2017-09 Index: 36GA1GB.310110.0 0124

ATMOS® A 161 / A 261 / C 161 / C 261 Aspirator

English

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ATMOS

Telefon: + 49 7653 689-0

Fax: + 49 7653 689-392 (Vertrieb Inland) + 49 7653 689-391 (Export)

e-mail: atmos@atmosmed.deInternet: http://www.atmosmed.de

MedizinTechnik GmbH & Co. KGLudwig-Kegel-Str. 1679853 LenzkirchDeutschland / Germany

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

Table of contents

8.0 Cleaning/Disinfection .......................................... 12-168.1 Basic information .......................................................... 128.1.1 Bacterialfilter .............................................................. 128.1.2 Suction hose, hose connector and vacuum hose ....... 128.1.3 Fingertip ....................................................................... 128.1.4 Secretion canister ........................................................ 128.1.5 Canister lid .............................................................. 12-138.1.6 Device surface ............................................................ 138.1.7 Rinsing Canister ........................................................... 138.1.8 Accessories .................................................................. 138.2 Oversuction ................................................................. 138.3 Cleaning instructions .................................................... 138.4 Recommended instrument disinfections .................... 148.5 Recommended surface disinfections .......................... 148.6 Cleaning and servicing plan ................................... 15-16

9.0 Maintenance and servicing ....................................... 179.1 Maintenance and servicing .......................................... 179.2 Reprocessing ............................................................... 179.3 Sending in the device ................................................... 17

10.0 Trouble-shooting ........................................................ 18

11.0 Accessories, consumables, ...................................... 19 spare parts 11.1 Accessories .................................................................. 19 11.2 Consumables ............................................................... 1911.3 Spare parts ................................................................... 20

12.0 Technicalspecifications ............................................ 21

13.0 Checking / Reprocessing / Disposal ........................ 2213.1 Checking ATMOS® suction devices .............................. 22 13.2 Reprocessing ............................................................... 2213.3 Disposal ....................................................................... 22

14.0 Notes on EMC ............................................................. 23

7.0 Operation Medi-Vac® / Serres® ....................................117.1 Holder for Medi-Vac® secretion canister ........................117.2 Assembling the Medi-Vac® secretion canister set ........ 117.3 Connect hose ............................................................... 117.4 Holder for Serres® secretion canister ............................117.5 Assembling the Serres® secretion canister set ............ 117.6 Connect hose ............................................................... 11

6.0 Operation Receptal® ................................................... 106.1 Holder for Receptal® secretion canister ....................... 106.2 Assembling the Receptal® secretion canister set ........ 106.3 Connect hose ............................................................... 10

4.0 General operation ATMOS® A / C 161 / 261 Aspirator 84.1 Suction hose .................................................................. 84.2 Adjust vacuum ................................................................ 84.3 Suction procedure ......................................................... 84.4 Hose rinsing .................................................................. 8

5.0 Operation ATMOS® A / C 161 / 261 Aspirator / DDS ... 95.1 DDScanisterandbacterialfilter .................................... 95.2 Insertion of the DDS canister ......................................... 95.3 Connect hose ................................................................. 9

1.0 Introduction .................................................................. 31.1 Note of the operating instructions .................................. 31.2 Function ......................................................................... 41.3 Intended use .................................................................. 41.4 Extents of supply ............................................................ 51.5 Transport and storage ................................................... 51.6 Explanation of symbols ................................................. 5

2.0 Safety advice ................................................................ 6

3.0 Setting up and starting up ........................................... 73.1 Operating elements ....................................................... 73.2 Connection ..................................................................... 73.3 Starting up ...................................................................... 7

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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® A / C 161 / 261 Aspirator safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-time. That increases, amongst other things, the reliability and service-life of the device.These operating instructions serve not only for new operating personnel to be instructed in its use,but also for use as a reference manual. These operating instructions must always be kept available near the device.

Care and period tests in conjunction with professional execution provide for operational safetyand readiness for use of your ATMOS® A / C 161 / 261 Aspirator and are therefore a must besides regular cleaning.Repair work and period tests may be carried out only by expert personnel authorised byATMOS. By applying only original spare parts you will have the guarantee that operational safety,readiness for work and the value of your ATMOS® A / C 161 / 261 Aspirator will be preserved..

●The product ATMOS® A / C 161 / 261 Aspirator bears CE marking CE according to the EC guideline of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this guideline.●The product ATMOS® A / C 161 / 261 Aspirator 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.de.●ThequalitymanagementsystemappliedatATMOShasbeencertifiedaccordingtointernational standards 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 correspond to the design of the ATMOS® A / C 161 / 261 Aspirator and the status of basic safety engineering standards on going to press. ● Reproduction of these instructions – even in part – only with the written permission of ATMOS.● Subject to alterations and changes.

Please store this document near the device for later use!

• ATMOS® C 261 Aspirator / DDS REF 313.0100.0 with 1 l DDS secretion canister

• ATMOS® C 261 Aspirator / Receptal® REF 313.0165.0 with 1.5 l Receptal® canister

• ATMOS® C 261 Aspirator / Medi-Vac® REF 313.0102.0 with 1 l Medi-Vac® canister

• ATMOS® C 261 Aspirator / Serres® REF 313.0103.0 with 1 l Serres® canister

These operating instructions are valid for the following devices:

• ATMOS® A 161 Aspirator / DDS REF 313.0200.0 with 1 l DDS secretion canister

• ATMOS® A 261 Aspirator / DDS REF 313.0300.0 with 1 l DDS secretion canister

• ATMOS® C 161 Aspirator / DDS REF 313.0000.0 with 1 l DDS secretion canister

• ATMOS® C 161 Aspirator / Receptal® REF 313.0065.0 with 1.5 l Receptal® canister

• ATMOS® C 161 Aspirator / Medi-Vac® REF 313.0002.0 with 1 l Medi-Vac® canister

• ATMOS® C 161 Aspirator / Serres® REF 313.0004.0 with 1 l Serres® canister

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1.2 FunctionThe ATMOS® A / C 161 / 261 Aspirator is a very handy small suction unit. It is driven by an electromotive, maintenance-free swing piston pump. During operation, the pump generates a vacuum within the hose system andthecollectioncanister,thussuckingoffsecretionsorfluids(e.g.bymeans of a suction catheter).Thefluidisgatheredinthecollectioncanister.

Valid for ATMOS® C 161/ 261 AspiratorThefinalvacuumand,following,theair-flowratecanbeadjustedbyme-ansofthefinecontrolandthevacuumgauge.Anovertemperaturestopcontrolled by electronics avoids overheating of the unit.

Valid for ATMOS® A 161/ 261 AspiratorThefinalvacuumand,following,theair-flowratecanbeadjustedbymeans of 3 step vacuum regulation. An overtemperature stop controlled by electronics avoids overheating of the unit.

