The document describes the Leoni series of neonatal and pediatric ventilators produced by Heinen + Löwenstein GmbH. It provides details on the operation, specifications, ventilation modes, settings, components, accessories, and total system of the Leoni plus, Leoni 2, and Leoni mobil ventilators. High-frequency oscillatory ventilation is discussed as an option for treatment of lung diseases with reduced compliance.

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2. Leoni Ventilators Leoni mobil Leoni 2 Leoni plus

3. Mode of Operation The Leoni neonatal and pediatric ventilator functions according to the constant flow generator principle . A constant gas flow of mixed Oxygen/Air is delivered to the patient via a hose system. The desired concentration of the inhaled gas mixture is produced by a valve bank . During the inspiration phase, the expiratory valve on the end of the hose system is closed, so that the flow must go towards the patient . Exhalation is effected by opening the expiratory valve. The lung then deflates due to the pressure decrease .

4. Specifications x x Lopps: F/P, V/P, F/V x x Curves: Pressure / Volume / Flow x Curves: Pressure x x Volume trigger x Touch screen, removeable x TFT Colour screen x x LCD Display x x x Integrated battery x x x VIVE x x x Electronic gas blender x x x O 2 Monitor Leoni plus Leoni 2 Leoni mobil

5. Ventilation modes x x x Manual Ventilatory Drive x Volume Guarantee x x Volume Limit x HFOV x x SIMV - PSV x x SIPPV - PSV x x SIMV x x SIPPV x x x IPPV x x x CPAP Leoni plus Leoni 2 Leoni mobil

6. Leoni plus Ventilation modes  CPAP  IPPV / IMV  SIPPV  SIMV  PSV SIPPV PSV SIMV HFOV

7. CPAP Ventilation mode  Demand-CPAP  With support frequency

8. IMV/IPPV Ventilation mode  IMV

9. IPPV Ventilation mode  I PPV

10. SIPPV Ventilation mode  Leakage com- pensated volume trigge- ring  Trigger sensi- tivity related to VTi (5 – 30 %)

11. SIMV Ventilation mode  Leakage com- pensated volume triggering

12. PSV Ventilation mode  PSV SIPPV  PSV SIMV

13. HFOV Ventilation mode  HFOV on the membrane prin- ciple with recruit- ment breath function

14. Setting ranges IPPV/ IMV SIMV SIPPV CPAP Breath rate FREQUENCY [BPM] 6 .. 200 2 .. 100 2 .. 100 - Inspiration time I-TIME [sec] 0.10 .. 2.00 0.10 .. 2.00 0.10 .. 2.00 - Expiration time E-time [sec] 0.20 .. 10.00 0.50 .. 30.00 0.20 .. 30.00 - Inspiratory Flow INSP FLOW [l/min] 1 .. 32 1 .. 32 1 .. 32 - Expiratory Flow E Flow [l/min] 2 .. 10 2 .. 10 2 .. 10 -

15. Setting ranges IPPV/ IMV SIMV SIPPV CPAP Inspiratory Pressure P INSP [cmH2O] 6 .. 60 6 .. 60 6 .. 60 - Backup Pressure P-BACK [cmH2O] - - - 6 .. 60 Positive End Expiratory Pressure PEEP [cmH2O] 0 .. 20 0 .. 20 0 .. 20 - CPAP [cmH2O] - - - 1 .. 20

16. Setting ranges IPPV/ IMV SIMV SIPPV CPAP O 2 Concentration OXYGEN [%] 21 .. 100 21 .. 100 21 .. 100 21 .. 100 O 2 Concentration Oxygen flush O2-Flush [%] 23 .. 100 23 .. 100 23 .. 100 23 .. 100 Volume trigger TRIGGER [% VTi] - 10 .. 30 10 .. 30 -

17. Setting ranges HFOV Mean Pressure Pmean [cmH2O] 10 .. 30 High Frequency HFFreq [Hz] 5 .. 20 High Frequency Amplitude HFAmpl [cmH2O] 5 .. 80 Recruitment Frequency FreqRec [1/min] 0 .. 10 Recruitment Inspiration Time TI Rec [s] 0.1 .. 3

18. Casing front Control Panel Touch Screen Rotary Pulse Encoder Inspiratory Connection Expiratory Connection Pressure Gauge Connection HFOV- Connection 2 1 3 5 7 6 4

19. Casing rear Earth Connection Serial Interface Ethernet Connection Flow Sensor Connection Oxygen Connection O 2 Sensor Access Compressed Air Connection Mains Connection Nurse Call 3 2 1 9 5 6 7 8 4

20. Accessories Proximal Pressure Line Expiration Hose Inspiration Hose Y-Piece Flow Sensor Test Lung Flow Sensor Cable HFOV Hose with Filter 8

