Instructions for Use Kröber O2
Contents
1. 4 Fasten the humidifier on the angle connection 1 4 Bee ___ 5 Push the nasal cannula with its socket end over the outlet connection of theKr ber 02 2 Fig 11 Humidifier assembly A WARNING Danger of tripping over On the back of the Kr ber 02 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 25 Kr ber 02 Taking into service Kr ber 26 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 Fig 14 Safety hose for oxygen sz l s Fig 15 Humidifier Max mark 1 Insert the mains lead into a professionally grounded socket od ATTENTION The Kr ber 02 is only designed for operation on a 230 Volt 50Hz mains network Screw the angle connection to the oxygen outlet of the Kr ber 02 Plug the safety hose for oxygen extension hose onto the adapter Fill the humidifier up to the top MAX mark 1 Kr ber Kr ber 02 Taking into service Fig 16 Humidifier assembly Fig 17 Humidifier bracket Screw the angle adapter 1 to the humidifier Plug the safety hose for oxygen extension hose onto the angle adapter 2 Push the nasal cannula with its socket end over the outlet connection of the Kr ber 02 3 Stand the humidifier in2. ERROR gt ERROR 3 High 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 33 Kr ber 02 Operation Kr ber 34 Alarm category LC display Description Volume flow alarm LIT Li lpm LERROR Medium 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 correctly connected SP wore If the volume flow output is too high the output and generation of oxygen is interrupted for safety reasons DSP wore The acoustical volume flow alarm can be inhibited by the setting in the PC service program A high volume flow alarm will always be activated A WARNING Risk of health damage Before resuming operation of the unit make sure that fault and cause of fault have been rectified professionally Kr ber 02 Kro be r Maintenance 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 The following notes on maintenance c
3. O2 concentration 1 to 4 I min 95 3 4 to 5 l min 85 3 5 to 6 l min 75 H 3 Status display O2 concentration 82 status display at operating temperature 60 deficiency display max recommended volume flow 6 l min Volume flow at 0 or 7kPa 1 6 l min acc to pre setting max output pressure 70 kPa Overpressure relief 200 kPa oxygen reservoir 250 kPa compressor 19 20 Kr ber 02 Technical data Kr ber concentration in Characteristic at a counter pressure of 0 kPa 02 95 90 85 80 75 70 3 4 Flow in l min Kr ber 02 Hro ber Transport packaging and storage 6 Transport packaging and storage The following should be noted when transporting the Kr ber 02 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 not accept the delivery or only with reservation Acknowledge the receipt only with reservation e g on the freight document Specify the ex
4. Replace the air intake filter SP wo TE With extremely dirty ambient air the filter must be changed earlier with changing patients The Kroeber O2 must be cleaned with a damp cloth and disinfected after with changing patients Replace the humidifier with changing patients Replace the coarse dust filter with changing patients Replace the air intake filter with changing patients If the Set for external humidification is used the Kr ber 02 Kro be r Maintenance Interval Cleaning work bracket must be cleaned and disinfected with changing patients Replace the nasal cannula AN WARNING Health risk In order to avoid cross infection each user of the Kr ber 02 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 Kroeber O2 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 Inspection annually Safety inspection 37 Kr ber 02 Maintenance Kro ber 9 4 Maintenance work Maintenance work Description Cleaning the 1 Unscrew the humidifier from the angle connection humidifier N Unscrew the l
5. and declaration of manufacturer Electromagnetic compatibility interference emission The Kr ber 02 is intended for use in an environment as described below The operator of the Kr ber 02 must make sure that the unit is operated in such an environment Measurement of interference c Pe Electromagnetic environment er ompatibility emission regulations The Kr ber 02 uses HF energy solely for its own function The HF HF emissions acc to Group 1 emission is therefore very low and CISPR 11 any interference with adjacent electronic equipment is very unlikely HF emissions acc to Class B CISPR 11 The Kr ber 02 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 1 Electromagnetic compatibility interference emission 41 Kr ber 02 Appendix Kr ber 11 1 2 Electromagnetic compatibility interference emission Regulations and declaration of manufacturer Electromagnetic compatibility interference emission The Kr ber 02 is intended for use in an environment as described below The operator of the Kr ber 02 must make sure that the unit is operated in such an environment Immunity test IEC 6060
