JFRMEDICAL Cube 30 ATV User Manual Download Page 7

Page: 7 / 70

Overview of the device

11. Connection socket for respiratory

humidifier

12. Type plate
13. Air outlet (if used with respiratory

humidifier)

14. LED for respiratory humidifier
15. Audio-pause key
16. Navigation buttons
17. OK key
18. Ramp key
19. Display

18
17

Summary of Contents for Cube 30 ATV

Page 1: ...nts GmbH Ostuferhafen 15 24149 Kiel Germany T 0431 7298 740 0 F 0431 7298 740 19 E info jfr gmbh de Customer Service Version 04 2017 User Manual Cube 30 ATV English Software Version 1 X X Cube 30 ATV Ventilator User Manual ...

Page 2: ...lter 15 4 USING THE DEVICE DAILY 16 4 1 Starting therapy 16 4 2 Setting the respiratory humidifier 16 4 3 Switching therapy sets 17 4 4 Handling alarms 17 4 5 Stopping therapy 20 4 6 Switching off the device 20 4 7 Travelling with device 20 5 FUNCTIONAL DESCRIPTION 22 5 1 General function of the device 22 5 2 Therapy modes 22 5 3 Additional therapy functions 24 5 4 Alarms 24 6 SETTING THE DEVICE 2...

Page 3: ... 1 Standard scope of delivery Cube 30 ATV 54 9 2 Accessories spare parts 54 10 TECHNICAL DATA 55 10 1 Technical data 55 10 2 Display values therapy status range 58 10 3 Setting ranges and accuracy of the therapy settings 59 10 4 Setting ranges and accuracy of the alarm parameters 61 10 5 Pneumatic circuit diagram 61 10 6 Protective Distance 62 11 SAFETY INFORMATION WARNINGS 63 11 1 Operating the d...

Page 4: ...y These clinical pictures include Chronic obstructive pulmonary disorder COPD Neurological muscular and neuromuscular complaints such as paresis of the diaphragm Restrictive ventilation disorders e g scoliosis thorax deformities Central respiratory regulatory disorders Obstructive sleep apnoea OSA The device is suitable for use at home and in clinics hospitals sleep labora tories etc 1 2 Contraind...

Page 5: ...nflammation 1 3 Side effects Please contact your doctor immediately if you experienced severe headache unusual chest pain or shortness of breath The following side effects can arise with non invasive ventilation with this de vice Irritation of the eye conjunctiva inflammation Ear and nasal cavity symptoms Nose bleeds Skin irritation or damage Dryness of the mouth throat or nose Bloated stomach or ...

Page 6: ...ntrol panel with display 2 Start stop button 3 Safety clip mains cable 4 Mains socket 5 USB A connection 6 Micro USB connection 7 Air outlet if used without respira tory humidifier and silicone cover for air outlet 8 Loudspeaker 9 Air outlet if used with respiratory humidifier 10 Air inlet and fine or coarse filter 1 2 3 4 5 6 7 8 9 10 ...

Page 7: ...ion socket for respiratory humidifier 12 Type plate 13 Air outlet if used with respiratory humidifier 14 LED for respiratory humidifier 15 Audio pause key 16 Navigation buttons 17 OK key 18 Ramp key 19 Display 11 13 12 19 18 17 14 15 16 ...

Page 8: ...y humidifier 22 Air outlet 23 Connection socket for respiratory device 24 Release button 25 Heating plate 26 Cover for water chamber 27 Opening lever to the water cham ber 28 Heat transfer plate bottom 29 Level indicator to the water cham ber 30 Water bowl to the water chamber 31 Unlocking handle to the water chamber 21 22 24 23 25 20 28 26 27 31 29 30 29 ...

Page 9: ...atory humid ifier 33 Storage compartment for the sili cone cover of the power connector if respiratory humidifier is used 2 1 2 Further accessories Tube system in accordance with ISO 5367 Respiratory mask diagram not included in the scope of supply 32 33 ...

Page 10: ...Overview of the device 7 Bacterial filter diagram not included in the scope of supply Mains cable EU type Transport bag ...

