imtmedical bellavista 1000 User Manual
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imtmedical bellavista 1000 User Manual

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the art of ventilation
User Manual
bellavista Ventilator

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Summary of Contents for imtmedical bellavista 1000

  • Page 1 the art of ventilation User Manual bellavista Ventilator...
  • Page 2 User Manual bellavista Ventilator Thank you very much for choosing bellavista. You have purchased a top-quality ventilator that meets the highest standards.
  • Page 3 Gewerbestrasse 8 9470 Buchs (SG) Switzerland sales@imtmedical.com...
  • Page 4 Stopping ventilation, shutdown 2.15 Servicing and maintenance 2.16 Transport Description of the device Overview of bellavista 1000 Overview of bellavista neo Overview of bellavista 1000 e System overview Air and oxygen supply Preparing for ventilation Checking delivery First steps Connecting supply lines Battery operation...
  • Page 5 NIV, non-invasive ventilation Ventilation of neonates Operation Index of applications Changing the monitoring settings Changing the curve display Zooming gestures Safety-protected settings Login, user level Configuration Assist Data Assist iVista Setting up ventilation Making ventilation settings beMode Assist Starting ventilation (ventilation menu) Introduction to the ventilation modes ATC Automatic Tube Compensation PLV Pressure Limited Ventilation Sigh...
  • Page 6 10 Stopping ventilation, shutdown 10.1 bellavista shutdown 11 Servicing and maintenance 11.1 Factory repair 11.2 Changing fuses 11.3 Batteries 11.4 Disposal 11.5 Reprocessing, cleaning, disinfection 11.6 Calibration Assist 12 Specifications 12.1 Standards 12.2 Classification 12.3 Device data 12.4 Ambient conditions 12.5 Units and languages 12.6 Pressure, flow 12.7 Connection data...
  • Page 8 Volume Controlled Synchronised Intermittent Mandatory Ventilation Adaptive Ventilation Mode HFOT High Flow Oxygen Therapy beModes Special modes for Day / Night, DualVent, MaskFit, TargetVent, Apnea Backup ventilation TargetVent Pressure-regulated, volume-controlled ventilation mode   Neonatal option not available in all countries. imtmedical ag...
  • Page 9 Software version 6.0 • bellavista 1000 neo (G6) SN: MB160000 and higher Software version 6.0 In the following document the device “bellavista 1000 neo” will be described with the following name: “bellavista neo”. • bellavista 1000 e (G6) SN: MB170000 and higher Software version 6.0...
  • Page 10 If a defective bellavista is used, malfunctions may directly or indirectly endanger the bellavista patient's health. Before putting bellavista into operation, always check to make sure it is functioning properly. Never use bellavista if it has been found to be faulty. Have any defects re- paired without delay. imtmedical ag...
  • Page 11 The safety of the patient being ventilated is the responsibility of the attending physician or nursing staff. Their judgement takes priority over the content of this User Manual. Always ensure that appropriate measures are taken to adequately monitor the patient. imtmedical ag...
  • Page 12 • a new patient • a new flow sensor • “Calibrate flow sensor” alarm In the case of non-invasive ventilation, the expiratory measurements of volumes and capnography values can differ considerably from the actual expiration on account of leakage. imtmedical ag...
  • Page 13 Do not use bellavista in a hyperbaric chamber (pressurised chamber). imtmedical ag...
  • Page 14 Ventilation modes nCPAP and nIPPV may only be used with a compatible nasal inter- face, in order to ensure correct alarms. Do not reuse single-use accessories because this can lead to a detrimental effect on sterility, functionality and general performance. Do not use antistatic breathing circuits! imtmedical ag...
  • Page 15 The following changes to the network / data sharing system can lead to risks and thus require additional analyses. Changes to the network / data sharing system particularly include the following: • Changes in configuration • Connection of additional elements • Update or upgrade of connected devices imtmedical ag...
  • Page 16 In the event of a leak during manoeuvres the accuracy of measurements (parameters and loops) is reduced. Bear in mind that ventilation after the recruitment manoeuvre will continue with PEEP imtmedical ag...
  • Page 17 Always perform the quick check in full. After the quick check, return the settings to the correct values. 2.16 Transport bellavista is a medical device and should be transported carefully. bellavista and ac- cessories must be shipped in their original packaging. Keep the original packaging in a dry place. imtmedical ag...
  • Page 18 Description of the device Description of the device Description Overview of bellavista 1000 Alarm lights Screen with touch-screen function Speaker Attachment of expiratory valve or dual limb adapter Handle Cover for cooling air filter Cover for patient air filter Connection Assist button...
  • Page 19 External 24 VDC power supply Power indicator (green LED = battery charging) Power plug Device fuse 2 × T 6.3 AH, 250 V Display Port (for servicing purposes) * It is recommended not to plug in or unplug any USB devices when ventilation is taking place. imtmedical ag...
  • Page 20 Description of the device Description Overview of bellavista 1000 e Alarm lights Screen with touch-screen function Speaker Display Port (for servicing purposes) Cover for cooling air filter Cover for patient air filter Connection Assist button External device interface (blue) Connector for SpO sensor •...
  • Page 21 Measurements taken by the flow sensor are in the section “Specifications” used to determine the pressure, flow and volume. under “Pneumatic block dia- gram”. An oxygen sensor monitors the oxygen concentration of the gas delivered to the  pa- tient. imtmedical ag...
