Kröber O2-4.0 Index
Contents
1. orrnanrnnrnnnrnnrnnnnnnnnnnrn 66 Angle connection arrrnrrnnrrrnnrvnrevnnennne 65 Assembly 70 72 C Carrier handle rrrarernnrorarernanennnnnnnre 65 Choosing the location 71 Cleaning intervals 86 COMMING EE 86 Coarse dust filter 65 Control Dae EE DE 65 Copyright protection 59 D DAMS Varna 61 64 DESIO EE a 65 Disinfecting oososeesesresresrerrerrerrrrrer rer rrn rr nr ana 86 DIS 0 VEERE 65 E ENG Lesere 63 EMC regulations arornnrrnnnrnranennnnnnnnnnn 92 Enty Ol all sses 71 Equipment TUSC vsccosscdacavsinnasaesimdacmnsimaran 90 Explanation of symbols on the unit 97 F Fire hazard orennronnrnanvnnrnannnnrnanvnnnnnnenn 62 FONCION EE 65 FE 66 Kr ber 02 4 0 Index G General description rrrrarrnrnnrennnnrnnnn 65 H HF communication equipment 63 ON acess qeasepesmtosenccasences 64 Humidifier rnronnnonnnonnnennnennnennnnnnnennne 65 Instructions for USE rrrnrrennrrrnnrernvrenne 56 L UTI IN EE 57 EO CAE ON espn EE E ants 63 M Mains ET 65 Maintenance rernrrnnnrrennvrnnnrennvrennrennven 86 Maintenance plan 87 Maintenance Work c ccsceseeeeeeeeeeeees 89 Medical Device Directive 55 Mobile phones rrrnrennnrnrnrernnrevnnennnen2. day daily Nasal cannula should be disposed of and replaced in case of stationary or every day ambulant use daily Clean the nasal cannula when used in homes or for nursing care If the Set for external humidification is used it must be cleaned and disinfected every week every 14 days The Kr ber O2 4 0 must be cleaned with a damp cloth earlier if necessary and disinfected after Replace the coarse dust filter every 4 weeks Replace the nasal cannula when used in homes or for nursing care annually after 5000 Replace the air intake filter SP note With extremely dirty ambient air the filter must be changed earlier disinfected after If the Set for external humidification is used the operating hours 87 Kr ber O2 4 0 Interval Cleaning work bracket must be cleaned and disinfected with changing patients Replace the nasal cannula A WARNING Health risk In order to avoid cross infection each user of the Krober O2 4 0 should wear his her own nasal cannula after infections After an infection a new nasal cannula should be used to prevent re infection after service work The Kr ber 02 4 0 must be cleaned with a damp cloth and disinfected after after service work Nasal cannula should be disposed of and replaced by a new one after service work Replace the coarse dust filter after service work Replace the air intake filter Interval annually Safety inspectio
3. 63 O Operation oossosseosressreesreerrrerrrrrr rer ren rr rn rann 79 Ge EE 62 Oxygen concentrator sssssesseosrenna 55 Oxygen CyliNClClossnmsssssressressrrorrenrrenrn enn ran 61 Oxygen savings system 61 Oxygen SUPPIY ssssossressressresrrenrrrrnrrrrrrrnr ran 55 R FREQ UN 0 EE rer rrnrrn rna 65 S Sr EE 60 Safety during maintenance 86 99 Kr ber 02 4 0 Index Service laD eener 66 EO de 55 61 62 Spare parts sossossessessresrenrrrrrenrrrr ren r rn nanna 91 Steerable casStorS 65 Sterile water system 89 SLE 210 B eae ee ee 69 SWC 65 gt 111912 nee EEN 58 T Technical data ccccccceeeeeeeeeeeeeeees 67 TRANS poe 69 100 Kr ber Transport cartOon arannnnnnnnnnnennnevnnnnnnen 69 Transport damage 69 Transport inspection 69 V Volume flow rannnnnennnnnnnrnnnennnennnrnnnennee 65 W Warranty seooeonoronnnonnnennnennnennnennnennnnnnnrn 57 Waste disposal 59
4. and mobile radio equipment should not be used closer to the Kr ber O2 4 0 and the leads than the safety distance calculated by using the equation applicable for the transmission frequency Recommended safety distance radiated HF d 1 2 VP for 80 MHz to interference ace 10 g0 MHz to 2 5 GHz CMT d 2 3 VP for 800 MHz to 2 5 GHz 94 Kr ber 02 4 0 Hr be r Appendix e Electromagnetic Immunity test IEC 60601 test level Compatibility level environment regulations directed HF 3 Vert d 1 2 VP interference acc to 5 5 IEC 61000 4 6 Oka Oe Mn with P being the rated power of the transmitter in Waitt W acc to the specifications of the transmitter manufacturer and d being the recommended safety distance in metres m According to an in situ examination the field intensity of stationary radio transmitters is with all frequencies lower than the compatibility level In environments marked with the following symbol interferences are possible 9 NOTE 1 For 80 MHz the higher value is valid NOTE 2 These regulations may not apply in all situations The propagation of electromagnetic waves is influenced by the absorption and reflection by building objects and persons The field intensity of stationary transmitters such as base stations of radiophones and land mobile services amateur stations AM and FM radio and television stations can theoretically not be exactly predetermined In order to det
5. as well as for clinical applications However should problems arise with the Kr ber 02 4 0 you may contact your dealer at any time This medical care product from Kr ber is labelled with the CE sign according to MDD Medical Device Directive Only use the Kr ber 02 4 0 after a medical indication and only in compliance with the doctor s orders by following these instructions for use If side effects or extreme health restrictions occur during the therapy you should immediately consult your doctor 55 Kr ber O2 4 0 56 General Kr be r 2 General 2 1 Information in these instructions for use These instructions for use describe the installation operation and maintenance of the unit Strict compliance with the stated notes on safety and instructions for use is a prerequisite for safe and proper work with the unit Moreover compliance with the accident prevention instructions valid at the location of use and the general safety regulations is mandatory This instruction manual is part of the product and should be kept near the unit so that it is at any time available for personnel involved in installation operation maintenance and cleaning The graphic illustrations in this manual may perhaps differ slightly from the actual design of the unit Kr ber 02 4 0 Kr be r General 2 2 Type plate The type plate of the Kr ber O2 4 0 is attached to the back of the unit above the coarse dust filter 2 3 Liabil