Page 11: ...ection rating II Type BF application part IP21 Protection from IP21 spillage Protection against the ingress of solid foreign bodies 12 5 mm diameter and larger and against vertically falling water droplets plus spillage CE declaration of conformity The device cannot be disposed of in domestic waste You can find information about the proper disposal of the device on Page 62 ...

Page 12: ...ING This symbol designates an extraordinarily dangerous situation Fail ure to follow this information can result in serious injuries and even death CAUTION This symbol designates a dangerous situation Failure to follow this information can result in slight or moderate injuries Note This symbol designates information indications and tips on how to handle the device without any problems ...

Page 13: ...t the mains plug can be unplugged at any time without problems Pay attention that the therapy tube cannot strangulate the patient 3 2 Connecting the device The device can be used with or without respiratory humidifier The respiratory humidifier is not yet available at the moment Without respiratory humidifier 1 The openings to the air outlet and the connection socket for the respira tory humidifie...

Page 14: ... the device Secure the power cable to the device with the help of the safety clip Insert the other end of the mains cable into a socket 3 Connect the respiratory tube on the air outlet on the back of the device 4 Connect the other end of the respiratory tube to the mask ...

Page 15: ...he silicone cover 2 Ensure that the silicone cover for the respiratory humidifier s connection socket under the device has been removed 3 There is a storage recess for the silicone cover of the connection under neath the respiratory humidifier Insert the silicone cover into this storage recess to avoid this getting lost by accident Underside of respiratory humidifier ...

Page 16: ...so that it is connected on the front Ensure that the lock clamp of the respiratory humidifier hooks into the corresponding lugs of the device Press the back of the device down 5 Connect the power mains cable to the device Secure the power cable to the device with the help of the safety clip Insert the other end of the mains cable into a socket ...

Page 17: ...end of the respiratory tube to the mask 3 3 Fitting the respiratory mask Note The device requires a respiratory mask with integrated air outlet Other wise CO2 may be reinhaled The device is suitable for use with nasal oral nasal pillow and full face masks Please follow the relevant user instructions before fitting the respiratory mask ...

Page 18: ...d the tube sys tem Please also note the manufacturer s user instruction Please only use bacteria filter which comply to ISO 23328 1 23328 2 Warning If the plan is to use the device with several patients e g in a small clinic it is necessary to provide the device with a bacterial filter to protect it from conta mination with bacteria ...

Page 19: ... Always leave the device to cool for at least 10 minutes after the end of therapy before you remove the water chamber Check the water level in the water chamber of the respiratory humidifier Pressing the right left keys of the navigation buttons on the device allows the required heat level to be set on the standby screen of Patient mode The heat output of the respiratory humidifier can be selected...

Page 20: ...ferent setups during day and night time Through Menu Therapy settings Dual set the current set can be changed The status bar shows which set is currently enabled The chosen therapy set is shown in the status bar or the screen which chan ges the color to purple in case the second set is chosen 4 4 Handling alarms The device has different alarms and error messages that can occur during the operation...

Page 21: ...and turquoise for low priority If the device is in the standby state i e has not been operated for at least two minutes an alarm list that completes the entire display appears and an acous tic signal sounds The alarm list shows the 5 highest prioritised alarms The device changes to the active state after you press any key The alarms are then detailed in the status bar ...

Page 22: ...n during the activated 2 min ute counter the duration is reset to two minutes provided there is still a triggering event The counter is deactivated if the triggering event has been rectified in the meantime The Audio pause key may also be pressed as a matter of precaution if there is a foreseeable condition for an alarm e g before secretion is taken from a patient At this point the alarms are swit...

Page 23: ...respiratory mask Clean the respiratory mask and the tube system Read a description about this on Page 58 4 6 Switching off the device The device can remain in standby mode However should you wish to switch it off completely pull the mains connector out of the socket 4 7 Travelling with device Remember to pack the following items Device Power supply Tube system Respiratory mask including exhalation...

Page 24: ... es between 100 and 240 V It is therefore not necessary to make any changes relating to this on the device You may need a travel plug adapter to be able to use the power cable in the destination country The Cube 30 ATV can be used on the plane if the plane is operated via a 100 240 V AC power source ...

