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Kröber aeroplus m, Manual

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Kröber aeroplus m Manual Download Page 52

aeroplus m 

 

 

Appendix

 

 

52

 

Immunity test 

IEC 60601 test level 

Compatibility level 

Electromagnetic 
environment - regulations 

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 √P for 80 MHz to 
800 MHz 
d= 2.3 √P for 800 MHz to 
2.5 GHz 

Summary of Contents for aeroplus m

Page 1: ...m Preliminary statement 1 Kröber Medizintechnik GmbH Salzheck 4 D 56332 Dieblich Germany Tel 49 0 2607 94040 Fax 49 0 2607 940422 E Mail info kroeber de Internet www kroeber de Dok ID Version 3 dated 14 05 2013 ...

Page 2: ...e 12 4 Design and function 13 4 1 General description 13 4 2 Design 13 4 3 Keypad 14 4 4 Display 15 5 Technical Data 16 6 Transport packaging and storage 17 6 1 Transport inspection 17 6 2 Storage 18 6 3 Mobile Use 18 7 Taking into service 19 7 1 Before assembling 19 7 1 Choosing the location 19 8 Short operating instructions 20 9 Main operating functions 22 9 1 Furnish the power supply 22 9 1 1 C...

Page 3: ...lume 36 10 10 Alarm tone volume 37 10 11 Trigger signal volume 38 10 12 Quasi constant flow 39 11 Messages and Alarms 40 11 1 Alarm priority 40 11 2 Information messages 40 11 3 Alarms 41 11 4 Alarm muting 44 12 Maintenance 45 12 1 Safety 45 12 2 General notes 45 12 2 1 Cleaning 45 12 2 2 Disinfecting 45 12 3 Maintenance plan 46 12 4 Maintenance work 48 13 Accessories 49 14 Appendix 50 14 1 EMC re...

Page 4: ...aeroplus m Preliminary statement 4 ...

Page 5: ...ghly reliable portable oxygen concentrator intended for mobile or stationary use in homes or at home as well as for clinical applications However should problems arise with the aeroplus m you may contact your dealer at any time This medical care product from Kröber Medizintechnik is labeled with the CE sign according to MDD Medical Device Directive Only use the aeroplus m after a medical indicatio...

Page 6: ... 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 graphic...

Page 7: ...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 5 Return and waste disposal If the unit has been delivered through a parcel service and not directly by a dealer you sh...

Page 8: ...our local authorized dealer You can contact the customer service team of Kröber GmbH as follows Office hours Mo Fr 8 00 a m 3 30 p m Address Kröber Medizintechnik GmbH Salzheck 4 D 56332 Dieblich Germany Phone 49 0 2607 94040 Fax 49 0 2607 940422 Internet www kroeber de eMail info kroeber de ...

Page 9: ...maged or illegible decals must be replaced immediately 3 2 Operator 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 perfe...

Page 10: ...sk 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 WARNING Risk of he...

Page 11: ...phere 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 rea...

Page 12: ...siness or hospital environments ATTENTION Keep the minimum distance The air intake of the aeroplus m is located on the front 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 aeroplus m must not be used directly bes...

Page 13: ...he 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 with each detected breath 4 2 Design 1 Carrying handle 2 Keypad 3 Color display 1 Oxygen outlet 2 Coarse dust filter 3 DC Voltage input 1 2 3 1 2 3 ...

Page 14: ...plus m Design and function 14 1 Battery drawer NOTE The typeplate of the aeroplus m is located underneath 4 3 Keypad 1 Color display 2 Arrow up key 3 Alarm mute key 4 On Off key 5 Menu key 6 Arrow up key 1 ...

Page 15: ...aeroplus m Design and function 15 4 4 Display 1 Mains supply 2 Battery capacity 3 Therapie setting 4 Message line 5 System state green all systems o k blue information message yellow alarm status ...

Page 16: ... Coarse dust filter underneath the oxygen outlet Finefilter inside Interface USB mini WARNING Unsafe connection Use only authorized and approved equipment on this interface Weight 3 6 kg unit 0 7 kg battery Dimensions HxBxT 25 x 23 x 16 cm Warranty of the manufacturer 2 years O2 Abgabe CMV 150 ml per setting CMV constant minute volume 10 therapy settings from 0 5 to 5 0 O2 Konzentration 90 Trigger...

