ATMOS C 361
Contents
1. ZC N AMOS N7 MedizinTechnik ATMOS C 361 Surgical Suction Unit N KL O es QO Ben Ze UU ei KL es AR Ben ei O 340 0001 B 340 0002 B 340 0003 B 340 0004 B 340 0005 B 4 0124 340 0351 B 340 0350 B 2013 09 Index 15 ATMOS MedizinTechnik Ludwig Kegel Str 16 Tel 49 0 7653 6 89 0 atmos atmosmed de GmbH amp Co KG 79853 Lenzkirch Germany Fax 49 0 7653 6 89 190 www atmosmed de Contents XJ ATMOS MedizinTechnik GmbH amp Co KG Ludwig Kegel Strake 16 79853 Lenzkirch Germany Deutschland Tel 49 0 76 53 689 0 Fax 49 0 76 53 689 190 49 0 76 53 689 393 Service Center atmos atmosmed de www atmosmed de ect oe ee web RWwWN 2 0 Page Introduction Notes on operating instructions eeeeeeeeeeeeen 3 Intended USe nee eens eee ee ee 4 FUNCION caer cased coerce E tee teeneesemness 4 Explanation Of symbols nananeeeannneeennnenennnenen 5 Selten 6 Setting up Operating elements 7 Connection area in unit DASE sssssssnssennnnnnnnennnnnn 8 Operation Insert remove DDS bacterial filter OVEFSUCTION StOp cccecccseeecceeeeceeeeseeeseeeeeeeesaees 9 Using the DDS splash protechor 9 Attach remove DDS secretion canister lid 9 Attach DDS secretion canister handle 10 Close open DDS secretion canister handle 10 Secure DDS secretion Canister 10 DDS hose holder 10 Insert DD2. Greiser Geschaftsfuhrer Managing Director Directeur Inspector Charg e de la S curit Qad 148 10_CE0124 Ila ATMOS General terms and conditions 1 General Our General Standard Terms and Conditions apply exclusively Clients terms and conditions which are contrary to or deviate from our General Standard Terms and Conditions are not recognised unless their validity is explicitly confirmed in writing Our General Standard Terms and Conditions also apply even if we deliver to clients without reservation in the knowledge of the client s contrary terms and conditions Our General Standard Terms and Conditions also apply to all future business with that client 2 Proposal Order Confirmation Our proposals are subject to change without notice unless otherwise stated in our order confirmation Each order is only accepted by us following our written order confirmation 3 Orders Every order requires an exact description of all of our product s details We assume no liability for errors and damage caused by inaccurate or incomplete ordering details 4 Prices Unless otherwise stated in the order confirmation our prices in the order confirmation are ex factory prices and exclude packaging and value added tax Packaging is charged separately at cost price in the invoice Value added tax is charged separately in the invoice according to the legal rate on the invoice date We reserve the right to change prices appropriately
3. application site A suction catheter attachment or a medical aspiration set must always be connected to the hose When disconnecting the device from the power line first remove the plug from the wall outlet Then the power cord may be disconnected from the device Never touch the plug or cord while your hands are wet The ambient conditions specified in section 10 0 must be strictly observed When using different canister systems there is a risk of contamination when operating the device without overflow protection hydrophobic bacteria filter Do not use the device respectively the canister without bacterial filter There is a risk of an electric shock when liquid penetrated the overflow protection hydrophobic bacteria filter Set up the device so that the operator has a clear unob structed view of and easy access to the front panel The device must be placed on a solid level surface The ATMOS C 361 fully complies with the electroma gnetic immunity requirements of standard IEC 601 1 2 EN 60601 1 2 Electromagnetic compatibility Medical Electrical Equipment Warranty period for this unit 2 years This period is unaffected by any repair or maintenance carried out under the terms of the warranty Please also pay attention to our enclosed General Standard Terms and Conditions The warranty will be rendered invalid in case of damages caused due to the utilization of accessories or con sumab les which are not approved
4. by ATMOS for use with this unit ATMOS is not liable for personal injury and damage to property if e no original ATMOS parts are being used e the advice for use in these operating instructions is not being observed e assembly new settings alterations extensions and repairs have been carried out by personnel not authorised by ATMOS This operation manual corresponds with the construction of the unit and with the current status of safety related standards at the time of printing Proprietary rights are exi sting for all described circuits processes names software programs and units This product is not re sterilisable Repeated reuse of components which are marked with a is forbidden In case of repeated reuse these compShents lose their function and there is a high infection risk Please do not store DDS filters under heavy objects since this may lead to deformation and with it to loss of function There is a risk of contamination for the device 3 0 Setting up Bild 1 N AMOS K Always set the equipment up on a secure level surface 3 1 Operating elements On Off switch with pilot lamp Vaccuumgauge Vacuum controller Vacuum connection Direct Docking System ts The vacuum connection between the pump and the secretion canister is created automatically as soon as the DDS canister is positioned correct fN 3 0 Setting up Amos M 3 2 Connection area in unit base Co
