinTechnik cannot be hold liable for any damage caused by wrong con-centration of the disinfectants or by the application of any other disinfectants.Patients with suspicion of a clinical disease or who developed a transmissible spongiform encepha-lopathy (CJK, vCJK, etc.) have to be treated at facilities which are able to provide for the necessary preventive measures against infection. The repro-cessing of the reusable instruments and material may only be performed at facilities which have an externally certifi ed QM Management acc. to DIN EN ISO 13485.The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250 always have to be consi-dered.

Important information

Wipe cleaning and wipe disinfection: All surfaces have to be wiped with a clean (disposable) wipe which is damped with disinfectant solution; the entire surface has to be wiped thoroughly and may not be dried afterwards.

1) Please observe the manufacturer‘s operating instructions.2) Alternative to manual cleaning und disinfection: Wash-Disin-fector 78°C / 172°F6) Material dimensionally stable at 134°C

Recommended disinfectants3) Surface disinfectionfor coated surfaces:• Green & Clean SK (ATMOS)• Dismozon® plus (Bode Chemie)• Kohrsolin® FF (Bode Chemie)• Perform® (Schülke & Mayr)• Terralin® Protect (Schülke & Mayr)

Other surfaces:• Dismozon® plus (Bode Chemie)• Kohrsolin® FF (Bode Chemie)• Mikrobac® forte (Bode Chemie)• Perform® (Schülke & Mayr)• Terralin® Protect (Schülke & Mayr)• Surface disinfection FD 312 (Dürr Dental)

4) Instruments - manual disinfection:• Korsolex® med AF (Bode Chemie)• Korsolex® basic (Bode Chemie)• Korsolex® plus (Bode Chemie)• Korsolex® extra (Bode Chemie) • neodisher® Septo MED (Dr. Weigert)• neodisher® Septo 3000 (Dr. Weigert)• Sekusept® PLUS (Ecolab)• Sekusept® aktiv (Ecolab)• Gigasept® Instru AF (Schülke & Mayr)• Gigazyme® (Schülke & Mayr)• Gigasept FF neu (Schülke & Mayr)

5) Instruments - automatic disinfection:• Dismoclean® 24 Vario (Bode Chemie)• Dismoclean® 28 alka med (Bode Chemie)• Dismoclean® twin basic/twin zyme

(Bode Chemie)• neodisher® FA (Dr. Weigert)• neodisher® MediClean forte (Dr. Weigert)• Thermosept® alka clean forte

(Schülke & Mayr)• Thermosept® RKN-zym (Schülke & Mayr)

7) Endoscopes - manual disinfection:• Helipur® H plus N (BBraun)• Helix® Ultra (BBraun)• Korsolex® Basic (Bode Chemie)• neodisher® MediClean forte (Dr. Weigert)• Sekusept® aktiv (Ecolab)

8) Endoscopes - automatic disinfection:• Korsolex® Basic (Bode Chemie)• neodisher® MediClean forte (Dr. Weigert)• Gigasept® FF neu (Schülke & Mayr)• Endozime® AW Plus (Ruhof)• ADAPTACLEAN™ (ASP)

Please see the manufacturer‘s instructions for concentration, contact time, temperatureand the compatibility of materials.

ATMOS MedizinTechnik GmbH & Co. KGLudwig-Kegel-Str. 16 79853 Lenzkirch/GermanyPhone +49 7653 689-0 Fax +49 7653 [email protected] www.atmosmed.de

Wrong concentration of disinfectants may

lead to damage!

GA3GB.110300.0 2017-05 Index: 05


28

6.0 Maintenance and Service

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.ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected.

At least every 12 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS recommendsaninspectionaccordingtothemanufacturer‘sspecifications.

In case of any malfunction please contact your ATMOS partner or our service hotline +49 7653 689 222.

6.1 Sending in the device• Remove and properly dispose of consumables.• Clean and disinfect the product and accessories according to the operating instructions.• Place used accessories with the product.• Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate.

) This form is enclosed to each delivery and can be found at www.atmosmed.com.• The device must be well padded and packed in suitable packaging.• Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate in an

envelope.• Affixtheenvelopetotheoutsideofthepackage.• Send the product to ATMOS or to your dealer.

