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PRESENTS:

OPERATIONAL MANUAL FOR THE TRANS RESPIRATOR® F00038-2

FOR LUNG RECRUITMENT (TLR™) AND MAINTENANCE


2 GENERAL OR MASS CASUALTY MILITARY/CIVIL PULMONARY VENTILATOR F00038-2 NOTE: Special Military device specs may vary.

THE ENCAPSULATED TRANS RESPIRATOR® SINUSOIDAL BRONCHOTRON CLAIMS ARE: A PNEUMATIC "FLOW-TIME" CONTROLLED LUNG STABILIZATION PERCUSSIONATOR® WITH THERAPEUTIC LUNG RECRUITMENT (TLR™), AS WELL AS ACCESSORY MONITORING, WHICH ARE CONTAINED WITHIN A HIGH IMPACT, CLOSABLE HOUSING. A TIME-PROVEN COMBINED SINUSOIDAL BRONCHOTRON PERCUSSIONATOR® WITH OD-CPAP LUNG STABILIZATION AND THERAPEUTIC LUNG RECRUITMENT, ALLOWING CIVIL OR MILITARY CARDIOPULMONARY CLINICIANS TO VENTILATE ANY NEONATAL, PEDIATRIC or ADULT LUNG CAPABLE OF BEING MECHANICALLY VENTILATED INVASIVELY OR NON-INVASIVELY, DURING LAND, SEA, OR AIR TRANSPORT AND/OR FOR LONG TERM CRITICAL CARE VENTILATION.

A pulmonary ventilator independent of any electrical source, using available conventional air/oxygen supplies to power the ventilator and ventilate the patient with a proven reliability “equal to or better than” any existing pulmonary ventilatory device. 1. Powered by any remote source of a 50- 80 psi respiratory gas, which is then internally regulated to OPERATIONAL GAS PRESSURES from 30 psig for Neonates, 35 psig for Pediatrics and 40 psig for Adults, as well as 45 psig for patients with extremely low pulmonary compliance. 2. Scheduling allows mechanical ventilation through invasive or non-invasive airways, providing for patient assist/control “Oscillatory Demand CPAP” with Sinusoidal Therapeutic Lung Recruitment (TLR) while allowing spontaneous breathe through. 3. A convective “Flow-Time Cycled Percussive Pressure Limited Ventilator” with selectable Inspiratory and Expiratory Time (I/E ratios) for sinusoidal HFOV programming. Lung recruitment is determined by scheduled Therapeutic Lung Recruitment (TLR) intervals. 4. A higher frequency INTRAPULMONARY PERCUSSIVE VENTILATOR (IPV) with simultaneous therapeutic endobronchial aerosol delivery for endobronchial secretion mobilization and clearance, enhancing airway recruitment and maintenance.


3 5. A universal, easy to program therapeutic lung recruitment ventilator with OSCILLATORY DEMAND CPAP combinable with SINUSOIDAL PERCUSSIVE OSCILLATORY VENTILATION (HFPV), for ventilating Neonatal through Pediatric to large Adult patients with extremely “congested lungs.” 6. By combining OSCILLATORY DEMAND CPAP for mechanical endobronchial gas mixing and lung stabilization directed toward PaO2 management, with a periodic sinusoidal HIGHER FREQUENCY OSCILLATORY CONVECTION interval, “a balanced invasive or non-invasive critical care ventilatory scheduling is programmed” while maintaining a "lung protective strategy." NOTE: THE TRANS RESPIRATOR® USES A SINUSOIDAL BRONCHOTRON® F00038-1 COMBINED WITH A UNIVERSAL MONITRON® F00007-B ENCAPSULATED WITHIN A MILITARY-TYPE CLOSING CASE.

THE UNIVERSAL MONITRON® MODEL F00007-B The Universal Monitron® provides for a straightforward, independent visual/aural source of respirator/Percussionator® trending, beyond normal one on one clinical surveillance.


4 The Monitron® is totally independent of respirator/Percussionator® functions, and any display failure within the Monitron® has no effect upon the host device.