Valid for ATMOS® A / C 161 / 261 Aspirator / DDS:The reusable secretion canister is connected to the pump housing via direct-docking, without any pedestrian hose system. Only the suction hose has to be plugged in by the user.

Abacterialfilter,locatedinthelidofthesecretioncanister,avoidsente-ring of bacterias and liquids into the pump interior. A mechanical over-suction stop integrated in the canister lid additionally avoids accidentally absorption of secretion into the pump head.

1.3 Intended useName: ATMOS® A 161 Aspirator / ATMOS® A 261 Aspirator ATMOS® C 161 Aspirator / ATMOS® C 261 AspiratorMain functions: Temporarily and spontaneously suction of secretions, blood and body fluids which typically accumulate during respiratory tract suction and ENT treatment.Med. indications/ application: Suction of the upper respiratory tract and throat, nose, earSpecification of the main function: Drainage and temporarily collection of body fluids. By means of an electrical suction pump, a negative pressure will be created. The integrated secretion canister allows a temporarily col-lection of the derived body fluids.Application organ: Upper respiratory tract (oral cavity, nasopharyngeal cavity and bronchial system) and throat, nose, earApplication time: Temporary use on the patient during respiratory tract suction (< 60 min.) or short-term use at ENT treatment (up to 30 days).Application site: The application site of respiratory tract suction is the clinical, practices, nursing and home care sector. In ENT medicine the devices are used in clinic and practice. The application of the device may only be performed by medical trained and introduced staff.Contraindications: Not adapted for: • the continuous operation in case of drainages in the low vacuum range (e.g. thoracic drainage or wound drainage).• permanently endoscopic use.• the use outside of the medical sector.• the suction of flammable, corrosive and explosive substances.• the suction in explosion-risk areas.The product is: x active □not activeSterility: The device is not sterile.Single use product / reprocessing: The device and parts of the acces-sories are reusable, for information on reprocessing and disinfection please see the operating instructions.

ATMOS® C 161 / 261 Aspirator / DDS Sliding cover Vacuum adjustment (individually adjustable) Vacuum gauge Hose storage

1.0 Introduction

Fig 1a.

ATMOS® A 161 / 261 Aspirator / DDS Vacuum adjustment (3-step adjustment) Hose storage

Fig 1b.

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1.4 Scope of supply

● Prior to dispatch, this ATMOS device was subjected to an extensive functional test and has been carefully packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).

In addition to the basic device, the scope of delivery comprises the following parts:

1.6 Explanation of symbolsThe CE sign shows that this product meets the appropriate requirements of the EC guidelines.

1.5 Transport and storage● Thetransportofthedevicemaybeeffectedonlyinadispatch

cartonupholsteredandofferingsufficientprotection.

● Pleasedocumentandreportdamagesintransitimmediately.For complaints or return deliveries, please use the enclosed form QD 434.

● The unit must be allowed to stand for up to six hours at room temperaturepriortostartingupforthefirsttimefollowingtransport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage its diaphragms.

Warning, special diligent notice!

Serial number

Order number

Application part type BF

Creation date

Refer to operating instructions.

ON (feed-in, power connection)

OFF (feed-in, power connection) Fuse

Protection class II

Important information!

● Ambient conditions: Transport/Storage: -30...+50°C; 5...90 % humidity non-condensing at air pressure 700...1060 hPa

Operation: +10...+35°C; 20...80 % humidity non-condensing at air pressure 700...1060 hPa

ATMOS® A / C 161 / 261 Aspirator, scope of supply of all versions:

Grad. secretion canister (1 l)

Lid for secretion canister withtriple oversuction safety

mains cable for 230 V~/50-60 Hz

silicone suction hose Ø 6 mm, L = 1.30 m

Medi-Vac® canister (1 l)

Support

Receptal® canister (1.5 l)

Support

1.0 Introduction

C 161 Battery 2 DDS bacterialfilter C 161 Battery 1 DDS bacterial filter

Medi-Vac® suction bag (1 l)with integrated bacterialfilter

Receptal® suction bag (1.5 l)with integrated bacterialfilter

Serres®

canister (1 l)

Support

Serres® suction bag (1 l)

Protection against the ingress of-solidforeignobjectsØ≥12.5mm- vertically dripping water

Follow operating instructions! (blue)

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DDS Receptal®Medi-Vac® Serres®

IP 21

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2.0 For your Safety

Danger to thedevice

● Donotallowanyliquidtogetintotheunit.Ifliquid has penetrated the unit, it may not be operated again until it has been checked by the customer service centre.

● Theunitmustbesetuponafirm,levelsur-face. The switched-on unit might get overheat-ed if it is placed on an uneven surface (e.g. mattress, cushion, padded seat etc.).

● Themainvoltagespecifiedonthetypeplatemust match the power supply system.

● The unit may not be started: • If cables or plugs are defective, • if it has been dropped down before, • if obvious defects might restrict safe operation. Prior to returning the device for repair, clean it.

● Pay attention to the ambient conditions de-scribed in chapter 1.5 Transport and storage.

● The unit must be checked periodically on its functionandsafetydeficiencies,e.g.pins,secretion canister, housing, etc.

● Never connect the unit to defective power sockets or extension cables.

Avoid moisture on plug and switches.● The unit, collection canister, mains cable, acces-

sories, connection cables and hoses must be checked for damage prior to starting up. Dam-aged cables and hoses must be replaced imme-diately. Prior to use, check the unit functions.

Danger of injury!

● The ATMOS® A / C 161 / 261 Aspirator has beendesignedforaspiratingbodyfluidsinmedical ranges. Never remove explosive gasesandinflammableorcorrosivefluids.

● Only persons instructed in medical use may apply the ATMOS® A / C 161 / 261 Aspirator to patients.

General safety information

● ATMOScannotguaranteeperfect functioning neither will it be liable for damage to people or property if: • Any non-original ATMOS parts are

used, • the user instructions given in this

manual are not followed exactly or are disregarded, • Assembly, resetting, alterations, extensions and repairs are not carried out by people authorised by ATMOS.

● Prior to starting up the ATMOS® A / C 161 / 261 Aspirator, read these operating instructions

carefully.

● Nowarrantyrightsshallexistintheeventof damage or failure caused by the use of non-ATMOS® accessories or non-ATMOS® consumables

● ThesafetystandardoftheATMOS® A / C 161 / 261 Aspirator corresponds with recognized medical technical regulations and the direc-tions of the law relating to medical products.

● Theelectricaloutletisinfactcarriedoutthree-pole, but the middle contact pin (normally ground wire connection) in the interior of the unit is not connected.

● Sterile packed parts may no longer be used if their packing was damaged during transport or storage.

Danger of infection for the patient.

● Alwaysremovetheplugfromthewallsocketfirstinordertodisconnecttheunitfromthemains. Only then may the connecting cable be disconnected from the unit:

• Before cleaning the unit, • before the collection canister is evacuated, • before leaving the room.

Never pull at the cable! Never touch the plug or cable with wet hands.