  • Page 22 • Enter patient type • Specify start parameters for ventilation • Start ventilation • During ventilation: You will find more options in the section “Operation”. Cockpit for ventilation and settings Select and set ventilation mode Monitoring Alarms Shutdown imtmedical ag...
  • Page 23 If there are concerns about the condition or set-up of the earth wire, bellavista may only be operated in battery mode. Earthing is only reliable if the device is plugged into a socket marked as being suitable for medical equipment. imtmedical ag...
  • Page 24 Preparing for ventilation Battery operation bellavista 1000 can be operated in battery mode for at least 4 hours. The ventilation settings will have a significant impact on battery life. Battery operation is monitored by several alarms. Battery indicator Display the battery indicator by clicking on the top of the screen.
  • Page 25 For configuration of O supply <1.5 bar or O supply <100 % O  see Configu- ration Assist. If there is an oxygen sensor failure, the oxygen options can be temporarily disabled in Configuration Assist imtmedical ag...
  • Page 26 An optional filter protects the patient air inlet of bellavista against external contamina- tion. It is fitted instead of the standard inlet filter. Two different filter types are available. See also the relevant set of instructions 302.505.000 • 302.303.000 Inlet filter HEPA H14 imtmedical ag...
  • Page 27 Oxygen Therapy). ATC Automatic Tube Compensation (disabled in Configuration Assist) Breathing circuit (1- / 2-tube, expiratory valve, flow sensor) 4 d Perform breathing circuit test. Ventilation adjustment parameters (See all: Start ventilation. Access to the main menu without starting ventilation. imtmedical ag...
  • Page 28 This step is of major importance because the proper functioning of sensors, valves and alarms depends on it. 4.8.2 Quick check on start-up Perform the quick check each time the device is started. Breathing circuit test Circuit test successful/ventilation overlay imtmedical ag...
  • Page 29 • a new patient • a new flow sensor • “Calibrate flow sensor” alarm In the case of non-invasive ventilation, the expiratory measurements of volumes and capnography values can differ considerably from the actual expiration on account of leakage. imtmedical ag...
  • Page 30 Flow Oxygen Therapy) rate list of validated accessories.  Proximal pressure measure- ment Configure breathing circuit using the  Expiratory flow calculated start screen. When inserting or re- moving the tubes, grip by the sleeve. No breathing circuit test required! imtmedical ag...
  • Page 31 Patient connection with expiratory valve (breathing circuit C, D) or leak (A) Patient connection with Y-piece (tube E) Expiratory limb (breathing circuit E, with water trap) Connection to expiratory valve (only breathing circuit E) 5 + 6 Alternatively: heated expiratory tube imtmedical ag...
  • Page 32 The connections for the measuring lines must always point upwards to Flow sensor for proximal flow measurement prevent penetration of liquids. • The flow sensor must be calibrated before use on the patient. If two con- secutive calibrations are incorrect, replace the flow sensor with a new one. imtmedical ag...
  • Page 33 • Connect pressure tube of the nebuliser to the nebuliser connector marked yellow • Start and stop ventilation: • Cockpit • Ventilation menu • It is possible to enable the nebuliser for pure aerosol therapy even if ventila- tion has been stopped (on standby). For specifications see section “Specifications” imtmedical ag...
  • Page 34 Check and clean, or re- place, the expiratory valve In the inspiratory limb on a regular basis. Bear in mind that nebu- lisation has an impact on the concentration of oxygen administered. Between Y-piece and flow sensor Recommended nebuliser installation imtmedical ag...
  • Page 35 Preparing for ventilation 4.17 Dual limb adapter For details  of how to use and clean the dual limb adapter (301.522.000 for bellavista 1000 or 304.585.000 for bellavista 1000 e) see the relevant set of instructions (301.520.000). The dual limb adapter with expiratory valve 4.18 Integrated expiratory valve For details of how to use and reprocess the integrated expiratory valve (302.529.000)
  • Page 36 The green LED indicates that the device is ready for operation Do not autoclave the sensor or place it in a liquid. Do not pull on the sensor cable. Comply with the operating temperature range. imtmedical ag...
  • Page 37 Assist. Please also consult the instructions for use of the used SpO Sensor. The SpO sensor measures functional oxygen saturation of arterial hemoglo- bin (% SpO ) and pulse rate (BPM) for adult, paediatric, infant and neonatal patients. imtmedical ag...
  • Page 38 Only use the sensor on a patient if you have the necessary expertise. Before using a defibrillator, remove the sensor from the patient or discon- nect it from the device. Application of SpO Sensor with excessive pressure for prolonged peri- ods can induce pressure injury imtmedical ag...
  • Page 40 HFOT (High Flow Oxy- Available for adult, paediatric and neonatal patients. gen Therapy) Only use with a special interface for oxygen therapy (e.g. nasal cannula). Do not use nasal CPAP masks or prongs! imtmedical ag...
  • Page 41 NIV, non-invasive ventilation imtmedical ag...
  • Page 42 Ventilation of neonates The ventilation of neonates* and infants as of ≥ 2 mL tidal volume is possible with bellavista neo, and optionally also with bellavista 1000 and bellavista 1000 e. Invasive, pressure-controlled and pressure-supported ventilation as well as TargetVent (target volume) are available.
  • Page 43 Autoset Leakage Adapt leakage and disconnection criteria with the Autoset Leakage button (see section “Alarms”). Ensure that the nasal interface is connected properly to the patient, when activating the Autoset leakage button. Follow the instructions on the information window. imtmedical ag...