29

7.0 Troubleshooting

Description Cause Measure

Electric power supplyNo function, main switch is active, control light does not light up

No voltage to power plug Check house fuses, possibly they burnt through

Cable/plug defect Exchange cable/plug

SuctionWeak suction rate or no suction rate at allVacuum is available at the canister support

Suction hose is clogged Clean suction hoseActive oversuction protection Check oversuction protection, replace, if

necessaryFilter moistened/blocked ReplacefilterSuction hose snapped off Remove breaks, pass hose a different waySystem leaky Check all joints, new assembly of the

systemHose adapter is not securely connected to the canister lid

Insert the hose adapter correctly

Seal of the canister lid is defective Replace the sealMissing lid clip Filter, close upper edge of the secretion

canisterWeak or no suction rate at allNo vacuum at canister support

Secretion penetrated the suction pump Inform the service department

Suction pump does not switch on or off

Draggled/defect light barrier in suction hose holder

Clean both light barriers openings in the suction hose holder, if necessary inform service department

No suction, but force pump is operating

Positions of handles have been mixed up

Insert handles in the right holder

Vacuum pump does not start Handle for compressed air system and the suction hose were simultaneously removed from the support

Put the compressed air handle back into the support

30

7.0 Troubleshooting

Description Cause Measure

Compressed airCompressed air pump does not switch on or off

Draggled/defect light barrier in compressed air holder

Clean both light barriers openings in the compressed air holder, if necessary inform service department

No compressed air, but suction pump is operating

Positions of handles have been mixed up

Insert handles in the right holder

No adequate pressure build-up Leaky connections Check joints, if necessary inform service department

Sprayer does not work Sprayer is clogged Clean sprayer, clean ventilation borehole in sprayer headDouble sprayer nozzle is falsely clipped on(seefig.inchapter5.1.3medicationsprayer).

Mirror quick heaterHeater does not switch on Switch or control unit defect Inform service department to exchange the

switch or control unitInsufficientornoheaterpower Heater coil defect, no glow Exchange heater coilHeater does not switch on Vacuum pump active Put the vacuum handle back into the

supportInsufficientheatingperformance Interruption of heating due to required

vacuumIf the vacuum is no longer needed, please put the handle back into the support

Light sourcesLight does not switch on Plug is loose (see error compressed air

pump does not start)Insert the plug

Light does not switch off Light source does not sit properly in the support

Adjust the position of the light handle

Other light source disturbs the sensor on the support

Reposition secondary light source

HeadlightHeadlight does not switch on The headlight hook is impaired by

another weightRemove the weight

Automatic headlight hook is not free moving

Restore free mobility

31

8.0 Options, accessories, and consumables

Suction REFATMOS® DDS secretion canister 1.5 l 340.0050.0

ATMOS® DDS secretion canister 3 l 340.0051.0

DDSbacterialfilterforsecretioncanister,10pcs. 340.0054.0

Disposable suction hose, not autoclavable, 10 pcs. 006.0058.0

Receptal® external canister 1 l 312.0464.0

Receptal® suction bag 1 l, not autoclavable, 50 pcs. 312.0463.0

Serres® external canister 1 l 312.0465.0

Serres® suction bag 1 l, not autoclavable, 36 pcs. 312.0466.0

Medi-Vac® external canister 1 l 312.0473.0

Medi-Vac® suction bag 1 l, not autoclavable, 50 pcs. 312.0474.0

Compressed-air system REFSprayer bottle 000.0577.0

Sprayer, straight 506.5225.0

Sprayer with rotatable nozzle (360° rotation) 506.5120.0

Sprayer for powdery medications 505.0253.0

Spare nozzle for straight sprayer 505.0280.0

Spare nozzle for sprayer with rotatable nozzle (360° rotation) 000.0219.0

Spare hose for sprayer bottle, after change of medication (pack of 10) 506.5229.0

Ear irrigation / Thermal nystagmus stimulation REFWater storage canister 250 ml 508.0451.0

Ear irrigation bowl 505.0353.0

Jet connection for water irrigation handle 80 mm 508.0427.0

Jet connection for water irrigation handle 110 mm 508.0429.0

Hose tips, 30 pcs. 502.0844.0

Splash protection to be slipped on jet connection 501.0331.0

Seal 501.0311.1

32

8.0 Options, accessories, and consumables

Instrument management REFDeposit for used instruments 541.1200.0

Instrument tray, melamine, 190 x 150 mm 000.0746.0

Instrument tray, melamine, 190 x 300 mm 000.0747.0

Instrument tray, aluminium-anodized, 184 x 142 mm 508.0058.0

Instrument tray, aluminium-anodized, 284 x 184 mm 505.0516.0

Instrument tray, stainless steel, 180 x 140 mm 508.0058.2

Instrument tray, stainless steel, 280 x 180 mm 508.0058.2

Serrated instrument holder, small 508.0567.0

Serrated instrument holder, big 508.0566.0

Holder for ear speculum / Politzer olives (in small tray) 508.0545.0

Light module economy REFLithium-ionic rechargeable battery for the mobile use 507.4510.0

