Product presentation :

1. Product presentation:

2. Paravent is a high-frequency jet ventilator aiming to complement conventional respirators in the clinical or critical situations hardly solvable by conventional means of ventilation (not to replace or compete with them) Primary advantages / distinguishing features from other respiratory products (HF ventilators as well as conventional ventilators) are: true advantages of high-frequency jet ventilation (higher oxygenation, no interference with spontaneous breathing, etc.) introduction of Inpulsion and Expulsion effects (lung lavage) ventilation of full weight and age spectrum of patients on the single ventilators (from neonatal to over-weight adults) ventilation over a longer distance (up to 10 – 11 m) possibility to ventilate more than two patients on single device Main goal of Paravent

3. Brief theoretical background of HFV There are critical clinical conditions (when not possible to ensure adequate alveolar ventilation with the use of the conventional ventilation or its modifications) thatrequire the resolve with the non-conventional ventilation methods. • Examples of such cases are: • Cases related to decrease of compliance of lungs and decrease of functional residual capacity (lungs fibrosis, aspiration pneumonia, advanced ARDS, obstruction of breathing motions, e.g. while backfilled by soil, other statuses characterised by limited chest movement) • Bilateraldisparity of mechanical characteristics of lungs and thorax (unilateral trauma of lungs and thorax, diaphragmatic hernia, bronchopleural fistula, alar pneumonia). • Cases with non-uniform mechanical characteristics of the same side of lungs (emphysema bulosum). • Cases when minimal pressure effects of artificial ventilation of lungs lead to heavy disorder of hemodynamics (cor pulmonale, natal heart defects, hypovolemia). • Extreme operative acts on trachea, bronchi or lungs. • Such clinical cases => cause an issue to secure the adequate alveolar ventilation using conventional approach. Appropriate resolve to the mentioned cases is • High-Frequency Ventilation

4. High Frequency Lung Ventilation (HFV) HFV is: • artificial lung ventilation where supra-physiologic frequencies of ventilation cycles are being used (frequencies exceeding 60 – 80 cycles/min; in compare, spontaneous breathing frequencies are 10 – 40 breaths/min in adults and up to 60/min in small children) • divided into several groups (according to frequencies and type of technology): 1. HFPPV (High frequency positive pressure ventilation), freq. from 60 to 200 b/min. 2. HFJV (High frequency jet ventilation), freq. applied: 80 – 600 b/min 3. HFO (High frequency oscillation), freq. exceeding 600 b/min. • High-Frequency Jet Ventilation (HFJV) has the most application modes at present. • The so called Czech and Slovak type of HFJV characterized by an original physical principle, original theory and technical solution is a special sub-unit in the specialty (invented by Mr. Ing. Ondrej Brychta, CSc.).

5. High-frequency jet ventilator • the latest in the PARAVENT line (Paravent P, PA, PAT) Improvements in the product: • possibility of ventilation frequency switching from conventional frequency to high-frequency (HF) • controlled electronically (mains feed or internal reserve power supply) • further possibility to work as pneumatic device • All features in a single device (used for neonatal and adult applications) • based on more than 20 years of experience and testing results of HFJV research on clinical and experimental working sites in Czech republic and Slovakia • Based on the concept of so called Multi-Nozzle Jet Injector (MNJI)

6. Multi-Nozzle Jet Injector (MNJI) • a set of different sizes of MNJIs (range 3mm up to 10mm in diameter) • ventilator performance change is given by adaptation of MNJIs to intubation cannules which are adapted to different patient sizes • consists of 3 inspiratory and 1 expiratory nozzles • each insufflation nozzle => different diameter => enable to change ventilator performance (Pgmax) in a 100% range by changing the insufflation hose connection site to particular chosen nozzles (I,II,III) without changing the driving pressure (PIN) The Set of MNJIs allows: • safe and comparableventilation of all weight and age spectrum of patients, including new-born babies (600 grams (premature babies) up to 140 kg (adults) • Application of the expulsion and inpulsion effects