  • Page 44 O suction, Night Mode, ATC settings, P , Ramp, circuit test confirmation Cockpit Ventilation settings and monitoring Configurable button 1 (Preset to Monitoring) Configurable button 2 (Preset to Settings) Alarm menu Alarm settings imtmedical ag...
  • Page 45  Curves and parameters. Trending  Evaluation of ventilation parameters. Maneuver  Inspiratory and expiratory Hold manoeuvres as well as Lung Recruitment Tool (optional). Alarm settings  Customisation of alarm limits. Alarms  Current alarms and alarm protocols. imtmedical ag...
  • Page 46 Access to the User Manual either in Main- or in the con- text menu during ventilation. About bellavista   Overview of enabled options, software version and operating hours. Cockpit  Monitoring and settings. Chameleon  Summary of various user control philosophies. Symbol for female Symbol for male imtmedical ag...
  • Page 47 … context menu appears: “Specifications” under “Curves to delete the monitoring parameter • and loops” to change the monitoring parameter • After deleting a monitoring parameter the empty space can be used for Filled curve: 1..4 new parameters. Synchronised breath. “Empty” curve: Mandatory breath. imtmedical ag...
  • Page 48 Automatic scaling of all curves. Zoom in on time scale Zoom out on time scale Stop curve (Freeze), ≤ 3 min, see also screenshot function. Freeze a reference loop. Superimposition of loops (Adult: 60 s, Paediatric: 30 s, Neonatal: 15 s). imtmedical ag...
  • Page 49 Some settings require further confirmation for safety reasons: • Adjust the control until the lock appears • Touch the lock to enable the extended adjustment range • Continue to adjust the control Enable the protected adjustment range only after careful assessment of the situation. Lock-protected adjustment range imtmedical ag...
  • Page 50 Technical information, calibration, etc. Activate password protection in Configuration Assist: “Automatic login”. Here you can select the user level at which the device will start up. All higher user levels require a password. Changing password on the next page (swipe). imtmedical ag...
  • Page 51 User level after starting up or logging off 1st Use Assist: place bellavista in state as delivered • Lock patient cockpit: no ventilation settings are possible in the • patient cockpit Set default screen and switchover delay • Periphery Selection of protocol for the external interfaces * Not available in the USA. imtmedical ag...
  • Page 52 Direct export of all parameters of the last seven days to a Windows Excel-com- patible data format. The status bar indicates the progress of the export. You can now exit the export screen. The second Data Assist screen is used for data export imtmedical ag...
  • Page 53 The parameters indicated can be exported to the Excel-compatible CSV format. Connection Shows whether a connection exists with the bellavista database of imt- medical. About Contact and version information iVista can be downloaded at www.ivista.ch. imtmedical ag...
  • Page 54 “Introduction to the ventilation modes” Ventilation Select according to mode and indication. settings Apply Only by clicking Apply are the settings enabled. If you exit the screen without confirming, the settings will be discarded. imtmedical ag...
  • Page 55 Touch “Backup Ventilation” to make the settings. Configure Apnea Backup Ventilation carefully in order to ensure ade- quate ventilation if it is activated. Before a change in beModes the ventilation settings must be checked carefully. imtmedical ag...
  • Page 56 Day/Night is used with patients who require ventilation support that is different at night from during the day. To disable the timer the night (or day) can be set to zero. Then it is only possible to switchover manually. imtmedical ag...
  • Page 57 DualVent B. Then no alarm is triggered. • DualVent B: the patient does not have adequate spontaneous breathing and requires mandatory ventilation. If the patient triggers an adjustable number of breaths in succession, bellavista automatically switches over to DualVent A. imtmedical ag...
  • Page 58 • bellavista provides not only visual feedback but also audible feedback so that breathing with a mask can be learned. 8.2.6 AVM as beMode If AVM is selected on the beMode screen, SingleVent is automatically selected with the AVM ventilation mode. imtmedical ag...
  • Page 59 If the tidal volume administered is greater than 50% of the target volume, the maximum Pinsp change per breath is ± 2 mbar. Quick adaptation If tidal volume is more than 30% higher than the target volume, the breath is discontinued in order to avoid over-inflation. imtmedical ag...
  • Page 60 Switch from transpulmonary to transalveolar pressure by entering endotracheal or tracheo- can be suspended by touching stomy tube diameter. the O suction button at any time. Circuit test Indication of successful or not performed circuit test. * Not available in the USA imtmedical ag...
  • Page 61 Synchronised/mandatory (S/T) Many ventilation modes use the synchronised/mandatory combination (S/T). • Spontaneous respiratory efforts can, if required, trigger synchronised breaths. • If not triggered spontaneously, a mandatory breath is delivered. 1/Rate With mandatory breaths the curve remains empty imtmedical ag...
  • Page 62 I-Time Insp 1/Rate T’ I’ E’ E = Expiration time E’ = 0.2 s minimum expiration time T = Expectation window trigger T’ = Trigger I = Inspiration I’ = 0.1 s minimum inspiration time P = Plateau imtmedical ag...
  • Page 63 • Compensation of leakage and nebuliser volume also in volume-controlled modes. • Accurate volume delivery based on proximal measurement. • Automatic compensation for breathing circuit compliance. PLV (Pressure Limited Ventilation) is always enabled. Flow Pattern Insp Trigger Plateau I-Time Insp 1/Rate T’ I’ E’ imtmedical ag...
  • Page 64 • Differential pressure trigger: substantial expiratory effort on the part of the pa- tient (e.g. coughing) results in a sudden pressure rise that  immediately initiates expiration. imtmedical ag...