Page 25: ...lp of which it can be adapted for each individual patient and their individual requirements Most of the therapies have two pressure levels Bilevel and differentiate be tween inhalation and exhalation phase A breathing cycle starts at the begin ning of inspiration and lasts to the end of expiration Breathing frequency are the number of breathing cycles within a minute The doctor can set the followi...

Page 26: ...duration of the cycle on the set respiratory rate PSV Bilevel ST Pressure Support Ventilation The patient is respirated with a bilevel mode at which the pressure support of the breaths is either triggered by the patient himself or the device The mode is similar to the PSV S Bilevel S only that the device runs at a set respiratory rate and therefore time controlled respiratory cycles in the absence...

Page 27: ...dal volume is lower the device will increase the support pressure 5 3 3 Target minute volume The device offers the option to set an intended air volume that the patient is to achieve over the period of a minute In case the air volume is lower the device will increase the support pressure 5 4 Alarms The device is able to recognise the following fixed and modifiable alarms Each alarm has a priority ...

Page 28: ...ion 25 Leakage Low Non vented mask Moderate Low minute volume Moderate High respiratory rate Low Low respiratory rate Moderate Target volume not reached Moderate Target minute volume not reached Moderate Display Priority ...

Page 29: ...the middle of the navigation buttons Only the keys that currently have a function are lit 6 1 1 Operating principles You are able to navigate in the menu using the left right up and down keys The OK key selects the corresponding menu option and confirms the entry You get back to the previous menu level using the menu op tion back on the top edge The status bar in the bottom edge shows the menu pat...

Page 30: ...e Cancel field is selected and confirm Cancel with the OK key 6 2 Standby screen The standby screen shows the time and date in the top section If the respira tory humidifier is connected the set heating performance of the respiratory hu midifier is displayed in this area The heat level then works via the right left keys The menu or a graph of the current therapy can be selected on the left hand si...

Page 31: ...olume is the integral of the measured patient flow during inspiration MV Breath minute volume The breath minute volume is the volume of res piratory air that is inhaled and exhaled per minute The breath minute volume is calculated from the last five tidal volumes with the correspond ing breath frequencies LK Leakage The calculated flow that escapes through the leakage valve and possible leaks at t...

Page 32: ...this has been enabled can be found in the middle of the status bar Status bar in Normal mode Status bar in Alarm mode Audio pause key has been pressed and the counter of two minutes has been activated The alarm priority is indicated one symbol for low priority two symbols for mod erate priority three symbols for high priority Time Connected USB device has been found The device is in Patient mode T...

Page 33: ...pears on the display in real time The current measured value is displayed on the left hand side of each of the graphs The values of the therapy status area are displayed at the bottom see Page 28 6 3 Menu 6 3 1 Quick view You will find a list of the therapy time used per day the total usage of the de vice and the current software firmware version under Quick view ...

Page 34: ...ice settings The following parameters can be set for the device Parameter Setting range Default Description Brightness Display active Default 100 Range 40 100 Step 10 Sets the brightness of the display in normal mode THERAPY SETTINGS ALARM SETTINGS DEVICE SETTINGS MASK CHECK QUICK VIEW LANGUAGE DATA LOGS HUMIDITY BACTERIAL FILTER PRESSURE UNIT TUBE RAMP PRESSURE RAMP TIME THERAPY SETTINGS MODE MEN...

Page 35: ...100 Step 10 Sets the brightness of the LED that displays if the respiratory humidifier is switched on Volume keys Default 30 Range Off 10 100 Step 10 Sets the volume of the keys Time Default set by Service Sets the time of the device Time format Default 24 hours Options 24 hours 12 hours Sets the time format Date Default set by Service Sets the date for the device Date format Default DD MM YYYY Op...

Page 36: ... last alarm that occurred is at the top It includes 50 alarms After this the oldest alarm is overwritten each time The alarm log is retained even after the failure of the device s power supply 6 4 2 Settings log To get a display of the previous device settings you have select the Settings log menu option Go to the Menu Data logs Settings log and press the OK key to con firm The log appears on the ...

Page 37: ... The therapy and device data can be saved via the USB A port with a USB stick The device can be connected to a PC via the micro USB port 6 5 1 Backing up patient data Connect the USB stick to the USB A connection on the back of the device The device checks the USB stick to see if there is sufficient storage space available to back up the patient data If the USB stick is suitable the device starts ...

