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Chapter 9: Appendix

Disclaimer

HOFFRICHTER GmbH accepts no liability for consequences in terms of safety, reliability
and performance of the product if:

•

interventions, modifications, extensions, calibration, repairs and maintenance are
carried out by persons not authorised by us,

•

other manufacturers’ accessories and spare parts are used that have not been
approved by us for use on the product,

•

the product is used for purposes other than stipulated in the user’s manual or

•

the hygiene and cleaning instructions stipulated in the user’s manual have not been
complied with.

Statutory guarantee rights remain unaffected by this disclaimer.

Содержание LAVI

Страница 1: ... device software 1 400 LAVI Ventilator HOFFRICHTER GmbH Mettenheimer Straße 12 14 19061 Schwerin Germany Telephone 49 385 39925 0 Fax 49 385 39925 25 E mail info hoffrichter de www hoffrichter de LAVI Patient ENG_2019 09 25_5 0 LAVI user s manual for patients 5 0 0 0 0 6 8 2 ...

Страница 2: ......

Страница 3: ...t you are always working with the most current version of this user s manual Should you have any questions please contact the ventilation device provider or check our information at www hoffrichter de The following documents are available in addition to this user s manual LAVI user s manual for physicians and medical professionals LAVI brief instruction Service manual Hygiene concept Maintenance s...

Страница 4: ...ce s serial number here You will find the serial number on the rating plate on the bottom of the device Please always provide the serial number in case of queries and complaints CE mark and number from the notified body The medical device complies with the applicable regulations of EU 93 42 EEC for medical products ...

Страница 5: ...issioning 24 Using oxygen 24 Safety related test 25 Chapter 3 27 Description of Device 27 Front side of device 28 Rear of device 28 Bottom of device 29 Top of device 29 Chapter 4 33 Commissioning 33 General information 34 Setting up the device 34 Power supply 35 System setup non invasive ventilation 41 System setup invasive ventilation 42 Calibrating the tube circuit 45 Using the functional bag 49...

Страница 6: ...tion 65 Audible alarm output audio alarms 67 Visible alarm output 68 Alarm overview 69 Messages 74 Chapter 7 75 Cleaning and Exchange of Components 75 Important information 76 Overview 76 Cleaning the device 78 Cleaning the mask 78 Cleaning the tube circuit 78 Cleaning the exhalation valve 79 Cleaning exchanging the air filter 79 Chapter 8 81 Routine Tests and Maintenance Work 81 Overview 82 Batte...

Страница 7: ...Inhaltsverzeichnis 7 Manufacturer s declaration on electromagnetic compatibility 92 Disposal 96 Disclaimer 97 ...

Страница 8: ...tion with non vented mask 41 Figure 13 System setup invasive ventilation with external humidifier 43 Figure 14 System setup invasive ventilation with HME filter 44 Figure 15 Inserting the SD card 47 Figure 16 Removing SD card 48 Figure 17 Functional bag 49 Figure 18 Home screen 56 Figure 19 Measurement screen factory setting 58 Figure 20 Graph screen 58 Figure 21 Parameter screen 59 Figure 22 Even...

Страница 9: ...pter 1 Introduction 9 Chapter 1 Introduction Please note This user s manual for patients is included in the scope of delivery It does not replace the user s manual for physicians and medical professionals ...

Страница 10: ...tart ventilation press briefly Stop ventilation press briefly MFK Switch device on Press 4 s Switch device off Press 4 s PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Set 3 Set 2 Mode IPAP PEEP Frequency Time Inspiration I Slope E Slope PCV 20 0 hPa 5 0 hPa 12 bpm 2 0 s 3 3 Set 1 Device is powering up or is running on line power Brief instructions Mains cable Ventilateur p...

Страница 11: ...e and transport HANDLE WITH CARE IF DAMAGED KEEP UPRIGHT LITHIUM ION RECHARGEABLE BATTERIES INSIDE No lithium metal Do not damage or mishandle this package If package is damaged batteries must be quarantined inspected and repacked For additional emergency information call 49 385 39925 0 ENTHÄLT WIEDERAUFLADBARE LITHIUM IONEN BATTERIEN Kein Lithium Metall Vorsichtig behandeln Bei Beschädigungen der...