The Universal Monitron provides: •

A near instantaneous digital read out of effective cycling frequency.

Digital presentation of proximal airway pressure rise and mean.

Aural alarming for failure to maintain a proximal airway pressure rise.

An educational means of demonstrating unique programmable functions.

INTERFACING THE UNIVERSAL MONITRON® WITH THE PERCUSSIONAIRE® RESPIRATOR/PERCUSSIONATORS® Located on the back-side of the Monitron® is a RED service socket which receives proximal airway pressures from the RED service socket of the host device. Special red interfacing tubing is contained in the accessory kit shipped with the Universal Monitron®. Normally, the Universal Monitron® is installed on the stand post below the host device, using supplied post brackets. Interconnect the Universal Monitron® and the Percussionator® host device red service sockets to servo the Universal Monitron®. The Frequency Counter can be activated by depressing the “Push to Start” button. Each activation will result is an approximate five minute display period. The Disconnect Aural Alarm is activated by the manual ON/OFF Switch. Failure to turn the switch off upon purposeful disconnect will result in an aural alarming. This device is powered by standard internal batteries: AA batteries for the Frequency Counter, and a 9 volt battery for the disconnect alarm. Both batteries can be changed by a Biomed Technician: Remove and set aside the four 6x32 screws and nylon washers from the front panel. Carefully slide the panel forward. This provides access to the battery clips. Remove the battery(s) and recycle according to local laws. Replace with fresh batteries and slide the panel back into position and secure with the four 6x32 screws and nylon washers.


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OF CLINICAL INTEREST All Percussionator® devices conceived by Dr. F.M. Bird employ his concept of “balanced respiration.” That is, the Percussionator® devices are “indexed to the patient” by the selection of an Operational Pressure. Then, with the Arrows on the appropriate control knobs under their 12:00 indexes, a starting schedule is established. If trend analysis demonstrates increased Oxygen uptake requirements, gradually rotate the appropriate control knob counterclockwise for increased intrapulmonary diffusion. If Carbon Dioxide retention is observed, gradually rotate the appropriate control knob clockwise to increase convection for CO2 washout. Clinical experience with each device will allow increasing clinical efficacy through learning to balance diffusion against convection. The Universal Monitron® was not conceived as a programming device to establish a specific ventilatory program for any cardiopulmonary patient requiring mechanical respiratory support. Consult the Clinical Manuals for each specific host ventilatory device. Percussionaire® technical services can advise special programming features for specific Percussionaire® Percussionators®.

THE SINUSOIDAL BRONCHOTRON PERCUSSIONATOR® MODEL F00038-1


6 ALL CINICAL PROVISIONS FOR THE SINUSOIDAL BRONCHOTRON F00038-1 ARE THE SAME FOR THE TRANS RESPIRATOR® Model F00038-2

SUGGESTED NEONATAL/PEDIATRIC INVASIVE OR NON INVASIVE PROGRAMMING OF THE SINUSOIDAL BRONCHOTRON® F00038-1 1. Interconnect the Sinusoidal Bronchotron® to a 50-80 psig source of a respiratory gas supply.

WARNING- Do not attach Sinusoidal Bronchotron to a free flow Oxygen therapy regulator.

Note: If desired, the Breathing Circuit can be isolated by filters on the Nebulizer Inlet and the Phasitron® outlet. NOTE: Starting FiO2 will be judged by available blood/gas studies and/or clinical observation. 2. Interconnect NEONATAL RESPIRATORY BREATHING CIRCUIT A50209-A with green Percussionator® body and three channel interfacing harness with (white, yellow and red) tubings to the Sinusoidal Bronchotron® service sockets. 3. Program Sinusoidal Bronchotron for Neonatal use: A. Rotate black OPERATIONAL PRESSURE control knob full (counterclockwise) OFF. B. Rotate black INSPIRATORY and EXPIRATORY TIME control knob Arrows under their 12:00 Indexes. C. Rotate green PULSATILE FLOWRATE control knob Arrow full (clockwise) OFF. D. Rotate grey PULSE FREQUENCY control knob Arrow under the 12:00 Index. E. Rotate green OSCILLATORY CPAP control knob Arrow under the 12:00 Index. F. Toggle Nebulizer switch up to the ON position. Note: use normal Saline or prescribed medications in Nebulizer. See Section on The Nature and Action of Topical COPD Aerosols. G. Activate (turn on) 50-80 psi OPERATIONAL GAS SOURCE. H. Rotate black OPERATIONAL PRESSURE REGULATOR control knob (clockwise) until 30 psig is read on OPERATIONAL PRESSURE monitoring gauge.