21. Control panel  Mode / Home  Loops  Curves  Alarm Limits  Power Failure LED  Battery Operation LED  Alarm LED  Alarm Mute Button  StandBy  Manual Ventilatory Drive  Rotary Encoder  ON/OFF  Start Ventilation  Numerical Values Switch-Over

22. Start Screen Flow Sensor Flow Sensor Calibration Oxygen Sensor Calibration Main Menu Bar Calibration Button

23. Main Sreen Alarm Bar Curves Softkeys Numerical Values

24. Curve Display Flow Curve Pressure Curve Volume Curve Curves freely scalable 3 Curves at the same time

25. Loop Screen Flow over Pressure Flow over Volume Volume over Pressure Full-screen presentation possible Loops freely scalable Up to 3 loops at the same time

26. Alarm limits Manual Adjustment Autoset Adjustment Alarm Logbook Function

27. Simultaneous Presentation Simultaneous Presentation of: Loops Curve Screen Alarm Limits Monitoring

28. HFO Leoni plus High-frequency ventilation (HFV) as a ventilatory therapy has reached increasing clinical application over the past ten years. The term comprises several methods. High-frequency jet ventilation must be differentiated from high-frequency oscillatory ventilation (HFOV or HFO). In this booklet I concentrate on high-frequency oscillatory ventilation. Therefore, the difference in meaning notwithstanding, I use both acronyms, HFV and HFO, interchangeably.

29. Indications for HFV Since the early eighties results on oscillatory ventilation have been published in numerous case reports and studies. Yet there are only few controlled studies based on large numbers of patients. In newborns HFV has first been employed as a rescue treatment. The goal of this type of ventilation is to improve gas exchange and at the same time reduce pulmonary barotrauma. Oscillatory ventilation can be tried when conventional ventilation fails, or when barotrauma has already occurred or is imminent. In the first place this applies to pulmonary diseases with reduced compliance. The efficacy of HFV for these indications has been proven in the majority of clinical studies. In severe lung failure, HFV was a feasible alternative to ECMO When to switch from conventional ventilation to HFV must certainly be decided by the clinician in charge, according to their experience. Some centres meanwhile apply HFV as a primary treatment for RDS in the scope of studies. Likewise, in cases of congenital hernia and during surgical correction, HFV has been successfully used as a primary treatment

30. Indications; HFV+IMV Also in different kinds of surgery, especially in the region of the larynx and the trachea, HFV has proven its worth. Moreover, in primary pulmonary hypertension of the newborn HFV can improve oxygenation and Ventilation. Always observing the contraindications in our NICU we follow this proven procedure: If conventional ventilation* fails, we will switch over to HFV. We will assume failure of conventional ventilation, if maintaining adequate blood gas tensions (pO2 > 50mmHg, SaO2 > 90%; pCO2 < 55 to 65 mmHg) requires peak inspiratory pressures (PIP) in excess of certain limits. Those depend on gestational age and bodyweight: In small prematures we consider using HFV at PIP higher than 22 mbar. With PIP going beyond 25 mbar we regard HFV even as a necessity. In more mature infants the pressure limits are somewhat higher

31. Combining HFV and IMV, and sustained inflation Oscillatory ventilation on its own can be used in the CPAP mode, or with superimposed IMV strokes, usually at a rate of 3 to 5 strokes per minute. The benefit of the IMV breaths is probably due to the opening of uninflated lung units to achieve further ‘volume recruitment’. Sometimes very long inspiratory times (15 to 30 s) are suggested for these sustained inflations (SI). By applying them about every 20 minutes compliance and oxygenation have been improved and atelectases prevented.

32. Combining HFV and IMV, and sustained inflation Especially after volume loss by deflation during suctioning the lung soon can be reopened with a sustained inflation. However, whether these inflation manoeuvres should be employed routinely is subject of controversial discussions. In most of the clinical studies no sustained inflations were applied. In animal trials no increased incidence of barotrauma was found. Prevention of atelectases, which might occur under HFV with insufficient MAP, is the primary benefit of combining HFV and IMV. HFV superimposed to a normal IMV can markedly improve CO2 washout (‘flushing the deadspace’ by HFV) at lower peak pressures

33. Indications; HFV+IMV Effect of a sigh manoeuvres through sustained inflation (SI): prior to the SI the intrapulmonary volume equals V1 at the MAP level (point a); the SI manoeuvres temporarily increases pressure and lung volume according to the pressure-volume curve; when the pressure has returned to the previous MAP level, pulmonary volume remains on a higher level, V2 (point b), because the decrease in pressure occurred on the expiratory limb of the PV loop. Pressure Volume

34. Standard Accessories Hose system, heated and non-heated Flow Sensor / Y-Piece / Connecting cable Expiration valve / Expiration membrane Oxygen cell HFOV Hose

35. Total System

36. Thank you very much for your open interest Heinen + Löwenstein GmbH Arzbacher Straße 80 D-56130 Bad Ems Tel. +49 (0) 2603 9600-0 Fax +49 (0) 2603 960050 www.hul.de