Страница 12: ... user s manual Protection class II protective insulation BF application part IP22 Protection against solid foreign objects with diameters from 12 5 mm access to hazardous parts with a finger falling dripping water as long as the housing is tilted up to 15 Serial number CE mark and number from the notified body The medical device complies with the applicable regulations of EU 93 42 EEC for medical ...

Страница 13: ...nstructions in the user s manual Connections FiO2 FiO2 sensor connection DC DC connection COM COM interface Connection of remote alarm nurse call ESD sensitive component do not touch USB interface O2 Oxygen connection Control Release button for the integrable humidifier On off button ...

Страница 14: ...s and general safety regulations in force in the area of use must be observed This symbol denotes hazardous situations that lead to serious injuries or death This symbol denotes hazardous situations that may lead to serious injuries or death This symbol denotes hazardous situations that may lead to moderate injuries This symbol denotes situations that may lead to material dam age or damage to the ...

Страница 15: ...meters set using the control ele ments Ventilation can be monitored based on measurements and graphs on the display In case the custom and permanent alarm parameters are violated visual and acoustic alarms are emitted If the prescribed ventilation is no longer possible due to a techni cal error an acoustic alarm is emitted for at least 2 minutes If LAVI is operated with an internal battery ventila...

Страница 16: ...on the doctor s individual diagnosis Contraindications Risk of injury due to contraindications Ventilation may be contraindicated for certain pre existing conditions The following conditions may be a contraindication for non invasive ventilation Severe cardiac arrhythmia Severe hypotension Severe epistaxis Pneumothorax or pneumomediastinum Pneumoencephalus Cranial trauma Status after cranial or br...

Страница 17: ...entilation Ventilator associated pneumonia Effects on the cardio vascular system User qualification The respiration and alarm parameters may only be set by trained specialist personnel under the supervision of a doctor Care staff and patients have been instructed on how to use and handle the device These people must be familiarised with operation of the device and must have read all of and underst...

Страница 18: ...18 Chapter 1 Introduction ...

Страница 19: ...Chapter 2 Safety warnings 19 Chapter 2 Safety Information Please note Heed all important information in this user s manual Otherwise there is a risk of accidents injury and material damage ...

Страница 20: ...ly and document the incidents You will generally find the operator contact data on the device as well as in the medical device book The device must only be used by persons who have fully read and understood this user s manual before commissioning and have familiarised themselves with the device Disregarding these instructions can lead to life threatening situations for the patient In cases of emer...

Страница 21: ...lease ensure that the total resistance of the ventilation system does not exceed 6 hPa with a flow of 60 l min for adults and 30 l min for children Any modification to the device poses a threat to its reliability and is thus not permitted Masks may only be used on the prescription of a physician and after training by qualified medical staff Only use the mask after instruction by qualified medical ...

Страница 22: ... the devices with regard to error free and proper operation The use of accessories or power supplies we have not approved for the ventilator can increase the emission of electromagnetic radiation reduce interference immunity or lead to an increased patient leakage current Only the supplied power supply unit may be used for operating the ventilator Only LAVI and a humidifier may be connected to a p...

Страница 23: ... ambient tem peratures can result in an increased ventilation air temperature Ö Ö Please note the operating transport and storage conditions The air inlet at the rear of the device as well as all ventilation slots must not be blocked The display and the info LEDs must not be covered and must be visible to the user at all times No objects must be placed on the device The system must never be stored...

Страница 24: ... of the manufacturer or distributor from whom you obtain your oxygen If the patient is supplied with oxygen via the device the FiO2 should be measured On the LAVI FiO2 measurement is possible using the optional FiO2 sensor We recommend using this particular sensor exclusively Keep the FiO2 sensor out of the reach of children and animals To prevent incorrect calibration of the FiO2 sensor make sure...

Страница 25: ...fore observe the fire protection regulations applicable for using oxygen Please ensure that the oxygen fittings as well as all ports and surfaces near the oxygen lines are free of grease Do not smoke and do not handle naked flames When using oxygen an increased oxygen concentration in the ambient air can occur Safety related test In order to ensure the operating safety of the device a safety relat...

