ATMOS C 451 - This is the ATMOS Content Delivery Network
Contents
1. 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 s Declaration Emissions The ATMOS C 451 is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS C 451 should ensure that it is used in such an environment Electromagnetic Environment Guidance The ATMOS C 451 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 RF Emissions Class B CISPR 11 Harmonics IEC 61000 3 2 Flicker match IEC 61000 3 3 The ATMOS C 451 is suitable for use in all esta blishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 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 intended operation in this arrangement 12 2 Guidelines and Manufacturer s Declaration Immunity The ATMOS C 451 is intended for use in the electromagnetic environment specified below The customer or user of2. Buyer will receive a faxed notice with a shipment date for products that are not in stock ATMOS is not liable for a delay beyond the pro mised delivery date or for damages resulting from delivery Unless otherwise stated in the order confirmation delivery is ex factory The risk of damage or loss to the products is on the buyer as soon as the products leave the factory Delivery will be insured by ATMOS at buyer s expense unless explicitly otherwise agreed No insurance is arranged by ATMOS for products picked up by buyer at ATMOS s factory or place of business Buyer is responsible for disposing of the packaging at its own cost Terms and conditions Applicable to any buyer of ATMOS products 7 Installation For products which require specific installation or assembly skills ATMOS reserves the right to perform such installation and assembly at buyer s delivery location or to deliver the products to an authorized installer and have the authorized installer install and assemble the products at buyer s delivery location In either case ATMOS reserves the right to charge the buyer for the additional costs 8 Manufacturer s warranty ATMOS warrants that new products sold to buyer will be free from defects in workmanship and mate rial for 24 months after manufacture when properly maintained by buyer and used as intended by ATMOS ATMOS also warrants that accessories and spare parts will be free from defects in workm
3. Weigert Hamburg 6 0 Cleanin ATMOS g mos EEE 6 4 Recommended disinfectants for surfaces Disinfectant Contents in 100 g Manufacturer Mikrobac forte benzyl C12 C18 alkyldimeththyl 1999 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 Osterreich 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 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 check according to EN IEC 62353 have to be performed 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 O Operational and functional disorders which cannot be resolved by me
4. 15 General information on cleaning and disinfection isis ia 14 Cleaning and sterilizing the unit surface 15 Recommended disinfectants for instruments 15 Recommended disinfections for surfaces 15 Recommended cleaning agents 18 NISSEN EEGEN 15 Change fuse 16 Trouble ShootiNQ ccconccconcncccncncoonanconnnaronnannnnnos 16 Accessories consumables and Spare partS zuuuuuununannnnnnnnnnnnnnnn nun nun nun 18 18 Technical Specifications zuus222202222022 19 Checking Reprocessing Disposal 20 Checking ATMOS suction devices 20 Reprocessing MA 20 q EE 20 Notes on EM see EENRR KEEN E EEN EE 21 23 General Standard Terms and Conditions 1 2 N Introduction ATMOS mos EEE 1 1 Notes on operating instructions These operating instructions contain important notes on how to operate the ATMOS C 451 costs from ATMOS safely correctly and effectively Reading this booklet helps avoid risks and also to reduce repair 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 Any reprint even in extracts only after written permission These operating instructions must always be kept available near the device
5. 340 0357 0 ATMOS C 451 Praxispaket 31 REF 340 0338 0 mit Normschiene ATMOS C 451 ATMOS C 451 fahrbar REF 340 0358 0 mit Vakuumextraktionspaket REF 340 0355 0 mit Normschiene 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 C 0124 Nom Adresse et Num ro d identification de l organisme notifi DEKRA Certification GmbH Handwerkstra e 15 D 70565 Stuttgart Konformit tsbewertu ngsverfahren Richtlinie 93 42 EWG Anhang II 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 evaluation de conformit Directive 93 42 CEE Annexe Il 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 M rz 2015 Valid till further changes on the product until March 29th 2015 Valide jusqu modification du produit juse au 29 mars 2015 Lenzkirch den 04 06 2013 Place and date of issue Frank Greiser Gesch ftsf hrer agter Safety Manag