5. level Ambient conditions Transport Storage Operation Dimensions Weight Protection class IEC 601 Applied Part Degree of protection Classification acc to Annex IX EEC directing 93 42 EEC CE marking Rules applied UMDNS Code Reference No Soundlevel GMDN Code Canadian Classification Device Group PNC Risk Class Description 1 bar 750 06 mm Hg 1000 hPa depends on daily atmospheric pressure 36 4 I min 91kPa 910 mbar or 682 5 mmHg NN 1 0 bar 16 mbar class 1 6 mechanical regulating valve ball vacuum regulator 1 51 or 3 canisters made of polysulphone 6 mm or 10 mm 230 V 50 60 Hz 340 0001 0 approx 0 45 A for 230 V approx 100 W gt 8 h of continuous operation without interruption within 24 h T 630 mA H for 230 V lt 0 1 mA NC max 100 J s lt 50 dB A 1 m ISO 7779 30 50 C 5 90 humidity non condensing air pressure 700 1060 hPa 5 35 C 20 80 humidity non condensing air pressure 700 1060 hPa HxWxD H 330 x W 240 x D 360 mm with secretion canister H 900 x B 410 x T 450 mm with trolley 6 3 kg with secretion canister lI Type BF IPX 1 lla CE 0124 see annexed list 10 217 340 0001 0 230 V lt 50dB A 1 m ISO 7779 36 77 General amp Plastic Surgery 79QBU 2 ASPIRATOR SURGICAL Rules applied DIN EN 1041 DIN EN 1441 DIN EN 60601 1 DIN EN 60601 1 2 DIN EN ISO 10079 1 DIN EN 980 DIN EN ISO 10993 1 20 T
6. spring clips are locked into place Then reconnect mains cable A N 8 0 Trouble shooting Amos M The ATMOS C 361 was subjected to a thorough quality control before shipment If there is nevertheless some malfunction you possibly might solve this problem yourselves if you observe the following instructions Problem Possible cauces Remedy Unit does not start Insufficient performance or no suction Loose power plug no power voltage Defective fuse Leakages within the hose system or in the secretion canister lid Filter is clogged vacuumgauge indicates a vacuum Secretion or blood has been sucked in Check connection to supply socket Check inbuilding fuse Replace fuse Check secretion canister lid and hose system replace sealing ring on secretion canister lid if necessary Replace filter check filling level in secretion canister evacuate canister necessary Unit has to be returned for repair and valve plates of the pump are 17 Fig 20 18 Spare parts and accessories Amos M oo 8 Oo 6 7 9 1 Spare parts Description Article No DDS canister handle DU 340 0055 0 DDS bacterial filter oversuction stop hydrophobic disposable part price TOR 10 ee 340 0054 0 DDS hose adaptor set 6 10 mm 340 0057 0 DDS canister lid with gaskets 0 0 05 340 0053 0 DDS splash protection 340 0056 0 GO DDS secret
7. traced to the final customer The specialist trader undertakes to immediately report to us all events and risks which must be reported in connection with our products 8 Passage of Risk Packaging Unless otherwise stated in our order confirmation delivery is agreed ex factory The risk of the goods damage or loss is therefore transferred to the client as soon as the goods leave the factory or the client is in default of acceptance of the goods This also applies to cases where we confirm prepaid carriage Transport packaging and all other packaging according to the packaging regulations is not returnable Our client is responsible for disposing the packaging at its own cost Our deliveries are insured by us at the client s expense unless explicitly otherwise agreed No insurance is arranged in the case of goods which are collected by our clients In the case of transport damage claims are only handled if the client receives confirmation of any damage reduced weight or loss by the shipping company before accepting the delivery 9 Warranty The client is responsible for examining the delivered goods immediately after receiving them to determine any eventual deficiencies or delivery errors and to report these immediately Should the client fulfil this examining and reporting responsibility and should payment conditions be fulfilled we shall be liable to the client within the scope of legal regulations Our period of warranty shall in all
8. 002 0 Stations Paket 1 5 low 340 0004 0 ATMOS C 361 ATMOS C 361 Praxispaket 21 340 0003 0 Stations Paket 21 340 0005 0 ATMOS C 361 ATMOS C 361 Praxispaket mobil 1 51 340 0351 0 Praxispaket mobil 3 340 0350 0 allen anwendbaren Anforderungen der Richtlinie 93 42 EWG entspricht meets all applicable requirements of the Directive 93 42 EEC repond a toutes les exigences applicables de la directive 93 42 CEE Name Adresse und Kennnummer der Benannten Stelle Name address and identification number of Notified Body 0124 Nom Adresse et Num ro d identification de l organisme notifi DEKRA Certification GmbH HandwerkstraBe 15 D 70565 Stuttgart Konformitatsbewertu nesverfahren Richtlinie 93 42 EWG Anhang lI des Rates ber Medizinprodukte vom 14 Juni 1993 zuletzt ge ndert am 5 September 2007 Conformity assessment procedure Directive 93 42 EEC Annex Il on medical products passed by the commission on 14th June 1993 last amended on 5th September 2007 Proc d d valuation de conformit Directive 93 42 CEE Annexe II du Conseil sur les produits m dicaux pass e en commission le 14 juin 1993 derni re modification le 5 septembre 2007 Gultig bis auf weitere Anderungen am Produkt bis 29 Marz 2015 Valid till further changes on the product until March 29th 2015 Valide jusqu modification du produit jusgfau 29 mars 2015 Lenzkirch den 04 06 2013 Place and date of issue Frank
9. ATMOS C 401 and ATMOS C 361 is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS C 401 and ATMOS C 361 should ensure that it is used in such an environment mn Te IEC 60601 Conon cE Ne Electromagnetic Environ y Test Level H ment Guidance ESD IEC 61000 4 2 EFT IEC 61000 4 4 Surges IEC 61000 4 5 Power Frequency 50 60 Hz Magnetic field IEC 61000 4 8 6 kV Contact 8 kV Air 2 kV Mains 1 kV I Os 1 kV Differential 2 kV Common Floors should be wood concrete or ceramis tile If floors are synthe tic the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be that of a typical com mercial or hospital environment 23 24 Notes on EMC ATMOS Notes on ENG O Ae Z N Immunity Test IEC 60601 Compliance Level Electromagnetic Environ Test Level ment Guidance LL Voltage Dips Dropout lt 5 IEC 61000 4 11 gt 95 Dip of bel for 0 5 Cycle 40 U 60 Dip of the U_ for 5 Cycles 70 U 30 Dip of the U_ for 25 Cycles lt 5 U gt 95 Dip of the U_ for5s Mains power quality should be that of a typical commercial or hospital environment If the user of the ATMOS C 401 und ATMOS C 361 demands