Страница 26: ...26 Chapter 2 Safety warnings ...

Страница 27: ...Chapter 3 Description of device 27 Chapter 3 Description of Device ...

Страница 28: ...xygen connection 2 DC connection The DC plug is connected here See also page 35 3 RS232 interface service interface 4 Connection of remote alarm nurse call Only relevant for clinical use 5 Micro USB connection PC connec tion service interface Figure 3 Rear of device 6 Ventilation slots 7 Filter cassette coarse and fine filter For information on exchange see page 80 Left side of device 1 1 Oxygen o...

Страница 29: ...et 3 Set 2 Mode IPAP PEEP Frequency Time Inspiration I Slope E Slope PCV 20 0 hPa 5 0 hPa 12 bpm 2 0 s 3 3 Set 1 6 5 4 1 3 2 1 Display 2 Info LED 3 It also provides information on the alarm device status priority Colour State Priority status Red Flashing HIGH Yellow Flashing MEDIUM Turquoise Lit LOW Green Lit Ventilation is running White Flashing Device is booting Lit Device for operation Figure 6...

Страница 30: ...paused Press briefly Escape key Function Action Exit current screen Press briefly Exit selected parameter Press briefly Cancel action Press briefly Heater key If an integrable humidifier is connected the heating key is available On the home screen and In the first level when the home screen icon is pressed on the home screen Function Action Switch on off heating for the integrable humidifier Press...

Страница 31: ...ctivated by pressing the alarm key before an alarm event occurs Pressing the key again reactivates the audible alarm in case an alarm event has occurred Audio alarm paused counter Indicates how much longer the audible alarm will be paused Error detected On the home screen press the error key to display the error message s You can find a list of all potential errors on on page86 Humidifier Heating ...

Страница 32: ...ce internal battery Defective battery or Battery capacity too low or Battery incompatible Mains operation active 1 Explanation of symbols on the pressure bar Symbol Meaning T Trigger lock On setting T Trigger lock triggered S Spontaneous breathing detected The device has detected spontaneous breathing by the patient This triggered the inspiration trigger The symbol will remain visible during inspi...

Страница 33: ...Chapter 3 Description of device 33 Chapter 4 Commissioning ...

Страница 34: ...he device was previously in an environment where the air temperature was not the same as in the new operating location allow approximately 1 hour until the temperatures have evened out before commissioning Setting up the device Place the device on a flat and stable surface Make sure that the device is placed securely and that the air inlet at the rear of the device is not blocked Make sure that th...

Страница 35: ...the device is supplied with power by the power supply unit The device can remain connected to the mains continuously without posing a risk If inserted in the device the internal battery is also charged Connect the device to the mains supply as follows C B A A Power supply unit B Power supply unit holder with integrated strain relief C Power supply unit cable Figure 8 Assembling the power supply un...

Страница 36: ...ocket Please note The DC plug is a POWER DIN plug with snap lock Do not pull on the cable to disconnect the cable from the device instead grasp the plug and disconnect it by pulling it in a straight line away from the device 5 Insert the mains cable plug into the power socket 100 240 V 50 60 Hz 6 Press the on off button for more than 4 s to switch on the LAVI 7 The device boots while performing a ...

Страница 37: ...age86 The device cannot be started if certain errors are in effect In this case contact your service provider SW Version x xxx Booting C B A A Progress bar B Status C Software version Figure 10 Start screen If no errors were detected during the self test or the errors have been confirmed the display will switch to the home screen It takes up to 1 minute to boot the device after which the device wi...

Страница 38: ...shown The time at which the device will switch to standby operation can be modified using the Standby parameter on the system screen The default factory setting is 5 min If you do not want the device to switch to standby operation set the parameter to off To exit standby operation press a key or the MFK In the event of an alarm standby also stops and the home screen is displayed Standby screen Mea...

Страница 39: ...he battery the battery must be maintained in accordance with the Battery maintenance on page 83 In battery operation the device cannot be operated with a humidifier Device operating times with a new fully charged battery Battery power level Time Alarm 100 0 approx 200 min 201 0 approx 35 min Low Internal Battery approx 5 0 approx 5 min Internal Battery Empty Measuring conditions Output volume Vdel...