Page 17: ... the nasal cannula and the power supply cord ATTENTION Quiet alarm signals The alarm signals are quieter when the device is operated in the carrying case Take the aeroplus m oxygen concentrator out of the carrying case whenever it is possible and use this bag for transport only 6 1 Transport inspection It is highly recommended to check the complete delivery for completeness and possible transport ...

Page 18: ...hat 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 6 3 Mobile Use To use the aeroplus m mobilely Insert the aeroplus m into the carryin case and close the zippers Connect the nasal cannula Flip the caddy open Let the c...

Page 19: ...a 3 battery 4 power supply 5 instructions for use 6 coarse dust filter 7 carrying case 8 caddy 7 1 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...

Page 20: ...heck the condition of the coarse dust filter and replace it if needed Connect the power supply to the mains and to the aeroplus m Connect the 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 ...

Page 21: ...annula to avoid any skin irritation caused by movements of the device WARNUNG Missing trigger Eventually the aeroplus m is not able to detect all breathing efforts Optimize the trigger sensitivity and adjust the placement of the nasal cannula prongs Press the ON Off button to start the therapy WARNING Strangulation danger Pay attention for a proper tubing routing without any loops to reduce the ri...

Page 22: ...ted fails However if the aeroplus m oxygen concentrator is not in use for a longer period of time remove the battery from the system to ensure optimum battery lifetime 9 1 1 Connecting to the mains power For connecting to the mains power system first connect the desktop power adapter with a wall outlet Plug in the DC connector into the mating jack on the aeroplus m The connector must snap into pla...

Page 23: ...bol goes dark NOTE While the aeroplus is used after disconnection from the mains supply the unit goes unterbrechungsfrei in battery operation mode if the installed battery has sufficient capacity NOTE If a battery has not been installed the whole device will be without current the display goes dark 9 1 3 Battery operation Internal battery charging For charging the battery internally connect the ae...

Page 24: ...or that purpose push both sliders to the middle Pull out the drawer including battery Remove the battery from the drawer For doing so lift the battery at the connector and pull the battery out Charge the battery in the external charger Observe additional instructions for use for this optional accessory Insert the charged battery into the drawer the connector must match into corresponding opening o...

Page 25: ... therapy mode the remaining battery capacity is displayed in minutes of operation NOTE The remaining capacity is continuously updated according to the actual settings Depending on the therapy setting and breathing frequency this figure can slightly fluctuate 9 2 Starting the therapy To start the therapy press the on off button shortly The aeroplus m starts the oxygen production process initially w...

Page 26: ...uring operation For manual control perform an inspiration and check for oxygen delivery If proper oxygen delivery is detected the system is ready for operation In addition always check for the remaining battery capacity 9 4 Terminating or interrupting the therapy NOTE There is no distinction between an interruption or a termination of the therapy In both situations the aeroplus m is set into stand...

Page 27: ... the arrow doan button decreases the volume NOTE The settings can be adjusted in steps of 0 5 If activated in the menu each button activation is confirmed with a short acoustical signal NOTE The therapy setting can also be adjusted through the main menu see chapter 10 4 Therapy setting NOTE The maximum gas output temperature is maximum 6 degree higher than the ambient temperature ATTENTION The uni...

Page 28: ... button the inverted menu item is selected and can be further adjusted In addition this button has a confirming function 10 2Menu structure Following menu and submenu items can be selected Menu level 1 Menu level 2 Description Information Operating hours Operating hours counter for device operation Therapy hours Operating hours counter for therapy sessions Software version Software revisions Seria...

Page 29: ...es Either press arrow up or arrow down button to access further information or confirm return with the menu button to return to the main menu The arrow up button leads to the therapy hours in format hours minutes hier 25 hours 40 minutes Either press arrow up or arrow down button to access further information or confirm return with the menu button to return to the main menu The arrow up button lea...

Page 30: ... rechargeable battery here S N 119 Either press arrow up or arrow down button to access further information or confirm return with the menu button to return to the main menu In case that no battery is detected dashes appear One further press on the arrow up button leads to the operating hours counter menu item ...