6. 1 test level Compatibility level Electromagnetic environment regulations Discharge of static electricity acc to IEC 61000 4 2 6 kV contact discharge 8 kV Air discharge 6 kV contact discharge 8 kV Air discharge Floors should be made of wood or concrete or should be covered with ceramic tiles If the floor is covered with synthetic materials the relative humidity must be at least 30 fast transient electric interference bursts acc to IEC 61000 4 4 2 kV for mains leads 1 kV for input output leads 2 kV for mains leads 1 kV for input output leads The quality of the supply voltage should match the typical office or hospital environment Surge voltages acc to IEC 61000 4 5 1 kV Push pull 1 kV Push pull The quality of the supply voltage should match the typical office or hospital environment Voltage dips short term interruptions and fluctuations in supply voltage IEC 61000 4 11 s5 Ur gt 95 dip in Ur for period limited functionality 40 Ur 60 dip in Ur for 5 periods Mains failure alarm Restart of unit 70 Ur 30 dip in Un for 25 periods limited functionality lt 5 Ur 95 dip in Ur for 5 s Mains failure alarm Restart of unit The quality of the supply voltage should match the typical office or hospital environment NOTE Uris the a c supply voltage before application of the t
7. G Anhang IX Classification according 93 42 EEC annex IX Konformit tsbewertung assessment details Benannte Stelle notified body Verfahren nach RL 93 42 EWG route of directive 93 42 EEC Zertifikate certificates Sauerstoff Konzentrator Oxygen concentrator Kr ber O2 Il a nach Regel 11 II a per rule 11 T V Rheinland Product Service GmbH Vollst ndiges Qualit tsmanagementsystem gem Anhang II Full Quality Assurance System acc Annex Il HD 60004429 0001 Angewandte Normen used standards Harmonisierte Normen harmonized standards Sonstige Normen other standards Kennzeichen versehen products are CE marked Dieblich 08 06 2005 EN 60601 1 1990 A1 1993 A2 1995 A13 1996 IEC 60601 1 2 2001 EN 60601 1 4 1996 EN ISO 8359 1997 EN ISO 14971 2000 Wir erkl ren in alleiniger Verantwortung da die oben beschriebenen Produkte den Anforderungen der Richtlinie 93 42 EWG und des deutschen Medizinproduktegesetzes MPG entsprechen Die Produkte werden mit dem CE We declare under sole responsibility that the products described above are in compliance with directive 93 42 EEC and the German Medical Device Act MPG The C 0197 MIL Horst Kr ber Gesch ftsf hrer Kr ber 02 Kro be r General 2 3 Type plate The type plate of the Kr ber 02 is attached to the back of the unit above the coarse dust filter Kr ber GmbH 56332 oiebiich Modell Kr
8. Kr ber MEDIZINTECHNIK Instructions for Use Kr ber 02 Kr ber 02 Kr ber taking into operation check system components control emergency stop and safety equipment for condition damage and correct function Kr ber Medizintechnik GmbH Salzheck 4 D 56332 Dieblich Phone 49 0 2607 9404 0 Fax 49 0 2607 9404 22 E Mail info kroeber de Internet www kroeber de Dok ID KRO2 00 Rev 3 Kr ber 02 Kr ber Kr ber 02 Kr ber 1 Preliminary statement si 00H ee nah nee se k s haare nenne 6 2 General en onen 7 2 1 Information in these instructions for use nsu2ssssnnsannsannnnnnnnnnnnnnnnnnnnnnnnnnnennnennnnnn nenn 7 2 2 Declaration of Manufacturer is 2202 reor ren rr renar nenten ennnen RR RR RR RAKA RR RAR Renan 8 2 3 Type plate a ni ee ee HSN ee ee ee ee 9 2 4 Liability and WAND ee ee ER OE N Ee 9 ENGEN ER RR AE EN 9 2 6 Explanation Of ii ee AE EE EE OE OE EE N ER OE IR OR 10 Ede el BU OUSC UO ee EE AE EE EE EE ER 11 2 8 Return and waste disposal is ER EG ee ee ee ee e ee ee ee ee ee ee ee ee ee ee ee 11 2 9 Customer SEIVICO nenn vives ka es 11 ESE EE EE EE N N OE EE EE 12 4 1 General iin ee as 12 3 2 Customer S responsibility EER EE rr rss rr rr rss ss sr ARR ER EE nan EE 12 3 3 Intended uS eee 13 3 4 Dangers which may arise from the unit sesse ee EE Re Ee ee ee Ke AE Ee rr sr rasens sn eed 13 3 5 What to