10. S hose adaptor snannnonnnnannenennnanenn 11 elei ee E 11 Jn ol SWING EE 11 OE VAC UIE Magee dicaseannsirancseeasaveanseeaneeracicsameinaamnaces 11 UIC OM ca ge 12 Test DDS bacterial filter oversuction stop 12 Options Trolley with standard rail 13 Securing the unit cece ceeececeeeeeeeeeeeeaeeeens 13 Use of suction unit with disposable systems 14 Cleaning General information on cleaning and disinfection cccceecceseceeeeeeeeeeeeeeteneeseeeens 15 Reprocessing of hoses and secretion Coantsier 15 Cleaning and disinfecting the unit surface 16 Recommended instrument disinfectants 16 Recommended surface disinfectants 16 Recommended cleaning agents saaenaeeeen 16 Maintenance seccactiveseressuavsnceviceasatevvesacsceeseacisuainte 16 Te EE 17 Trouble SNooting cccccsseeeeeeeeeeeeeeeeeeeeeseeeenenes 17 Spare parts and accessories eil 18 FRCCCS EE 19 21 Technical Specifications ccccccseeesseeeeeeeees 20 DEDOS A E 21 Notes on EMC General Standard Terms and Conditions Introduction Ke 1 1 Notes on operating instructions These operating instructions contain important notes on how to operate the ATMOS C 361 safely correctly and effectively Therefore they are intended not only for new operating personnel to be instructed in its use but also for use as a reference manual They help to avoid risks and also
11. and designations used in this document are property of the respective manufacturer We do not take over any warranty and liability in the case of missing inscriptions Subject to modifications and amendments
12. bles and hoses for signs of damage Damaged cables and hoses must be replaced immediately Check also function of the unit The ATMOS C 361 may be used in supervised operation by qualified personnel only which has been authorised by ATMOS and which has been trained for operating the appliance IEC 601 1 EN 60601 1 The ATMOS C 361 may be operated only in rooms used for medical purposes but not in areas zones M and G subject to explosion hazards and in oxygen rich envi ronments Explosion harzards may result from the use of combustible anaesthetic agents skin cleansing agents or disinfectants Liquids must not be allowed to enter the device Should liquids have penetrated into the device it must be inspec ted by an authorized service technician before being used again After transport at cold temperatures below the freezing point the unit must accli matize prior to first use leave it unoperated at room temperature for a period of up to 6 hours If the unit is not acclimatized it must not be operated as the membranes of the pump might get damaged Dispose of the packaging material observing the appli cable waste control regulations Before connecting the device to the power line check that the voltage and frequency ratings of the power line are similar to those indicated on the device Never connect the unit to defective power sockets or ex tension cables The suction hose must never come into direct contact with the
13. cases be two years Our client can make use of the warranty as follows so long as he can provide first buyer proof in the form of an invoice or delivery note and provided that the product still has the original unchanged serial number a We choose whether to fulfil our guarantee by providing repair services free of charge either on the client s premises or in our factory or replacing the product We can also provide these guarantee services through an authorised company b Should a product be returned to us the client agrees to send the product in its original or similar packaging offering the same protection as the original packaging to our address or any address notified by us c Our guarantee ceases to apply if changes of any kind have been made to our product unless such changes have been made by us or a company authorised by us or have been previously agreed upon in writing by us Our guarantee also ceases to apply if third parties have carried out repairs to our products or replaced parts thereof This applies regardless of the fact whether these measures individually or collectively led to a deficiency of the product d We accept no responsibility for damage defects caused by operational wear and tear incorrect installation or incorrect or insufficient maintenance N ATMOS XY MedizinTechnik is limited to damage which is regarded as typical for tthat case This also applies in the case of our culpable infringemen
14. continued function even in case of interruptions of the energy supply it is recommended to supply the ATMOS C 401 und ATMOS C 361 from an uninterrup tible current supply or a battery NOTE U is the mains alternating current prior to application of the test levels 12 3 Guidelines and Manufacturer s Declaration Immunity The ATMOS C 401 und ATMOS C 361 is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS C 401 und ATMOS C 361 should ensure that it is used in such an environment innate Test IEC 60601 TEE E Electromagnetic Environment 7 Test Level H Guidance Conducted RF OV ie V V IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m E V m IEC 61000 4 3 80 MHz to 2 5 GHz Portable and mobile communications equipment should be separated from the ATMOS C 401 und ATMOS C 361 incl the cables by no less than the distances calcu lated listed below Recommended distances d 3 5 V VP d 3 5 E VP d 7 0 E VP where P is the max power in watts W and D is the recommended separation distance in meters m Field strengths from fixed transmitters as determined by an electromagnetic site a survey should be less than the compli ance level b Interference may occur in the vicinity of equipment containing following symbol i Notes on EMC AM NOTE 1 With 80 MHz and 800 MHZ the higher frequency range applies NOTE 2 These guidelines don t li