6. having stayed in a possible oxygen saturated atmosphere you should thoroughly aerate your cloths because oxygen adheres to the clothes very well An ignition source e g a burning cigarette could easily cause burning of your clothes Materials that do not burn in air may burn very vigorously and even spontaneously in oxygen or oxygen enriched air This already applies for an enrichment of only a few percent Oil and grease even creams and gels can react in an explosion like manner when coming in contact with oxygen It is therefore mandatory to keep the unit free of oil and grease Oxygen considerably increases the temperature of a flame and the speed of combustion Do not fill the humidifier with flammable fluids Kr ber O2 4 0 Kr be r Safety A WARNING Danger of electric current Electric energies can cause severe injury Damaged insulation or components cause a danger to life Therefore Work on the equipment must only be performed by trained professionals Pull the mains plug out before starting work on the unit Check mains leads for damage before every use p ATTENTION Observe high frequency safety Medical equipment can be influenced by mobile HF communication equipment e g mobile phones Do not use mobile radio equipment in the vicinity of the Kr ber 02 4 0 as close as 3 5 m wM ATTENTION Observe electromagnetic compatibility Electrical medical equipment is subjected to stringent pro
7. to use the unit 1 2 The unit is standing next to the user during use The user uses the Set for external humidification In this case the unit can stand in another room w ATTENTION The FireSafe Nozzle is a thermal fuse designed to stop the flow of oxygen in the event that the downstream PVC tube is ignited In doing so the fire in the PV tube is inclined to extinguish because PVC will not normally burn in air The FireSafe Nozzle is fitted directly to the outlet of each oxygen delivery device typically an oxygen flowmeter or the outlet of an oxygen concentrator Read through this entire chapter before installing this FireSafe Nozzle As with all medical equipment attempting to use or install this device without a thorough understanding of its operation and limitations may result in patient or user injury 1 This device is intended to be fitted to the outlet of a medical oxygen or oxygen concentrator where breathing circuits that have low static operating pressures not exceeding those stated in the device specification It must not be used for other applications 2 This device is a flow direction sensitive device It must be place with respect to the correct flow direction otherwise it is ineffective and does not protect the patient in case of fire 3 Do not install this device near an open flame or near a source of excessive heat that is likely to exceed 40 C 4 Oxygen is not flammable but the presence of oxygen will d
8. Kr ber 02 4 0 Index Kr ber 2172 DEN 65 STENA en 67 6 Transport packaging and Storage arxranuennnunnnnnnnnnnnnnnnnnnnnnnnnnnnennnuennnnnnnnennnnnnnnennnnennnunnn 69 bl KENSPOT INS PECUHUON sinos 69 SZ ST T 0 REE 69 Taking NO S FVICE arr 70 7 1 Before assembling srosmnesessesresresresrerrerrerrer rer rer rar rar rar rar rr r aAa KKR KKR KKR KKR KKR KKR KKR KKR KKR KKR RR RR Krans 70 Fe OO MNO M OC aO e E E 71 TET E RER ns sisters bien ER ERE 72 7 3 1 Without external humidification raronnrennnevnnevnnrvnnevnnennnrnnnennnrnnnrnnnennnennnennnennnennne 73 7 3 2 With external humidification sostnmsssssesrssrssserrsrrsreran rar reser rar rr rrr rar rn r rr RR KRA e KARA RR AR ROR ARR a 76 OPEN 79 8 1 Taking into Service suoseoseeserseeseoseoreosenrenrerrerrer rer rrr rer ren ren ren ran ren ete eket RKS R KRK RR KSR KRK RR KRK nn 79 8 2 Adjusting the oxygen volume flOW sssssroseesresresrssresrorrorrrrenrrr rer rrn ren ren rr rr ren r rn rr nr rn ee RK nro rn 80 8 3 Status messages and alALMS venn 82 8 3 1 Status MESSAGES sirooseosressesseorresreorrerrenrrerrerrrrr rar rer ran rr eke rr RR RR RKS ARR RR KR RR KRK KRA k ket ket 82 PENN 82 oe FE OL 0 EEE EE EEE EEE 82 OO AE GAC OO EE NN NN RN 83 9 MaiMena NGE sasni Ea NN EN le RSKR ESSER SNRA 86 gt AOU EEE EEE EE NE NESS NESS 86 9 2 General notes misoeeeossessrersreerrresrrerrrerrrerrrerr rens rar narr narr ran RR KRA RKS RR RR RR KAR KKR RR KKR KRK RR RAR R
9. RR RAR RR nn nn 86 TR 86 ER DS 151611 0 RE 86 9 3 Maintenance plan sosnosessessessressesresreererrerrer rer rer nns rer rar rar rr r rr rar R RR RAR KKR KKR KKR KKR KKR KKR KKR KKR KKR RR ann 87 SME eda 10010 REE 89 VS AES E bss ren bene rn E E A A E E 91 LE AD oe EEE E 92 TJ ENG VOCUIAVIONG c 4 2 ccccsectudecuisatecensansdocnd saseteissuisdeaudssteansausdocndcasenensinecenndsebetanseusceceede 92 11 1 1 Electromagnetic compatibility interference EMISSION sssnossrsssressrerrrerrrenrreneronr rr arr na 92 11 1 2 Electromagnetic compatibility interference EMISSION ccceeceeeeeeeeeeeeeeeeeees 93 11 1 3 Recommended Safety distances cccccseccceeeceeeeceeeceeeceucecseeceeesueeseeessueenaess 96 11 2 Explanation of symbols on the UMNIt ssssossessessressressrrrrrrrrrrrrrrrnr rer rar rrrr rankens narr arr rn rr rn rena 97 52 Kr ber O2 4 0 Kr ber de V2 NN ens 99 53 Kr ber O2 4 0 Index 54 Hr ber Kr ber 02 4 0 Ar ber preiiminary statement 1 Preliminary statement Your doctor has found that you require an additional oxygen supply With the Kr ber O2 4 0 you received a German brand product for oxygen supply which has been developed on the basis of the latest knowledge in both medical engineering and electronics Permanent quality inspections ensure uniform quality on the highest level The Kr ber 02 4 0 is a highly reliable oxygen concentrator intended for use in homes or at home