9. N Attention observe the information in the instructions for use Application part type BF Ol Degree of protection II C 0197 Nominated authority TUV Rhineland I O On Off switch 46 Kr ber 02 Kro ber Appendix 47 Kr ber 02 Index Kr ber 48 12 Index A ACCESSOLICS ccceccceeceeceeceeceeeeeeeeeeeeeeeess 40 Accident ii EE RE ie kai 16 Adjusting the oxygen volume flow 29 Air intake filter 18 ET RE aaa 30 Angle connection ee Rea 17 Assembly ee none nana 22 24 c Carrier handle n 17 Choosing the location 23 Cleaning intervals 35 Cleanliness uennen 35 Coarse dust filter esse see ee 17 Control panel ee ee ee ee ee 17 Copyright protection 11 D Dangers ee ee ee ee rann rann 13 16 Declaration of Manufacturer 8 DIES Of Teer rennen Raser 17 Disinfecting are 35 Display nnssnnnsnnenneesenerrrnsrrrsrrrrrrrrrrrrrene 17 E E 6 a OE ENG 15 EMG regulations sisie ss rs 41 Enty Di AI sae GRASSE EE EED RE rie AE 23 Equipment fuse ees ee ee ee 39 Explanation of symbols on the unit 46 F Fire hazard 22 2222244424 nn 14 FUNKHON ee nennen 17 FUSES sea ee RE ER GED AE 18 G General descriptiON ee se R
10. PC Verbindung display Temperatur Alarm Betriebsstundenzahler Fehler Anzeige Fig 19 LC display 28 Kr ber Kr ber 02 Operation OD TN Is Fig 20 Nasal cannula 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 Risk of health damage Do not smoke while operating the Kr ber 02 Oxygen must NOT be used near open fire sparks glowing objects etc 8 2 Adjusting the oxygen volume flow Fig 21 Adjusting the 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 No TE Perform the following steps to adjust 0 2 min in steps of 0 1 2 4 l min in steps of 0 2 4 6 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 29 Kr ber 02 Operation Kro ber 30 DSP vote It may take up to 2 minutes until the actual volume flow corresponds with the setting If the output is closed the out
11. ain after switching on you should inform the service department Lack of oxygen alarm Medium priority The oxygen concentrator Kr ber 02 is equipped with an innovative multi function sensor to monitor the oxygen concentration of the oxygen output If this drops below 60 the lack of oxygen alarm is triggered Countermeasures Check humidifier and hoses for leaks Inform the customer service SP wore The acoustical oxygen failure alarm can be inhibited by the setting in the PC service program Kr ber Kr ber 02 Operation Alarm category Description LC display Oxygen status Low priority alarm un LI nd Ipm ERROR The oxygen concentrator Kr ber 02 is equipped with an 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 vo TE The acoustical oxygen failure alarm can be inhibited by the setting in the PC service program Sensor alarm G d al k EERROR Medium 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 Check whether the accessories are correctly connected System alarm
12. berO2 Ser Nr 950300008 230 V 50 60 Hz 350 VA Schutzklasse Typ II C 95 O2 2 Ipm 0197 2 4 Liability 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 5 Warranty Differing from our General Terms of Business we grant an extended warranty of 30 000 operating hours for all functional parts e g compressor control board valve technology etc used in our oxygen concentrator Kr ber 02 This extended warranty is valid for maximum 5 years from
13. ce GR Ee GR Ee ee ee GE ee ee ee ee ee GR ee ee ee ee ee Rn nn ee ee 36 9 4 Maintenance Work SA ME EO OE N 38 ES Tvl SE EE OE OE EE N EE ET 40 ke o 1 1 1 e OE EEREEETEREERFEEEEREEEEERNEERRNEERFNENEEEEEEEREREEREREEREREENEERERREREEEERREEEEREEEREEEEREREERREEN 41 tit EMC regulation S OE N OE EE PEFFRTRTETERFRNEERERTKEITIERANERERHERELVERFEFFRUFFFILBEINIRFEER 41 11 1 1 Electromagnetic compatibility interference EMISSION smnsmsssssssrrsrrssrsssssrernsrs nennen 41 11 1 2 Electromagnetic compatibility interference EMISSION ee ee ee 42 11 1 3 Recommended safety distances iese see ee ee ER EE Ee Ge ee eek EE rna REG rss sr sr renen 45 11 2 Explanation of symbols on the UNI esse ee ee Re ee ee RR ee ee ee ee rr sn ee ee ee ee 46 12 nde ego gee E ee ed ee os de DA vb N ki AE 48 Kr ber 02 Preliminary statement Hro ber 1 Preliminary statement Your doctor has found that you require an additional oxygen supply With the Kr ber 02 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 guality inspections ensure uniform quality on the highest level The Kr ber 02 is a highly reliable oxygen concentrator intended for use in homes or at home as well as for clinical applications However should problems arise with the Kr ber 02 you may contact your dealer at any time This medical care product from Kr ber is labelled wi