6. Conditions The warranty will be rendered invalid in case of damages caused due to the utilization of accessories or consumables which are not approved 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 The design of the ATMOS C 451 fulfills the requirements of IEC 60601 1 EN 60601 1 and of protection class I 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 power cable and accessories for signs of damage Damaged cables must be replaced immediately Check also function of the unit The ATMOS C 451 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 60601 1 EN 60601 1 The ATMOS C 451 may be operated only in rooms used for medical purposes but not in areas zones M and G subjec
7. a Return Material Authorization RMA number before returning any products All items returned for service or calibration must contain paperwork describing the reason for return contact name phone and fax number ATMOS will provide buyer with a quotation prior to any non warranty service Costs for shipping calibrations and service are non refundable 11 Exclusive Jurisdiction Waiver of Trial by Jury Any action by buyer against ATMOS must be brought in the court of appropriate jurisdiction in Lehigh County Pennsylvania or the United States District Court for the Eastern District of Pennsylvania Buyer consents to the exclusive jurisdiction of these courts and waives all claims of improper venue and jurisdiction BU YER WAIVES TRIAL BY JURY WITH RESPECT TO ALL DEMANDS CLAIMS AND COUNTERCLAIMS RESULTING FROM THE PURCHASE RENTAL MAINTENANCE OR USE OF THE PRODUCTS PURCHASED HEREUNDER ATMOS Inc 3717 Huckleberry Road Allentown PA 18104 November 2008 Tel 610 351 7221 Fax 610 351 6827 sales atmosmed com www atmosmed us
8. Care and safety inspections in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS C 451 and are therefore a must besides regular cleaning Repair work and safety inspections may be carried out only by expert personnel authorised by ATMOS By applying only original spare parts you will have the guarantee that operational safety readiness for work and the value of your ATMOS C 451 will be preserved e The product ATMOS C 451 bears CE marking CE 0124 according to the EC Directive of the council for medical products 93 42 EEC and meets the basic requirements of appedix of this directive e The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and EN ISO 13485 e Prior to start up please peruse chapter 2 0 For your safety in order to be prepared for any possible dangerous situations Intended use The Surgical Suction Unit ATMOS C 451 is a compact suction unit for medical application It is especially intended for aspira tion and collection of secretions body fluids and tissue Its main fields of application are in the 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 aspi
9. N ATMOS MedizinTechnik ATMOS C 451 Surgical Suction Unit Y e O Ce ra ul UI E C Ce Sam Q O 340 0300 B USA C 01 24 2013 09 Index 18 Dd a OnKRWN AO 2 0 3 0 3 2 4 0 4 12 4 3 Introduction sek ENNER KEREN REENEN EN 3 5 Notes on operating instructions cooccccccccncc 3 Intended Use cis 3 FUN ON carrasco loci cateo re 3 Explanation of pictures and symbols 4 Scope of Supply cis ria 5 Transport and Storage 5 For your safety zunuesnnnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenn 6 Seng UD 7 8 Operating elemments Au 7 Connection area in unit base nuennnnnnunnnnnnnnnnnnnnnnnenn 8 Oper AUG EE 9 10 DAA ee 9 Set en een E 9 SUCHO ee ae 10 ATMOS MedizinTechnik GmbH amp Co KG Ludwig Kegel Str 16 79853 Lenzkirch Deutschland Germany 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 9 0 10 0 11 0 11 1 11 2 11 3 12 0 ODUIONS naar 11 13 Foot swtch 11 System trolley ooooooonccccococcncconoccnncnnncnononononnnos 11 Securing the unt 12 Travelling with the trolley 12 Tray in foot of system trolley 13 Potential eoualteaton 13 Use of suction unit with disposable systems 13 Battery Backup SySteM ccooocccccccccccocncocononononos 13 GAMING nenne 14
10. a H 330 x B 240 x T 260 mm H 1010 x B 360 x T 440 mm with system trolley Ca 6 7 kg Every 2 years Typ BF IPX 1 lla acc to EC directive 93 42 EEC CE 0124 EN 60601 1 2007 EN ISO 10079 1 2000 10 217 36777 340 0300 0 Technical data issued on 04 07 2011 19 Checking Reprocessing 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 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 and 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 It must be sent to an ATMOS certified service partner Handling of the suction device determines to a large extent its reliability and safety The hygiene measures described in the previous chapters are necessary measures for the protection of patients and users and to maintain functional reliability 11 3 Disposal e The ATMOS C 451 is not comprised of any hazardous materials e The materials of the housi