9. Advantages of HFJV • Physiological and medical advantages: • non-interference with spontaneous ventilation • programmable movement of extraneous matters (Expulsion and Inpulsion mode) – cleaning of airways using HFJV (as a supplement to conventional long-term ventilation) • Expulsion and Inpulsion as a healing process for extraction of aspiration or little extraneous matter (e.g. dust, dirt) and application of pharmaceuticals (lavage) • decreases the volume of lung extra-vascular water • rising PEEP in ≈ 0,5 kPa = 5 cm H2O • lower Pawmax than in conventional ventilation (ca. 30%) • low risk of barotrauma • application in bronchopleural fistula (lower leak of gases) • slight increase of diuresis • not necessary to interrupt external cardiac massage (chest compressions) during CPR (for artificial inspirium) – improved transport of O2 and SpO2 • in cases of lung oedema, HFJV is sovereign method of ventilation support

10. Advantages of HFJV (cont.) • Technological advantages: • easy use and application (fast switch on and set up of patient) • application by non-invasive method (mask) – easy applicability – for paramedics as well • long-distance ventilation (up to 10 m by use of special kit) – crashes, disasters in mines, tunnels, blocked patient in a car wrack, etc. • ventilation while patient in anaesthesia in examinations in Nuclear magnetic resonant tunnels • crisis management (HFJV ensures at least minimal ventilation required for patient to survive even in the cases of compressed thorax and stomach, e.g. buried by ground) • trans-tracheal application – as a possibility (crisis management in ‘no intubation – no ventilation’ situations) • possibility to use single ventilator for ventilation of patient from weight range from 600 g up to 150 kg • possibility of selective bi-bronchial ventilation

11. Advantages of HFJV (cont.) • Technological advantages: • possibility of urgent ventilation of two patients at the same time with single unit – e.g. in transportation • ventilation during bronchoscopics, bronchographics, including extraction of contrast media (filling) at the end of bronchgraphics • application of healing aerosol, also during ventilation by mask (nebulizer) • use in special applications – ventilation in contaminated space, e.g. by chemicals or gas, etc. • catheter ventilation in surgery of airways • prevention of aspiration in use of unsealed (uncuffed) endotracheal tube • use in emergency vehicles – use by paramedics or doctors in emergency rescue systems • easy and fast application in natural disasters and mass accidents • Paravent contains limiter of maximal pressure in airways - „total stop“

12. Points to consider for HFJV • higher demand for experience in long application in ICU • necessity of proper training of paramedics and doctors (users) • issues with humidifying (Paravent is mostly used for short-term high-frequency jet ventilation – without humidifying, or for longer-term application by the use of mask) • long-term applications – require special humidifying system • in non-adequate application – e.g. with the use of non-original components – risk of barotraumas is high (use only with original components) • swift changes of blood gases - hypocapnia • possibility of monitoring of MV (minute volume) and VT (tidal volume) (only approximation) • in non-adequate application of Expulsion or Inpulsion modes – flush out of surfactant and creation of yatrogenous ARDS • necessity of monitoring Paw (Pt) • occasional issues with sealing of mask on patient’s face (e.g. moustache, anodontia, deformations, trauma) in HFJV by mask • HFJV is absolutely contraindicated in severe astma, or other cases with serious bronchospasm

13. Application ranges& users

14. 1. Ventilation in critical cases model -urgent ventilation Target Users: Emergency Medical Service (EMS), Cardio Pulmonary Resuscitation (CPR), Delivery Room, Rescuers, standby ventilation in the case of electric current damp or ventilator failure in the critical care unit etc. - generally in cases that requireinstantaneous support • Important advantages: • acknowledged contribution of HFJV as such • simplicity and safety of operations with Paravent (performance determined by the selection of the suitable endotrachael tube (ETT) and corresponding MNJI and corresponds with the weight category of the patient) • minimized personnel attendance in ventilator set-up • also advantageous ventilation with untight ETT