Page 38: ... to check the alarms follow the instruc tions regarding alarm simulation Alarm simulation To simulate the alarm please set up the device as follows with a 1 80 m 22 mm tube a nasal respiratory mask without respiratory hu midifier and without bacterial filter Check that the settings have been made accordingly under therapy settings Alarm Simulation Circuit disconnection Start the therapy Pull the t...

Page 39: ...therapy The alarm should sound within 10 seconds Low minute volume Ensure that the alarm is activated Set the PCV Bilevel T mode Connect an artificial lung with a cubic capacity of 500 ml and leak system Set the therapy parameters to the following values Respiratory rate to 8 bpm IPAP to 15 hPa cm H O EPAP to 5 hPa cm H O Low minute volume alarm to 6 l Start the therapy The alarm should sound with...

Page 40: ...ure support to 0 5 hPa Maximum pressure increase per breath to 0 5 hPa Connect an artificial lung with too low a respiratory volume The alarm should sound when the set value is not reached despite the maximum pressure increase for 15 seconds Target minute volume not reached Set the alarm Target minute volume not reached and switch all other alarms that can be modified off Set the PCV Bilevel T mod...

Page 41: ...ic signal also sounds see following table Moderate priority The result of a moderate priority alarm can be reversible injury to the patient It is shown in the device display by two yellow An acoustic signal also sounds see following table Low priority The result of a low priority alarm can be minor reversible injuries to the patient or slight damage to the device It is shown in the device display ...

Page 42: ...rigger Measure Circuit dis connec tion High c a f a f The device detects a fall in pressure in the exhala tion system The tube sys tem has prob ably become detached 10 sec Checks the tube system s connec tions Mains fail ure Moderate Beep for 2 minutes The device no longer has power supply Direct Check the power supply connection Tube blocked Moderate c a f The device detects an obstruction in the...

Page 43: ...iled Direct Please disconnect the connector to end the acoustic signal Please contact Ser vice High pres sure Moderate c a f The therapy pressure exceeds the set limit value 10 sec Stop the therapy This alarm cannot occur unless the patient has breathed strongly against the device Please contact Ser vice department if the alarm still occurs Leakage Low e c The device detects a high system flow lea...

Page 44: ...di tion should be checked High res piratory rate Low e c The respira tory rate exceeds the set limit value 5 sec The patient s condi tion should be checked Low res piratory rate Moderate c a f The respira tory rate is below the set limit value 5 sec The patient s condi tion should be checked Target vol ume not reached Moderate c a f The target volume is not reached despite the maximum indicated in...

Page 45: ...ssure Immedi ately if not reached despite the maxi mum addi tional pressure The patient s condi tion should be checked Reason of the signal Frequency and interval System start 261 Hz for 80 ms 80 ms pause 523 Hz for 80 ms Button strike 220 Hz for 20 ms Therapy stop 880 Hz for 250 ms 100 ms pause 1760 Hz for 100 ms Accepted 880 Hz for 750 ms Abort 880 Hz for 150 ms 150 ms pause 880 Hz for 150 ms 15...

Page 46: ...have the settings checked If the error mes sage appears again please contact your ser vice partner Clock not set The time on the device is not set Please set the time in the menu If the error mes sage appears several times the clock battery will soon be depleted Please contact your ser vice partner Clock not calibrated The clock on the device has not been calibrated Please contact your ser vice pa...

Page 47: ...s not reach the set therapy pressure CPAP IPAP Filter is dirty Check the filters and clean change them if necessary Air outlet is blocked for exam ple Ensure the air inlet to the device is freely accessible There is a leakage in the res piratory mask or tube system Check the respiratory mask and tube system are fitted cor rectly and for potential faults Replace any relevant compo nents if necessar...

Page 48: ...up Check the settings and the water chamber of the respira tory humidifier Make any changes to the settings and fill the water chamber of the air humidifier if necessary Dry nasal mucous membrane Device is being operated with out respiratory humidifier Install a respiratory humidifier to reduce possible symptoms such as dry nasal mucous membrane dried out mouth or sore throat by moistening the inh...