Страница 40: ...tery begins charging when the power level falls below 95 Power failure Please note During a power failure the battery capacity display must be monitored and an alternative power source kept ready If the power supply is interrupted by a power failure and the device is on the device is supplied with power via the internal battery Power failure and thus the switch to the internal battery is indicated...

Страница 41: ...e exhalation valve remains open so that expired air can escape During non invasive ventilation the user must always be able to exhale expire This can either be accomplished using a vented mask with integrated exhalation valve or a non vented mask with separate exhalation valve The exhalation valve is optionally available as an accessory Setup with vented mask Setup with non vented mask Connect the...

Страница 42: ...n system the patient could suffocate Ö Ö Use a separate exhalation valve Risk of suffocation due to closed exhalation valve If the opening of the exhalation valve is closed the patient could suffocate Ö Ö Make sure that the opening of the exhalation valve remains open so that expired air can escape Risk of injury due to cold or dry breathing air Cold or dry breathing air presents an increased risk...

Страница 43: ...water can accumulate in the patient s lungs or in the ventilator If water accumu lates in the tube circuit we recommend using water traps Connect the components as follows FiO2 PA T I E N T F D B C D E A A Tracheal cannula B Catheter mount tube C Passive exhalation valve D Leakage tube E Bacterial filter F Humidifier Figure 13 System setup invasive ventilation with external humidifier 1 Connect al...

Страница 44: ...ease note When using a HME filter read the user s manual from the respective manufacturer In particular follow all information related to replacement intervals Connect the components as follows FiO2 PA T I E N T B D E A C A Tracheal cannula B Catheter mount tube C HME filter D Leakage tube E Passive exhalation valve Figure 14 System setup invasive ventilation with HME filter 1 Connect all componen...

Страница 45: ...ect calibration data the pressure measurement may be distorted Ö Ö Before commissioning and changing the tube circuit per form tube calibration To calibrate the tube circuit Please note During tube calibration the patient tube circuit must be open and ven tilation switched off A mask can be connected 1 On the home screen navigate to System and press the MFK 2 Navigateto CalibrateTube andpresstheMF...

Страница 46: ...s the MFK to Confirm If you do not perform a tube calibration the calibration data from the last tube cali bration are used When commissioning the device for the first time the default cali bration data1 stored in the device are used 1 Operation without humidifier Leakage tube circuit 22 mm 1 80 m Height ca 44 m NHN air pressure approx 1008 hPa Connected ventilation components and accessories no O...

Страница 47: ...not in progress If therapy is active the data cannot be copied in full 1 Insert the SD card into the SD card slot until it clicks into place as shown in the illustration then appears on the toolbar Figure 15 Inserting the SD card 2 On the home screen navigate to System and press the MFK 3 Navigate to Copy data and press the MFK PCV Set 1 75 50 40 30 20 10 0 p hPa f bpm VI l I E Copy Data Run Possi...

Страница 48: ...ppear Press the MFK to close the notice window PCV Set 1 75 50 40 30 20 10 0 p hPa f bpm VI l I E Press the MFK to Continue Copy Data Finished ok 5 Press the MFK 6 To remove the SD card carefully press the SD card into the SD card slot Then remove the SD card Figure 16 Removing SD card ...

Страница 49: ...he device in the functional bag the following instructions must be observed to ensure safe and trouble free operation Make sure that all alarm messages are visible through the viewing window and that the air vents of the bag are not blocked The air supply for the device must be guaranteed at all times Use the bag in such a way that the device is protected from overheating dust and water All access...

Страница 50: ...operation To switch the LAVI on in battery operation press the on off button for more than 4 seconds Switching off the device Mains operation Stop ventilation To switch on the device press the on off button for more than four seconds Battery operation Stop ventilation The device shuts off after approximately two minutes To switch the device off right away press the on off button for more than four...

Страница 51: ...Chapter 5 Device operation 51 Chapter 5 Operating the Device ...