14. d or breakdown DSP wore This symbol highlights hints and information to be observed for efficient and non disrupted operation of the unit Kr ber 02 Kro be r General 2 7 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 8 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 who is then responsible for proper disposal of the unit Non infectious used accessories e g nasal cannula can be disposed off as domestic waste Infectiou
15. ded 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 reguires 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 economy 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 AN WARNING Risk of health damage Particular supervision is reduired 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 super
16. do if a hose caught fire aan DEERE ede EE PG EE We ae De ke sed ed 16 4 Design and fUNCtiON sissies Ee n N ai 17 4 1 General descriptiON ie ER ER GE GE Ee eee cece GR ee rr rar rr rr ee ee ee ee ee ee ee ee ee RR ee ee ee ee 17 4 2 DB ER EE E EE N EE 17 5 Technical data ei Etes iewe ee ee wa ESEG ee eed GERS Re eke beg ee eie ee sie 19 6 Transport packaging and storage eie see RR ER RR RE EE RE EER RR RR RR RR RR Re RR RR RR RR RR RR RR Re Rea 21 6 1 Transport inspection ee ER ER ER ER ER GR GR EE ee ee ee ee ee GR ee ee ee ee ee ee RR ee ee ee ee ee ee ee ee 21 Re ie ee AAR EA HA N EE EN 21 7 Taking WAU SCIVICE ini 22 TA Before assembling EE EE URNA EE 22 7 2 Choosing the ESME ss asses ees bdk ERK ES Scout BA SE RR RR ee RD ee SE as de 23 le AR ERA EE EE OE OR DE EE AR N 24 7 3 1 Without external humidificatiON ee ee ee ee ennen nn 24 7 3 2 With external humidification ee ee ee ee ee ee ee ee 26 Kr ber 02 Kr ber S Operatori RE EE RENTE RANN OE ON OE ER OE OE EE EE ELLLET 28 8 1 Taking Into ie es ee 28 8 2 Adjusting the oxygen volume HOW ee ees se ee ee ee Ge AA ee ee ee ee RR ee ee nn 29 Re ag RE MI een es EE EO N 30 8 3 1 Alarm priorities ee ee ee RAR ee ee ee ee 30 oe gee eed m 2a 31 9 Maintenance AR N EE EE EE REN 35 ES AE AE EE N N OE EO EE 35 Re dee OR N N OR RR OE EE N EE ON NE EE 35 EREGAS EE EE N EA 35 9 2 2 DISINTEC NO RE OE N EE 35 9 3 Maintenance plan RE EE ce
17. e 17 H HF communication equipment 15 POSS ING orsa as DER RR Aa es ea ee 16 Flumidiiier see 17 Instructions for USE 7 L dis AR EN 9 Location RE EN ee Re 15 M Mains Ee OE seten 17 Maintenance SEE EE ESE Ee EE 35 Maintenance plan 36 Maintenance work 38 Medical Product Law 6 Mobile phones esse eke Re Re ee nana 15 O Operation ee 28 WY OEM esta OE EE 14 Oxygen concentrator 6 Oxygen cylinder n 13 Oxygen economy SyYySteM 13 Oxygen SUPER SE se N EE Re Re RE id 6 R Reg lat r una 17 Replacement delivery n 9 Kr ber Kr ber 02 Index S T EA N ges t kek 12 Technical data iss ss se es Ee Ee N rr rn 19 Safety during maintenance 35 WIS DOIN EE EE iama 21 Service flap ER RR ER ER nana 18 Transport Carton ee ee 21 Side effects a e 6 13 Transport damage nee 21 Spare parts se ek ER ER nanna nr nana 40 Transport inspektion ee ee 21 Steerable castors iss eise ee GR REK KEER 17 Vv Sell WAT A einer gt Volume TOW EE RE ae 17 O OT JB ees EE EDE BEERS ERGE DE ee 21 WwW Switch ee ER ER ER ER nn nn nn nr rann 17 SYMBOS cosccsscsssccsccsesssssessseesesssssesseeeeeen 10 Warranty EE Ee 9 Waste disposal ee 11 49
18. est levels Magnetic field at a supply freguency 50 Hz acc to IEC 61000 4 8 3 A m Magnetic fields at mains frequency must comply with the typical values found in office or hospital environments Kr ber Kr ber 02 Appendix Immunity test IEC 60601 test level Compatibility level Electromagnetic environment regulations Portable and mobile radio equipment should not be used closer to the Kr ber 02 and the leads than the safety distance calculated by using the equation applicable for the transmission frequency Recommended safety distance radiated HF interference acc to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 1 2 NP for 80 MHz to 800 MHz d 2 3 NP for 800 MHz to 2 5 GHz 43 Kr ber 02 Appendix Kro ber Electromagnetic Immunity test IEC 60601 test level Compatibility level environment regulations directed HF 3 Ver 3 Ver d 1 2 NP IE ig la fo 150 kHz to 80 MHz with P being the rated power of the transmitter in Watt 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 NOTE 1 Fo