15. 2. Transportation Target Users: Primary transportation requiring ventilation support: EMS Secondary transportation:Critical Care Unit (CCU), Intensive Care Unit (ICU), Pathological New-born Unit (PNU) (secondary transportation including inside oneroentgenology, computer tomography examination, operating theatre, etc.) • Important advantages: • as mentioned earlier • the possibility of spontaneous ventilation, respectively hard ventilation with superposition of HFJV on spontaneous breathing • patient’s depression and dependency on ventilator is decreased • non-existence of interference with ventilator • brings down the necessity of intubation and relaxation

16. Two Patients Ventilation Before and During a Transport • One of the obvious problems of premature twins transport -> ventilation with two ventilators needed • => simple and efficient resolve by HFJV / Paravent • possibility to ventilate premature twins as well as two adults (similarly sized as well as from two different weight categories, e.g. 12 kg child and 80 kg adult) Paravent ventilators are the only mass produced ventilators enabling differentiated ventilation of more than one patients at once, suitable for transport and resuscitation ventilation.

17. 3. Airways cleaning / lavage of lungs / Tracheo-bronchial Toilette Target Users: CCU, delivery room, PNU, ICU during conventational ventilation for lavage, mucolytics instalation, suction etc. Of significant use the possibility of longer manipulation in the airways without necessity to interrupt ventilation especially in the case of limiting hypoxy status • Important advantages: • possibility of realization of inpulsion and expulsion mode of HFJV during conventional ventilation - predominant contributions of HFJV for clinical practice • Inpulsion mode • - for application of mukolytics, therapeutic aerosols, local anaesthetics, catecholamines etc. with the use of lavage valve • Expulsion mode • - for mobilization / extraction of expectorations, foreign body (dirt, vomit, etc.) or other obstructions from distal part of breathing ways (accumulated at ET tube from where drained without traumatization of mucous => very good results in chronic obstructive bronchopulmonal disease, massive aspiration, atelectation -> significantly reduced time need for ventilation, lower mortality of critical care patients

18. Example of inpulsion and expulsion modes

19. 4. Critical care and intensive care model -Resuscitation and intensive care Target Users: Critical Care Unit (CCU), Intensive Care Unit (ICU), Pathological New-born Unit (PNU) or Pediatric ICU (PICU) • Important advantages: • airways ventilation analog to periodical respiration „ambuing“ • short-term hyperventilation in the case of intracranial hypertension with significant decreasing of intracranial pressure • certain hypoxy status cases not reacting to conventional ventilation manoeuvres • replacing of ventilators and breathing circuits, etc.

20. 5. Mask ventilation model (Non-invasive HFJV Ventilation) • Target Users: • Critical Care Unit (CCU), Intensive Care Unit (ICU), Pathological New-born Unit (PNU) • in clinical practice, HFJV-M is a nearly ideal way to solve ventilatory problems in cardiac and non-cardiac lung edema, used in cases of re–curarisation in the post-operative period, in chest trauma, partial respiratory insufficiency, replacing of ventilators and breathing circuits, airways ventilation analog to periodical respiration „ambuing“, certain hypoxy status cases not reacting to conventional ventilation manoeuvres, etc. • Important advantages: • a noninvasive ventilatory support • quick application and low aggressivity => no need for sedation or anaesthesia for intubation • doesn’t interfere with spontaneous breathing (doesn’t exclude patient’s cooperation) • HFJV-M significantly decreases ventilation work => crucial in any acute respiratory failure situations