15. cretion canister vertically up wards for insert it again allow it to slide vertically down wards into the securing device 4 7 DDS hose holder Inthe case that you would like to use the hose holder REF 340 0066 0 please mount it between the canister lid and the hose adapter as described in figure 11a f N 4 0 Operation Amos M Fig 14 4 8 Insert DDS hose adapter Press the required DDS hose adapter with 6 or 10 mm diameter into the Patent hole of the DDS secretion canister lid twisting slightly to ensure a tight fit D Twist slightly in the same manner when removing 4 9 Connect hose 4 10 On off switch Press the I symbol to switch the unit on Press the OU symbol to switch the unit off 4 11 Set vacuum Close the suction hose and set the desired vacuum by turning the vacuum controller according to the direction of the arrow t Do not use force to turn the knob at its limits Test the system for leaks if the desired vacuum is not achieved 11 12 4 12 Suction Use appropriate suction catheters suction tips or suction instruments Prior to starting suction containers must be checked for cracks Damaged containers may not be used VS Keep an eye on the level of liquid in the secretion canister during suction The hydrophobic bacterial filter safely prevents liquid from getting into the pump Nevertheless the secretion canister should be replace
16. cretion containers and hoses must be thoroughly cleaned and disinfected The device surface must be disinfected 22 Notes on EMC Notes on EMC oO Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc to following EMC notes m Portable and mobile HF communication facilities can influence medical electrical equipment m The use of other accessories other converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system 12 1 Guidelines and Manufacturer e Declaration Emissions The ATMOS C 401 and ATMOS C 3671 is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS C 401 and ATMOS C 361 should ensure that it is used in such an environment Electromagnetic Environment Guidance The ATMOS C 401 und ATMOS C 361 is suitable for use in all establishments including domestic Harmonics IEC 61000 3 2 Flicker IEC 61000 3 3 and those directly connected to the public low vol tage power supply network that supplies buildings used for domestic purposes If operation next to or piled with other devices is necessary please watch the device to check its intended Oo The device may not be used directly next to other devices or piled up with other devices operation in this arrangement 12 2 Guidelines and Manufaturer e Declaration Immunity The
17. d when 2 3 full 4 13 Test DDS bacterial filter oversuction stop The DDS bacterial filter oversuction stop is disposable gt Before each use check that the DDS bacteria filter over suction stop is clean and dry Wet or dirty filters must be replaced with new ones The filter is no longer in optimum condition if the vacuum displayed is above 0 3 bar when the vacuum controller is in the max position and the suction hose is open The filter must then be replaced 3 Replace the DDS bacterial filter at least once a day Use only original ATMOS bacterial filters t Never operate the unit without the DDS bacterial filter oversuction stop N 5 0 Options Amos M 5 1 Trolley with standard rail A trolley with standard rail which can also be used with disposable systems if necessary is available for mobile use Always position the trolley on a flat sturdy surface Fig 16 5 1 1 Securing the unit It is only possible to ensure safe operation as a mobile suction unit by using the special trolley available for use with the unit The suction unit is placed on the trolley so that it s feet lock into place in the holes of the unit carrier and it can be firmly attached to the unit carrier from underneath by means of a knurled screw It is imperative that the unit is securely attached to the trolley to ensure safe operation and safe travel Use the lockable castors if neces
18. echnical Specification 04 07 2011 10 0 Technical specifications Canadian Classification Device Group General amp Plastic Surgery PNC 79QBU Risk Class 2 Description ASPIRATOR SURGICAL 1 bar 750 06 mm Hg 1000 hPa depends on daily atmospheric pressure Rules applied DIN EN 1041 DIN EN 1441 DIN EN 60601 1 DIN EN 60601 1 2 DIN EN ISO 10079 1 DIN EN 980 DIN EN ISO 10993 1 Technical Specification 01 04 2005 21 d Checkina Reprocessina Disposal 11 1 Checking ATMOS suction devices The ATMOS suction devices are maintenance free in the case they are used according to the operating instructions Ho wever every 2 years an inspection and a safety related check according to EN IEC 62353 have to be performed Regular thoroughly cleaning and disinfection of the hoses and the application parts respectively the operation in line with the operating instructions are assumed A regular check of the condensate controller on the rear side is necessary Pull out the plastic plug at check the colour at the end of the hose In case of discolouration deposits a maintenance measure must be performed by a certified ATMOS service partner 11 2 Reprocessing In case secretion was sucked into the device it may not be operated until it is repaired by the ATMOS service Handling of the suction device determines to a large extent its reliability and safety The hygiene measures described in the previous chapters are necessary mea
19. eck according to EN IEC 62353 have to be performed 16 Repairs The following may require repairs from the manufacturer or an authorized service partner Prior to sending in the device please contact your service partner by phone Liquids have penetrated the device Sudden occurrence of unusual noises Operational and functional disorders which cannot be resolved by means of the hints describes in the chapter Troubleshooting Measures to be taken prior to sending in the device If the device has to be sent in for repair after consultation with the manufacturer or an authorized service partner we ask you to observe the following Please send in the complete device see scope of delivery Please remove all disposable parts and consumables Thorough cleaning and disinfection Airtight packing ke Please enclose a detailed error description Warranty ATMOS cannot guarantee an error free function nor can ATMOS be held liable for damage to people or goods if non original ATMOS parts are used the information in these operating instructions are disregarded assembly new installations modifications extensions and repairs are done by people who are not authorised by ATMOS 7 1 Change fuse Remove mains cable holder Press the spring clips of the fuse holder together on both sides with a small screwdriver and pull out the fuse Replace the fuse and push the holder back in until both