● This suction unit may not be applied without disposablebacterialfilterplate.

● The suction hose must never come into direct contact with the application site.

Always use a sterile suction catheter resp. a medical accredited aspiration set.

● The unit may not be operated in splash water range.

● Usetransparenthosesexclusively.

● TheATMOS® A / C 161 / 261 Aspirator may be op-erated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments.

● Thisproductisnotre-sterilisable.Repeatedreuse 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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3.0 Setting up

Setupthedeviceonalevel,firmsurface.

3.1 Operating elements 1 Shove blind for covering the operating elements (ATMOS® C 161 / 261 Aspirator) 2 Vacuum adjustment3 Vacuum gauge (ATMOS® C 161 / 261 Aspirator)4 Hosestorage(fig.1,page4)5 Suction hose storage (accessory)6 Switch On I / Off O

3.2 Connection

Themainvoltagespecifiedonthetypeplatemustmatchthe power supply system.Check mains cable for damages. Damaged cables must be replaced immediately!

3.0 Setting up and starting

3.3 Starting up

● The ATMOS® A / C 161 / 261 Aspirator is delivered ready for use.

● Lift the unit out of the cardboard. Check whether the voltage values on the data plate correspond with the inbuilding voltage.

● Setupthedeviceonalevel,firmsurface.

● Prior tofirstoperation,payattention to thesafetyinformation in chapter 2.0.

● The unit must be allowed to stand for up to six hours atroomtemperaturepriortostartingupforthefirsttime following transport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage its diaphragms.

● ATMOS® A / C 161 / 261 Aspirator / DDS: Always hold ready at least one ATMOS® DDS bacterial filter, as the device may not be operated without one!

Fig 3.Fig 2a.

Fig 4.

Fig 5.

Fig 2b.

5321 6

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● Only for C 161 / 261 Aspirator Adjustyourdesiredvacuumbyclosingfingertip( 9 ) and auxiliary air vent ( 8 ). The vacuum is then generated. Open the regulating valve / vacuum adjustment (page 4, ) until the vacuumgauge shows the desired vacuum value

● Only for A 161 / 261 Aspirator Adjust your desired vacuum by turning the three-steps adjustment (page 4, ) to the suitable position.

-25 kPa* low, -55 kPa*medium, -75 kPa* high * depends on daily atmospheric pressure and ambient condi-

tions ● Choose a suction catheter of the right size (10, which are

available from ATMOS in 3 different sizes) or a suction instrument which is only available from specialized dealers.

4.0 General operation

4.2 Adjust vacuum

4.1 Suction hose● Join the suction hose ( 7 ) and the suction catheter (10)bymeansofthefingertip(notincludedindelivery)(9 ).

4.4 Hose rinsing● Dispose the suction catheter and rinse the

suction tube with clean water or disinfec-tion liquid after every suction procedure. We recommend to use the rinsing bottle in which you can carry clean water along with you.

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Important notes on safety

● Makesurethatthecollectioncanisteris evacuated in time. As soon as the canisterishalf-filled,itmustbeemptied(this principle proves right in all application ranges).

● Attention: Suction procedures in the respiratory tract may only be implemented after appropriate instruction by hospital or special staff.

● When themaximum level is exceeded,theoverflowsafety reacts and suction isstopped. Empty the canister.

● Checkthevacuumreadoutregularly!

● If secretionhasbeensoakedup into thepump due to improper use or manipulation, the device must be repaired from ATMOS or a service authorised by ATMOS.

● Foraspirationuseonlyapplicablesuctioncatheters, attachments or a medical aspira-tion sets.

● Whilstaspiratingpleasepayattentiontothefillinglevelofthesecretioncanister.

AUXILIARY AIR VENT OPEN = suction procedure is interrupted (e.g. when leading in the catheter) AUXILIARY AIR VENT CLOSED WITH THE FINGER = suction

Fig 6.

7 Suction hose8 Auxiliary air vent9 Finger tip

10 Suction catheter

Prior to these notes please read the foregoing chapter of your respective version of the ATMOS® A / C 161 / 261 Aspira-tor!

4.3 Suction procedure

● Then, lead in the catheter in the same way as shown by your hospital staff and start the suction procedure.

● Control the suction procedure with the auxiliary air vent

( 8 )onthefingertip.

ThehydrophobicDDSbacterialfilter/oversuctionstop avoids ingress of moisture. Nevertheless you should empty

thecanisteratafilllevelof1/2.

● The secretion canister system is designed the way that secretionsflowslaterallytothewall.Thereforethefoamformation in the canister is reduced.

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9 10

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5.0 Operation DDS

Important notes on safety for the DDS canister system

● Do not operate the device without a bacterialfilter.Werecommendyoualways to store at least one spare bacterialfilter.

● Alwaysweardisposablegloveswhenchangingthebacterialfilter!

● Exchangethebacterialfilterwhenchang-ing the patient. ATMOS recommends: Replacethebacterialfilterafter14days,even if there is no patient change.

● Priortoeachusepleasecheckwheth-erthebacterialfilterisdryandclean.Replacethebacterialfilterwithanewfilterifitisdiscoloured,contaminatedoroversucked.Abacterialfiltermaynever be reused

● Vacuum connection Direct-Docking-System The vacuum connection between the pump

and the collection canister is created au-tomatically as soon as the DDS canister is positioned correctly.

5.1 DDS canister and DDSbacterialfilter

WiththeDDScollectioncanisteronafirmsurface,positionthe lid horizontally on top (the lid may not be twisted!)

Press down lightly onto the collection canister using both hands until limit is reached (Fig 7).

5.2 Insertion/Removal of the DDS canister

The filtermust be fixed to the housing.Afterwards thesecretion canister is inserted. For insert the DDS collec-tioncanister,shiftithorizontallyontothebacterialfilter;forremoval, pull it horizontally outside (Fig 8).

Please note that this order is strictly observed otherwise power loss of the device could be the consequence!

5.3 Connect hose

Press the required DDS hose adapter with 6 or 10 mm diameter into the hole of the DDS collection canister lid twistingslightlytoensureatightfit (Fig 10).

Twist slightly in the same manner when removing.

Fig 9.

Fig 8.

Fig 7.

Fig 10.

iTip

If required the canister can be ejected even easier from the device by means of a lever instrument (e.g. plain spattle); see Fig. 9.

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6.0 Operation Receptal®

6.2 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.

Insert the vacuum hose.

Onlybagswithintegratedbacterialfiltermaybeused!

Fig 12.

Fig. 13.

● Onlyusesecretionbagswithintegratedbacterialfilter!

Abacterialfilteravoidsdivulgementofbacterias.

● Sterilepackedpartsmaynolongerbeused if their packing was damaged during transport or storage

Danger of infection for the patient.

6.1 Holder for Receptal® secretion canister

Plug the screw thread of the holder from the top into the borehole at the bottom side of the device.Screw it together with the provided screw nut.

Fig. 11.