Page 49: ...ay Increase the set value if necessary Note After switching on the respiratory humidifier it has a preheating time of approxi mately 30 minutes to heat the water in the water chamber Water chamber is empty Check that the water chamber for the respiratory dehumidifier has been filled and fill it with more water if necessary Respiratory dehumidifier is defective If none of the other possible causes ...

Page 50: ...evice with damp cloth Mains cable When needed Clean power cable with damp cloth Respiratory mask Daily Clean respiratory mask Weekly Clean respiratory mask thor oughly in accordance with the user instruction Tube system Daily Clean tube system Annually Change tube system Coarse filter Weekly Clean coarse filter At the latest after 1500 operating hours Replace coarse filter earlier in the case of d...

Page 51: ... the device please do not continue to use but contact the service department Disconnect device from the power supply Wipe the device with a damp cloth to remove any dust Allow the housing to dry completely before you use the device again Water chamber of the res piratory humidifier Daily Clean water chamber of the respiratory humidifier Transport bag When needed Clean transport bag Warning After c...

Page 52: ...espiratory mask Wash the tube system with mild soapy water Carefully rinse out the tube system with clean water Allow the tube system to air dry Coarse filter Remove the dark coarse filter on the back of the device Wash the coarse filter with mild soapy water Rinse the coarse filter with clean water Allow the coarse filter to dry completely before you use it again Water chamber of the respiratory ...

Page 53: ...ber Remove the gasket from the upper half of the water chamber Clean all parts of the water chamber with mild soapy water Rinse all parts of the water chamber with clean water Allow the individual parts to dry completely before you put them together again ...

Page 54: ...k coarse filter on the back of the device Remove the clear fine filter that is located immediately behind the coarse filter Dispose of the old fine filter in normal domestic waste Replace the fine filter Place the coarse filter in front the fine filter again Replace bacterial filter Note Please observe the manufacturer s information Detach the bacterial filter from the tube system and device Repla...

Page 55: ...severely infectious diseases you may disinfect the following device components Housing Mains cable Tube system Please only use permitted disinfection agents You will find more detailed in formation in the hygiene concept that can be obtained from your service part ner Housing Disinfect the housing and the air outlet in particular using a wipe down disin fectant Tube system To disinfect the tube sy...

Page 56: ...rity waste disposal company for correct disposal You can obtain the ad dresses from your municipal authority Or send the device back to your service partner Packaging Your can dispose of your device s packaging in normal domestic waste Accessories and wear parts You may dispose of the filters in normal domestic waste Please dispose of the tube and mask in accordance with the manufacturer s instruc...

Page 57: ...m P001Z001 EU power cable P001Z005 UK power cable P001Z006 Fine filter P001Z007 Coarse filter P001Z008 Transport bag P001Z009 User instruction P001Z010 Part Order number Tube system Ø 22 mm length 1 80 m P001Z002 Tube system Ø 22 mm length 2 70 m P001Z003 Tube system Ø 22 mm length 3 60 m P001Z004 Respiratory humidifier P001Z011 Silicone cover for air outlet P001E001 Cover respiratory humidifier P...

Page 58: ...ation 600 hPa to 1100 hPa Note The power of the device can be restricted to below 800 hPa Transport storage conditions Temperature range Relative air humidity range Air pressure range 20 C to 50 C 10 95 excluding condensation 600 hPa to 1100 hPa Tube system Flexible plastic For 22 mm diameter 1 80 m 2 70 m 3 60 m length For 15 mm diameter 1 80 m length Sound pressure ranges Sound pressure level in...

Page 59: ...tient connection opening for a flow of 60 l min 4 05 hPa 4 18 hPa Inspiration trigger Flow based inspiration trigger Accuracy 20 Expiration trigger The expiration trigger is triggered dur ing the following percentages of the maximum flow during inspiration 30 70 of the IPAP value Accuracy 20 Pressure measurement Integrated pressure converter in the respiratory device Accuracy 0 4 hPa Short term pr...

Page 60: ... accordance with EN 60601 1 2 07 2007 CISPR 11 class B Product category in accordance with Directive 93 42 EEC II a Classification to IEC 60601 1 2013 against electric shock BF type class II IP protection class IP 21 Protection from IP21 spillage Protection against the ingress of solid foreign bodies 12 5 mm diameter and larger and against vertically falling water droplets plus spillage Expected o...