19. id 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 N OU A Sterile water system If the Kr ber 02 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 Cleaning the nasal 1 Disconnect the hose of the nasal cannula from the Kr ber cannula 02 2 Clean the nasal cannula in warm soapsuds You may alternatively use a weak acetic solution 10 vinegar 90 water 3 Rinse the nasal cannula with lots of clear water 4 Letthe nasal cannula dry in air The nasal cannula may only be used again for the therapy after it has properly dried 38 Kr ber 02 Kro be r Maintenance Maintenance work Description Replacing the 1 Remove the coarse dust filter cover bracket from the back of coarse dust filter the Kr ber 02 2 Remove the coarse dust filter and place a new filter into the bracket 3 Reattach the coarse dust filter cover Replacing the air 1 Open the service flap take ee 2 Pull the old air intake f
20. igh 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 SF vote The oxygen supply is immediately stopped to protect the patient However the compressor keeps on running 31 Kr ber 02 Operation Kr ber 32 Alarm category Description LC display Mains failure alarm High priority ERROR The power supply for the unit is interrupted This causes immediate function failure of the Kr ber 02 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 wore Further information concerning checking the equipment fuse of the Kr ber 02 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 DSP wore If the alarm is triggered ag
21. ilter with a slight twist off the filter off the filter holder 3 Plug the new filter element on 4 Close the service flap Checking the eduipment fuse 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 OO a BOON Reinstall the fuse 39 Kr ber 02 Spare parts Kr ber 40 10 Spare parts KA ATTENTION The intended use of the eguipment 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 Article number Designation KRO2 01 Instructions for use for Kr ber 02 KRO2 02 Angle connector for humidifier KRO2 03 Set for external humidification KRO2 04 Hose connection with cap nut KRO2 05 Bracket for humidifier KRO2 06 Humidifier for refilling KRO2 07 Nasal cannula KRO2 08 Nasal cannula 5 m KRO2 09 Coarse dust filter for Kr ber 02 KRO2 10 Air intake filter KRO2 11 Bacteria filter Kr ber 02 Kro ber Appendix 11 Appendix 11 1 EMC regulations 11 1 1 Electromagnetic compatibility interference emission Regulations
22. 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 SP wo TE The unit can be safely lifted and moved by the carrier handle on top of the unit p ATTENTION Ensure a sufficient air supply The Kr ber 02 oxygen concentrator must not be operated directly next to or even stacked with other equipment Ensure a sufficient distance from the walls etc 23 Kr ber 02 Taking into service Kro ber 24 7 3 Assembly There are generally two possible ways to use the unit 1 The unit is standing next to the user during use 2 The user uses the Set for external humidification In this case the unit can stand in another room 7 3 1 Without external humidification If the unit is to stand next to the user it is started up as follows 1 Insert the mains lead into a professionally grounded socket TA ATTENTION The Kr ber 02 is only designed for operation on a 230 Volt 50Hz mains network Fig 8 Mains lead 2 Screw the angle connection to the oxygen outlet of the Kr ber 02 Fig 9 Angle connection 3 Fill the humidifier up to the top MAX mark 1 Nase Fig 10 Humidifier Max mark Kr ber 02 Kro ber Taking into service
23. munication equipment transmitters and the Kr ber 02 according to the maximum output power of the communication equipment as recommended below The Kr ber 02 is intended for operation in an electromagnetic environment with controlled HF interferences Rated power of transmitter Safety distance acc to transmitting freguency W m 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 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters 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 45 Kr ber 02 Appendix Kro ber 11 2 Explanation of symbols on the unit Symbol Meaning I
24. orrespond with the recommendations of the professional association SPECTARIS 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 liguid 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 35 Kr ber 02 Kr ber Maintenance 9 3 Maintenance plan Maintenance and cleaning work must be performed at regular intervals as specified in the 36 table below Interval Cleaning work daily The humidifier must be cleaned and disinfected every day daily Nasal cannula should be disposed of and replaced in case of stationary or ambulant use every day daily when used in homes or for nursing care Clean the nasal cannula weekly If the Set for external humidification is used it must be cleaned and disinfected every week every 14 days earlier if necessary The Kroeber O2 must be cleaned with a damp cloth and disinfected after every 4 weeks Replace the coarse dust filter every 4 weeks when used in homes or for nursing care Replace the nasal cannula annually after 5000 operating hours