Receptal® bag

Receptal® canister

11 Vacuum channel 12 Vacuum hose13 Connection for vacuum hose

The secretion is sucked off through the vacuum channel.

6.3 Connect hose

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7.0 Operation Medi-Vac® and Serres®

7.1 Holder for Medi-Vac® secretion canister

Plug the screw thread of the holder from the top into the borehole at the bottom side of the device.Screw it together with the provided screw nut.

Fig. 14.

7.2 Assembling the Medi-Vac® secretion canister system

Fig.15.

Medi-Vac® bag

Medi-Vac® canister

11 Vacuum channel 12 Vacuum hose13 Connection for vacuum hose

7.3 Connect hose

Fig. 16.

Fig. 16a. Fig. 16b.

Fig. 16c.

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.

Insert the vacuum hose.

Onlybagswithintegratedbacterialfiltermaybeused!!

7.4 Holder for Serres® secretion canister

Plug the screw thread of the holder from the top into the borehole at the bottom side of the device.Screw it together with the provided screw nut.

7.5 Assembling the Serres® secretion canister system

7.6 Connect hose

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.

Insert the vacuum hose.

Onlybagswithintegratedbacterialfiltermaybeused!!

11 Vacuum channel 12 Vacuum hose13 Connection for vacuum hose

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11 12 13

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8.0 Cleaning / DisinfectionThe way the suction device is used determines its reliability and safety. These hygiene measures are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device.When the suction device is used on another patient or in casethe device has been oversucked a professional reprocessingbythemanufacturer,byacertifiedATMOSpartnerorbyaspecialist, who is authorised by ATMOS, in compliance withMedical Devices Operator Ordinance, Medical Devices Act andBV-Med rules is required (please see chapter 9.2 reprocessing).

8.1 Basic information● The following cleaning measures must only be performed if the

device was used. When the device is only rarely used then a function check must be conducted at least every three months. Only when you adhere to these points the function of the device can be guaranteed.

● We recommend you to document any maintenance work and also any exchange of parts.● Please always wear disposable gloves for any work you perform.● Prior to cleaning the device please remove and dispose all disposable parts like filter, fingertip and catheter.● Prior to cleaning please remove the mains cable from the device.● The described measures for cleaning and disinfection do not replace valid rules for operating the device!● Please observe the instructions for use prescribed by the

manufacturers of disinfectants. Especially regarding concentration and regarding their suitability for use.

● Attention: The lid parts and silicone hoses might get dyed by some disinfectants; a fact which does not take effect on the attributes of the materials.● Basically all parts (canister, cover, overflow safety and hose) which come into contact with suction material must be cleaned and disinfected. Single-use parts like, for example,

filters, catheter, fingertip... must be exchanged as soon as the device is used in another patient. Please see the different instructions for cleaning (chapter 8.3).

● In case the suction device is used in one patient only device and accessories should, for hygienic reasons, be cleaned and disinfected. Please see the different instructions for

cleaning (chapter 8.3).● Cleaning in an automatic cleaner and disinfector is also possible (hose connector, secretion canister and canister lid). Thermal disinfection is carried out at 93° C.

8.1.1 Bacterialfilter● Exchangethebacterialfilterwhenchangingthepatient.ATMOS

recommends:Replacethebacterialfilterafter14days,evenifthere is no patient change.

● Replacethebacterialfilterwithanewfilterifitisdiscoloured,contaminated or oversucked.

● Payattentiontostoringasufficientnumberofreplacement bacterialfilters.

8.1.2 Suction hose, hose connector and vacuum hose

● Suctionhoseandhoseconnectormustalwaysbedisinfectedwith an instrument disinfectant recommended on page 14 in case the device is used in another patient. Prior to disinfection or autoclaving the parts must be rinsed with clear water for at least10secondsinordertoincreasecleaningefficiency.

Please observe the instructions for use of the relevant disinfectant solution!

8.1.3 Fingertip

● Fingertip is not included in delivery, please order separately.

● Prior to using the device in another patient the fingertipmustbeexchanged.● In case the device is used in one patient only we recommend for hygienic reasons the exchange of thefingertipeveryday.

8.1.4 Secretion canister

● Thesecretioncanistermustalwaysbe disinfected with an instrument disinfectant recommended on page 14 in case the device is

used in another patient. Prior to disinfection resp. autoclaving please take care to empty the canister and to rinse it with clear water in order to increase cleaningefficiency.

Please observe the instructions for use of the relevant disinfectant solution!● Incasethedeviceisusedinonepatientonlywe recommend disinfection of the canister every day

as described above.● Forhygienicreasonswerecommendtoemptythe

secretion canister after every suction procedure and to rinse it with clear water. Information on how to remove the canister you willfindinchapter5.2onpage9.

● Incasethepartsareusedinonepatientonly we recommend an exchange every 4 weeks.● Inadditionwerecommendtothoroughlyrinse hose, hose connector and vacuum hose with clear

water and to disinfect them at least once a day as described above.

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8.1.5 Canister lid● The canister lid must always be disinfected with an instrument disinfectant recommended on page 14 in

case the device is used in another patient. Prior to disinfection please take care to remove the bacterial

filterfromthelidandtodisassemblethelidintoits singlecomponents(lid,floatballandhose connector). Prior to disinfection or autoclaving the parts

must be rinsed with clear water for at least 10 seconds inordertoincreasecleaningefficiency.Afterwardstheparts have to be disinfected.

Fig 17.

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8.0 Cleaning / Disinfection● The complete surface of the hose rewind, the trolley and the device support must always be cleaned with a damp (not wet) cloth and disinfected with a surface disinfectant stated on page 14 prior to use the device in another patient.● In case the device is used in one patient only the device sur-

face should be cleaned if it is contaminated however at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant stated on page 14.

8.2 OversuctionWhen is a suction unit oversucked?A suction device is oversucked if suction material penetrated intothe interior of the device.How can one realise that the suction device is contaminated?Generally a reduced suction capacity is a sign of possible oversuction. The ATMOS® C 161 / C 261 Aspirator have a condensate collector at the bottom of the device. For visual inspection please remove the cap. The device is oversucked if humidity or contamination is visible in the condensate collector.MeasuresThedevicemustbereprocessedbythemanufactureroracertifiedATMOS partner if the device is oversucked or if any reservations exist regarding the hygiene condition. A contaminated suction device bears a risk for the patient as well as for the caregiver. Therefore, we recommend regular checking of the condensate collector.

8.3 Cleaning instructions

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Exchangebacterialfilter X X X

Rinsing the suction hose X X

Disinfecting/autoclavingthe suction hose X X

Exchanging the suction hose X

Exchangingthefingertip X X

Emptying the secretion canister X X

Rinsing the secretion canister X X

Disinfecting the secretion canister X X

Rinsing the lid components X X

Disinfecting the lid components X X

Cleaning of the device surface X X X

Wipe disinfection of thedevice surface X X X

Rinsing the vacuum hose X X

Disinfection of the vacuum hose X X

Disinfection of the hose connector X X

Please observe the instructions for use of the relevant disinfectant.