  • Page 65 PLV flow pattern Plateau Max Alarm – 5 mbar Max Alarm Chart on the left: PLV pressure limitation prevents excess pressure and thus ensures that the set tidal Flow Pressure control contr. volume is administered. imtmedical ag...
  • Page 66 The amplitude of a sigh is … % larger than that of a normal breath: % of P for pressure-controlled breaths • Insp % of P for pressure-supported breaths • Support % of Vt for volume-controlled breaths • Sigh interval Number of breaths between sighs. Sigh breaths Number of consecutive sighs imtmedical ag...
  • Page 67 EPAP = EPAP + 4 mbar Start Start IPAP IPAP EPAP + IPAP - EPAP Start Start = Start EPAP EPAP set by the user (Expiratory Positive Airway Pressure) IPAP IPAP set by the user (Inspiratory Positive Airway Pressure) imtmedical ag...
  • Page 68 PEEP) is created. CPAP If apnea occurs and apnea backup ventilation is switched on, bellavista auto- matically issues an alarm and switches to backup ventilation mode. Setting Description CPAP Continuous Positive Airway Pressure Oxygen Adjustment of oxygen concentration imtmedical ag...
  • Page 69 Additional inspiratory pressure of a manual breath, relative above CPAP. Insp Man Duration of the manual breath. Insp Man Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. Burst Number of consecutive mandatory backup breaths/Off. Backup imtmedical ag...
  • Page 70 Description Inspiratory pressure (relative above PEEP) Insp PEEP Positive end-expiratory pressure Rate Controlled breaths per minute Inspiratory time Insp Rise Rise time of inspiratory pressure Oxygen Adjustment of oxygen concentration + PEEP Insp Rise Time PEEP Insp 1/Rate imtmedical ag...
  • Page 71 * Flow trigger * Inspiratory flow for trigger activation. Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. * Only P-A/C + PEEP = IPAP Insp Rise Time PEEP Trigger * I-Time T Insp 1/Rate imtmedical ag...
  • Page 72 Limit for switching from inspiration to expiration in the case of pres- sure-supported breaths. Manual/auto.sync. Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. + PEEP Insp + PEEP Exp Trigger Support Rise Time PEEP Trigger Insp 1/Rate imtmedical ag...
  • Page 73 Rise time of inspiratory pressure. Rate Backup rate (minimum respiratory rate). For mandatory backup breaths Backup Insp Insp Max Oxygen Adjustment of oxygen concentration. + PEEP = IPAP Support Exp Trigger Rise Time EPAP PEEP Trigger I-Time 1/Rate Insp Max Backup imtmedical ag...
  • Page 74 Limit for switching from inspiration to expiration in the case of pres- sure-supported breaths. Manual/auto.sync. Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. + PEEP Rise Time Support High Exp Trigger PEEP Trigger High 1/Rate imtmedical ag...
  • Page 75 Exp Trig Limit for switching from inspiration to expiration in the case of pres- sure-supported breaths. Manual/auto.sync. Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. Support High Exp Trigger Rise Time High Trigger Rise Time High imtmedical ag...
  • Page 76 Pressure below PEEP for trigger activation. trigger * Flow trigger * Inspiratory flow for trigger activation. Pattern Pattern of inspiratory flow. Oxygen Adjustment of oxygen concentration. * Only V-A/C Flow Pattern Insp PEEP Trigger * Plateau Insp 1/Rate imtmedical ag...
  • Page 77 Limit for switching from inspiration to expiration in the case of pres- sure-supported breaths. Manual/auto.sync. Pattern Pattern of inspiratory flow. Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. Flow Pattern + PEEP Exp Trigger Support Rise Time Insp PEEP Trigger Plateau Insp 1/Rate imtmedical ag...
  • Page 78 Inspiratory flow for trigger activation. Exp Trig Limit for switching from inspiration to expiration in the case of pres- sure-supported breaths. Manual/auto.sync. Rise Rise time of inspiratory pressure. Oxygen Adjustment of oxygen concentration. Limit Exp Trigger Rise Time PEEP Trigger imtmedical ag...
  • Page 79 Ramp Period of time during which flow is increased slowly to the set value. toring. Oxygen Adjustment of oxygen concentration * For range and resolution see section “Specifications” under “Ventilation settings”. Flow Pressure limitation active Limit Flow Ramp imtmedical ag...
  • Page 80 . A message is displayed during pressure limitation. Limit Smart alarm for oxygen concentration. The following alarms are enabled during HFOT: Alarm message  low Pulse rate high Pulse rate low Breathing circuit disconnection Check breathing circuit Occlusion Pressure limit reached imtmedical ag...
  • Page 81 Flow sensor Not available Breathing circuit test Not available, not necessary Set ventilation mode Not available Height, gender, Not available lung damage Maneuver Not available beModes Not available Manual breath Not available Apnea backup ventilation Not available imtmedical ag...
  • Page 82 Same functionality as Advanced but without the configuration op- tions and with fewer applications. Advanced Access to all applications and settings. The cockpit and the adjacent screens: Maneuvers – Cockpit – Settings – Backup settings (from left to right) imtmedical ag...
  • Page 83 Deflation can be slow (with the set slope) or quick (immediate in order to minimise manoeuvre duration). Pressure at the end of the assessment manoeuvre. Ventilation continues with previous PEEP setting after assessment. PEEP Ventilation continues with PEEP as the new PEEP after recruit- ment manoeuvre. imtmedical ag...