Страница 52: ... Alarms Alarms 10 07 2016 00 56 l Set 1 Therapy stopped 10 07 2016 00 06 l Set 1 Therapy started 03 07 2016 l 22 08 l Set 1 2 5 3 0 hPa High Press Tolerance 26 06 2016 l 05 12 l Set 1 4 5 6 5 hPa PEEP PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Events Alarms Alarms 15 07 2016 23 41 l Set 1 Apnoe 09 07 2016 22 02 l Set 3 Low Volume 16 06 2016 l 21 33 l Set 3 Low Frequency...

Страница 53: ...tings Night Mode Heater Humidifier Off 3 PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Set 2 Set 1 Set 3 8 000 6 000 4 000 2 000 0 MV l Minute Ventilation 5 25 75 50 95 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 Jan 17 1 5 System screen Statistics screen Service screen PCV Set 1 75 50 40 30 20 10 0 p hPa f bpm VI l I E Press to Cancel Enter PIN PIN ...

Страница 54: ...arm key Heating key On off button To activate the menu lock 1 Hold the MFK in the home screen for longer than 1 second until the window appears at the side Keep the MFK pressed until the progress bar has completed and is displayed Then release the MFK Please note If therapy is in progress the measured values screen will auto matically appear upon activating the menu lock The home screen will be sh...

Страница 55: ...hPa f 12 bpm VI 0 570 l I E 1 1 5 Disable Menu Lock To disable the menu lock keep pressing the MFK 2 Select Yes and then press the MFK The symbol will be hidden from the toolbar PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Yes No Disable Menu Lock Disable menu lock User profiles For ventilation outside a clinic the device must be operated in the Home user mode If the devi...

Страница 56: ...s technically dependent alarms Events Displays events System screen System settings calibrations counters and device information Statistics screen Statistical evaluation reports Service screen System calibration and tests for service work PIN code protected PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Statistics Parameter Event Log Service Monitoring Thursday I 19 05 2016...

Страница 57: ...10 System 2 Press the MFK to activate the selected screen Change the display mode In the factory state the screen switches automatically 2 minutes after the last operation During ventilation to the measurements graph screen depending on which screen was most recently active or When ventilation is off to the home screen The physician can set the time for the timer screen change on the system screen...

Страница 58: ... FiO2 concentration FiO2 PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 4 500 MV l 25 0 Leck l min 21 FiO2 Off Off Off Graphs Measurements A B A Measurement configured B No measurement configured Figure 19 Measurement screen factory setting Graphs The Measurements Graphs section displays the following ventilation parameters when ven tilation is running Pressure Flow Volume ...

Страница 59: ...e to activating the wrong ventilation set The ventilation sets can contain different ventilation and alarm parameters Sets are not suitable for all applications Ö Ö Only activate the sets that the doctor has discussed with you 1 On the home screen navigate to Parameters and press the MFK 2 Navigate to the ventilation set you wish to activate PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 5...

Страница 60: ...tting to Yes and press the MFK to confirm the set ting PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Set 3 Activate Set Mode IPAP PEEP Frequency Time Inspiration I Slope Set 1 Set 2 Yes PCV 20 0 hPa 5 0 hPa 12 bpm 2 0 s 3 ...

Страница 61: ... hPa f 12 bpm VI 0 570 l I E 1 1 5 Alarms Alarms Events 15 07 2016 23 41 l Set 1 Apnoea 09 07 2016 22 02 l Set 3 Low Volume 16 06 2016 l 21 33 l Set 3 Low Frequency 24 05 2016 l 18 03 l Set 3 Leakage C A B A Timestamp date time and set B Alarm priority C Selected alarm Figure 22 Event log screen alarms Events Under Events you can see the last 50 parameter changes and events PCV Set 1 75 50 40 30 2...

Страница 62: ...r Calibrate the FiO2 sensor Copy data Copy data to the SD card Format the SD card Formats the SD card This will delete all data from the SD card Night mode on off Switch night mode on off In night mode the display colours are reduced and the brightness delay is lowered to 5 Heater Humidifier 1 5 Set the heating level for the AquaTREND uni humidifier Level 1 lowest heating level Level 5 highest hea...