Information on how to remove the secretion canisterlidyouwillfindinchapter5.2on

page 9.● Werecommendtothoroughlyrinsethelidandits components with clear water after each suction procedure in case the device is used in one patient only. Attention!Pleaseremovebacterialfilterpriorto this!

8.1.6 Device surface● Priortousethedeviceinanotherpatientthe complete device surface must always be cleaned

with a damp (not wet) cloth and disinfected with a surface disinfection solution stated on page 14.

● Incasethedeviceisusedinonepatientonlythe device surface should be cleaned if it is contaminated however at least once every week with

a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant stated on page 14.

Discolouration of the surface could occur by some disinfectants; a fact which does not take effect on the attributes of the material.

Prior to cleaning please make sure to disconnect the device from the mains! The device may never be autoclaved, rinsed under running water or immersed into any liquids!

8.1.7 Rinsing Canister

● Therinsingcanistermustalwaysbedisinfected in case the device is used in another patient.

Prior to disinfection please take care to empty the canister and to rinse it with clear water in ordertoincreasecleaningefficiency.

● Incasethedeviceisusedinonepatientonly we recommend disinfection of the canister every week.

● Therinsingcanistermayonlybecleanedwithaphneutral cleaning liquid which does not contain the following ingredients:

ammoniac, amines, amides, phenol derivates, ani-onic tensides.

● Thedisinfectionisexclusivelyallowedwithdisinfect-ant which does not contain the following ingredients: alcohol, aromatic hydrocarbons, ammonia, amine.

● Cleaninginadishwasherispossiblewhenusingphneutral cleaning liquids (5 cycles).

8.1.8 Accessories

● Hoserewind(313.0007.0)/ Trolley (320. 0070.0) / Device support (313.0012.0)

!

!

!

!

!

14

8.0 Cleaning

8.4 Recommended disinfectants for instruments

Disinfectant Contents (in 100 g) Manufacturer

GIGASEPT FF Succindialdehyde 11.0 g Schülke & Mayr, Norderstedt (Application concentrate) Dimethoxytetrahydrofurane 3.0 g not for rinsing canister Corrosion inhibitors Non-ionic tensides and fragrances Sekusept PLUS1 Glucoprotamine 25.0 g Ecolab, Düsseldorf / not for rinsing canister (Application concentrate) Non-ionic tensides Solvents, complexing agents

8.5 Recommended disinfectants for surfaces

Disinfectant Contents (in 100 g) Manufacturer ATMOS® Green & Clean SK Alkyldimethylbenzylammoniumchloride <1 g Metasys, Rum (Austria)(application solution) Dialkyldimehtylammoniumchloride <1 g Alkyldimethylethylbenzylammoniumchloride <1 g

Dismozon pur Magnesium peroxyphthalate Bode Chemie, Hamburg(granulate) Hexahydrate 80 g End of product 12/2014

Dismozon plus Magnesium peroxyphthalate Bode Chemie, Hamburg(granulate) Hexahydrate 95.8 g

Kohrsolin FF Glutaral 5 g Bode Chemie, Hamburg(application solution) Benzyl-C12-C18-alkyldimethyl- 3 g not for rinsing canister ammoniumchloride Didecyldimethylammoniumchloride 3 g

Mikrozid sensitive wipes Quaternary Ammonium compounds 0.26 g Schülke & Mayr, Norderstedt Perform Pentakalium bis(peroxymonosulphate)- Schülke & Mayr, Norderstedt(application solution) bis(sulphate) 45.0 g

Bacillol 30 Foam Ethanol 14.0 g Bode Chemie, Hamburg Propan-2-ol 10.0 g not for rinsing canister Propan-1-ol 6.0 g Alkylamino- propylglycine < 1 g

Mikrobac forte Benzyl-C12-C18-alkyldimethyl- 19.9 g Bode Chemie, Hamburg ammoniumchloride N-(3-Aminopropyl)-N-dodecylpropan 1.3-diamin

Discolouration may result if disinfectants containing aldehydes and amines are used on the same object.

Cleaning and servicing plan for ATMOS® A 161 / A 261 / C 161 / C 261 Aspiratorstart date: name of the item: serial number:

*Beforefirsttimeoperationofabrandnewdevice,respectivelyatechnicallyaswellashygienicallyproperdevice.

daycleaning secretion canister

cleaning canister

lid

cleaning of the

housing

exchange of bacterialfilter

exchange offingertip

exchange of suction hose,

1.3 m

cleaning/exchange performed

name signature

exchange* exchange* exchange*

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

daily

, res

pect

ivel

y af

ter e

ach

use

daily

, res

pect

ivel

y af

ter e

ach

use

daily

, res

pect

ivel

y af

ter e

ach

use

ATMOS MedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 16 / D-79853 LenzkirchPhone: +49 (0)7653-689-0 / Fax: +49(0)7653-689-292 www.atmosmed.de / e-mail: atmos@atmosmed.de

other products must be avoided. The intervals stated in the list are non-bin-ding guide values. Depending on the use shorter intervals may be necessary.

For each patient a new or technically as well as hygienically proper suc-tion device must be used. Otherwise there is high and acute danger of infection for the patient, the user and any third person!

Special notes: Before operating the suction device, the user has to make sure that the device functions and is in good order and condition. The user has to observe the instructions in the operating manual as well as all other safety-related and maintenance information enclosed.

For cleaning and disinfection only agents which are recommended by the ma-nufacturer, may be used.Only sterile, single-use suction catheters may be used for suctioning. They have to be exchanged before each suction process. During use utmost atten-tion to hygiene (e.g. disinfection of hands, wearing single-use gloves) is indis-pensable. After each use the secretion canister and the hose must be rinsed thoroughly with water. During storage the contamination of the device and

Important notesGeneral information

The way the suction device is used determines its reliability and safety. These hygiene measures are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device.

If there is a change of patient or ownership then the device must be reprocessed acc. to Medical Devices Operator Ordinance, Me-dical Devices Act and BVMed guidelines. An oversucked (conta-minated) device must be repaired by the manufacturer, by a certi-fied ATMOS partner or an ATMOS authorized, specialized dealer.

This cleaning and servicing plan as well as the relevant notes result from many years of experience. Depending on the use and the user’s experience shorter intervals may be necessary.

ATMOS recommends the following sets of consumables:

According to this cleaning and servicing plan the following consumab-les have to be changed:

suction catheter, length: 50 cm

Disconnect the mains plug from the socket before commencing with cleaning and disinfection!

Please observe the notes in the operating instructions, especially regarding the recommended agents.

Cleaning of the secretion canister

Please empty the secretion canister after each use, rinse it thorough-ly with clear water and clean it with washing-up liquid. Tenacious contaminations can be removed with a standard bottle brush.