Page 61: ...0 001 l 150 ml Start of expiration MV Range 0 65 535 l Step 0 1 l 150 ml mean value formation Start of expiration LK Range 0 250 l min Step 1 l min 3 l min mean value formation Marginal condi tion dependent upon the leakage and leakage change Pressure hPa cm H O Range 5 40 hPa cm H O Step 0 1 hPa cm H O IPAP 0 4 hPa EPAP 0 4 hPa CPAP 0 4 hPa 2 ms mean average forma tion Flow Range 247 247 l min St...

Page 62: ...00 2 000 l Step 0 100 l 0 2 Pa Target minute vol ume Range Off 2 000 10 000 l Step 0 100 l 0 2 Pa Pressure support Range 0 25 hPa cm H O Step 0 5 hPa cm H O Dependency 30 IPAP 0 4 hPa Maximum pres sure increase per breath Range 0 1 2 hPa cm H O Step 0 1 hPa cm H O 0 4 hPa Inspiration slope Range Step 1 6 Step 1 0 4 hPa Expiration slope Range Step 1 6 Step 1 0 4 hPa Inspiration trigger Range Step 1...

Page 63: ...f a respiratory cycle 1 ms Ti min Range 0 3 5 s Step 0 1 s Dependency Max inspiration time 1 ms Ti max Range 0 3 5 s Step 0 1 s Dependency Min inspiration time 1 ms Ramp pressure Range 3 20 hPa cm H O step 0 5 hPa cm H O Dependency CPAP EPAP 0 4 hPa Ramp time Range 0 60 min Step 5 min 1 ms Parameter Setting range Accuracy ...

Page 64: ...rement with regulator characteristics Alarm Setting range Accuracy High respiratory rate Range Off 10 60 bpm Step 1 bpm 1 bpm Low respiratory rate Rate Off 4 20 bpm Step 1 bpm 1 bpm Low minute volume Range Off 2 000 10 000 l Step 0 100 l 0 2 Pa Leakage Range On off Not necessary Non vented mask Range On off Not necessary Target volume not reached Range On off 0 2 Pa Target minute volume not reache...

Page 65: ...devices such as mobile phones Otherwise the therapy of the de vice might be influenced Maximum nominal power of sending source in W Protective distance depending on frequency in m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 ...

Page 66: ... appropriate special device Avoid the device being exposed to high temperatures above 80 C There is a risk of damage to the device and beyond this injury to the patient during therapy Ensure that there is someone close at all times during therapy who is able to operate the device and react to alarms Otherwise alarms may be ignored Do not carry out therapy while the device is connected to the PC vi...

Page 67: ... ventilation source 11 2 Transport maintenance WARNING The prescribed service intervals see Page 56 and Page 60 must be observed to guarantee the device runs smoothly Otherwise the quality of the therapy may suffer The device must be hygienically prepared by the manufacturer or the ser vice partner in the event of a change of patient if no bacterial filter was used previously Otherwise there is a ...

Page 68: ...piratory humidifier has been emptied prior to being transported Any ingress of water into the device may result in damage The heating plate of the respiratory humidifier and the heat transfer plate on the underside of the water chamber may reach temperatures in excess of 85 C during the operation There is a risk of burns Leave the device to cool following therapy before you remove the water chambe...

Page 69: ...ice Set device parameters 31 Switch off 20 Display Brightness 31 Brightness standby 32 Dual Set Switch therapy sets 17 F Function test 35 G Graph 30 K Keys 4 L Language 32 M Menu 30 Graph Info 30 Operation 26 Overview 31 Quick view 30 P PCV Bilevel T Mode 23 Plane Use in the 21 PSV Bilevel ST Mode 23 PSV S Bilevel S Mode 22 Q Quick view 30 R Ramp 24 Respiratory humidifier Connect 12 ...

Page 70: ...filter 15 Device 10 Respiratory humidifier 12 Standby screen 27 Starting therapy 16 Stopping therapy 20 T Target minute volume 24 Target volume 24 Therapy Modes 22 Start 16 Status range 28 Stop 20 Time 32 Travelling with device 20 U USB stick 34 V Volume Keys 32 ...

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