10. Safe Nozzle in the oxygen tubing routing as close to the patient as possible Connect the other terminal to the short oxygen tubing 0 33 m Kr ber 02 4 0 Hr ber taking into service 3 Connect the oxygen tubing to the humidifier TS vo TE The humidifier can be used directly at the oxygen concentrator or with the kit for external humidification near to the patient Fig 39 Connection with the humidifier A WARNING Danger of tripping over On the back of the Krober O2 4 0 you will find a winding device for the mains lead This should be used when the unit is out of use to avoid any danger of tripping over 15 Kr ber 02 4 0 7 3 2 With external humidification If the unit does not need to stand next to the user the installation is carried out as follows 1 Insert the mains lead into a professionally grounded socket HH ATTENTION The Krober O2 4 0 is only designed for operation on a 230 Volt 50Hz mains network Fig 40 Mains lead Screw the angle connection to the oxygen outlet of the Kr ber 02 4 0 with a wrench metric size 17 Connect the oxygen outlet connector Fig 42 Oxygen outlet connector 76 Kr ber 02 4 0 Ar ber taking into service 4 Connect the 15m oxygen safety tubing to the connector Fig 43 Oxygen outlet connector 5 Fill the humidifier up to the top MAX mark 1 Fig 44 Humidifier Max mark Screw the angle adapter 1 to the humidifie
11. WARNING Risk of health damage Particular supervision is required if the unit is to be used in the vicinity of children or bedfast persons The unit must under no circumstances be used with children without additional supervision A WARNING Danger of side effects Do not modify your device You can endanger your health 61 Kr ber O2 4 0 Safety 62 Kr ber A WARNING Danger caused by device modifications If side effects or extreme health restrictions occur during the therapy you should immediately consult your doctor A WARNING Fire hazard caused by oxygen Oxygen is vital but in concentrators with only a few percentage points above the normal oxygen content in the air it is a highly dangerous fire accelerant There are only a few materials which will not burn off like an explosion under a raised concentration of oxygen Therefore Oxygen may only be handled by trained or specially instructed persons Follow all mandatory instructions for installing and use of fire reducing equipment such as the angular connector and Firesafe check valve The misuse of oxygen e g to cool down or improve the ambient air to cool down and dust or blow off of persons clothes furniture etc is dangerous and therefore prohibited Smoking and handling ignition sources and open flames is prohibited when working with oxygen Keep a minimum distance of 2 metres from all spark generating equipment and open fire After
12. arm signals per unit of time increases 82 Kr ber Kr ber 02 4 0 Operation 8 3 4 Alarm categories Alarm category LC display Temperature alarm System alarm ERROR gt ERROR Medium priority The operating temperature inside the concentrator is too high Countermeasures The unit should be switched off immediately Check whether the air flow into the unit is restricted Also make sure that the unit has a sufficient clearance to other objects wall cupboard etc It may be necessary to replace the coarse dust filter in the back wall of the unit Further information concerning this matter can be found in the section Maintenance SP note The oxygen supply is immediately stopped to protect the patient However the compressor keeps on running Medium priority Micro processor fault Countermeasures Switch off the unit immediately and inform the customer service SP Note Output and generation of oxygen is stopped for safety reasons 83 Kr ber O2 4 0 Operation Kr be r Alarm category Description LC display Mains failure alarm Medium priority The power supply for the unit is interrupted This causes immediate function failure of the oxy 6000 Countermeasures The following should be checked Is the mains lead properly plugged into the socket Has a fuse tripped Check the fuse replace if necessary SP ote Further inf
13. by movements and shifts of the prongs A WARNING Risk of health damage Do not smoke while operating the Kr ber 02 4 0 Oxygen must NOT be used near open fire sparks glowing objects etc Fig 51 Nasal cannula 8 2 Adjusting the oxygen volume flow 1 Press the adjustment regulator 1 for at least 2 seconds When a signal sounds and the volume flow indication in the LC display flashes the adjustment mode has been activated Change the volume flow by turning the adjustment regulator Turning clockwise increases the volume flow turning the regulator anti clockwise reduces the volume flow Fig 52 Adjusting the volume flow TZ vote 80 Kr ber O2 4 0 Kr be r Operation Perform the following steps to adjust 0 2 I min in steps of 0 1 2 4 l min in steps of 0 2 4 5 l min insteps of 0 5 The settings are accepted by pressing the adjustment regulator again The input is once again acknowledged by an audible signal SP nore The supplier may have restricted the available volume flow range to customized settings such as 1 4 lom SP vote It may take up to 2 minutes until the actual volume flow corresponds with the setting If the output is closed the output pressure can increase up to 0 35bar The maximum gas outout temperature is maximum 6 degree higher than the ambient temperature SP vote After adjusting the oxygen flow setting the alarms and status messages for oxygen conce
14. ccording to the Technical Service Manual Extent of warranty the free of charge replacement of defective parts The defective parts must be submitted to us for inspection of warranty claims For processing the warranty claim the serial number as well as date of purchase and the operating hours of the affected device must be stated If devices are sent to us for warranty repair free of charge we will also cover the labor costs for any warranty repairs Locally resulting travel and service expenses are not covered by us Excluded from this warranty are filters and zeolites damage from improper handling and mechanical damage of parts e g transport damage 57 Kr ber O2 4 0 General Kr be r 58 2 5 Explanation of symbols Important safety and equipment related notes in these instructions for use are highlighted by symbols These notes must be strictly adhered to in order to avoid accidents personal injuries and damage to property A WARNING This symbol warns of dangers that can lead to adverse effects on health injuries permanent physical damage or to death Strictly comply with all notes regarding work safety and be particularly careful in these situations A WARNING Danger of electric current This symbol draws attention to dangerous situations involving electrical currents There is a danger of serious injury or death if the safety notes are not complied with The related work may only be carried out by qualif