20. ining detailed circuit descriptions and schematics as well as information on adjustment and servicing to service organizations au thorized by ATMOS Reprints also in extracts only with written permission by ATMOS Abbreviations symbols in these operating instructions Indicating a list e Subdivision of a list activity The recommended sequence must be followed in each case Indicating particularly important advice IN Introduction Amos M 1 2 Intended use The Surgical Suction Unit ATMOS C 361 is a compact suction unit for medical application It is especially intended for aspi ration and collection of secretions body fluids and tissue Its main fields of application are inthe OPD in the OR for sucking off and collecting e g drain pockets abscesses body and rinsing solutions and during lipectomy in endoscopy e g to aspirate secretions or rinsing So lutions as well as for operative fixation in gynaecology for suction curettage In ENT applications to aspirate secretions rinsing so lutions cerumen or to extract foreign matters inthe ward recovery ward and ICU for the spon ta neous aspiration of body fluids and foreign matters e g from the respiratory tract The ATMOS C 361 must not be used in non medical applications to draw off combustible or explosive fluids or gases for drainage in the low vacuum range e g thorax drai nage for s
21. ion canister polysulphone 1 5 340 0050 0 DDS secretion canister polysulphone 3 0 340 0051 0 Expansion bellows silicone rubber 000 0739 0 Fuse 230 V T 0 63 A H enee et 008 0634 0 Fuse 115 V ER BN 008 0720 0 Mains cable angle angle Dm 008 0818 0 Push in foot for bousimg 505 0337 0 Clamping ring for fixing SCreW c sseeeeeeees 000 0727 0 Operating Ipstruchons 340 0001 i Spare parts and accessories Amos M 9 2 Accessories 9 2 1 Canisters Description Article No DDS secretion canister polysulphone PT 340 0050 0 DDS secretion canister polysulphone 21 340 0051 0 DDS canister lid with oaskeis 340 0053 0 DDS canister handle Sall cicsseccicceciscaicesscdaraccedsccastexsavacsssancaectiaceeievoesuncens 340 0055 0 DDS splash e te ed 340 0056 0 DDS hose adaptor set Grimm 340 0057 0 9 2 2 For ATMOS C 361 with trolley le eet lee KEE 320 0070 1 DDS standard rail adaptor with vacuum connection for the use of disposable systems at the unit ee eeeeeeeeeeeeeeeeeeeeanees 340 0059 0 grad secretion canister 3 glass siiacscsissdiciacdsaediwiatensaaescee DEENS 444 0033 0 grad secretion canister 51 QlaSS ccccecccssscecsescecseseeseeseesesseeseeseeseaees 444 0034 0 Secretion canister lid complete for 3 51 glass Canisier 441 0208 1 Holder for 3 glass CGantster 000 0040 0 Holder for 5l glass Canister E 000 0041 0 Receptal container set Il support with 2 x collect
22. ion container Hecepntal canster 1D5I 310 0221 0 Receptal canister 2 EE 444 0256 0 Receptal canister 3 l ec sassncsccceseeenceduhscleders shetontendddvenadispectslaviadeciehecionecdaceets 444 0157 0 Receptal suction bag 1 5 l not autoclavable 50 pce 310 0222 2 Receptal disposable bag 2 without integrated overflow protection 443 0257 0 Receptal suction bag 2 with integrated overflow protection 443 0257 2 Receptal suction bag 3 without integrated overflow protection 444 0153 0 Receptal suction bag 3 with integrated overflow protection 444 0154 0 9 2 3 Facilities to simplify the handling Hose holder on R TE rrenan nrn nnn r rnnnn ennnen 340 0066 0 Catheter quiver for flex catheters attached to trolley cccseceeeeeeeeeees 444 0140 0 Catheter quiver with holder for rail system f r catheter SUMING EE 443 0780 0 Quiver holder small incl standard rail NOldeD cccccceeeceesseeeeeeeneeeeees 444 0145 0 Hose holder for attaching to standard rail nee E AAA 0450 0 19 Technical specifications Air flow rate of pump Max vacuum at sea level Vacuum readout Additional air regulation Secretion canister Suction hose Rated voltage Rated current Power consumption Operating time Fuses Protective earth conductor resistance Earth leakage current Enclosure leakage current Patient leakage current Heat emission Noise
23. ke to be applicable in any case The propagation of electromangetic sizes is influenced by absorptions and reflections of buildings objects and people The field strength of stationary transmitters such as base stations of cellular phones and mobile terrain radio equipment amateur radio transmitters com broadcast and TV stations cannot be predestined exactly To determine the electromagnetic environment in regard to stationary transmitters a study of the location is to be considered If the measured field strength at the location where the ATMOS C 401 und ATMOS C 361 is used exceeds the above compliance level the ATMOS C 401 und ATMOS C 361 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 Within the frequency range of 150 kHz to 80 MHz the field strength is to be below 3 V m 12 4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS C 401 und ATMOS C 361 The ATMOS C 401 und ATMOS C 361 is intended for use in electromagnetic environment in which ratiated disturbances are controlled The customer or user of the ATMOS C 401 und ATMOS C 361 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communica tions equipment and the ATMOS C 401 und ATMOS C 361 as recommended below according to the maximu