21. Example of connection of MNJI to face-mask for HFJVM application

22. 6. Bronchoscopy / Jet relief bronchography Target Users: Critical Care Unit (CCU), Intensive Care Unit (ICU), Pathological New-born Unit (PNU), Roentgenology • Bronchoscopy • modification of bronchoscope in a way that MNJI is attached to the proximal end of the tubus (ventilation during the whole procedure) • intubation using a thinner ET tube (size 4-5) without a cuff (enough space for flexible bronchoscope) • intubation with larger ET tube and MNJI -> flexible bronchoscope introduced through MNJI and ET tube into the bronchial tree • Jet relief bronchography • instillation of contrast substance (radio–opaque medium) via inpulsion mode (create fine relief filling of airways) • Important advantages: • minimizes amount of the instilled contrast substance and possible complications • lavage possibility in inpulsion and expulsion modes

23. 7. Special applications in otolaryngologic and thorax surgery • Bi-bronchial or selective synchronous lungs ventilation • there is a wide range of lung pathologies affecting lungs unilaterally (pneumonia, contusion, haematoma etc.) => require selective lung ventilation the way that healthy and impaired lungs will be ventilated differently in accordance with their actual status • possibility of selective ventilation of particular bronchi during broncho-pulmonary surgery • For otolaryngologic surgery in the larynx area with specially adapted ventilation instrumentation for the subglottic and supraglottic ventilation. • cleanliness of the operational area • comfort of operator and patient • increases ventilation safety during the action • For special lung surgery possibility of synchronous selective ventilation for operations for open bronchus, lung resection, etc.

24. 8. HFJV during special examination in Nuclear magnetic resonant tunnels The ventilation issue: all parts of ventilation circuit must be non-magnetic (ventilation with ventilation tubes long as much as 10m) HFJV by Paravent ventilator offers an effective resolve by use of 10 – 11 m long hose and MNJI (non-magnetic) without the risk of significant change of parameters of the fictive circuit

25. 9. Other special applications (examples of critical cases) • Application after being landed-up, in Cases of Decreased Compliance of the Rib-cage, in Ichtyosis, etc. • Ventilation of patients unable to breathe because of extreme pressure applied to their thorax and abdomen (application of conventional ventilation in these situations ineffective (no space for chest and diaphragm movements) • HFJV proves very effective, ensures satisfactory gas exchange in majority of cases enabling bringing off the victim • Solution in Upper Airways Critical Obstruction • gain life saving time necessary for the preparation of a proper tracheostomy or other intervention • as an alternative solution in extreme emergency cases, an application of a special bi-lumen needle advanced into trachea with following trans-tracheal HFJV

26. 9. Other special applications (examples of critical cases) • HFJV application in Extraordinary Situations • HFJV by specially adapted Paravent ventilators (according to customers’ requirements) can be applied in extraordinary situations such: • mass accidents • blasts in chemical factories, air contamination, military attack (via face mask or intubation - apply neutralizing or therapeutic solutions after toxic, corrosive (e.g. chlorine) or hot gas inhalation • “remote” ventilation mode in patients trapped in narrow shafts (ventilation by 10-11 m long connecting tubes) • Important advantages: • simple to use, attended by paramedics or emergency medical technicians when trained in intubation or who can handle ventilation in transported patients previously intubated by a physician

27. Contribution of Paravent ventilatorsin the Clinical Practice Conclusion for Paravent ventilator: • a simple ventilator dedicated for artificial lung ventilation in emergency medical service, short-term use in patient transport between wards, operating theatres and cardiopulmonary resuscitation or longer-term, non-invasive use by face-mask (possibility of longer-term use with a need of humidification) • allows a possibility to use it in all age and weight groups (capable to ventilate children with body weight of 600g and adults up 150 kg of body weight) • introduces the inpulsion and expulsion effects and resulting applications (lavage, move out mobile bodies - foreign bodies, mucus, aspirate, etc.) • ………

28. ???Please ask any of your questions.Thank you for your attention. Contact:Kalas, s.r.o.Tel.: +421 907 066623E-mail: info@kalas.skWeb: www.kalas.sk