  • Page 84 After termination of the manoeuvre, cursors are available for manual evaluation. Inflection points or the maximum dV volume difference can thus be evaluated manually. Monitoring parameters indicate manoeuvre-specific or cursor-de- pendent measurements. Save manoeuvre: saves a screenshot for comparison later. imtmedical ag...
  • Page 85 • if non-invasive ventilation (NIV) has been selected. • if a spontaneous breathing mode has been selected. • if the breathing circuit selected is not type D or E. • if the patient is breathing spontaneously (% Spont > 10%). imtmedical ag...
  • Page 86 During inflation, airway pressure cannot be increased or maintained by • leakage or disconnection. Occlusion compliance too low Indicates that compliance during inflation is very low, which may indicate an occlusion. Occlusion deflation Indicates that the manoeuvre is unable to reduce pressure during deflation. imtmedical ag...
  • Page 87 A separate screen makes it possible to compare different lung recruitment and meas- uring manoeuvres. Step Description Select Comparison. With the arrow buttons select the required manoeuvre that has been saved previously. Compare manoeuvres. Export all manoeuvres saved to USB memory. imtmedical ag...
  • Page 88 The button will be greyed out when no probe is connected to the P interface. During P measurement P is deactivated. imtmedical ag...
  • Page 89 The Chameleon application allows you to operate bellavista in a similar way to other ventilators. Training effort can thus be reduced. The Chameleon application only supports SingleVent and has a freely adjustable  apnea backup mode with the same functionality as the bellavista backup mode. Chameleon classic screen imtmedical ag...
  • Page 90 The alarm display consists of three screens: Screen Contents Alarm settings For details see section “Alarm limits” For details see section “List of alarms” Alarms Alarm log Alarms having occurred in the past. The alarm settings can be found in the third alarm screen imtmedical ag...
  • Page 91 The user must take appropriate precautions, however. Short tone, blue alarm lights All alarms occurring are saved. The alarm list remains intact even in the event of a power failure. See section “List of alarms” and “Alarm limits” imtmedical ag...
  • Page 92 Drag the slider to the right to confirm the stop command. Remove the mask from the patient when ventila- tion has been stopped. Leaving the mask in place may considerably in- crease airway resistance and CO re-inhalation. bellavista main menu imtmedical ag...
  • Page 93 Drag the slider to the right to confirm, or cancel the shutdown process. The shutdown process takes approx. 30 s. If you cannot shut down bellavis- ta in the software, keep the ON button on the left-hand side of the device pressed for 7 s. imtmedical ag...
  • Page 94 “Appendix”. Only trained professionals authorised by the manufacturer may per- form maintenance and repair work. Appropriate measuring equipment e.g. imtmedical CITREX H3, H4, H5 or FlowAnalyser PF-30x and testing equipment must be available for testing and calibrating bellavista ventilators. Before subjecting bellavista to any maintenance work •...
  • Page 95 Ethyl alcohol • Disinfectant wipes (alkyl dimethyl benzyl ammonium) • Allow to dry in the air • * Not available in the USA 11.5.2 Reprocessing of accessories and consumables Follow the instructions for use issued by the relevant manufacturers. imtmedical ag...
  • Page 96 For good aeration, move the sensor freely through the air to remove any incorrect CO respiratory residual CO from the airway adapter. gas measurement. During zero-point calibration place the sensor horizontally on a flat surface, away from any expiratory air. imtmedical ag...
  • Page 97 1- or 2-point calibration is performed. During ventilation only 1-point calibration is performed because FiO  drops to 21%. If 1-point calibration fails to provide satisfactory results, 2-point calibration will be necessary: allow bellavista to warm up for 30 minutes, with no ventilation in progress, supply connected. imtmedical ag...
  • Page 98 12.2.2 UMDNS Code Universal Medical Device Nomenclature System Code Term (DE) Term (EN) 15-613 Beatmungsgerät Ventilators 16-938 -Monitor, Atemgas Carbon Dioxide Monitors, Exhaled Gas 17-445 Gassensor Gas sensor 17-148 Oximeter, Puls Oximeters, Pulse 17-551 Stativ, Beatmungsgerät Mounts, Ventilator imtmedical ag...
  • Page 99 Specifications 12.2.3 GTIN-13/EAN-13 Code Global Trade Item Number/European Article Number Designation GTIN-13/EAN13 bellavista 1000 Device 7640149381115 • Packaged 7640149380019 • bellavista 1000 neo Device 7640149381047 • Packaged 7640149381238 • bellavista 1000 e Device 7640149381191 • Packaged 7640149380026 • 12.2.4 UDI Code...
  • Page 100 Max. possible working pressure 100 mbar Maximum pressure limits 75 mbar / 105 mbar* * Extended Pressure Range Option Max. flow @ 0 mbar ≥ 260 L/min Max. flow @ 60 mbar ≥ 130 L/min Generation of ventilation flow Blower (turbine) and proportional valve for flow regulation imtmedical ag...
  • Page 101 Maximum length Power cord set >3.0 m allowed DC power cable ≤3.0 m Sensor cable ≤3.0 m Sensor cable ≤3.0 m RJ45 LAN cable >3.0 m allowed USB cable ≤3.0 m bvBus cable ≤3.0 m Nursecall cable >3.0 m allowed Monitor cable ≤3.0 m PDMS Interface ≤3.0 m imtmedical ag...
  • Page 102 Response time <1 s < 3 s with 2 m Nomoline ≤ 90 ms rise time sampling line 10 – 90% of reading Sampling flow 50 mL/min Ambient operating For operation, bellavista specifications apply conditions imtmedical ag...
