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Kröber aeroplus E, Instructions For Use Manual

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Kröber aeroplus E Instructions For Use Manual Download Page 5

 

 

 

aeroplus E  

Preliminary statement 

 

 

5 

 

1 Preliminary statement 

Your doctor has found that you require an additional oxygen supply. With the aeroplus E 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 aeroplus E 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 aeroplus E, you may contact your dealer at any 
time. 

This medical care product from Kröber is labelled with the CE-sign according to MDD 
(Medical Device Directive). 

 

 

Only use the aeroplus E 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. 

Summary of Contents for aeroplus E

Page 1: ...16 Instructions for Use aeroplus E ...

Page 2: ...liminary statement 2 Kröber Medizintechnik GmbH Salzheck 4 D 56332 Dieblich Deutschland Tel 49 0 2607 9404 0 Fax 49 0 2607 9404 22 E Mail info kroeber de Internet www kroeber de Dok ID TD071608 R5 Version 21 08 2019 ...

Page 3: ...al description 15 4 2 Design 15 5 Technical data 17 6 Transport packaging and storage 18 6 1 Transport inspection 18 6 2 Storage 18 7 Taking into service 19 7 1 Before assembling 19 7 2 Choosing the location 21 7 3 Installing the humidifier stand 22 7 4 Assembly 23 8 Operation 27 8 1 Taking into service switching on 27 8 2 Setting the oxygen volume flow 30 8 3 Taking out of service switching off 3...

Page 4: ...aeroplus E Preliminary statement 4 9 3 4 Life time 40 9 4 Maintenance 40 10 Spare parts and accessories 42 11 Symbols 43 11 1 1 Recommended safety distances 45 ...

Page 5: ...The aeroplus E 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 aeroplus E you may contact your dealer at any time This medical care product from Kröber is labelled with the CE sign according to MDD Medical Device Directive Only use the aeroplus E after a medical indication and only in complian...

Page 6: ... 2 3 Liability and warranty All details and notes for the operation maintenance and cleaning of the device 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 t...

Page 7: ...only be carried out by qualified electricians ATTENTION Information highlighted with this symbol must be strictly complied with in order to avoid damage to the machine malfunction and or breakdown NOTE This symbol highlights hints and information to be observed for efficient and non disrupted operation of the device 2 5 Copyright protection This instruction for use is to be treated confidentially ...

Page 8: ...proper disposal of the device Do not dispose of the device 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 7 Customer service Service work ...

Page 9: ...gible decals must be replaced immediately 3 2 Customer s responsibility This instruction for use must be kept near the device 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 ...

Page 10: ...device may only be used according to medical indications and only in accordance with the medical prescription and the operating instructions NOTE To ensure the success of the therapy the effectiveness of the therapy in relation to the set volume flow should be checked regularly by the attending physician Intended use also includes following the assembly instructions and the instructions for cleani...

Page 11: ... and or doctor WARNING Risk of health damage Particular supervision is required if the device is to be used in the vicinity of children or bedfast persons The device must under no circumstances be used with children without additional supervision WARNING Small parts choking hazard Contains small parts e g FireSafe check valve keep away from children WARNING Danger of side effects Do not modify you...

Page 12: ...alve Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death Do not allow smoking within the same room where the oxygen concentrator or any oxygen carrying accessories are located If you intend to smoke you must always turn the oxygen concentrator off remove the cannula and leave the room where either the cannula or mask or the oxygen concentrator is located If ...

Page 13: ...N 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 aeroplus E ATTENTION Observe electromagnetic compatibility Electrical medical equipment is subjected to stringent protective measures concerning electromagnetic compatibility EMC and must be installed and operated in acc...

Page 14: ...ient needs the device ATTENTION Accessories containing phtalats If children pregnant or breastfeeding women use the aeroplus E it is recommended to use phtalat free accessories such as O2 hoses or nasal cannulas Phtalats are known to increase the risk of allergies and asthma ATTENTION System building The responsible organisation is also responsible for the compatibility of all components of the sy...

Page 15: ...tion of the room air The remaining gas contains up to 95 pure oxygen and is supplied to the patient with up to 5 liter per minute 4 2 Design Setup 1 Carrying handle 2 O2 flowmeter 3 Control panel 4 Casters 5 Mounting bracket for humidifier 6 Filter lid 7 Device inlet filter behind filter lid and air inlet 8 USB service connection behind filter lid WARNING Risk of device malfunction Connect only au...

Page 16: ...he oxygen concentration has yet not reached the guaranteed specifications for oxygen purity 14 Mains power switch switches the concentrator on and off 15 Alarm tone mute key mutes the alarm sound for 20 seconds 16 Symbol consult instruction for use 17 Technical error LED activated in case of technical fault always in combination with LCD error code 18 O2 error LED activated in case of low oxygen c...