15. cidents Unit e Unit Kr ber 02 4 0 e User manual Fig 30 Scope of delivery 1 Weitere Bestandteile Coarse dust filter Humidifier FireSafe check valve Angular connector Nasal cannula for oxygen 2m Nasal cannula for oxygen 5m Oxygen safety hose 15m Wall bracket for humidifier Oxygen safety hose 0 33m 8 9 10 Angular connector Abb 32 Scope of delivery 3 11 Hose connector christmas tree style 70 Kr ber O2 4 0 Ar ber taking into service 7 2 Choosing the location Please consider the following when choosing the location The unit should have 30cm clearance from any walls curtains and other large objects e g cupboards to ensure unrestricted entry of air through the back of the unit The unit is air cooled It must therefore not be placed near heaters etc At such a location there is a risk of overheating The unit should be operated only in places where it is not impaired by air pollution or smoke SP vote The unit can be safely lifted and moved by the carrier handle on top of the unit L ATTENTION Ensure a sufficient air supply Ensure that the air inlet of the Kr ber 02 4 0 oxygen concentrator is located in a well vented spot The Kr ber O2 4 0 oxygen concentrator must not be operated directly next to or even stacked with other equipment Ensure a sufficient distance from the walls etc 71 Kr ber O2 4 0 72 7 3 Assembly There are generally two possible ways
16. d with ceramic 61000 4 2 8 KV Air discharge 8 kV Air discharge tiles If the floor is covered with synthetic materials the relative humidity must be at least 30 fast transient 2 kV for mains leads 2 kV for mains The quality of the supply electric sa aroma oui leads voltage should match the interference bursts p p typical office or hospital acc to IEC 61000 eads 1 kV for input output Snvironment 4 4 leads Surge voltages acc 1 kV Push pull 1 kV Push pull The quality of the supply to voltage should match the IEC 61000 4 5 typical office or hospital environment Voltage dips short lt 5 Ur limited functionality The quality of the supply term interruptions and fluctuations in supply voltage 60 dip in Ur for 5 Restart of unit periods voltage should match the typical office or hospital environment gt 95 dip in Ur for 72 period 70 Ur limited functionality 30 dip in Ur for 25 periods NOTE lt 5 Ur Mains failure alarm Uris the a c supply voltage before application of the test levels 95 dip in U for5s Restart of unit Magnetic field ata 3 A m Magnetic fields at mains supply frequency frequency must comply with 50 Hz acc to the typical values found in IEC 61000 4 8 office or hospital environments 93 Kr ber O2 4 0 Appendix Kr be r 5 ai Electromagnetic Immunity test IEC 60601 test level Compatibility level environment regulations Portable
17. ent fuse Kr ber 1 Remove the coarse dust filter cover bracket from the back of the Kr ber O2 4 0 Remove the coarse dust filter and place a new filter into the bracket Reattach the coarse dust filter cover Open the service flap Pull the old air intake filter with a slight twist off the filter off the filter holder 3 Plug the new filter element on 4 Close the service flap A WARNING Danger of electric current Before checking the fuse switch off the unit and pull the mains plug out of the socket Open the service flap Apply slight pressure and turn the fuse cover anti clockwise Remove the fuse Inspect the fuse visually If necessary replace the fuse Reinstall the fuse Kr ber 02 4 0 Ar ber Spare parts 10 Spare parts ty ATTENTION The intended use of the equipment is only possible when using approved accessories The use of accessories that have not been designed for use with this unit can severely affect the performance of the unit The following article numbers should be used when ordering 91 Kr ber O2 4 0 Appendix Kr be r 92 11 Appendix 11 1 EMC regulations 11 1 1 Electromagnetic compatibility interference emission Regulations and declaration of manufacturer Electromagnetic compatibility interference emission The Kr ber O2 4 0 is intended for use in an environment as described below The operator of the Kr ber 02 4 0 must make sure that the unit
18. ermine the electromagnetic environment and the effect of stationary HF transmitters it is recommend to examine the corresponding location If the detected field intensity at the location of the Kr ber 02 4 0exceeds the compatibility level specified above the Kr ber O2 4 0must be examined at a different location with respect to its normal operation If unusual performance characteristics are detected it may be necessary to apply additional measures such as reorientation or relocation of the Kr ber O2 4 0 a Beyond the freguency range from 150 kHz to 80 MHz the field intensity is less than 3 V m Table 2 Electromagnetic compatibility interference emission 95 Kr ber O2 4 0 Appendix Kr be r 96 11 1 3 Recommended safety distances Recommended safety distances between portable and mobile HF communication equipment and the Kr ber O2 4 0 The Kr ber O2 4 0 is intended for operation in an electromagnetic environment with controlled HF interferences The customer or user of the Kr ber O2 4 0can help to avoid electromagnetic interferences by maintaining minimum distances between the portable and mobile HF communication equipment transmitters and the Kr ber O2 4 0 according to the maximum output power of the communication equipment as recommended below Rated power of transmitter Safety distance acc to transmitting frequency 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2vP d 1 2 P d 2 3 P For transmit