Страница 63: ...Set 1 75 50 40 30 20 10 0 p hPa f bpm VI l I E Screen Change Standby Brightness Display Brightness LED Language Pressure Unit Volume Unit Display Time Insp off off 3 2 English hPa l Seconds 3 Change the language setting by turning the MFK then confirm by pressing the MFK If your language is not set here locate the desired language in the list below Sprache Deutsch Language English langue Français ...

Страница 64: ...inute Ventilation Frequency Tidal Volume I E Leak Rates PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Set 2 Set 1 Set 3 8 000 6 000 4 000 2 000 0 MV l Minute Ventilation 5 25 75 50 95 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 Jan 17 1 5 A A Statistics options Figure 25 Statistics screen The statistics options enable you to switch between statistics views and the date of...

Страница 65: ...d and the priority has been lowered but the alarm remains active until it has been con firmed with the alarm key The LAVI ventilator is equipped with fixed and adjustable alarms relating to the respec tive ventilation modes There are three alarm priorities Alarm priority What action is required HIGH Immediate action is required Monitor the patient and the cause of the alarm closely MEDIUM Fast act...

Страница 66: ...e Disconnection alarm 1 Connect the device to the mains supply 2 Switch the device on Do not connect the leakage tube system 3 Start ventilation 4 After a few seconds the Disconnection alarm occurs If this is not the case the device must be returned for servicing PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Statistics Parameter Event Log Service Monitoring Thursday I 19 0...

Страница 67: ...le alarm will sound again after two minutes Please note Some alarms cannot be muted You will find these in the Alarm over view on page 69 PCV Set 1 1 45 High Inspiration Volume 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 B A A Audio alarm paused symbol B Audio alarm paused counter Figure 26 Alarm displays on the toolbar The audio alarm may also be suppressed by pressing the alarm key...

Страница 68: ...e highest priority will be displayed first Still all occurring alarms are listed in the event log Alarm output on the toolbar Alarms are shown on the toolbar by the Alarm active icon and displayed with an alarm message The icon s colour indicates the alarm priority Red symbol high priority alarm Yellow symbol medium priority alarm Turquoise symbol low priority alarm If multiple alarms are triggere...

Страница 69: ...flashing Measured FiO2 is less than the set Min FiO2 None Leak rate MEDIUM c a f Yellow flashing Leakage mea sured greater than Leak Rate 3 breaths in a row High pressure MEDIUM c a f Yellow flashing Pressure is higher than the set High Pressure Toler ance 3 breaths in a row Low pres sure MEDIUM c a f Yellow flashing Presser below set Low Pressure Tol erance 3 breaths in a row High fre quency MEDI...

Страница 70: ...eaths in a row Muting Can be deleted by pressing the MFK Fixed alarms Fixed alarms are alarms whose conditions are fixed in the device and thus cannot be changed by the user Priority Audible alarm Info LED status Cause Correction Error flow sensor HIGH Ccc Cc Red flashing Flow sensor defective Device must be serviced Pressure sensor error HIGH Ccc Cc Red flashing Pressure sensor defective Device m...

Страница 71: ...xceeded Switch device on and off If the error occurs again return the device for servicing Stenosis HIGH c a f a f Red flashing No volume detected for 3 breaths Check tube circuit and tubes for wear Ventila tion off HIGH Ccc Cc Red flashing Ventilation has been switched off due to one of the following alarms None System flow Low leak rate Motor speed low Overcurrent Overpressure Overpres sure HIGH...

Страница 72: ... Defective bat tery Replace battery Internal Battery Empty MEDIUM C c c Yellow flashing Device operat ing on battery power supply battery charge 5 Battery must be charged only 5 minutes until power supply fails completely venti lation only possi ble with external power supply Power failure MEDIUM C c c Yellow flashing Power supply from the mains AC connec tion has failed Restore the power supply F...

Страница 73: ...sponding error text PCV Set 1 75 50 40 30 20 10 0 p 19 8 hPa f 12 bpm VI 0 570 l I E 1 1 5 Error internal battery Statistics Parameter Event Log Service Monitoring Thursday I 19 05 2016 I 23 10 System 2 Press the alarm button to disable the alarm Please note After the alarm has been dis abled by pressing the alarm button it is still shown on the toolbar with the symbol and the corresponding error ...