Page 17: ...Temperature fuse compressor compartment 84 C Weight 17 5 kg Dimensions HxWxD 60 x 29 x 40 cm O2 purity 0 5 bis 4 l min 93 3 4 bis 5 l min 90 3 O2 purity measurement is implemented internally under die a m operating conditions min recommended volume flow 1 0 5 l min max recommended volume flow 1 5 l min Volume flow 5l min 1 0 kPa pressure 5 l min 7 kPa pressure min 4 8 l min max outlet pressure 60 ...

Page 18: ...y after detection because damage claims can only be lodged within the applicable claims periods The packaging material should be stored it may be needed if the device 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 ...

Page 19: ...ddress of the manufacturer can be found on page 8 The a m organization should also be contacted in case of unexpected events or incidents NOTE After unpacking the device the transport or storage temperature may have to be adjusted to the operating temperature Before switching on the device please observe the waiting times specified in section 6 3 Acclimatization times Device aeroplus E incl these ...

Page 20: ...al cannula 5m right Firesafe check valve left 2 pcs O2 safety hose 0 33m right O2 safety hose 15m operational setup a Oxygen concentrator b 0 33 m safety hose c Humidifier holder d Humidifier e Mounting strips f 15m O2 safety hose g Firesafe valve h 2 m oxygen nasal cannula ...

Page 21: ...f overheating The device should be operated only in places where it is not impaired by air pollution or smoke Always place the device on a horizontal surface NOTE The device can be safely lifted and moved by the carrier handle on top of the device ATTENTION Ensure a sufficient air supply The aeroplus E oxygen concentrator is not to be used directly next to or stacked with other equipment Ensure su...

Page 22: ...evel or outside a temperature of 5 to 40 C or above a relative humidity of 93 an adverse effect on the volume flow and the percentage of oxygen is to be expected and consequently an impairment of the quality results of the therapy 7 3 Installing the humidifier stand The humidifier holder provides a safe and upright storage of the humidifier during use 1 Position the humidfier stand such that the h...

Page 23: ...stored in the vicinity of an open flame or strong heat source which could exceed a temperature of 40 C 3 Do not install this FireSafe TM check valve near an open flame or near a source of excessive heat that is likely to exceed 40 C 4 Oxygen itself is not flammable whereby the speed and extent of a combustion process are considerably increased in an enriched oxygen environment Oil and or grease ar...

Page 24: ...TTENTION To ensure a sufficient level of sterility only use boiled water 4 Screw the angle adapter 1 to the humidifier 5 Plug the already installed 0 33 m safety hose for oxygen extension hose onto the angle adapter 2 6 Push the other 0 33 m safety hose for oxygen onto the outlet connector of the humidifier 3 7 Put the humidifier into the holder 1 of the device 1 1 3 2 1 ...

Page 25: ...ace the FireSafe check valve in the oxygen tubing routing as close to the patient as possible 9 Connect the other terminal to the short oxygen tubing 0 33 m 10 Completely assembled system with a Oxygen concentrator b 0 33 m O2 safety hose c Holder for humidifier d Mounting strips e Humidifier f 15 m O2 safety hose g Firesafe check valve h 2 m O2 nasal cannula i Mains connection cable Nasal cannula...

Page 26: ...roplus E you will find a winding device for the mains connection cable This should be used when the device is out of use to avoid any danger of tripping over and strangulation Oxygen safety hoses and nasal cannulas shall be always routed such that no tripping or strangulation are created ...

Page 27: ...or a safe operation Keep animals vermin as well as children away from the aeroplus E 8 1 Taking into service switching on 1 Start the device by actuating the mains switch in the front panel The aeroplus E performs a self test all LEDs except the power failure LED are switched on the LCD segments light up and the buzzer is activated The sensor and the microprocessor itself are automatically checked...

Page 28: ...ion sequence acc To chapter 8 4 Oxygen delivery is started NOTICE During the initial warm up phase the green mains LED flashes indicating that the oxygen concentrator has yet not reached the guaranteed performance level Once this can be assured the mains LED stops flashing and stays in active mode ...

Page 29: ...correct setup and positioning of the nasal cannula is important for the effectiveness of the therapy NOTICE After switching on it takes 2 minutes maximum before the oxygen concentrator reaches the specified oxygen concentration WARNING Danger of strangulation Care for a straight oxygen hose routing to minimize the risk of strangulations WARNING Skin irritations Make sure that the nasal cannula doe...

Page 30: ...dividually with the configuration of the equipment to be used including accessories 1 By turning the dial of the flowmeter the volume flow rate can be adjusted by turning the dial clockwise the flow of oxygen is decreased by turning the dial counter clockwise the flow of oxygen is increased NOTE The exact flow rate is given at the center of the ball NOTICE The flow of the gas to the nasal cannula ...