19. ied electricians ty ATTENTION Information highlighted with this symbol must be strictly complied with in order to avoid damage to the machine malfunction and or breakdown SP vore This symbol highlights hints and information to be observed for efficient and non disrupted operation of the unit Kr ber 02 4 0 Kr be r General 2 6 Copyright protection These instructions for use are to be treated confidentially They should only be used by persons who have been authorized accordingly It may only be passed on to third parties with the written consent of the manufacturer All documents are protected by copyright protection law It is not permissible to pass on or reproduce the documents either as a whole or excerpts thereof to evaluate or communicate their content unless explicitly entitled to do so Any violations are liable to prosecution and require compensation We reserve the right to exercise industrial property rights 2 7 Return and waste disposal If the unit has been delivered through a parcel service and not directly by a dealer you should keep the packaging material for possible service instances If there is no corresponding agreement regarding the return of packing material then the packing material remains with the customer He is responsible for environmental waste disposal in accordance with the applicable waste disposal legislation After use the unit may be returned to the dealer
20. is also applies if the person in question has already worked with just such a unit or similar equipment or was trained by the manufacturer Knowing the content of these instructions for use is a prerequisite for the avoidance of mistakes and for safe and trouble free operation of the unit Neither changes nor conversions may be carried out on the equipment which have not been explicitly authorized by the manufacturer to avoid dangers and to ensure optimal performance All safety decals and operating signs on the unit must be kept well legible at all times Damaged or illegible decals must be replaced immediately 3 2 Customer s responsibility These instructions for use must be kept near the unit so that it is available for the user at any time Apart from the notes on safety mentioned in this manual all generally valid safety and accident prevention instructions must also be observed and adhered to The machine may only be operated in a technically perfect condition and if operationally safe The information contained in the instruction manual is complete and must be adhered to without limitation Kr ber 02 4 0 Kr be r Safety 3 3 Intended use The operational safety of the unit is only assured when used for the purpose it is intended for as specified in the instructions for use The Kr ber 02 4 0 solely intended for use within the scope of a non life sustaining medical therapy for the additional supply of oxygen The u
21. is operated in such an environment Measurement of interference er Electromagnetic environment ee Compatibility ag emission regulations The Kr ber O2 4 0 uses HF energy solely for its own function The HF HF emissions acc to Sens emission is therefore very low and CISPR 11 p any interference with adjacent electronic eguipment is very unlikely HF emissions acc to Class B CISPR 11 The Kr ber 02 4 0 is intended for use in all facilities including living Emission of harmonics acc to Class A quarters and other environments IEC 61000 3 2 that are connected to the public supply network which also Emission of voltage supplies buildings used for the fluctuations flickers acc to IEC compatible purpose of living 61000 3 3 Table 2 Electromagnetic compatibility interference emission Kr ber O2 4 0 Hr be r Appendix 11 1 2 Electromagnetic compatibility interference emission Regulations and declaration of manufacturer Electromagnetic compatibility interference emission The Kr ber O2 4 0 is intended for use in an environment as described below The operator of the Kr ber O2 4 0 must make sure that the unit is operated in such an environment ere Electromagnetic Immunity test IEC 60601 test level Compatibility level environment regulations Discharge of static 6 kV contact 6 kV contact Floors should be made of electricity acc to discharge discharge wood or concrete or should IEC er be covere
22. ity and warranty All details and notes for the operation maintenance and cleaning of the unit are made to the best of our knowledge taking into consideration our experience and knowledge gained up to NOW We reserve the right to make technical changes to the machine dealt with in these instructions for use within the context of ongoing development Translations are also carried out to the best of knowledge We do not accept any liability for errors in translation The German version of the instructions for use which is also delivered with the unit is the definitive version Texts and illustrations do not necessarily correspond to the scope of delivery The drawings and graphics are not to scale 1 1 Read instructions for use carefully before starting operation of the unit The manufacturer will not assume liability for damage or disruptions that occur as a result of non compliance with the instructions for use Handing over these instructions for use to third parties is not permitted and results in the obligation for compensation 2 4 Warranty We grant in excess of the implied warranty the following extended warranty Warranty terms maximum 30 000 operating hours or 5 years from the date of purchase on all functional parts e g compressor electronic circuit board solenoid technology etc The first reached condition 30 000 hours or 5 years applies Condition precedent to the extended warranty is the periodic maintenance a
23. ly connected Switch from longer tubing lengths to shorter tubing lengths MB vote If the volume flow output is too high the output and generation of oxygen is temporarily interrupted for safety reasons A WARNING Risk of health damage Before resuming operation of the unit make sure that fault and cause of fault have been rectified professionally 85 Kr ber O2 4 0 86 9 Maintenance 9 1 Safety A WARNING Danger of electric current Before starting cleaning the unit must be switched off and disconnected from the mains supply 9 2 General notes Cleanliness is a prerequisite for the success of an oxygen therapy at home The specified cleaning intervals must therefore strictly adhered to 9 2 1 Cleaning The unit should be cleaned with a damp not wet cloth so that not fluid can enter You should only use commercial cleansing agents e g washing up liquid Aggressive cleansers must not be used under any condition 9 2 2 Disinfecting Any commercial disinfectant can be used for disinfecting An up to date list is available from the manufacturer The information for use issued by the disinfectant manufacturer must be strictly complied with Kr ber 02 4 0 Ar ber cc Maintenance 9 3 Maintenance plan Maintenance and cleaning work must be performed at regular intervals as specified in the table below Interval Cleaning work The humidifier must be cleaned and disinfected every