Страница 74: ... shown in place of the message as the alarm has a higher priority PCV Set 1 75 40 30 20 10 0 Back up Frequency Active A A Message Figure 28 Messages on the toolbar Message overview Message Cause Time delay Safety cycle active The device is in PSV mode the patient is not breathing spontaneously and is ven tilated at the set frequency None ...

Страница 75: ...Chapter 6 Alarms and messages 75 Chapter 7 Cleaning and Exchange of Components ...

Страница 76: ...in water or solvents Follow the accessory manufacturer s instructions for cleaning and disinfection Overview The following overview table describes the cleaning intervals of articles delivered by HOFFRICHTER For articles by other manufacturers please follow their cleaning instruc tions Component Name Cleaning Replace FiO2 LAVI ventilator as needed Power supply unit as needed Mains cable as needed ...

Страница 77: ...ter cassette without filter as needed Coarse filter weekly Cleaning Fine filter no monthly if severely contaminated FiO2 sensor as needed in accordance with manufacturer instructions PA T I E N T Bacterial filter no daily Functional bag as needed1 11 1 For cleaning information please read the section Cleaning the functional bag on page 80 ...

Страница 78: ...o the manufacturer s instructions Cleaning the tube circuit Risk of injury due to damaged tube circuit A heavily worn or damaged tube circuit can result in insuffi cient ventilation and thus health issues Ö Ö Dispose of heavily worn or damaged tube circuits and replace them with a new one The supplied leakage tube circuit is intended for use on one patient only It must not be used for other patien...

Страница 79: ...agents 2 Rinse the exhalation valve thoroughly with clear water 3 Let the exhalation valve air dry completely When using other exhalation valves the manufacturer s instructions must be observed Exhalation valves not designed for reuse must be disposed of properly Cleaning exchanging the air filter COM DC COM DC B C D A A Filter frame cover B Filter cassette C Fine filter white D Coarse filter blac...

Страница 80: ...ing the functional bag Please note The functional bag is not suited for cleaning in a washing machine or dry cleaning To clean the functional bag use a cloth moistened with water A mild cleaning agent may also be used if necessary Replacing the fine filter Replace the white fine filter monthly or in case of heavy soiling 1 Pull the filter cassette from the device 2 Remove the coarse filter black 3...

Страница 81: ...Chapter 8 Routine checks and maintenance work 81 Chapter 8 Routine Tests and Maintenance Work ...

Страница 82: ...anual Overview When What action is required By whom Before commissioning Safety related test Operator Weekly Clean replace the coarse filter see page 80 User Visually check the fine filter User Monthly or before if heav ily contaminated Replace fine filter see page 80 User Every 12 months during storage Charge battery1 User Every 2 years Maintenance 2 refer to the service manual Provider Service S...

Страница 83: ...ge it and then charge it to 100 again to recalibrate the battery indicator Please note Regularly check the battery power level Operate the device on the mains to ensure the battery is always charged As the number of charging cycles of lithium ion batteries is limited the internal bat tery must be replaced and disposed of after a certain period of time This is the case when the Replace battery mess...

Страница 84: ...84 Chapter 8 Routine checks and maintenance work ...

Страница 85: ...Chapter 9 Appendix 85 Chapter 9 Annex ...

Страница 86: ...must be serviced Secondary alarm sound transmitter is defective Secondary alarm sound transmitter is defective Device can continue to be used but must be serviced No alarm sound trans mitter available Primary and secondary alarm sound transmitter are defective Device can continue to be used but must be serviced RYB LED error Info LED defective Device can continue to be used but must be serviced Re...

Страница 87: ...symbol To show the error list detailing existing errors press the error key on the home screen PCV Set 1 75 50 40 30 20 10 0 p hPa f bpm VI l I E Error Primary alarmsound not working Error card reader Blower service necessary Press the MFK to Confirm B A A Error button B Error symbol Figure 30 Error list ...