  • Page 103 (302.739.000) HFOT High Flow Only use with a special interface for oxygen therapy (e.g. nasal Oxygen Therapy cannula). Do not use nasal CPAP masks or prongs! Not available in the USA imtmedical ag...
  • Page 104    Insp HFOT Only use with a special interface for oxygen therapy (e.g. nasal cannula) and active nebulisation. NIV Non-invasive ventilation Invasive ventilation  Supported Not supported ¹ Available in Neonatal mode Only Adult Only neonates imtmedical ag...
  • Page 105 Respiratory phase during which the nebuliser is enabled Inspiration It is possible to enable the nebuliser for pure aerosol therapy even if Expiration ventilation has been stopped (on standby). Continuous Duration of nebulisation 5 – 60 min ∞ infinite imtmedical ag...
  • Page 106 Specifications 12.13 Noise generation Test conditions as per ISO 80601-2-12. bellavista 1000 und bellavista neo Acoustic power level LwA (dBA) Tidal volume Vt (mL) 1-tube system 2-tube system delivered 45.4 50.8 46.3 51.5 46.8 50.8 bellavista 1000 e Acoustic power level LwA (dBA)
  • Page 107 Endotracheal tubes / tracheostomy tubes • atory pressure: IPAP Diameter 2.5 – 12 mm • Only one of the two mode groups can • Pressure Limited Ventilation, pressure limitation with volume-controlled be enabled at the same time. ventilation (section “Volume-controlled breath”) imtmedical ag...
  • Page 108 Constant flow that is delivered to the patient. With HFOT (section “HFOT”) through nasal • cannula 2 – 80 L/min 1 – 60 L/min In flow-based nCPAP (section “nCPAP”) the • flow through the nasal interface is convert- n. a. 2 – 18 L/min ed to airway pressure. imtmedical ag...
  • Page 109 Insp (“Automatic pressure rise”) Maximum pressure at the end of the inflation 10 – 100 mbar 10 – 100 mbar n. a. phase in lung recruitment and measuring ma- noeuvre. P is maintained throughout T Recruit (Section “Lung Recruitment Tool”) imtmedical ag...
  • Page 110 Trigger Inspiratory flow for trigger activation (leak-com- Off / pressure / flow pensated) Pressure Pressure below PEEP for trigger activation 0.1 – 15 mbar Trigger Flow trigger Inspiratory flow for trigger activation (leak-com- 0.1 – 20 L/min pensated) imtmedical ag...
  • Page 111 ±1% abs. for oxygen concentration related measurements 12.15.2 Response time for oxygen adjustment Response time from 21% to 90% FiO according to ISO 80601-2-12. Volume Respond time 500 mL 98 seconds 150 mL 100 seconds 30 mL 96 seconds imtmedical ag...
  • Page 112 0 – 100 mbar ±(2 mbar + 4%) n. a. difference inflation and deflation in lung recruitment 0 – 2500 mL ±10% c LR and measuring manoeuvres (section “Lung Recruitment Tool”) dV = V (P) – (P) recorded versus Deflation VInflation imtmedical ag...
  • Page 113 With optional Neonatal module (not available in the USA) With optional Esophageal Pressure module With optional Auxiliary pressure option Paux Curve display Loop % of readings Absolute value + % of reading Available as curve in optional Real-time Trending imtmedical ag...
  • Page 114 A measure for potential overdistension 0 – 900 % LM t of the lung = ∆V / ∆P last 20%Vol Insp before Ppeak last 20%Vol Dynamic compliance 0 – 1000 mL/mbar LM t = Vt / (P – PEEP) insp End Insp imtmedical ag...
  • Page 115 0 – 250 L/min 0.001 ±0.5 L/min; ±10% ±0.12 L/min; ±10% ity see section: “Breathing circuit-de- pendent functions”) Leak-compensated minute volume of 0 – 250 L/min 0.001 ±0.5 L/min; ±10% ±0.12 L/min; ±10% EM t Spont spontaneous breaths (for availability see section: “Breathing circuit-depend- ent functions”) imtmedical ag...
  • Page 116 −50 – +100 mbar ±(2 mbar ±4%) TAExp (resistance compensated) Transalveolar plateau pressure −50 – +100 mbar ±(2 mbar ±4%) TAStat – P TAStat Plat esInsp Inspiratory transpulmonary pressure −50 – +100 mbar ±(2 mbar ±4%) TPInsp Expiratory transpulmonary pressure −50 – +100 mbar ±(2 mbar ±4%) TPExp imtmedical ag...
  • Page 117 Insp Target breaths Ratio of inspiratory time to duration of 0 – 100% Insp respiratory cycle: T / (T Insp Insp Time A Time in Dual Vent A 99 days Time B Time in Dual Vent B 99 days imtmedical ag...
  • Page 118 TV t Target Trapped Volume, volume trapped in 0 – 2500 mL ±10 mL; ±10% ±1 mL ±10% Trapped the lungs by AutoPEEP. It is meas- ured at the end of the expiratory Hold manoeuvre by automatic expiration up to PEEP level. imtmedical ag...
  • Page 119 Absolute value + % of reading Larger value: specified value; % of reading Only available with proximal flow measurement Based on the body weight entered on the patient info screen (Section “Index of applications”) Parameter is available in trending Upper limit Lower limit imtmedical ag...
  • Page 120 Absolute value Lower limit Locking with safety lock at 65 mbar Can be switched off for NIV breathing circuits after unlock e Only NIV Adjust the alarm settings to the patient and the ventilation to prevent inappropriate alarms. imtmedical ag...