24. m output power of the communications equipment a Separation distance depending on transmit frequency m Nominal output of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter d 3 5 V HP d 3 5 E VP d 7 0 E P 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 P is the maximum nominal output of the transmitter in watts W acc to manufacturer s specification NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines don t like to be applicable in any case The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings objects and people 25 ZC NM ATMOS EG KONFORMITATSERKLARUNG EC DECLARATION OF CONFORMITY DECLARATION DE CONFORMITE CE Wir We Nous ATMOS MedizinTechnik GmbH amp Co KG Ludwig Kegel Stra e 16 79853 Lenzkirch Germany Tel 49 7653 689 0 erkl ren in alleiniger Verantwortung dass das Medizinprodukt declare under our sole responsibility that the medical device d clarons sous notre pleine et enti re responsabilit que le produit m dical Klassifizierung Classification Classification Uz N Name name Nom ES ATMOS C 361 n REF 340 0001 0 Varianten models Variante ATMOS C 361 ATMOS C 361 Praxispaket 1 5 I as 340 0
25. moke evacuation in connection with HF electrosurgery or laser surgery 1 3 Function The ATMOS C 361 is aline power operated surgical suction unit centering around a silent diaphragm type pump which generates a vacuum inside the secretion canister allowing secretions to be withdrawn and collected Using a vacuum regulator and the vacuum gauge the target vacuum and thus the air flow rate can be precisely adjusted Several secretion canisters of different sizes are available for use with the system section 9 0 Spare parts and ac cessories A hydrophobic bacterial filter in the lid of the secretion canister is implemented to prevent that secretions enter the pump resp bacteria the interior of the unit A trolley with standard rail is available for mobile use 1 0 introduction Amos M 1 4 Explanation of symbols Attention refer to operating instructions Fuse VY Potential equalization Type BF equipment Alternating current E Unit of protection class ll IPX1 Protection against penetration of damaging humidity drop water O Unit Off I Unit On For your safety Amos M The design of the ATMOS C 361 fulfills the requirements of IEC 601 EN 60601 and of protection class The device must only be connected to a properly installed socket with non fused earthed wire Before putting the device into operation visually check unit secretion canister power cable accessories connection ca
26. nised by German or foreign law Unless otherwise stated in the order confirmation our central office is the place of performance Lenzkirch September 2008 ATMOS MedizinTechnik GmbH amp Co KG 79853 Lenzkirch Germany incorrect operation of the product in contradiction to the operating instructions delivered with the product improper use or operating faults inappropriate or negligent handling and care especially with respect to dirt lime suction of fluids inappropriate cleaning and sterilisation using accessories and or replacement parts which are not explicitly approved incorrect assembly and or initial operation by the client or third parties the client s negligence in handling the product unacceptable operating conditions such as humidity temperatures the power supply vibrations accidents acts of God especially lightening water fire public unrest and insufficient ventilation We are not liable for damage to other objects apart from our product itself except in the case of any deliberate or grossly negligent actions by us or our representatives or agents Should no deliberate breach of contract be claimed our liability This document is copyrighted Duplication translations microfilming and savings on electronic systems particularly for commercialpurposes are illegal without prior agreement of the manufacturer All compiled data are based on manufacturers instructions All logos product names
27. nnect mains cable gt Use only mains cables with angled inlet connector for non heating appliances Check that the voltage and frequency ratings of the power line are similar to those indicated on the device f N 4 0 Operation Amos M 4 1 Insert remove DDS bacterial filter oversuction stop gt Use goves after having operated the unit 4 2 Using the DDS splash protector 4 3 Attach remove DDS secretion canister lid With the DDS secretion canister on a firm surface position the lid horizontally on top the lid may not be twisted Press down lightly onto the secretion canister using both hands until limit is reached Fig 7 To open the DDS secretion canister hold the canister firmly by the reinforcing clips of the securing device and then pull the secretion canister lid up and off by gripping the filter Fig 8 4 0 Operation Amos M 10 Fig 11a 4 4 Attach DDS secretion canister handle Insert the DDS secretion canister handle into the grooves of the lid with the snap in hooks open 4 5 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 6 Secure DDS secretion canister For removal lift the DDS se
28. onzentrat dimethoxy tetrahydrofurane 3 0g corrosion inhibitors non ionic tensides Sekusept aktiv sodiumpercarbonate phosphonates Ecolab Dusseldorf non ionic tensides 6 5 Recommended disinfectants for surfaces Disinfectant Contents in 100 g Manufacturer Mikrobac forte benzyl C12 C18 alkyldimeththyl 19 9g Bode Chemie Hamburg ammoniumchloride N 3 Aminopropyl N dodccylpropane 1 3 5 0g diamine Green amp Clean SK alkyl dimethyl benzyl ammoniumchloride lt 1g Metasys Rum sterreich Anwendungs dialkyl dimethyl ammoniumchloride konzentrat 6 6 Recommended cleaning agents Disinfectant Ingredients in 100 g Manufacturer neodisher MediClean forte non ionic tensides lt 5g Dr Weigert Hamburg Application concentrate NTA nitrilotriacetic acid 5 15 g enzymes preservative agent neodisher AN Phosphate gt 30g Dr Weigert Hamburg non ionic tensides lt 5g enzymes 7 b 0 Maintenance di A d Visually inspect the device hoses secretion canister and power cord before each use For hygienic reasons the bacterial filter must be replaced at least once a day The unit does not require any further maintenance Maintenance Before putting the device into operation visually check unit secretion canister and power cable accessories connection cables and hoses for signs of damage Damaged cables and hoses must be replaced immediately However every 2 years an inspection and a safety related ch