Cleaning of the canister lid

The bacterial filter must be removed before cleaning, please usesingle-use gloves. Please demount the canister lid after each use and rinse it thoroughly. The lid must be absolutely dry before reuse. Please payattentiontoacorrectfunctionoftheoverflowsafetywhenmoun-ting the lid.

Bacterialfilter

Thebacterialfilterpreventspenetrationofmicroorganismsandsecre-tion into the device, respectively blowing out from it and is therefore a protectionfortheuserandthedevice.Replacethebacterialfilterwithanewfilterifitisdiscoloured,contaminatedoroversucked.Exchangethebacterialfilterwhenchangingthepatient.ATMOSrecommends:Replace thebacterialfilterafter14days,even if there isnopatientchange.Inordertoincreasetheservicelifeofbacterialfilters,itisre-commended to empty the secretion canister when it is half-full. Always use the original ATMOS®bacterialfilter Thesuctiondevicemaynotbeoperatedwithoutbacterialfilter!Hoseconnection/fingertip

Thefingertipconnectsthesuctionhosetothesuctioncatheter.Asthefingertipisindirectcontactwithsecretionanditisdifficulttoclean,werecommend a daily exchange. When the device is used for another patientthefingertipmustbeexchangedimmediately.

Suction Hose

The suction hose conducts the secretion from the suction catheter to the canister. In order to prevent secretion from drying, the hose must be thoroughly rinsed with clear water after each use. The water can besucked into thesecretioncanister.Pleasefill thesecretioncani-ster only half. Frequent cleaning and disinfection may discolour and embrittle the hose. Therefore, a monthly exchange of the suction hose is recommended.

Cleaning of the device (housing)

When the device is contaminated but at least once per week the hou-sing must be wiped off with a moist (but not wet) cloth. A weekly dis-infection is recommended. Never irrigate the device with water and never emerge it into any

liquid.

Cleaning/disinfection

To improve the cleaning effect, standard washing-up liquid can be ad-ded to the warm water. In the case of tenacious contamination the parts should be steeped in water for a length of time or they may be removed with a soft brush or cloth. After thorough cleaning, canister, fingertipandhosescanbedisinfectedwithadisinfectionagent(seeoperating instructions).

Cleaning in an automatic cleaner and disinfecter is also possible (hose connector, secretion canister and canister lid). Thermal disinfection is carried out at 93° C.

white Ø 4 mm

green Ø 4.7 mm

orange Ø 5.3

bacterialfilter

fingertip

Suction hose1.3 m

ATMOS MedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 16 / D-79853 LenzkirchTelefon: +49 (0)7653-689-0 / Fax: +49(0)7653-689-292 www.atmosmed.de / e-mail: atmos@atmosmed.de

17

9.1 Basic information● Carryoutavisualinspectionoftheunitpriortoeach

use including hoses, collection canister and connec-tion cable. Damaged cables and hoses must be replaced immediately.

● Maintenance,repairsandperiodtestsmayonlybecarried 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.

● Pleasecomplywiththecountry-specificguidelines

regarding regular testing especially for the electrical safety. ATMOS recommends a test every 24 months.

● Forrepair,thisdevicecanbereturnedtoATMOS.

● Beforereturningthedeviceforrepair,cleanandafter-wards disinfect all secretion canister parts and hose parts. The device´s surface also has to be disinfected.

● ATMOScannotguaranteeperfectfunctioningneitherwill it be liable for damage to people or property if:

• Any non-original ATMOS® parts are used, • the user instructions given in this manual are not followed exactly or are disregarded, • assembly, resetting, alterations, extensions and

repairs are not carried out by people authorised by ATMOS.

● Nowarrantyrightsshallexistintheeventofdamageor failure caused by the use of non-ATMOS® accesso-ries or non-ATMOS® consumables.

● Inordertoprotecttheuser,theATMOS® A / C 161 Bat-tery must be in good condition with regard to technics and hygiene prior to passing on. If there is a change of patient or ownership then the device must be repro-cessed acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. An over-sucked (contaminated) device must be repaired by themanufacturer,byacertifiedATMOSpartneroranATMOS authorized, specialized dealer.

● Payattentiontoregulationsandinstructionsvalidforthe respective application range.

9.0 Maintenance

condensate collector for a quick view control of a possible contamination

9.2 Reprocessing The way the suction device is used determines its

reliability and safety. These hygiene measures descri-bed in the last chapter are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device.

When you can ensure the device was not oversucked then perform a reprocessing acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. The reprocessing consists of cleaning, surface disinfection as well as the exchange of consumables. An ATMOS® set of consumables is available for this purpose.

If you cannot exclude that the device was oversucked then the device must be repaired by themanufacturer,byacertifiedATMOSpartneror an ATMOS authorized, specialized dealer. Subsequently the device may be operated again.

When is a suction unit oversucked?A suction device is oversucked if suction material penetrated into the interior of the device.How can one realise that the suction device is contaminated?Generally a reduced suction capacity is a sign of possible oversuction. The ATMOS® C 161 / C 261 Aspirator have a condensate collectoratthebottomofthedevice(fig14 ). For visual inspection please remove the cap. The device is oversucked if humidity or contamination is visible in the condensate collector.MeasuresThe device must be reprocessed by the manufacturer or acertifiedATMOSpartnerifthedeviceisoversuckedorif any reservations exist regarding the hygiene condition. A contaminated suction device bears a risk for the patient as well as for the caregiver. Therefore, we recommend regular checking of the condensate collector.

14

9.3 Sending in the device1. Remove and properly dispose of consumables.2. Clean and disinfect the products and accessories

according to the operating instructions.3. Place used accessories with the device.4. Fill in the form QD 434 „Delivery complaint / return

shipment“ and the respective Decontamination certi-ficate.

• This form is enclosed to each delivery and can be found at www.atmosmed.com.

5. The device must be well padded and packed in suitable packaging.

6. Place the form QD 434 „Delivery complaint / return shipment“andtherespectivedecontaminationcertifi-cate in an envelope.

7. Affixtheenvelopetotheoutsideofthepackage.8. Send the product to ATMOS or to your dealer.

18

10.0 Trouble-shooting

Prior to dispatch, the ATMOS® A / C 161 / 261 Aspirator was subjected to an extensive functional test. If, nevertheless, a failure should appear, you may possibly clear it yourself if you follow these notes:

Problem Possible causes Remedy●Unitdoesnotstart – Discharged battery – Connect the battery charging

power pack to the device. The battery should be recharged for 1 – 2 hours prior to operation with battery.

– Loose power plug of the charging device – Check all plug and socket connections. Pay attention to the control lamp, it must be illuminated when all connections are o.k.

● Insufficientperformance – Discharged battery – Recharge the battery.

– Filter is blocked

–Exchangethefilter.

● 1.Lowornovacuum is indicated

–1.1DDSbacterialfilterismissing –InsertDDSbacterialfilter

– 1.2 Leakages within the hose system or in collection canister lid

– Check collection canister lid and hosesystemontightfitting.