Page 31: ...ion 31 ATTENTION The device is designed for operation up to an altitude of 3000 m above sea level If the device is operated outside this specification compliance with the specified performance data cannot be guaranteed ...

Page 32: ...NOTE Although the device is switched off some oxygen may still continue to flow 2 Take off the nasal cannula When not needed for a prolonged period empty the humidifier also 8 4 Abnormal conditions WARNING Risk of health impairment If the cause for an alarm condition cannot be resolved immediately switch to alternative or backup means to receive supplemental In addition consult your oxygen solutio...

Page 33: ...ricted Also make sure that the device has a sufficient clearance to other objects wall cupboard etc It may be necessary to replace the device inlet filter in the back wall of the device Further information concerning this matter can be found in the section Maintenance NOTE For protection the oxygen supply is set after a further waiting period and the error code nOP is displayed However the compres...

Page 34: ...OTE For safety reasons attempts are made to interrupt oxygen release and oxygen production O2 purity 82 LED O2 Escalation level 1 nOP Escalation level 2 Possible cause This oxygen concentrator is equipped with an innovative multi function sensor to monitor the oxygen concentration of the oxygen output If the average value for oxygen purity is less than 82 for more than 15 seconds this alarm is act...

Page 35: ... temperature exceed 60 C The oxygen concentration cannot be determined Counter measures see counter measures for temperature alarm Contact your service provider Checking the alarm function Block the exhaust air stream NOTE If the internal temperature exceeds 84 C the temperature fuse is activated and shuts off the device In this case contact your service provider Low pressure alarm Technical messa...

Page 36: ...res Check whether the oxygen hose is buckled or squeezed Check whether the accessories are correctly connected Check if the humidifier is calcified Otherwise Contact your service provider Checking the alarm function Block the oxygen outlet WARNING Risk of health impairment Before taking the device back into operation make sure the alarm and the cause have been resolved properly ...

Page 37: ... German respiratory industry advisory group SPECTARISmed An external contamination of the gas pathway is possible from the oxygen outlet nipple connector to the internal check valve 9 2 1 Cleaning The device 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 co...

Page 38: ...ructions in the service manual WARNING Patient as operator Service and maintenance must not be performed while the device is in use WARNING Risk of infections If oxygen accessories such as nasal cannulas are shared by different users an infection cannot be precluded Every user of the aeroplus E must have his own set of oxygen accessories 9 3 1 Hospital out of hospital use Component Hospital use ac...

Page 39: ...ith changing patients Component Required action aeroplus E Cleaning and disinfection Humidifier Dispose of Holder for humidifier Cleaning and disinfection Nasal cannula Dispose of Oxygen safety hoses Dispose of FireSafe check valve Dispose of Oxygen mask Dispose of Device inlet filter Dispose of 9 3 3 Following a Technical Service Component Required action aeroplus E Cleaning and disinfection Humi...

Page 40: ... 9 3 4 Life time As average life times we expect Component Life time aeroplus E 5 years min Humidifier 1 year Nasal cannula 1 month Oxygen hose 6 months Coarse dust filter 1 month Device inlet filter 1 year 9 4 Maintenance All maintenance activities can be carried out by the operator Eventually a new spare part has to be used in case of a replacement Please contact your service provider or the man...

Page 41: ...ifier systems Prefilled Humidifiers may 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 nasal cannulas oxygen hoses and masks 1 Disconnect the hose of the nasal cannula from aeroplus E 2 Clean the nasal cannula in warm soapsuds You may alternatively use a weak acetic solution 10 vine...

Page 42: ... Part number Product Part description AEE 01 Instructions for Use AEE 02 R2 Holder for humidifier KRO2 06 HAB01 916 Humidifier refillable up to 6 l min safety valve 410 mbar pressure KRO2 07 HSB11 S2 Nasal cannula 2 m up to 6 l min up to pressure 1 bar KRO2 08 HSB11 S5 Nasal cannula 5 m up to 6 l min up to pressure 1 bar KRO2 10 HGF01 0 INTAKE Inlet filter for aeroplus E K686 HSS11 15 O2 hose 15 m...

Page 43: ...TION NOTE CAUTION ATTENTION Attention observe instructions for use Applied part type BF Protection class II IP 21 Degree of protection for the ingress of liquids and small parts Notified Body TÜV Rheinland LGA Product GmbH I O On Off switch Do not smoke No open fire No oil or grease Do not remove any covers ...

Page 44: ...4 Symbols Explanation Do not dispose of in household waste Manufacturer Manufacturing year Serial number Technical message Oxygen concentration outside of manufacturer s specifications Stand by on Mains failure Alarm mute ...

Page 45: ...00 MHz d 1 2 P 800 MHz to 2 5 GHz 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 c...

Page 46: ...aeroplus E 46 ...

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