11. ans 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 O Please send in the complete device see scope of delivery Please remove all disposable parts and consumables O Thorough cleaning and disinfection Airtight packing 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 O assembly new installations modifications extensions and repairs are done by people who are not authorised by ATMOS 15 Maintenance be A J Visually inspect the device jar and power cord before each use O The unit does not require any further maintenance 7 1 Change fuse O Remove mains cable O Press the spring clips of the fuse holder together on both sides with a small screwdriver and pull out the fuse holder O Replace the fuse and push the holder back in until both spring clips are locked into place O Then reconnect mains cable Fuse REF 008 0749 0 The ATMOS C 451 was subjected to a thorough quality control before shipment If there is nevertheless some malfunction you possib
12. anship and material for 12 months from the date of purchase Any claim under this warranty must be made during the foregoing time periods or is conclusively waived This warranty is not assignable and applies only to buyer In addition this warranty does not apply in the case of mishandling incorrect installation or assembly by buyer or an unauthorized third party incorrect or insufficient maintenance unacceptable operating conditions such as unacceptable humidity ventilation temperature power supply or vibrations normal wear and tear changes of any kind to the product without first being authorized by ATMOS repairs to the products or the use of accessories or replacement parts without first being authorized by ATMOS incorrect operation of the product improper use inappropriate or negligent handling and care especially with respect to dirt lime suction of fluids inappropriate cleaning and sterilization accidents or acts of God No warranty is given with respect to disposable items In the event a product fails in normal use because of defects in workmanship or materials buyer s ex clusive remedy will be the repair or at ATMOS s sole option the replacement of the defective product At the sole choice of ATMOS ATMOS or an authorized repairer may provide repair services either on the buyer s premises or elsewhere To exercise this remedy buyer must provide proof of purchase from ATMOS and the product must still
13. described herein regarding cleaning and disinfection do not replace the regulations valid for operating the device SS The information regarding concentration of cleaning liquids and disinfectant solutions stated by the relevant manufacturers must strictly be observed 6 2 Cleaning and sterilizing the unit surface ts 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 Es Should liquids have penetrated into the device it must be inspected danger of an electric shock and the pump must be decontaminated resp exchanged infection risk 6 3 Recommended disinfectants for instruments Disinfectant Contents GIGASEPT FF neu succinic acid dialdehyde Anwendungskonzentrat dimethoxy tetrahydrofurane corrosion inhibitors non ionic tensides Sekusept aktiv sodiumpercarbonate phosphonates non ionic tensides neodisher AN Phosphate non ionic tensides Enzyme 14 Necessary N O Using the cleaning agent Neodisher AN manufactured by Dr Weigert Hamburg cleaning in an automatic cleaner and disinfecter is also possible Thermal disinfection is carried out at 93 C in 100 g 11 09 3 0g gt 309 lt 5g Manufacturer Sch lke amp Mayr Norderstedt Ecolab D sseldorf Dr
14. e 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 451 is used exceeds the above compliance level the ATMOS C 451 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 451 The ATMOS C 451 is intended for use in electromagnetic environment in which ratiated disturbances are con trolled The customer or user of the ATMOS C 451 can help prevent electromagnetic interference by maintai ning a minimum distance between portable and mobile RF Communications equipment and the ATMOS C 451 as recommended below according to the maximum output power of the communications equipment rap Separation distance depending on transmit frequency m Nominal out