25. osion 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 moisturizer with inflammable fluids 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 14 Kr ber 02 K ro b e r Safety Ei 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 immediate vicinity ofthe Kr ber 02 FA ATTENTION Observe electromagnetic compatibility Electrical medical eguipment is subjected to stringent protective 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 extremel
26. pected 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 60 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 20 to 70 C Store in a dust free environment Avoid mechanical shocks and damages 21 Kr ber 02 Taking into service Kro ber 7 Taking into service 7 1 Before assembling Check before assembling whether all components needed for correct operation are available Unit e Unit Kr ber 02 e User manual Fig 5 Scope of delivery 1 s Further components 1 Angle connection for humidifier 2 Humidifier 3 Coarse dust filter Fig 6 Scope of delivery 2 Nasal cannula for oxygen Safety hose for oxygen 15m Wall bracket for humidifier Set for external humidification optional Fig 7 Scope of delivery 3 22 Kr ber 02 Kro ber Taking into service 7 2 Choosing the location Please consider the following when choosing the
27. put pressure can increase up to 0 7bar The maximum gas output temperature is maximum 6 degree higher than the ambient temperature KA 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 8 3 Alarms A WARNING Risk of health damage If an alarm cannot be switched off by applying certain countermeasures you should immediately change over to an alternative oxygen supply e g oxygen cylinder You should also immediately contact the customer service of the manufacturer 8 3 1 Alarm priorities We differentiate between three alarm priorities Alarm priority Description High priority AN WARNING Risk of health damage Immediate countermeasures reduired to save the patient from any harm Medium priority Quick countermeasures by the user are required Low priority Utmost attention of the user is required DSP vote The alarm priorities can audibly be differentiated by different alarm sound sequences With a higher priority the number of alarm signals per unit of time increases SP wo TE Some acoustical alarms can be permanently inhibited by the setting in the PC service program Kr ber Kr ber 02 Operation 8 3 2 Alarm categories Alarm category Description LC display Temperature alarm H
28. r 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 determine 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 exceeds the compatibility level specified above the Kr ber 02 must 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 02 3 Beyond the frequency range from 150 kHz to 80 MHZ the field intensity is less than 3 V m Table 2 Electromagnetic compatibility interference emission 44 Kr ber Kr ber 02 Appendix 11 1 3 Recommended safety distances Recommended safety distances between portable and mobile HF communication equipment and thekr ber 02 The customer or user ofthe Kr ber 02 can help to avoid electromagnetic interferences by maintaining minimum distances between the portable and mobile HF com
29. reguisite 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 eguipment 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 K ro b e 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 solely intended for use within the scope of a medical therapy for the additional supply of oxygen The unit 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 doctors prescription by following these instructions for use The inten
30. s 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 9 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 from 7 30 a m 4 00 p m and Fr from 7 30 a m 2 00 p m Address Kr ber Medizintechnik GmbH Salzheck 4 D 56332 Dieblich Phone 02607 94040 Fax 02607 940422 Internet www kroeber de eMail info kroeber de 11 Kr ber 02 Safety K ro be r 12 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 This also applies if the person in guestion has already worked with just such a unit or similar eguipment or was trained by the manufacturer Knowing the content of these instructions for use is a pre