Страница 88: ...spiratory working pressure1 4 hPa Supply voltage Operating conditions Temperature range 5 C to 40 C Relative humidity 10 to 95 non condensing Air pressure range3 600 hPa to 1100 hPa approx 4000 to 400 m 1 Ensured by pressure control 2 AquaTREND uni 3 The air flow rate decreases with increasing altitude Transport conditions Temperature range With battery Without battery 20 C to 50 C 25 C to 70 C Re...

Страница 89: ...0003441 00003436 00003437 Cirri Mini Comfort nose mask 00003551 00003452 00003498 Cirri Comfort nose mask 00003497 00003486 00003487 00003488 Cirri Comfort mouth nose mask 00003483 00003484 00003485 Nasal Pillow 4in1 00003499 Without exhalation valve non vented Standard NIPPV mouth nose mask 00003461 00003442 00003438 0003462 Standard NIPPV mouth nose mask autoclavable 00003439 Cirri Comfort mouth...

Страница 90: ...A T I E N T O2 connection adapter angled 41000087 FiO2 measurement set consisting of FiO2 sensor T adapter FiO2 sensor adapter FiO2 sensor connect ing line with screw connector 00004944 FiO2 sensor 23000018 T adapter 23000019 FiO2 sensor adapter 23000020 FiO2 sensor connecting line with screw connector 00014116 ...

Страница 91: ... 9 Appendix 91 Name Article number Figure Remote alarm box complete including accessories 00014122 Remote alarm box without accessories 00004834 Cable for remote alarm box 00014115 LAVI functional bag 00013082 ...

Страница 92: ...ser of the LAVI ventilator must ensure it is operated in such an environment Emitted interference Compliance Electromagnetic environment guidance HF emissions according to CISPR 11 Group 1 The LAVI ventilator only uses HF energy for its internal functions Its HF emissions are thus very low and interference with nearby elec tronic devices is unlikely HF emissions according to CISPR 11 Class B The L...

Страница 93: ... 2 4 8 15 kV air discharge display Floors should be made of wood or concrete or be lined with ceramic tiles If the floor is lined with a synthetic material the relative humidity must be at least 30 Emitted HF distur bance as per IEC 61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 10 V m Portable and mobile HF communication devices including wires and antenna should be used at least 0 3 m suggested ...

Страница 94: ...ge outer conductor outer conductor 2 kV voltage outer conductor earth The quality of the sup ply voltage should corre spond to one of the typ ical business or hospital environments Conducted HF disturbances as per IEC 61000 4 6 3 VEffective value 150 kHz 80 MHz 6 VEffective valuein ISM and amateur radio bands between 150 kHz and 80 Mhz 3 V 6 V Portable and mobile radio devices should be used space...

Страница 95: ...30 dip of UT for 25 50 Hz periods 30 60 Hz periods 95 dip of UT for 250 50 Hz periods 300 60 Hz periods 95 dip of UT for 1 2 period 60 dip of UT for 5 periods 30 dip of UT for 25 periods 95 dip of UT for 5s or 6s The quality of the sup ply voltage should cor respond to one of the typical business or hos pital environments If the user of the LAVI venti lator requires continued functioning even in t...

Страница 96: ...ct the relevant customer services department to find out how to dispose of the device etc properly Batteries must not be disposed of when discharged If a battery is not fully charged there is a risk of a short circuit Short circuits can be prevented by insulating the contacts with adhesive strips Packaging The packaging is taken back by the distributor but it can alternatively be disposed of separ...

Страница 97: ...d maintenance are carried out by persons not authorised by us other manufacturers accessories and spare parts are used that have not been approved by us for use on the product the product is used for purposes other than stipulated in the user s manual or the hygiene and cleaning instructions stipulated in the user s manual have not been complied with Statutory guarantee rights remain unaffected by...

Страница 98: ...98 Chapter 9 Appendix ...

Страница 99: ...Chapter 9 Appendix 99 ...

Страница 100: ...100 Chapter 9 Appendix ...

Страница 101: ...Chapter 9 Appendix 101 ...

Страница 102: ...102 Chapter 9 Appendix ...

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Hoffrichter LAVI, Руководство пользователя для пациентов

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