15. est 17 9 0 Accessories consumables and spare parts 18 Bellows silicone rubber 000 0739 0 Fuse 230 V T 0 63 A H 008 0634 0 Fuse 115 V T 1 25 A H 008 0720 0 Mains cable angle angle 5 m 008 0818 0 Push in foot for housing 505 0337 0 Fixing screw for system trolley star handle 000 0726 0 Clamping ring for fixing screw 000 0727 0 Operating instructions 340 0300 B Technical specifications Air flow rate of pump Max vacuum Vacuum readout Additional air regulation Voltage Current input max Operating time Fuse Heat emission Noise level Ambient conditions Transport storage Operation Dimensions HxWxD Weight Regular safety relevant inspections Protection class EN 60601 1 Degree of protection Protection category Classification acc to Annex IXEEC directions 93 42 EEC CE marking Rules applied UMDNS Code GMDN Code REF 1 bar 750 06 mm Hg 1000 hPa depending on ambient air pressure 45 l min 3 5 l min 91kPa 910 mbar oder 682 5 mmHg NN 1 0 bar 16 mbar Klasse 1 6 63 mm mechanical regulating valve 230 V 10 50 60 Hz REF 340 0300 0 max 0 75 A bei 230 V gt 12 h continuous operation without interruption within 24 h T 800 mA H for 230 V max 173 J s lt 48 dB A 1 m ISO 7779 bei max Vakuum 222 4122 F 5 90 humidity non condensing air pressure 700 1060 hPa Os FE 20 80 humidity non condensing air pressure 700 1060 hP
16. have the original serial number In addition if required by ATMOS the buyer agrees to send the product freight prepaid in its original or similar packaging offering the same protection as the original packaging to the shipping address provided by ATMOS THE FOREGOING WARRANTY IS EXCLUSIVE AND IS GIVEN IN LIEU OF ALL OTHER WARRANTIES EITHER EXPRESS OR IMPLIED INCLUDING WI THOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FORA PARTICULAR PURPOSE 9 LIMITATION OF LIABILITY The remedies of buyer set forth herein are exclusive and the total liability of ATMOS with respect to this order and buyer s subsequent ownership and use of the product whether based on breach of contract breach of warranty negligence indemnification strict liability or otherwise and even if ATMOS has been advised of the possibility of damages shall not exceed the purchase price of the product or component upon which liability is based In no event shall ATMOS be liable for consequential incidental or special damages including buyer s loss of profits or liabilities of buyer to any third persons 10 Return policy Any ATMOS product which buyer is not satisfied with except customized products e g ENT workstations patient chairs can be returned within 14 days for a full refund less shipping charges It must be received in the original packaging with the proper documentation and in its original condition Please contact ATMOS for
17. ing Director Directeur Inspector Charg e de la S curit 1 General These Terms and Conditions apply to buyer s purchase of ATMOS products Buyer s terms and conditions which are contrary to or deviate from ATMOS s Terms and Conditions are not part of any contract between ATMOS and buyer unless ATMOS explicitly accepts them in writing even if ATMOS has knowledge of the buyer s contrary terms and conditions ATMOS s Terms and Conditions also apply to all future business with buyer 2 Quotation Order Confirmation Confidenti ality If these terms and conditions are submitted as part of a proposal from ATMOS then ATMOS reserves the right to modify its proposal including without limitation the price until the final terms are stated in an order confirmation In addition ATMOS reserves the right to make design or manufacturing changes at any time without prior notice and without incurring an obligation to modify or change products manufac tured or delivered prior to such changes Each order is considered accepted by ATMOS only following ATMOS s written order confirmation All price quotes from ATMOS and all plans illustra tions calculations and other documents included with a quote are confidential and are not to be disclosed by buyer to any other party without first receiving written authorization from ATMOS 3 Orders Every order requires an exact description of all of the product s details ATMOS assumes no liabili t
18. ly might solve this problem yourselves if you observe the following instructions Problem e Unit does not start Loose power plug Check connection to supply socket no power voltage Check inbuilding fuse Defective fuse Replace fuse O Insufficient performance Leakages within the hose system or in Check collection jar lid and hose or no suction the collection jar lid system replace sealing ring on collection jar lid if necessary Filter is clogged Replace filter check filling level in vacuumgauge indicates a vacuum collection jar evacuate jar if necessary Secretion or blood has been sucked in Unit has to be returned for repair and valve plates of the pump are contaminated 16 Accessories for ATMOS C 451 Standard rail set for system trolley instead of DDS docking system for 2 system jars System trolley basic version for ATMOS C 451 Potential equalization for system trolley Trolley with standard rail Trolley with standard rail for ATMOS C 451 basic device DDS standard rail adapter 25 x 10 mm with vacuum connection for the use of disposable systems at the unit Quick connector for ATMOS C 451 Optional foot switch for ATMOS C 451 when used as desk top unit or with trolley installation is effected in factory Holder for Battery Backup Battery Backup Medical Grade 340 0081 0 340 0070 0 340 0082 0 320 0070 1 340 0058 0 340 0059 0 000 0769 0 340 0060 0 on request on requ