31. th the CE sign according to MPG Medical Product Law Only use the Kr ber 02 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 Kr ber 02 Kro be r General 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 i 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 General Kr ber 2 2 Declaration of Manufacturer Kr ber GmbH Salzheck 4 56332 Dieblich Tel 02607 94040 Fax 02607 940422 Produktspezifikation product details die Konformit tserkl rung Declaration of Conformity Produktbezeichnung product name Type type Systemkomponenten Systems Components Klassifizierung nach RL 93 42 EW
32. the date of purchase This warranty does not cover filters and zeolites damage caused by improper handling and mechanical damage of parts e g transport damage Our warranty is limited to the free of charge replacement delivery for defective parts The defective components must be returned to us for inspection Locally arising costs for travel and labour time will not be refunded If units are returned to us free of charge for warranty repair we will also cover the labour costs for probable warranty repairs Kr ber 02 General Kro be r 10 2 6 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 qualified electricians fd ATTENTION Information highlighted with this symbol must be strictly complied with in order to avoid damage to the machine malfunction an
33. tion The Kr ber 02 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 1 a A OQ N Fig 1 Front Fig 2 Back 8 Fig 3 Control panel Design Carrier handle Control panel Angle connection Humidifier Steerable castors 6 Mains lead 7 Coarse dust filter On Off switch 9 Volume flow regulator 10 LC display 17 Kr ber 02 Design and function Kr ber 18 Fig 4 Service flap 11 Service flap 12 Fuses 13 Air intake filter Kr ber Kr ber 02 Technical data 5 Technical data Model Kr ber 02 Classification acc to MPG Ila Operating voltage 230 V 50 Hz Ambient operating temperature Operation 10 to 40 C Storage 20 to 70 C Sound pressure level lt 35 dB A Power input 360 W Coarse dust filter in back of housing Bacteria filter behind service flap Fuses mains side 2 x TT2 5A H 250 V internal 1x T1 0A L 250 V Interface USB Temperature range 10 to 40 C Atmospheric pressure range 700 mbar to 1060 mbar Weight 19 8 kg Dimensions HxWxD 53 5 x 20 3 x 52 cm without castors Warranty of manufacturer 30 000 operating hours max 5 years see chapter 2 5
34. to the bracket 1 S 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 AN WARNING Danger of tripping over On the back of the Kr ber 02 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 21 Kr ber 02 Operation Kro be r 8 Operation A WARNING Health risk Inappropriate use of the Kr ber 02 can lead to severe personal and or material damage You should therefore only start up the unit in strict compliance with the instructions for use 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 02 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 During the start up phase the unit also shows the operating hours This information disappears after 30 Fig 18 Control panel seconds Sauerstoffmangel Alarm Volumenstrom Anzeige Information concerning the operating status of the unit can be found in the Netzausfall Alarm
35. vision A WARNING Danger of side effects If side effects or extreme health restrictions occur during the therapy you should immediately consult your doctor 13 Kr ber 02 sie Krober 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 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 eduipment and open fire After 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 expl
36. y strong magnetic fields Magnetic fields at mains frequency must comply with the typical values found in business or hospital environments M ATTENTION Keep the minimum distance The air intake of the Kr ber 02 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 02 oxygen concentrator must not be used directly beside or even stacked with other equipment EA ATTENTION Avoid overheating The unit is air cooled in order to avoid overheating it must not be placed near heaters etc 15 Kr ber 02 Safety K ro be r 16 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 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 Kr ber 02 Design and function 4 Design and function 4 1 General descrip
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