Page 31: ...m this choice in the main menu with the menu button The selection is inverted with white back ground color NOTE The therapy setting can already be seen here setting 3 It is not necessary to enter the submenu just for control of the setting To increase the setting press the arrow up button To decrease the setting press the arrow down button To leave this menu press the menu button return The new th...

Page 32: ...ound color NOTE Already in the main menu the current setting can be controlled here setting 0 5 It is not necessary to call the submenu Confirm selected menu item with the menu button To increase the setting press the arrow up button To decrease the setting press the arrow down button To leave this menu press the menu button return NOTE If the lower limit has the same value as the upper limit this...

Page 33: ...ound color NOTE Already in the main menu the current setting can be controlled here setting 5 0 It is not necessary to call the submenu Confirm selected menu item with the menu button To increase the setting press the arrow up button To decrease the setting press the arrow down button To leave this menu press the menu button return NOTE The upper limit can only be set between the lower therapy lim...

Page 34: ... displayed only in the menu but not in the standard screen Display Message Description To adjust the trigger sensitivity select menu item Trigger in the main menu the selection is inverted with white back ground color Confirm selected menu item with the menu button To toggle the setting press arrow up or arrow down button NOTE Setting normal N corresponds with a trigger sensitivity of 0 2 cmH2O Se...

Page 35: ...sage Description To change menu the language select menu item Language in the main menu the selection is inverted with white back ground color Confirm selected menu item with the menu button To change the language setting press arrow up or arrow down button All currently available languages are displayed Select the desired language and or exit the menu by pressing the menu button return ...

Page 36: ... change the Button tone volume select menu item Button Vol in the main menu the selection is inverted with white back ground color Confirm selected menu item with the menu button To set the volume press arrow up or arrow down button The sound level can be set between 0 off and 9 very loud NOTE With each modification a sample tone with the set volume is generated To leave this menu press the menu b...

Page 37: ...olume select menu item Alarm Vol in the main menu the selection is inverted with white back ground color Confirm selected menu item with the menu button To set the volume press arrow up or arrow down button The volume can be set between 0 off and 9 very loud NOTE With each modification a sample tone with the set volume is generated To leave this menu press the menu button return ...

Page 38: ...escription To adjust the Trigger signal volume select menu item Trigger V in the main menu the selection is highlighted with white back ground color Confirm selected menu item with the menu button To set the volume press arrow up or arrow down button The volume can be set between 0 off and 9 very loud NOTE With each modification a sample tone with the set volume is generated To leave this menu pre...

Page 39: ...essage Description To activate the CF mode select menu item CF mode in the main menu the selection is highlighted with white back ground color Confirm selected menu item with the menu button NOTE This setting can be only selected during normal oxygen operation Without available oxygen this menu item is hidden CF is displayed NOTE The constante flow mode can be only stopped by turning off the devic...

Page 40: ...ation of the aeroplus m Display Message Description Low battery capacity The battery capacity is low 10 or remaining operation time 15 minutes Only shortterm operation possible Counter measures Charge the battery Connect the aeroplus m to the mains power supply Replace the depleted battery with charged spare battery Where appropriate decrease the therapy setting increases the remaining operation t...

Page 41: ...an be triggered Alarm category Display Description Oxygen The product gas does not have the specified oxygen concentration The oxygen concentrator aeroplus m is equipped with an innovative multifunctional sensor that monitors constantly the oxygen concentration of the production process In case of a deviation from the technical specifications the oxygen alarm is triggered Counter measures with con...

Page 42: ...l cannula is slipped away check the fit and position of the nasal prongs Possibly the tubing is blocked check the routing for kinks Possibly the nasal cannula is not connected properly check the connection to the oxygen outlet at the aeroplus m Possibly the inspiration trigger signal is too weak set the inspiration trigger sensitivity to sensitive Battery capacity The battery capacity is no longer...

Page 43: ...re battery Compressor temperature The temperature of the compressor is too high for operation The aeroplus m stopps operations automatically and performs a controlled shut down Counter measures Take the aeroplus m to a lower ambient temperature Check the fan for proper operation Check at the air in and outlet for air flow System System failure Counter measures Disconnect battery and mains supply R...