24. mains side 2 x 13 15 AH 250 V internal 1 x T1 0AL 250 V Interface USB A WARNING Unsafe connections Connect only manufacturer authorized devices to this USB port Weight 16 kg Dimensions HxWxD 53 5 x 20 3 x 52 cm without castors Warranty 30 000 hours maximum 5 years see chapter 2 4 O2 concentration 1to4l min 95 3 4 to 5 l min 85 3 Status display O2 concentration 82 status display at operating temperature 60 deficiency display max recommended volume flow Volume flow at 0 or 7kPa max output pressure Overpressure relief 67 Kr ber O2 4 0 Technical data O2 characteristic at a counter pressure 9402 Volume Flow of 0 kPa 02 concentration in dependent from height m Volume flow Ipm 68 Hr ber Kr ber O2 4 0 Mr bDEr Transport packaging and storage 6 Transport packaging and storage The following should be noted when transporting the Kr ber 02 4 0 The unit should only be shipped and transported in its original packaging For transport e g by car the unit may stand upright or lay on one of the two large flat sides Open the transport box from the top Do not stand the transport carton upside down or on one of its narrow sides 6 1 Transport inspection It is highly recommended to check the complete delivery for completeness and possible transport damage immediately after receipt In case of externally detectable transport damage you should n
25. n As average life times we expect pie une Oxygen hoses nasal 1 month cannula 88 Kr ber Kr ber O2 4 0 Maintenance 9 4 Maintenance work 1 Cleaning the humidifier Cleaning the nasal cannula Unscrew the humidifier from the angle connection Unscrew the lid from the humidifier and pour out any water residues Clean the humidifier with clear warm water Disinfect the humidifier as instructed Fill fresh distilled water into the humidifier Turn the lid back on Fasten the humidifier on the angle connection SP vote When changing patients the humidifier must be disposed of Sterile water system If the Kr ber O2 4 0 is used with a sterile water system the following must be observed Sterile water systems must not be cleaned and refilled The old water flask must be disposed of The information provided by the sterile water producer package insert must be observed Disconnect the hose of the nasal cannula from the Kr ber 02 4 0 Clean the nasal cannula in warm soapsuds You may alternatively use a weak acetic solution 10 vinegar 90 water Rinse the nasal cannula with lots of clear water 4 Let the nasal cannula dry in air The nasal cannula may only be used again for the therapy after it has properly dried 89 Kr ber O2 4 0 Maintenance Maintenance work Description 90 Replacing the coarse dust filter Replacing the air intake filter Checking the equipm
26. nit may thereby be used in hospitals homes or at home The unit must only be used according to the medical indication and only in accordance with the doctor s prescription by following these instructions for use The intended use also includes the compliance with the assembly instructions as well as the notes on cleaning and maintenance of the unit Any other use of the unit beyond these limits is prohibited and is not considered as unintended use Claims of any kind against the manufacturer and or his authorized representatives resulting from damage caused by unintended use of the unit are excluded The customer is solely liable for any damage resulting from unintended use 3 4 Dangers which may arise from the unit The unit was subjected to a risk analysis The resultant construction and design of the unit corresponds to the current status of technology However there is still a remaining risk The unit requires responsibly minded and cautious operation Improper operation or operation by unauthorized persons can endanger persons A WARNING Risk of health damage If an absolutely safe oxygen supply is required it is strictly necessary to have a second independent oxygen source available as replacement e g a mobile oxygen savings system with an oxygen cylinder If the patient or the operator notices at any time that the available amount of oxygen is not sufficient you should immediately contact your dealer and or doctor A
27. ntration and volume flow deviations are deactivated for approximately one minute until the unit has reached a steady state During this period alarms are muted H ATTENTION The unit has been designed for operation at altitudes of up to 2000 m above seal level If the unit is used beyond this specification compliance with the specified performance data can no longer be guaranteed 81 Kr ber O2 4 0 Operation Kr be r 8 3 Status messages and alarms 8 3 1 Status messages SP note Status messages are NOT accompanied with acoustical warning signals 8 3 2 Status message Status message Description LC display Oxygen status The oxygen concentrator oxy 6000 is equipped with an alarm innovative multi function sensor to monitor the oxygen concentration of the oxygen output If this drops below 82 the oxygen status alarm is triggered Countermeasures Check humidifier and hoses for leaks Inform the customer service SP note According to the specifications of the oxy 6000 the oxygen status alarm is an allowed situation and not an error state for volume flow setting of greater than 5 0 pm 8 3 3 Alarm priorities We differentiate between two alarm priorities Quick countermeasures by the user are required Utmost attention of the user is required JT vote The alarm priorities can audibly be differentiated by different alarm sound sequences With a higher priority the number of al