19. ness immediately upon receipt see delivery note In addition to the basic device the scope of delivery comprises the following parts Basic device GF Mains cable 1 6 Transport and storage The transport of the device may be effected only in a dispatch carton upholstered and offering sufficient protection Please document and report damages in transit immediately For complaints or return deliveries please use the enclosed form QD 434 The unit must be allowed to stand for up to six hours at room temperature prior to starting up for the first time following transport at temperatures below freezing The unit may not be operated if it has not acclimatised as this might damage its diaphragms Operating instructions Oo Ambient conditions Transport Storage Operation System trolley Trolley 22 122 F 5 90 humidity non condensing at air pressure 700 1060 hPa 50 395 P 20 80 humidity non condensing at air pressure 700 1060 hPa nn For your safety Amos EEE For your safety The ATMOS C 451 fully complies with the electromagnetic immunity requirements of standard IEC 60601 1 2 EN 60601 1 2 Electromagnetic compatibility Medical Elec trical 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
20. ng can be recycled completely e Prior to disposal device and accessories must be decontaminated e The materials are to be separated carefully e 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 the device surface must be disinfected 20 Notes on EMC m Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc to following EMC notes
21. nt panel The device must be placed on a solid level surface This product is not re sterilisable Rep amp ted reuse of components which are marked with a is forbidden In case of repeated reuse these components lose their function and there is a high infection risk fN 3 0 Setting up Amos 7 XJ O Always set the equipment up on a secure level surface Fig 1 3 1 Operating elements O On Off switch with pilot lamp Vacuumgauge Vacuum controller 3 0 Setting up Fig 7 3 2 Connection area in unit base Connect mains cable t Use only mains cables with angled inlet connector for non heating appliances O Check that the voltage and frequency ratings of the power line are similar to those indicated on the device Connect footswitch optional O Thread knurled nut onto hose O Push hose onto connecting nipple O Tighten knurled nut Vacuum connection on base system trolley e To connect press coupling firmly into socket until latched into place serves for vacuum connection of collection jar attached to system trolley O To remove press the metal interlocking device apart side ways and pull the hose out of the socket 4 0 Operation 4 1 On off switch O Press the I symbol to switch the unit on O Press the 0 symbol to switch the unit off O The unit is ready for optional footswitch operation in the 0 position see options Fig 8 4 2 Set vacu
22. put of the 150 kHz bis 80 MHz 80 MHz bis 800 MHz 800 MHz bis 2 5 GHz transmitter d 3 5 3 VP d 3 5 3 VP d 7 0 3 VP 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 are not applicable in any case The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings objects and people 23 24 Declaration of Conformity MedizinTechnik 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 erklaren 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 ll a N Name name Nom Ane ATMOS CAT REF 340 0300 0 AIMOS C 451 fahrbar 2x3 REF 340 0334 0 varianten models Variante ATMOS C 451 fahrbar 2x5 REF 340 0333 0 ATMOS C 451 Praxispaket 1 51 REF 340 0339 0 ALMOS EE REF
23. rate secretions rinsing so lutions cerumen or to extract foreign matters in the ward recovery ward and ICU for the spon ta neous aspiration of body fluids and foreign matters e g from the respiratory tract Contraindications for Use Exposed arteries veins or organs Untreated osteomyelitis Necrotic tissue Malignancies and Fistulas for smoke evacuation in connection with HF electrosurgery or laser surgery Warning Do not use in non medical applications Do not use for emergency medical aid Do not use in the presence of combustible or explosive fluids or gases Do not use for drainage in the low vacuum range e g thorax drainage Caution Federal law restricts this device to sale by or on the order of a physician 1 The product ATMOS C 451 bears CE marking CE 0124 according to the EC Directive of the council for medical products 93 42 EEC and meets the basic requirements of appedix of this directive The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and EN ISO 13485 Prior to start up please peruse chapter 2 0 For your safety in order to be prepared for any possible dangerous situations 3 Function O TheATMOS C 451 is a line power operated surgical suction unit centering around a silent diaphragm type pump which generates a vacuum inside a collection jar Using a vacuum regulator and the vacuum gauge the target