–Connectthefilteronceagainto the connection nozzle.

– Check the suction lid on tight andcorrectfitting.

● 2.Highvacuumis indicated

– 1.3 Secretion or blood has been sucked in and valve plates of the pump are contaminated

–2.1DDSbacterialfilterisblocked.

– Unit has to be returned for repair.

–ExchangeDDSbacterialfilter

–2.2Floatofoverflowsafetycloses the collection canister inlet

– Check collection canister inlet; if necessary empty secretion canister, clean the oversuction protectionandcheckfloatballforflexibility.

19

11.0 Accessories, consumables and spare parts

DDS bacterial filter / oversuction stop

Hose connection,(fingertip)

Suction catheter

Plak-VacTM toothbrush

Trolley on 4 castors

Cover for secretion canister (incl. spare DDS filter)

Grad. secretion canister 1 l

Rewind system for suction hoses

Separaterinsing canister set

Basket for catheters

Device support

REF

11.1 Accessories for A and C classGrad. secretion canister, 1 l DDS, blue, PSU 313.0015.0Grad. secretion canister, 1 l DDS, transparent, PSU 313.0017.0Secretion canister lid, 1 l DDS, blue, with spare bacterial filter 313.0006.0Separate rinsing canister set for ATMOS® A- and C- classincl. lid and support

313.0008.0

Hose connector for hoses Ø 6 mm 000.0836.0Hose rewind for suction hoses for ATMOS® A- and C- class 313.0007.0Power cable, 3-wire Schuko connector, 2 m 008.0866.0Carrying bag, black 313.0011.0Device support for ATMOS® A- and C- class 313.0012.0Trolley on 4 castors, for A- and C- class 320.0070.2Support for Receptal® external canister 1 l and 1.5 l 313.0009.0Support for Medi-Vac® external canister 1 l 313.0010.0Support for Serres® external canister 1 l 313.0413.0

11.2 ConsumablesBacterial filter for ATMOS® DDS secretion canister, 10 pcs. 340.0054.0Set of consumables for ATMOS® A- and C-class DDS 313.0160.0

General accessoriesReceptal® external canister 1.5 l 310.0221.0Serres® external canister 1 l 312.0465.0Medi-Vac® canister 1 l 312.0473.0Basket for catheters, L = 340 mm 444.0140.0Basket with standard rail holder 320.0075.0

Suction hoses / fingertipPlak-VacTM tooth brush with suction mechanism 000.0821.0Suction hose, silicone, Ø 6 mm, minimum purchase 5 m 006.0009.0Suction hose, silicone, Ø 6 mm, L = 1.30 m, 1 pcs. 000.0013.0Suction hose, PVC, disposable, Ø 6 mm, L = 1.30 m, 10 pcs. 006.0057.0Suction hose, PVC, disposable, Ø 6 mm, L = 2.10 m, 50 pcs. 006.0059.0Fingertip, sterile, not autoclavable, minimum purchase 10 pcs.

000.0347.0

Suction bagsReceptal® suction bag 1.5 l, not autoclavable, 50 pcs. 310.0222.2Medi-Vac® suction bag 1 l, not autoclavable, 50 pcs. 312.0474.0Serres® suction bag, 1 l, not autoclavable, 36 pcs. 312.0466.0Suction cathetersSuction catheter, size: CH 12, L = 50 cm, 100 pcs. Ø 4 mm, white, straight, central opening, 2 small lateral openings, suction connection Ø 6 mm, #e, not autoclavable

000.0294.0

Suction catheter, size: CH 14, L = 50 cm, 100 pcs.Ø 4.7 mm, green, straight, central opening, 2 small lateral openings, suction connection Ø 6 mm, sterile, not autoclavable

000.0295.0

Suction catheter, size: CH 16, L = 50 cm, 100 pcs.Ø 5.3 mm, green, straight, central opening, 2 small lateral openings, suction connection Ø 6 mm, sterile, not autoclavable

000.0296.0

20

11.0 Accessories, consumables and spare partsREF

11.3 Spare partsHider (Valid for ATMOS® C 161 / C 261 Aspirator) 999.1996.0

Self-adhesive elastic buffer 5J-5017 000.0018.0

Plug GPN 300 000.0824.0

Ballforoverflowprotection 000.0839.0

21

IssueofTechnicalSpecifications:09.01.2017

ATMOS® A / C 161 Aspirator ATMOS® A / C 261 AspiratorAirflowrateofpump 16 ± 2 l/min 26 ± 2 l/min

Max. vacuum -80 kPa* ± 2 kPa -80 kPa* ± 2 kPa

Vacuum readout (ATMOS C 161 / C 261 Aspirator) -1...0 bar (± 25 mbar) (mmHg; kPa)*

Additional air regulation (ATMOS C 161 / C 261 Aspirator) mechanical regulating valve

Additional air regulation (ATMOS A161 / A 261 Aspirator) Three-steps-adjustmentlow= -25 kPa*, medium= -55 kPa*, high= -75 kPa*. * depends on daily atmospheric pressure and Ambient conditions

Collection canister 1 l DDS secretion canister or 1.5 l Receptal® canister system or 1 l Medi-Vac® canister system or 1 l Serres® canister system

Suction hose ø 6 mm, 1.30 m length

Voltage 230 V~ (+/-10%) 50/60 Hz

Current input (max.) ca. 0.85 A (230 V~) ca. 0.46 A (230 V~)

Power consumption ca. 170 VA (230 V~) ca. 105 VA (230 V~)

Power cable 2 m

Operating time Interrupted use over approx. 45 min at 230 V~, 50 Hz, 20°Ccooling period approx. 60 min., depending on ambient temperature

(Interrupted use over minimum 5 min. at 10 % higher rated voltage, 60 Hz, 35° C ambient temperature, 20 min. break)

Fuse T 1.25 A/H (230 V~) T 1,25 A/H (100-230 V~)

Protective earth conductor resistanceEarth leakage currentEnclosure leakage currentPatient leakage current

——N.C. < 0.1 mA—

Heat emission 100 J/s

Noise level (ATMOS C161 / C 261 Aspirator) 50.0 dB (A) @ 1m (nach ISO 7779)

Noise level (ATMOS A161 / A 261 Aspirator) 53.0 dB (A) @ 1m (nach ISO 7779)

Ambient conditions

Transport/storage

Operation

-30...+50°C 5...90 % humidity, non-condensing air pressure 700...1060 hPa

+10...+35°C 20...80 % humidity, non-condensing air pressure 700...1060 hPa

Dimensions HxBxT 250 x 255 x 180 mm

Weight 3.5 kg

Period tests Recommended: Testing every 24 months.