29. ot be caused by our deliberate infringement of contractual duties for which we are responsible our liability is limited to damage which is regarded as typical for that case We are liable according to the legal terms and conditions if and in so far as the delivery delay for which we are responsible is caused by an infringement of a substantial contractual duty In such cases our liability is also limited to damage which is regarded as typical for that case Should the delivery delay be caused by a culpable infringement of non substantial contractual duties our client is also entitled to claim a one off damage compen sation worth 3 percentage points of the delivery value of the goods for each week s delay up to a maximum which is no higher than 15 percentage points of the delivery value of the goods 7 Delivery Familiarisation In the case of the delivery of devices for the medico technical industry which require assembly and or familiarisation for the final customer using specialist trade personnel such as Ear Nose and Throat Apparatus and Suction Units we reserve the right to deliver the goods exclusively to the relevant specialist traders Should the trader not carry out assembly and or familiarisation for the final customer this is carried out by us In such cases we reserve the right to charge the client for the additionally created costs Our specialist traders operate a recording system so that if necessary our products can be
30. r claim compensation for any increased costs incurred up to that time without setting a further deadline The right to make further claims is reserved Furthermore in such cases the risk of coin cidental destruction or a coincidental deterioration in the quality of the delivered goods is transferred to the client in the case of default in accepting such goods or payment arrears Acts of God or stoppages due to insufficient supplies of material industrial disputes etc entitle us either to demand an appropriate extension of delivery periods or to partly or entirely dissolve the delivery contract This does not give the client the right to claim damages We have fulfilled delivery periods if the delivery goods have left our factory or the client has been informed of the goods readiness for delivery within such delivery periods Delivery periods stipulated by the client are not recognised by us unless they form part of our order confirmation We adhere to legal terms and conditions in cases where as a result of an undue delay in the delivery for which we are liable the client is entitled to claim that his interests in a continued fulfilment of the contract have ceased We also adhere to legal terms and conditions should a delay in delivery be caused by deliberate or grossly negligent action by us or our representatives for which we are responsible We are also responsible for such actions by our representatives or agents Should the delivery delay n
31. sary Fig 18 13 9 0 Options Amos M 14 Fig 19 5 2 Use of suction unit with disposable systems The suction unit may be also used as a tabletop unit with disposable systems that can be attached to a standard rail This requires the standard rail adapter with vacuum con nector Installation is performed in accordance with the attached installation instructions Optionally the suction unit may also be used on the trolley with disposable systems that can be attached to a stan dard rail When using the Receptal canisters the following supports have to be used 2x 1 5 REF 444 0027 0 1x 2 REF 444 0030 0 2x 21 REF 444 0028 0 1x Al REF 444 0031 0 2x 31 REF 444 0029 0 N awm UUO O O 6 1 General information on cleaning and disinfection For disinfection you may use all surface and instrument disinfectants listed in chapters 6 4 6 5 IS A number of disinfection agents may cause dis coloration at the secretion canister etc however this has no effect upon the parts s function Es Always observe the concentration specifications and instructions by the respective manufacturer 6 2 Reprocessing of hoses and secretion canister ts Before using the device on a new patient be sure to clean and disinfect the following parts DDSsecretion canisterincluding DDS secretion canister lid DDS hose adapter and DDS secretion canister handle Suction hose Unscrew all ho
32. se connectors pull the DDS hose adapter out of the DDS secretion canister lid open the lid empty the secretion canister and dispose of the suctioned material properly Take the DDS bacterial filter out of the DDS secretion canister handle All other parts except the bacterial filter must also be thoroughly rinsed under running water You may add a detergent if you wish Using the cleaning agent neodisher AN or neodisher MediClean forte manufactured by Dr Weigert Hamburg cleaning in an automatic cleaner and disinfecter is also possible Thermal disinfection is carried out at 93 C After disinfectation reassemble all parts section 4 0 Oper ation Autoclave all of the parts referred to above 134 C 3 bar 5 min 3x fractionated prevacuum 15 N 6 3 Cleaning and sterilizing the unit surface VS Always disconnect the device from the power line before cleaning and disinfecting the surface Wipe the surface clean with a cloth soaked in a cleaning solution or disinfectant Liquids must not enter the device All of the cleaning solutions and disinfectants listed below can be used EN Should liquids have penetrated into the device it must be inspected by an authorized service technician before being used again 6 4 Recommended disinfectants for instruments Disinfectant Contents in 100 g Manufacturer GIGASEPT FF neu succinic acid dialdehyde 11 0 g Schulke amp Mayr Norderstedt Anwendungsk