28. ormation concerning checking the equipment fuse of the oxy 6000 can be found in section Maintenance Note If a function test concerning the mains failure alarm is to be performed you should proceed as follows Pull the mains plug out of the socket Switch on the unit The alarm works if it is activated during the switch on self test TS ote If the alarm is triggered again after switching on you should inform the service department Lack of oxygen Low priority alarm The oxygen concentrator oxy 6000 is equipped with an innovative multi function sensor to monitor the oxygen concentration of the oxygen output If it is detected that the actual concentration does not match the technical specifications the alarm is activated Countermeasures Check humidifier and hoses for leaks Inform the customer service 84 Kr ber Alarm category LC display Sensor alarm Volume flow alarm En ate LF pm ERROR lt JA Kr ber 02 4 0 Operation Low priority There is a malfunction of the multi function sensor quantity and concentration of oxygen cannot be determined with sufficient accuracy Countermeasures Inform the customer service Search for kinks of the oxygen supply tubing Low priority The actual volume flow does not match the setting Countermeasures Check whether the oxygen hose is buckled or squeezed Check whether the accessories are correct
29. ot accept the delivery or only with reservation Acknowledge the receipt only with reservation e g on the freight document Specify the expected damage and inform the manufacturer immediately Hidden damage should be claimed immediately after detection because damage claims can only be lodged within the applicable claims periods The packaging material should be saved it may be needed if the unit has to be returned 6 2 Storage If the package is to be stored before it is taken into service please observe the following instructions Store in a dry environment Relative humidity max 93 without condensation It must be assured that the package is not stored outdoors It must also be assured that the floor used for storage is dry over the entire storage period Storage temperature 25 to 70 Store in a dust free environment Avoid mechanical shocks and damages 69 Kr ber O2 4 0 7 Taking into service 7 1 Before assembling Check before assembling whether all components needed for correct operation are available SP nore Contact the manufacturer or the local service provider if help is needed during operation or maintenance The address of the manufacturer can be found on page Fehler Textmarke nicht definiert The address of the manufacturer should have been disclosed during initial training on the device The a m organisations should also be contacted in case of unexpected events or in
30. r Plug the 15 m safety hose for oxygen extension hose onto the angle adapter 2 Push the 0 33 m safety hose for oxygen onto the outlet connector of the Fig 45 Humidifier assembly humidifier 3 17 Kr ber 02 4 0 Taking into service 78 Fig 47 Connection to the nasal cannula NER cannula P aana ee 02 tubinq Fig 48 Connection with the 02 tubing Krober 9 Stand the humidifier into the bracket 1 EB Note The bracket has the function of preventing the humidifier from falling over It is therefore recommended to mount the bracket to a wall a cupboard etc Plug the FireSafe Nozzle in oxygen flow direction into the nasal cannula m ATTENTION Observe flow direction indicated by the arrow p ATTENTION For the best protection of the patient place the FireSafe Nozzle in the oxygen tubing routing as close to the patient as possible Connect the other terminal to the short oxygen tubing 0 33 m A WARNING Danger of tripping over On the back of the Krober O2 4 0 you will find a winding device for the mains lead This should be used when the unit is out of use to avoid any danger of tripping over Kr ber 02 4 0 Kr be r Operation 8 Operation A WARNING Health risk Inappropriate use of the Krober O2 4 0 can lead to severe personal and or material damage You should therefore only start up the unit in strict compliance with the instructions for u
31. rastically increase the rate and severity of combustion Oil and or grease in the presence of oxygen become highly combustible Do not use oil or grease on this device In particular do not lubricate the seals or hose barb connector 5 Never administer oxygen or undertake oxygen therapy while smoking or when near an open flame Kr ber Kr ber O2 4 0 Taking into service 7 3 1 Without external humidification If the unit is to stand next to the user it is started up as follows Fig 33 Mains lead Fig 34 Angle connection tt Fig 35 Humidifier Max mark 1 Insert the mains lead into a professionally grounded socket ty ATTENTION The Krober O2 4 0 is only designed for operation on a 230 Volt 50Hz mains network The metal oxygen outlet is installed using a wrench metric size 17 Fill the humidifier up to the top MAX mark 1 73 Kr ber 02 4 0 Taking into service 14 Fig 36 Humidifier assembly Nasal cannula Fig 37 Connection to the nasal cannula Nasal cannula oe oo ee gt 02 tubinq Fig 38 Connection with the O2 tubing Krober Fasten the humidifier on the angular connection 1 Connect the 0 33m oxygen hose to the humidifier outlet 2 Plug the FireSafe Nozzle in oxygen flow direction into the nasal cannula ty ATTENTION Observe flow direction indicated by the arrow ATTENTION For the best protection of the patient place the Fire
32. se and the notes on safety 8 1 Taking into service Start the unit by actuating the mains switch 1 on top of the unit The Kr ber O2 4 0 runs a self test The oxygen production starts after the self test The LC display continuously shows the current oxygen volume flow and the equipment status SP vo TE During the start up phase the oxygen alarm appears for 2 minutes This alarm should disappear after two minutes If this does not happen the unit may be defective Fig 49 Control panel After maximum 5 min the unit will reach its complete performance according to the Technical Specifications During the start up phase the unit also shows the operating hours This information disappears after 30 seconds Sauerstoffmangel Alarm Volumenstrom Anzeige Information concerning the operating status of the unit can be found in the display O Netzausfall Alarm PC Verbindung Temperatur Alarm F Fehler Anzeige S Betriebsstundenz hler Fig 50 LC display 79 Kr ber O2 4 0 Operation Kr be r 2 Wear your nasal cannula Insert both cannula openings into your nose Place both feed hoses over your ears Pull the sling with the sliding piece tight under your chin A WARNING Danger of strangulation Care for a straight oxygen hose routing to minimize the risk of strangulations A WARNING Skin irritations Care for a good fit of the nasal prongs to minimize skin irritation caused