Page 44: ...ailure has been professionally fixed 11 4Alarm muting When during an alarm the alarm mute button is pressed the acoustical alarm is muted for the preset duration of 120 seconds In the display the remaining duration for alarm muting is displayed here 115 seconds NOTE A repeated press of the alarm mute button resets the muting counter to 120 seconds ...

Page 45: ...ng intervals must therefore strictly adhered to 12 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 12 2 2 Disinfecting Any commercial disinfectant can be used for disinfecting An up to date list is available from the manufactu...

Page 46: ...omes or for nursing care Replace the nasal cannula annually after 5000 operating hours Replace the air intake filter NOTE With extremely dirty ambient air the filter must be changed earlier with changing patients The aeroplus m must be cleaned with a damp cloth and disinfected after with changing patients Replace the humidifier with changing patients Replace the nasal cannula WARNING Health risk I...

Page 47: ...vice work Replace the coarse dust filter after service work Replace the internal air intake filter performed by a qualified technician Interval Inspection annually Safety inspection Lifetimes are expected as follows article Expected lifetime aeroplus m min 5 years Nasal cannula 1 month Coarse dust filter 1 months with average air pollution ...

Page 48: ... Let the nasal cannula dry in air The nasal cannula may only be used again for the therapy after it has properly dried Replacing the coarse dust filter 1 Remove the nasal cannula from the aeroplus m 2 Remove coarse dust filter drawer from the fron oft he aeroplus m press the latch down and pull out the drawer 3 Remove the used coarse dust filter 4 Insert the new filter 5 Reinstall the drawer Inser...

Page 49: ...se with this unit can severely affect the performance of the unit The following article numbers should be used when ordering Article Number Designation AEm 00 Instructions for Use aeroplus m KRO2 07 Nasal Cannula 2 m AEm 09 Coarse dust filter set of 3 AEm 01 Power adapter AEm 01 1 Power cord for power adapter EU plug AEm 02 Battery AEm 03 Carrying Case AEm 06 Caddy AEm 04 External Charger ...

Page 50: ...nt regulations HF emissions acc to CISPR 11 Group 1 The aeroplus m uses HF energy solely for its own function The HF emission is therefore very low and any interference with adjacent electronic equipment is very unlikely HF emissions acc to CISPR 11 Class B The aeroplus m is intended for use in all facilities including living quarters and other environments that are connected to the public supply ...

Page 51: ...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 5 UT 95 dip in UT for period limited functionality Th...

Page 52: ...level Compatibility level Electromagnetic environment regulations 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 P for 80 MHz to 800 MHz d 2 3 P for 800 MHz to 2 5 GHz ...

Page 53: ...luenced by the absorption and reflection by building objects and persons a 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 recomme...

Page 54: ...0 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 calculation of the...

Page 55: ...use Applied part type BF body floating Class of protection II IP 21 Degree of protection IP 21 Finger protection and protection against dripping water Notified Body TÜV Rheinland LGA On Off key Menu key Arrow up key increase values in menu navigate up Arrow down key decrease values in menu navigate down Alarm tone mute key No smoking No open flames ...

Page 56: ...aeroplus m Symbols 56 Symbol Meaning Do not use any grease or oil Do not remove any covers Do not dispose of into standard household waste ...

Page 57: ...aeroplus m 57 ...

Page 58: ...13 Choosing the location 19 Cleaning intervals 45 Cleanliness 45 Coarse dust filter 13 Color display 13 Color display 14 Connecting to mains 22 Constant flow 39 Copyright protection 7 D Dangers 10 12 DC Voltage input 13 Design 13 Disconnecting from mains 23 Disinfecting 45 Display 15 E EMC 12 EMC regulations 50 Entry of air 19 F Fire hazard 11 Funktion 13 G General description 13 H HF communicatio...

Page 59: ... Operator s responsibility 9 Oxygen 11 Oxygen concentrator 5 Oxygen cylinder 10 Oxygen outlet 13 Oxygen savings system 10 Oxygen supply 5 P Power supply 22 S Safety 9 Safety during maintenance 45 Short operating instructions 20 Side effects 5 10 Stand by 26 Storage 18 Symbols 6 System state 15 T Technical Data 16 Therapy setting 31 Therapy setting 15 27 Transport 17 Transport carton 17 Transport d...

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