7 OBSERVE: The Sinusoidal Bronchotron will start cycling with Aerosol delivery from the Nebulizer. CONNECT PHASITRON OUTLET DIRECTLY TO FACE MASK and/or invasive or non-invasive INDWELLING AIRWAY CATHETER (do not add dead space) as follows: I. Make invasive or non-invasive Patient AIRWAY CONNECTION. Then start rotating (adjusting) the OSCILLATORY CPAP control knob Arrow (counterclockwise or clockwise) until the entire bilateral chest is observed to be shaking (oscillating) from PERCUSSIVE OSCILLATION. For additional LUNG RECRUITMENT1. If PaO2 is low: a. If PaO2 is low, increase the OSCILATORY FREQUENCY to increase diffusive LUNG VENTILATION. b. Then gradually rotate the OCLILATORY CPAP control knob Arrow (counterclockwise) to increase intrapulmonary gas mixing. NOTE: If the OSCILLATORY CPAP control knob Arrow is rotated full (counterclockwise) without lung recruitment, increase OPERATIONAL PRESSURE by very gradually, rotating the black OPERATIONAL PRESSURE control knob Arrow (clockwise) until the desired peak oscillatory pressure is reached. Don’t select OPERATIONAL PRESSURES of over 40 psig. c. To still further increase LUNG RECRUITMENT gradually rotate the INSPIRATORY TIME control knob Arrow (I) (counterclockwise) to increase the peak sinusoidal oscillation interval time. 2. IF PaCO2 is elevated: a. If PaCO2 is high, decrease the OSCILLATORY FREQUENCY by gradually rotating the control knob Arrow (clockwise) to increase Intrapulmonary convective gas exchange. b. Then gradually rotate the PULSATILE FLOWRATE control knob Arrow (counterclockwise) for increasing CO2 “wash out”. c. To still further increase CO2 “wash out” rotate the EXPIRATORY (E) TIME control knob Arrow (clockwise) to create increased convective intrapulmonary gas exchange.


8 Unless the Neonate’s vital parameters and respiration is monitored, a one to one Clinician - Patient observation must be maintained. When making functional setting changes, beyond initial scheduling, allow time for setting change trends before entering next schedule change. DON’T CHASE KNOB SETTINGS. Note: The Neonatal Breathing Circuit has a Nebulizer that can be used without an internal float and/or an internal float that allows an IV bag of normal saline to be attached to keep the nebulizer automatically refilled.

SUGGESTED BRIEF INITIATING OPERATIONAL CHECK LIST SCHEDULING FOR LARGE PEDIATRIC OR ADULT PATIENTS, USING THE SINUSOIDAL BRONCHOTRON F00038-1 1. Connect to a reliable 50-80 psig respiratory gas source. 2. Set up Breathing Circuit with a yellow Phasitron Body breathing circuit. The white yellow and red interfacing tubing Bayonets must be twist locked into their color coded Sinusoidal Bronchotron Service sockets. Do not insert any Green tubing Bayonet into Green Service Socket. 3. Service Nebulizer with medication or set up automatic IV refill using Saline. See Section on The Nature and Action of Topical COPD Aerosols. 4. Rotate green PULSATILE FLOWRATE control knob Arrow full (clockwise) OFF. 5. Rotate all four remaining control knob Arrows under their 12:00 indexes. 6. Toggle Nebulizer switch up (ON). 7. Activate OPERATIONAL GAS SOURCE (turn ON). 8. Select OPERATIONAL PRESSURE. Neonatal- 20 psig. Pediatric- 30 psig. Adult40 psig. LOW COMPLIANCE LUNG- 45 psig. 9. Make invasive or non-invasive Patient AIRWAY CONNECTION. Do not add mechanical dead space 10. Then start rotating (adjusting) the OSCILLATORY CPAP control knob Arrow (LEFT or RIGHT) until the entire chest is observed to be shaking (oscillating) from a PERCUSSIVE SINOUSOIDAL WAVE FORMAT scheduling. 11. For additional LUNG RECRUITMENT- Gradually rotate the PULSATILE FLOWRATE control knob Arrow (counterclockwise) for periodic cyclic sinusoidal peak pressure increases.