33

9.0 Technical data

Voltage 100-240 V~ ± 10 %; 50/60 HzCurrent consumption Max. 1.5 A (230 V~)

Max. 2 A (127 V~)Power consumption Max. 270 WFuses 2 x T 2,0 A (high cut-off current 1.500 A), 250 VSuction system• Powerdensity(freeflow) Max. 34 l/min• Vacuum (absolute) 100 mbar• Vacuum (relative) 90 %Compressed-air system• Freeflow 18 l/min• Pressure Min. 220 kPaEar irrigation• Water temperature 37 °C +/- 2 °CLED power connections 1x 1000 mA (adjustable from 10 % - 100 %)

1x 700 mA (adjustable from 10 % - 100 %)LED cold light module Min. 80 kLux (1.000 mA)ATMOS® LS 21 LED 200 kLux (700 mA)ATMOS® HL 21 LED 100 kLux (700 mA)Operating time Continuous operation

Pump: max. 15 minMirror heater: ca .15 sec.

Protective earth conductor resistance Max.0,1ΩEarth leakage current Max. 0.5 mAEnclosure leakage current Max. 0.1 mAPatient leakage current Max. 0.1 mAAmbient conditions for transport/storage• Temperature -20...+50 °C• Humidity without condensation 30...95 %• Pressure 500...1060 hPaAmbient conditions operation• Temperature +10...+35 °C• Humidity without condensation 30...95 %• Pressure 700...1060 hPaMaximum operational altitude to 3000 m (NN)Contamination level 2Overvoltage category IIDimensions HxWxD Sitting 840 x 960 x 535

Standing 960 x 960 x 535Weight (complete equipment, without microscope, without accessories and mounting parts)

105 kg

Period tests Repeat test of the electrical safety every 12 months.Recommended:inspectionaccordingtothemanufacturer‘sspecifications.

Safety class (EN 60601-1) I

34

9.0 Technical data

Degree of protection Application parts type BFProtection category IP X0ClassificationaccordingtoAppendixIXEC Directive 93/42/EEC Class lIa according to regulation no. 11

CE marking CE 0124GMDN code 37004 ENT - treatment unitUMDNS code 11-585 ENT treatment unitID No. (REF) 541.0000.0 (sitting)

542.0000.0 (standing)

Issue of technical data: 12.01.2018

35

• The ATMOS® C 11 Systema does not contain any hazardous materials.• The housing is recyclable.• Device and accessories must be decontaminated prior to disposal.• Pay attention to a careful separation of the different materials.• Please observe national disposal regulations (e.g. waste incineration).

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.

Disposal within the ECThe device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of professionally. 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 in the respective country.

Disposal within the Federal Republic of GermanyIn order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it to ATMOS MedizinTechnik for disposal.

10.0 Disposal

36

11.0 Notes on EMC

11.1 Guidelines and Manufacturer´s Declaration - Emissions

The ATMOS®C11Systemaisdesignedforoperationintheenvironmentspecifiedbelow.ThecustomeroruseroftheATMOS® C 11 Systema should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - GuidanceRF Emissions acc.to CISPR 11 Group 1 The ATMOS® C 11 Systema uses HF energy for its internal

functions. Therefore, its HF emissions are very low and it is unlikely that nearby electronic devices will be affected.

RF Emissions acc.to CISPR 11 Class BThe ATMOS® C 11 Systema is suitable for use in all establishments, including domestic and those connected directly to a public power supply network that supplies buildings used for residential purposes.

Harmonic emissions according to IEC 61000-3-2

Class A

Voltagefluctuations/flickeraccordingto IEC 61000-3-3

Corresponds

11.2 Guidelines and Manufacturer's Declaration - Immunity

The ATMOS®C11Systemaisdesignedforoperationintheelectromagneticenvironmentspecifiedbelow.Thecustomeroruserof the ATMOS® C 11 Systema 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.