  • Page 121 Specifications 12.19 Pneumatic block diagram Valve normally closed Valve normally open imtmedical ag...
  • Page 122 Specifications 12.20 Models accessories, consumables, spare parts bellavista 1000 bellavista 1000 neo * bellavista 1000 e * Description Adult/Paediatric/Neonatal Neonatal ventilator with Adult/Paediatric/Neonatal ventilator with accessories accessories ventilator with accessories Screen 13.3" Full HD 13.3" Full HD 17.3" Full HD 1920 × 1080 pixels 1920 × 1080 pixels 1920 ×...
  • Page 123 For information about bellavista accessories contact your local dealer or www.imt- medical.com. 12.20.3 Consumables For information about bellavista consumables contact your local dealer or www.imt- medical.com. 12.20.4 Spare parts For information about bellavista spare parts contact your local dealer or www.imt- medical.com. imtmedical ag...
  • Page 124 302.384.000 Russian 301.789.000 Swedish 304.528.000 Slovak 301.790.000 Thai 301.525.000 Turkish 302.467.000 Vietnamese 302.468.000 Chinese 301.520.000 User Manual for dual limb Adapter (EN/DE) 302.437.000 User Manual for External Blender (EN/DE) 301.558.000 User Manual for O  Filter and Water Trap (EN/DE) imtmedical ag...
  • Page 125 The CE mark indicates conformity with Directive 93/42/EEC Temperature range for storage and transport −20 – 50°C Humidity range for storage and transport 10 – 90 % RH, non-condensing Atmospheric pressure for storage and transport 500 – 1100 hPa ≅ 0 – 4000 m above sea level imtmedical ag...
  • Page 126 ESD warning label on sensitive devices that can be damaged by static The marked product is CSA-certified for the USA and Canada and it meets the applicable standards The rating plate provides technical information about bellavista and specific declarations and it serves to identify the device. imtmedical ag...
  • Page 128 The following changes to the network / data sharing system can lead to risks and thus require additional analyses. Changes to the network / data sharing system particularly include the following: • Changes in configuration • Connection of additional elements • Updates or upgrades of other devices imtmedical ag...
  • Page 129 “IMCO_2” “mmHg” 0.. 190 Flow “exPkFl” “L/min” 0.. 600 Exp Peak Flow “inPkFl” “L/min” 0.. 600 Insp Peak “I:E 1:” “” 0.1.. 99 Leak Flow “Leak” “L/min” 0.. 200 “SpMV” “L/min” 0.. 250 Exp Spont Insp Spont imtmedical ag...
  • Page 130 0.. 999 Sigh interv. “sSghR” “” 0.. 999 Sigh no. “sSghNr” “” 0.. 999 Alarm Limits Alarm setting Label etCO  High/Low “ETCO_2” inCO  High “IMCO_2”  High “FIO_2” MV High/Low “MV” High/Low “Ppeak” Peak Rate High/Low “AWRR” Vt High/Low “TV” imtmedical ag...
  • Page 131 113, 115 Pressure low Rate low Rate high Volume high Pressure high 170, 171, 172, 244, 245, 246, 281, 391 Capnography All other patient alarms with medium priority Patient alarm All other technical alarms with medium Ventilator priority imtmedical ag...
  • Page 132 = 2.05 × e^(0.02 × Height(cm)) IBW Adult Male 145 – 250 = Max(IBW Paediatric; 50 + 2.3 × (Height (cm) – 152.4) / 2.54) IBW Adult 145 – 250 = Max (IBW Paediatric; 45.5 + 2.3 × (Height Female (cm) – 152.4) / 2.54) imtmedical ag...
  • Page 133 Here the suggested ventilation settings are used as a basis instead of the current monitoring parameters. Alarm Autoset ± 7% FiO ± 35% MV MV = Rate × Vt Insp insp ± 5 mbar = PEEP + P Peak Peak Insp Rate ± 35% rate ± 35% Vt Insp imtmedical ag...
  • Page 134  This IBW range was used together with the AARC recommendations (4) for calculating Rate_Comp.  Neligan's suggestion (9) was used for bellavista.  For non-invasive ventilation 5 mbar was subtracted because no tube compensation is required. This procedure is widespread in clinical practice. imtmedical ag...
  • Page 135 (8b) Tassaux D et al, Impact of Expiratory Trigger Setting on Delayed Cycling and In- spiratory Muscle Workload, Am J Respir Crit Care Med Vol 172. pp 1283–1289, 2005 (9) Neligan P, Using Airway Pressure Release Ventilation, http://www.ccmtutorials. com/rs/mv/strategy/page14.htm, 2005 imtmedical ag...
  • Page 136 2. Turn off bellavista (press and release the power button, then wait for two seconds, then press and hold the power button until shutdown 3. Contact local technical support Please follow these instructions accordingly and provide a ventilation alternative be- fore disconnecting the patient from the ventilator. imtmedical ag...
  • Page 137 High leakage Patient system has a leak that is too large. Discon- Check breathing circuit, improve mask fit if neces- nection of the patient. sary. Only in the case of invasive ventilation: create or disable alarm in Configuration Assist. imtmedical ag...
  • Page 138 211 H Battery nearly flat, connect to Device running on battery with a life less than 10 Connect to power supply immediately. mains supply immediately. minutes. Ventilation can come to a halt at any time without further warning. imtmedical ag...
  • Page 139 – or if the internal device temperature exceeds 80°C. Any additional temperature rise can endanger the patient or damage bellavista. For this reason, ventilation stops and all the valves move to a safety position that permits spontaneous breathing. imtmedical ag...