33. tective measures concerning electromagnetic compatibility EMC and must be installed and operated in accordance with the EMC information contained in the accompanying documents The following should be noted in particular Floors should be made of wood or concrete or should be covered with ceramic tiles If the floor is covered with a synthetic material the relative humidity must be at least 30 During operation the unit must therefore not be exposed to extremely strong magnetic fields Magnetic fields at mains frequency must comply with the typical values found in business or hospital environments p ATTENTION Keep the minimum distance The air intake of the Kr ber 02 4 0 is located on the back side of the unit the following is therefore of importance There should be a minimum distance of 30cm from walls curtains and other large objects e g cupboards so that an unrestricted entry of air is assured at the back of the unit The Kr ber O2 4 0 oxygen concentrator must not be used directly beside or even stacked with other equipment h ATTENTION Avoid overheating The unit is air cooled in order to avoid overheating it must not be placed near heaters etc 63 Kr ber O2 4 0 Safety Kr be r 64 3 5 What to do if a hose caught fire Should a hose catch fire despite all protective measures it is not enough to just switch the unit off because oxygen will continue to flow for a while after
34. ters for which the rated power is not contained in the tale above the distance can be calculated using the equation for the corresponding column whereby P represents the rated power of the transmitter in Watt W specified by the transmitter manufacturer NOTE 1 For calculation of the recommended safety distance for transmitters in the frequency range from 80 MHz to 2 5 GHz an additional factor of 10 3 was used in order to reduce the likelihood that a mobile portable communication unit that has unintentionally been brought near the patient will trigger an interference NOTE 2 These regulations may not apply in all situations The propagation of electromagnetic waves is influenced by the absorption and reflection by building objects and persons Table 3 Recommended safety distances Kr ber O2 4 0 Hr be r Appendix 11 2 Explanation of symbols on the unit Attention observe instructions for use Attention observe instructions for use Degree of protection for the ingress of liquids and small parts Applied part type BF Class Il OB 0197 Notified Body TUV Rheinland LGA Products GmbH AN AN On Off No oil or grease Do not remove any covers 97 Kr ber O2 4 0 Appendix Kr be r AR Do not dispose of in household waste 98 Kr ber 12 Index A CCESSOFIes rrrannnnnrvnnnvnnnvnnnvnnnnnnnnnnennnen 91 PN 64 Adjusting the oxygen volume flow 80 Air intake filter
35. the unit has been switched off Take the following steps Pull the oxygen hose off the unit to interrupt the oxygen supply Choke the flames e g with a blanket Ventilate well after extinguishing the fire because a burning PVC hose will emit toxic gases The metal connection on the oxygen outlet acts as a fire inhibitor preventing the flames from spreading into the unit Kr ber 02 4 0 4 Design and function 4 1 General description The Kr ber 02 4 0 oxygen concentrator for has been optimized for the oxygen supply at home The electronically controlled oxygen concentrator separates the oxygen from the ambient air and supplies the user through the nasal cannula with highly concentrated oxygen 4 2 Design Design 1 Carrier handle Control panel Angle connection Humidifier Steerable castors Fig 26 Front 6 Mains lead 7 Coarse dust filter Fig 27 Back 8 On Off switch 9 Volume flow regulator 10 LC display Fig 28 Control panel 65 Kr ber 02 4 0 Design and function 11 Service flap 12 Fuses 13 Air intake filter Fig 29 Service flap 66 Kr ber Kr ber O2 4 0 Ar ber echnical dat 5 Technical data Kr ber O2 4 0 Operating voltage 230 V 50 Hz Ambient operating conditions Operation temperature 5 to 40 Storage temperature 25 to 70 C Humidity 15 93 r H non condensing Atmospheric pressure 700 to 1060 mbar Sound pressure level Fuses
36. who is then responsible for proper disposal of the unit Do not dispose of the unit into the domestic household waste Non infectious used accessories e g nasal cannula can be disposed of as domestic waste Infectious accessories e g nasal cannula of an infected user must be disposed of through a specially approved waste disposal company Addresses are available from your local municipality 2 8 Customer service Service work should normally be carried out by your local authorized dealer You can contact Kr ber Medizintechnik GmbH as follows Office hours Mo Thu 7 30 a m 4 00 p m Fri 7 30 a m 2 00 p m Address Kr ber Medizintechnik GmbH Salzheck 4 D 56332 Dieblich Germany 49 2607 94040 www kroeber de info kroeber de Fax 49 2607 940422 59 Kr ber O2 4 0 60 Safety Kr be r 3 Safety This section provides an overview over all important safety aspects for safe and trouble free operation of the unit The individual chapter additionally contain actual safety notes highlighted with symbols which will help to avoid immediate dangers 3 1 General The machine is built according to the currently applicable rules of technology and is safe to operate However dangers may still arise from the unit if it is incorrectly operated or used for purposes it is not intended for Any persons using this unit must have read and understood these instructions before starting operation Th
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