• PortableandmobileHFcommunicationfacilitiescaninfluencemedicalelectricalequipment.• 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.

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - GuidanceElectrostatic discharge (ESD) according to IEC 61000-4-2

± 6 kV Contact

± 8 kV Air

± 6 kV Contact

± 8 kV Air

Floors should be made of wood or concrete ortiledwithceramictiles.Iffloorsaresynthetic, the relative humidity should be at least 30 %.

Fast electrical transient/burst IEC 61000-4-4

± 2 kV Mains

± 1 kV I/Os

± 2 kV Mains Mains power quality should be that of a typical commercial or hospital environment.

Surges IEC 61000-4-5 1 kVCommon

2 kVDifferential

1 kVCommon

2 kVDifferential

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

Magneticfieldatpowerfrequency 50/60 Hz acc. to IEC 61000-4-8

3 A/m Inapplicable Powerfrequencymagneticfieldsshouldbe that of a typical commercial or hospital environment.

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11.3 Guidelines and Manufacturer´s Declaration - Immunity

The ATMOS®C11Systemaisdesignedforoperationintheelectromagneticenvironmentspecifiedbelow.Thecustomeroruserof the ATMOS® C 11 Systema should ensure that it is used in such an environment.

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - GuidanceVoltage Dips / Dropout IEC 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® C 11 Systema requires continued operation upon the occurrence of disruptions in the energy supply, the ATMOS® C 11 Systema should make use of an uninterruptible power supply or a battery.

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

Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance

Conducted RF IEC 61000-4-6

3 Veff

150 kHz to 80 MHz3 V

Portable and mobile radio equipment should be used no closer to the ATMOS® C 11 Systema, including cables, than the recommended distance calculated according to that which applies to the transmission frequency.Recommended distances:d=1.167*√(P)d=1.167*√(P)d=2.33*√(P)

Where „P“ is the max. power in watts (W) and d is the recommended separation distance in meters (m).Fieldstrengthsfromfixedtransmitters,asdeterminedby an electromagnetic site (a) survey, should be less than the compliance level (b).Interference may occur in the vicinity of equipment containing following symbol:

Radiated RF IEC 61000-4-3

3 V/m80 MHz to 2.5 GHz 3 V/m

11.0 Notes on EMC

38

11.0 Notes on EMC

11.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS® C 11 Systema

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

NOTE 2These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and reflectionofbuildings,objectsandpeople.aThefieldstrengthofstationarytransmitters,suchasbasestationsofcellularphonesandmobileterrainradioequipment,amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environmentinregardtostationarytransmitters,astudyofthelocationistobeconsidered.Ifthefieldstrengthmeasuredatthe site where the ATMOS® C 11 Systema is used exceeds the compliance level above, the ATMOS® C 11 Systema must be observed to demonstrate proper function. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ATMOS® C 11 Systema.

bWithinthefrequencyrangeof150kHzto80MHzthefieldstrengthshouldbebelow3V/m.

The ATMOS® C 11 Systema is intended for use in an electromagnetic environment in which HF disturbances are controlled. The customer or user of the ATMOS® C 11 Systema can thereby help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communication equipment (transmitters) and the ATMOS® C 11 Systema - depending on the output of the communication device as indicated below.

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

transmitterW

150 kHz to 80 MHzd=1.167*√(P)

80 MHz to 800 MHzd=1.167*√(P)

800 MHz to 2.5 GHzd=2.33*√(P)

0.01 0.1167 0.1167 0.2330.1 0.37 0.37 0.741.0 1.167 1.167 2.3310 3.7 3.7 7.37

100 11.67 11.67 23.3For transmitters for which the maximum nominal output is not indicated in the above table, the recommended safety distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal outputofthetransmitterinwatts(W)acc.tomanufacturer'sspecification.

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

NOTE 2These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and reflectionofbuildings,objectsandpeople.

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For your notes

ATMOS MedizinTechnik GmbH & Co. KG

Ludwig-Kegel-Straße 16

79853 Lenzkirch / Germany

Phone: +49 7653 689-0

[email protected]

www.atmosmed.com

Documents

ATMOS Systema - cdn.atmosmed.comcdn.atmosmed.com/docs/907/ga_c11systema_gb_2018-03_vers20... · 3 1.0 Introduction 1.1 Notes on Operating Instructions These operating instructions