Protection class (EN 60601-1) II

Applied Part type BF

Degree of protection IP 21

Classificationacc.toAnnexIXEECdirections93/42/EEC IIa

CE marking CE 0124

UMDNS-Code 10-219 (tracheal suction device)

*1bar≈750,06mmHg≈1000hPa/dependsondailyatmosphericpressure

12.0 Technicalspecifications

22

13.3 Disposal

When the device is operated according to the operating instructions it has an expected service life of 5 years. A regular thorough cleaning and disinfection, respectively the operation in line with the operating instructions are assumed.

● The ATMOS® A / C 161 / 261 Aspirator is not comprised of any hazardous materials.

● The materials of the housing can be recycled completely.

● Prior to disposal, device and accessories must be decontaminated.

● The materials are to be separated carefully.

● Payattentiontocountry-specificregulationsfordisposal(e.g.wasteincineration).

13.0 Checking / Reprocessing / Disposal

Disposal within the EC

The suction 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. Since this type of product is mainly used at home for secretion suction in the respiratory tract (after laryngectomy), it must be assumed that those suction devices could be contaminated. Therefore, this type of device is excluded from the law for 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.

Prior to disposal respectively before transport all secretion canisters and hoses must be thoroughly cleaned, disinfected. The device surface must be disinfected.

13.1 Checking ATMOS suction devices

The ATMOS® suction devices are maintenance-free in the case they are used according to the operating instructions. Please comply with the country-specific guidelines regarding regular testing especially for the electrical safety. ATMOS recommends a test every 24 months

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

(Valid for ATMOS® C 161 / C 261 Aspirator)A regular check of the condensate-controller on the rear side is necessary. For visual inspection please remove the cap. The device is oversucked if humidity or contamination is visible in the condensate collector.

13.2 Reprocessing (in perfect technical and hygienic condition)

If there is a change of patient or ownership then the device must be reprocessed acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. Anoversucked(contaminated)devicemustberepairedbythemanufacturer,byacertifiedATMOSpartneroranATMOSauthorized, specialized dealer.

ATMOS MedizinTechnik GmbH & Co. KG offers their partners and customers a trouble-free and quick reprocessing and checking / period tests for ATMOS suction devices.

23

14.0 Notes on EMC

14.1 Guidelines and Manufacturer´s Declaration - EmissionsThe ATMOS®A/C161/261Aspiratorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer or user of the ATMOS® A / C 161 / 261 Aspirator should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - GuidanceHarmonics IEC 61000-3-2 Class A The ATMOS® A / C 161 / 261 Aspirator is suitable

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

Flicker IEC 61000-3-3

Inapplicable

■MedicalelectricalequipmentissubjecttospecialprecautionswithregardtoEMCandmustbeinstalledacc. to following EMC notes. ■PortableandmobileHFcommunicationfacilitiescaninfluencemedicalelectricalequipment.■Theuseofotheraccessories,otherconvertersandcablesthanstatedmayleadtoanincreasedemission or a reduced interference immunity of the equipment or system.

i

24

14.0 Notes on EMC

14.2 Guidelines and Manufacturer´s Declaration - Immunity for ATMOS® A / C 161 / 261 Aspirator

The ATMOS®A/C161/261Aspiratorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer or user of the ATMOS® A / C 161 / 261 Aspirator should ensure that it is used in such an environment..

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

ment - GuidanceESD IEC 61000-4-2

± 6 kV Contact

± 8 kV Air

± 6 kV Contact

± 8 kV Air

Floors should be wood, concrete, orceramicstile.Iffloorsaresyn-thetic, the relative humidity should be at least 30 %.

EFTIEC 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.

SurgesIEC 61000-4-5

± 1 kVsymmetric

± 2 kVsymmetric

± 1 kVsymmetric

± 2 kVsymmetric

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

Voltage Dips / DropoutIEC 61000-4-11

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

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

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

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

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

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

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

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

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS® A / C 161 / 261 Aspira-tor demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS® A / C 161 / 261 Aspirator from an uninterrupti-ble current supply or a battery..

Power Frequency 50/60 HzMagneticfieldIEC 61000-4-8

3 A/m Inapplicable Powerfrequencymagneticfieldsshould be that of a typical com-mercial or hospital environment.

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

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

25

14.0 Notes on EMC

14.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS®A/C161/261Aspiratorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer or user of the ATMOS® C 161 should ensure that it is used in such an environment.

Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environment

- Guidance

Conducted RFIEC 61000-4-6

3 Veff150 kHz bis 80 MHz 10 V

Portable and mobile communications equipment should be separated from the RS 221 incl. the cables by no less than the distances calculated/listed below.

Recommended distances:

d = 0,35 √P

d = 0,35 √P 80 MHz to 800 MHz

d = 0,70 √P800 MHz to 2,5 GHz

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

Fieldstrengthsfromfixedtransmitters,asdetermined by an electromagnetic site (a) survey, should be less than the compli-ance level (b). Interference may occur in the vicinity of equipment containing following symbol

Radiated RFIEC 61000-4-3

3 V/m80 MHz bis 2,5 GHz 10 V/m

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

NOTE 2 These guidelines don´t like to be applicable in any case. The propagation of electromagnetic sizes is influencedbyabsorptionsandreflectionsofbuildings,objectsandpeople.aThefieldstrengthofstationarytransmitters,suchasbasestationsofcellularphonesandmobileterrainradio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to beconsidered.IfthemeasuredfieldstrengthatthelocationwheretheATMOSA/C161/261Aspiratoris used exceeds the above compliance level, the ATMOS® A / C 161 / 261 Aspirator is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed arrangement or another location for the device.

bWithinthefrequencyrangeof150kHzto80MHzthefieldstrengthistobebelow3V/m.

26

14.0 Notes on EMC14.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS® A / C 161 / 261 Aspirator

Recommended separations between portable and mobile RF Communicationsequipment and the ENT-camera ATMOS® A / C 161 / 261 Aspirator

The ATMOS® A / C 161 / 261 Aspirator is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS® C 161 Aspirator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS® A / C 161 / 261 Aspirator as recommended below, according to the maximum output power of the communications equipment.

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

transmitter

W

150 kHz to 80 MHz

d=[0,35]√P

80 MHz to 800 MHz

d=[0,35]√P

800 MHz to 2,5 GHz

d=[0,35]√P

0,01 0,035 0,025 0,070,1 0,11 0,11 0,221 0,35 0,35 0,710 1,1 1,1 2,2100 3,5 3,5 7,0

For transmitters for which the maximum nominal output isn´t indicated in the above table, the recommended sepa-ration distance d in meters (m) can be determined using the equation belonging to the respective column whereas Pisthemaximumnominaloutputofthetransmitterinwatts(W)acc.tomanufacturer´sspecification.

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

NOTE 2 These guidelines don´t like to be applicable in any case. The propagation of electromagnetic sizes is influencedbyabsorptionsandreflectionsofbuildings,objectsandpeople.

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For your notes

ATMOS MedizinTechnik GmbH & Co. KG

Ludwig-Kegel-Str. 16

79853 Lenzkirch / Germany

Phone: +49 7653 689-0

atmos@atmosmed.de

www.atmosmed.com