  • Page 140 Check both measuring lines of the flow sensor. connected correctly wrong way round. 255 H 2 ×, NIV Proximal flow sensor not Flow sensor not connected completely or the Check both measuring lines of the flow sensor. connected correctly wrong way round. imtmedical ag...
  • Page 141 O  flow for more than 5 breaths. 273 H 2 × supply insufficient. O Oxygen concentration has dropped below the Supply more oxygen (increase flow or pressure, use suction concentration not alarm limit. shorter line). reached. imtmedical ag...
  • Page 142 Reference to the field of application of the sensor. Comply with the field of application. Acknowledge pulse oximeter. message. 286 I Observe additional dead Reference to the field of application of the sensor. Comply with the field of application. Acknowledge space of capnography. message. imtmedical ag...
  • Page 143 391 M 10 s Technical failure 391 - Gas sensor fault. Unplug gas sensor, wait 5 s and plug in again. If the Malfunction of gas sensor fault occurs again, notify the service technician. imtmedical ag...
  • Page 144 CISPR 11 including residential areas and those directly connected to a public power grid Harmonics according to IEC Class A which also supplies buildings used for 61000-3-2 residential purposes. Voltage fluctuations / flickers Fulfilled according to IEC 61000-3-3 imtmedical ag...
  • Page 145 For transmitters with a maximum rated output not included in the table above, the distance can be determined using the equation given in the respective column, where P is the maximum rated output of the transmitter in watts (W) according to the transmitter manufacturer. imtmedical ag...
  • Page 146 < 5% UT 5 s < 5% UT 5 s (> 95% dip) (> 95% dip) Power frequency magnetic fields 3 A/m 30 A/m (50/60Hz) according to IEC 61000-4-8 Note: UT is the AC mains voltage prior to application of the test level. imtmedical ag...
  • Page 147 If unusual performance characteristics are observed, additional measures may be necessary, such as a change in direction or placing bellavista at a different location. In the frequency range 150 kHz to 80 MHz the field strength should be less than 3 V/m. imtmedical ag...
  • Page 148 • Antistatic discharge by wrist strap and connection to the medical device or to earth. Connectors and pins that bear the ESD warning symbol must not be touched with the hand or a hand tool before the necessary safety measures have been taken. Otherwise the device may be damaged. imtmedical ag...
  • Page 149 Confirmation Selection of breathing circuit and patient type Ventilation settings Mode • Parameter • Connecting the patient, non-invasive Connecting to mask • Connecting the patient, invasive Connecting to tracheal cannula • Connecting to endotracheal tube • Start/stop ventilation imtmedical ag...
  • Page 150 Servicing and cleaning Topic Confirmation Cleaning Recommended cleaning agents • Cleaning the device • Cleaning the breathing circuit • Servicing Replacing the filter mats • Replacing the oxygen sensor • Replacing the fuse • 13.6.7 Trained personnel Name Function imtmedical ag...
  • Page 151 Hospital, institution Condition of use  Sale  Loan Place, date Signature of the person responsible at the hospital 13.6.8 Medical device consultant Name Function Medical device consultant Signature of the medical device consultant imtmedical ag...
  • Page 152 The expected life cycle of bellavista is 8 years, assuming the servicing operations are performed as specified by the man- ufacturer. We offer a shipping service for returning devices for repair. At http://easysend.imtmedical.com you will be taken through the shipping procedure. For returning equipment, please use the original packaging only.
  • Page 153 A patient air filter that is soiled or inappropriate can cause inadequate Patient air filter supply to the patient. Only use original bellavista air filters. Missing, incor- rect or soiled air filters can cause bellavista to become contaminated or overheated. imtmedical ag...
  • Page 154  21 vol %  ± 2 vol %  In the event of an error calibrate the O  sensor. The test can also be performed with the CITREX H5 and the imtmedical quick verification app. 13.8.3 Test alarm system Action Alarm Unplug power cable. Do not confirm Mains voltage failed (info) ...
  • Page 156 Bacterial filter Classification Cleaning Battery 23, Electronic nebuliser 32, Battery indicator 23, Clock Error beLevel Error messages bellavista 1000 ISA sidestream ESD warning symbol bellavista 1000e Esophageal pressure respiratory gas sensor 35, bellavista neo sensor Esophageal pressure monitoring beMode IRMA mainstream...
  • Page 157 V-A/C Philips IntelliBridge IRMA VC-SIMV Philips VueLink iVista Models Pneumatic block diagram Monitoring 44, 81, Pneumatic nebuliser 32, Curves Power plug set Parameter Pressure, flow Monitoring parameters Pressure Limited Ventilation Pressure rise automatic Pressure-supported breaths PTP/PTA 59, imtmedical ag...
  • Page 158 Spare parts 121, Specifications Ventilation 44, Start Standards Ventilation parameters Starting HFOT Ventilation settings Start screen 26, Ventilation Summary Settings Ventilator data Start-up Vent Summary Stopping ventilation Video display ventilation suction Supported ventilation modes Switching on Symbols Warnings imtmedical ag...
  • Page 160 Passwords for bellavista ventilator Default Patient Clinical clin Advanced Power password to override forgotten passwords: see Service Manual Service password: see Service Manual...
  • Page 164 . Gewerbestrasse 8 . 9470 Buchs . Switzerland T +41 81 750 66 99 . www.imtmedical.com...

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Bellavista neoBellavista 1000e

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