33. should price reductions or increases especially due to wage settlements changes in the price of materials or currency fluctuations be incurred Proof of such changes will be provided for the client on request 5 Payment Conditions Balancing Unless otherwise stated in the order confirmation our invoices are payable with a 3 discount within 10 days except for repair and assembly services or within 21 days from the invoice date net cash money receipts is decisive for complying with this term We are entitled to charge interest after the due date at a rate 2 above the relevant basic interest rate of the German Federal Bank Should the client have payment arrears we are entitled to charge interest on arrears at a rate 5 above the relevant basic interest rate of the German Federal Bank Should we be able to prove higher damages due to arrears we are also entitled to claim these The client only has the right to balance invoices against its own claims should such claims be confirmed in a court of law or recognised by us The client does not have the right of retention due to disputed counterclaims 6 Delivery Periods Fulfilment of our delivery duties requires the punctual and proper fulfilment of the client s duties The right to defense on the grounds of an unfulfilled contract is reserved Should the client default in accepting the goods delivery or breach other cooperation duties we are entitled either to withdraw from the contract o
34. sures for the protection of patients and users and to maintain functional reliability 11 3 Disposal The ATMOS C 361 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 Pay attention to country specific regulations for disposal e g waste incineration 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 se
35. t of substantial contractual duties The indispensable conditions of German Liability Law remain unaffected thereby For second hand equipment the period of warranty shall be reduced to a period of twelve months 10 Reservation of Ownership We retain ownership of our goods until the receipt of all payments arising from the business relationship including all demands arising from installation orders subsequent orders repairs accessory deliveries and replacement orders Should we have agreed upon payment on the basis of cheque and bill transactions the ownership reservation applies until the cheque received by us has been paid in and does not expire through our credit upon receiving the client s cheque In the case of a breach of contract by the client especially payment arrears we are entitled to repossess our goods Repossession of our goods repre sents a withdrawal from the contract unless explicitly declared in writing by us We have the right to utilise the product after its repossession whilst the income form such use is balanced against the client s arrears after deducting appropriate utilisation costs The client is responsible for handling the goods with care Should maintenance and inspection work be necessary the client must carry these out punctually at his own cost Our client is entitled to sell the goods he has bought from us in a proper sale transaction However he must immediately assign all outstanding claims to the
36. to reduce repair costs and down time Further more reliability and service life of the equipment will be increased For these reasons these operating instructions must always be kept available near the appliance Prior to first use please peruse the chapter 2 0 For your safety in order to be prepared for any possible dangerous situations It would be too late during in actual use The basic principles are Judicious and careful work provides best protection against accidents Operational safety and readiness for use depend not only on your capabilities but also on care and maintenance given to the ATMOS C 361 For this reason regular cleaning and service work are a must Major maintenance and repair work may be carried out only by expert personnel autho rised by ATMOS In case of repairs you should insist that original spare parts only are used You will then have the warranty that operational safety readiness for work and the value of your appliance will be preserved The product ATMOS C 361 bears CE marking CE 0124 according to the EEC guideline of the council for medical products 93 42 EEC and meets the basic requirements of annex of this guideline The declaration of conformity will be provided on request on indicating the serial number of the unit The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and ISO 13485 ATMOS will supply a service manual conta
37. value of the final invoice sum including value added tax of our claims to his customers or third parties The client is entitled to collect this claim even after such assignment Our right to collect the claim ourselves remains unaffected thereby We undertake to release the securities to which we are entitled if requested to do so by the client should the realisable value of the our securities be more than 10 percentage points higher than the outstanding claims We reserve the right to choose the securities to be released 11 Plans and Illustrations We retain ownership of and copyrights to all plans illustrations calculations and other documents which are attached to our proposals The client must receive explicit written permission before passing these on to third parties Imitating our legally patented products is forbidden and will be prosecuted 12 Jurisdiction and Place of Performance Our central office is the place of performance for all disputes in connection with these General Standard Terms and Conditions and the contracts closed with clients under them This jurisdiction excludes other jurisdiction relating to persons or subject matter Furthermore our client is not entitled to bring charges against us in another court should he file counter charges carry out counterbalancing or declare retention We however are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recog
Download Pdf Manuals
Related Search