24. t 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 The foot switch is suited for operation in above mentioned areas Liquids must not be allowed to enter the device Should liquids have penetrated into the device it must be inspec ted danger of an electric shock and the pump must be decontaminated resp exchanged infection risk After transport at cold temperatures below the freezing point the unit must acclimatize 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 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 Set up the device so that the operator has a clear unob structed view of and easy access to the fro
25. t with disposable systems that can be attached to a standard rail O Optionally the suction unit may also be used on the system trolley with disposable systems that can be attached to a standard rail O This requires the standard rail set for installation to the trolley in accordance with the attached instructions and the adapter with standard rail for installation to the securing device of the suction unit as described in the attached installation instructions This seals the upper vacuum con nection and provides the opportunity for attaching additional accessories on the standard rail thus available O When using the Receptal canisters the following supports have to be used 21 51 REF 444 0027 0 1x 2 REF 444 0030 0 2x 2l REF 444 0028 0 1x Al REF 444 0031 0 2x Al REF 444 0029 0 5 6 Battery Backup System Option O A Battery Backup UPS may be installed on the foot of the system trolley Can be usefull to brige over blackout brownout Installation of the board is performed in accordance with the attached installation instructions Make sure to combine the ATMOS C 451 only with Medical Grade UPS in clinical environment Follow the instructions of the user manual of the UPS 13 AAA 6 1 General information on cleaning and disinfection Prior to cleaning Medical devices must always offer a maximum in safety and function We therefore recommend Prior to each application Gef The measures
26. the ATMOS C 451 should ensure that it is used in such an environment Immun Test IEC 60601 eS Terra re Electromagnetic y Test Level H Environment 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 6 kV Contact 8kVAir 2 kV Mains 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 21 Notes on EMC Immunity Test IEC 60601 Compliance Level Electromagnetic Environ Test Level ment Guidance LU U Voltage Dips Dropout lt 5 lt 5 U Mains power quality should be IEC 61000 4 11 gt 95 Dip of the U gt 95 Einbruch der U_ that of a typical commercial or for 0 5 Cycle fur 0 5 Periode hospital environment If the user of the ATMOS C 451 demands 40 U 40 U continued function even in case of 60 Dip of the U 60 Einbruch der U interruptions of the energy supply for 5 Cycles f r 5 Perioden it is recommended to supply the ATMOS C 451 from an
27. um O 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 O Test the system for leaks if the desired vacuum is not reached Please also see chapter 8 0 Trouble shooting fN 4 0 Operation ATMOS os EEE 4 3 Suction O Use appropriate suction tubes catheters suction tips or suction instruments containers and hoses Prior to starting suction containers must be checked for cracks Damaged containers may not be used 3 Keep an eye on the level of liquid in the collection jar during suction gt Use only containers with oversuction protection 10 SN 2 0 Options ATMOS mos bs 9 1 Foot switch REF 340 0060 0 O The foot switch works pneumatically and is therefore sui table for use in connection with flammable anaesthetics class AP O Connect the foot switch as shown in section 3 2 O Set the unit to 0 off at the main switch foot switch mode O The unit is switched on by pressing the foot switch and switched off by pressing it again Fig 10 5 2 System trolley O A system trolley which can be used with a changeover adapter is available for use in the OT O Always position the system trolley on a flat sturdy sur face Fig 11 11 5 2 1 Securing the unit It is only possible to ensure safe operation as a mobile suction
28. uninterrup 70 U 70 U tible current supply or a battery 30 Dip of the U 30 Einbruch der U_ for 25 Cycles f r 25 Perioden lt 5 U lt 5 U gt 95 Dip of the U gt 95 Einbruch der U_ for5s f r5s 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 451 is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS C 451 should ensure that it is used in such an environment IEC 60601 Electromagnetic Environment Immunity Test Compliance Level Test Level Guidance equipment should be separated from the 2 a to 80 MHz Wald ATMOS C 451 incl the cables by no less than the distances calculated listed below Radiated RF 3 V m E V m IEC 61000 4 3 80 MHz to 2 5 GHz Recommended distances d 3 5 10 VP d 3 5 10 VP von 80 MHz bis 800 MHz d 7 0 10 VP von 800 MHz bis 2500 MHz 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 Dol 22 Notes on EMC 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 cas
29. unit by using the special system trolley available for use with the unit O The suction unit is placed on the system trolley so that its 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 system trolley to ensure safe operation and safe travel O Use the lockable castors if necessary Fig 13 5 2 2 Travelling with the trolley O Always push the trolley so thatthe open fork of the pedestal faces in the direction of travel O Push the suction unit using both hands in the handle area O Ensure that hoses and cables are secured in place 3 Never leave the system trolley on a sloping surface E SEN We _ V Lo GE kb d SE SES Ki F kal wer Fig 14 12 5 0 Options p mos EEE 5 3 Tray in foot of system trolley REF 340 0084 0 O A tray available as an optional extra may be inserted in the foot of the trolley Fig 15 A A 5 4 Potential equalisation PER dept A aed i ea REF 340 0082 0 O A potential equalization connector may be installed on the system trolley in the installation groove as an optional extra Installation is performed in accordance with the attached installation instructions 5 5 Use of suction unit with disposable systems O The suction unit may also be used as a tabletop uni
30. vacuum and thus the air flow rate can be precisely adjusted O A system trolley is available for mobile use N Introduction ATMOS mos EEE 1 4 Explanation of pictures and symbols Short cuts symbols contained in this manual Follow the arrows whilst proceeding El General information sequence A 3 e Please press where e Numeration E dot indicates Please read gt Subnumeration important information Pictures contained in this manual Warning especial diligent l notice gt Important information Keys on the control panel symbols at the ATMOS C 451 Potential equalization Alternating current l SN IPX1 Protection against penetration of REF damaging humidity drop water A Move plug in this Y direction gt Turn shift in this direction Y Replace y Engage check correct dlick a AR Observe operating instructions Application part type BF Serial number Order number m Creation date A Foot switch Off feed in power connection 0 f On feed in power SE connection The CE sign shows that this product meets the appropriate requirements of the EC Directives Protection class II Fuse 1 0 Introduction 1 5 Scope of supply N ATMOS XJ 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 complete
31. y for errors and damage caused by inaccurate or incomplete ordering details All orders must be in writing via E mail US mail or fax Verbal orders are not accepted or binding 4 Prices Delivery and Packaging Costs Unless otherwise stated in the order confirmation prices are net prices in US Dollar excluding tax insurance packing and shipping costs The price for this order is not applicable to any other order Any and all present or future government charges levies or taxes on the products shall be added to the price and paid by buyer unless buyer furnishes ATMOS with an exemption certificate acceptable to the taxing authorities Standard shipments are typically UPS Ground Ex press service is available at an additional cost Packaging is charged to buyer separately at cost 5 Payment Conditions ATMOS accepts COD bank check money order or most major credit cards Visa Mastercard An account with special payment conditions can be established for qualified buyers Once an account is opened all payments are due net 30 days unless otherwise stated in the order confirmation Any delay in payment of more than 2 weeks will be charged at an annual interest rate of 18 1 5 per month No shipments will be made to any delinquent accounts 6 Delivery Periods and Terms Risk of Loss Shipments of products are usually made within 2 weeks of an order unless noted otherwise in an AT MOS order confirmation or other ATMOS document
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