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12. For very stiff lungs, Operational Pressures can be progressively increased upward, toward 45 psig to increase peak Sub Tidal volume delivery pressures (PIP). 13. If PaO2 is low, gradually increase PULSE FREQUENCY by a (counterclockwise) rotation of the control knob Arrow. 14. PaO2 can be further controlled by selectively increasing the INSPIRATORY TIME interval (I) by rotating the control knob Arrow (counterclockwise) to lengthen the DIFFUSIVE Oscillatory Demand CPAP interval. 15. If PaCO2 is high, gradually decrease PULSE FREQUENCY by a (clockwise) rotation of the control knob Arrow. 16. PaCO2 can be further controlled by selectively decreasing the EXPIRATORY interval TIME by rotating the EXPIRATORY TIME (E) control knob Arrow (clockwise) to shorten the period of percussive baseline oscillation. 17. Patients can at any time spontaneously breathe through any existing LUNG RECRUITMENT or MAINTENANCE schedules. 18. The same contraindications of all positive pressure mechanical lung ventilators apply.


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LIMITED WARRANTY Model No:________________________________________ Serial No:___________________________________________ Purchased By: _______________________________________ (name of purchaser or company)

Date:____________________________

The products of Percussionaire® Corporation are warranted, for a period of one year from date of purchase, to be free from defects in materials and workmanship and to meet the published specifications. THE FOREGOING IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, except as to title, and can be amended only in writing by a duly authorized representative of Percussionaire® Corporation. The liability under this warranty is limited solely to replacing, repairing or issuing credit, at the discretion of Percussionaire® Corporation, for the parts that become defective or fail to meet published specifications during the warranty period; provided that, Percussionaire® Corporation will not be liable under this warranty unless (I) Percussionaire® Corporation is promptly notified in writing by Buyer upon discovery of defects or failure to meet specifications; (II) the defective unit or part is returned to Percussionaire® Corporation, transportation charges prepaid by Buyer; (III) the defective unit or part is received by Percussionaire® Corporation for adjustment no later than four weeks following the last day of the warranty period; and (IV) Percussionaire® Corporation's examination of such unit or part shall disclose, to its satisfaction, that such defects or failures have not been caused by misuse, neglect, improper installation, unauthorized repair or alteration or accident. Any authorization of Percussionaire® Corporation for repair or alteration by the Buyer must be in writing to prevent voiding warranty. In no event shall Percussionaire® Corporation be liable to Buyer for loss of profits, loss of use, consequential damages or damages of any kind based upon a claim for breach of warranty, other than the purchase price of any defective product covered hereunder. Percussionaire® Corporation warranties as hereinabove set forth shall not be enlarged, diminished or affected by, and no obligation or liability shall arise or grow out of the rendering of technical advice or service by Percussionaire® Corporation or its agents in connection with Buyer's order or the products furnished hereunder. PLEASE NOTE: In the event operation of a Percussionaire® product is in any way adversely affected by the use of components other than those designed, manufactured, or approved by Percussionaire® Corporation, Percussionaire® Corporation shall not be liable under this warranty with respect to such product. Percussionaire® Corporation recommends an annual preventive maintenance (PM) for each device. A mandated remanufacture/overhaul (OH) is required every three (3) years after the device is initiated into service or not later than four (4) years after the first date of purchase.


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Percussionaire® Corporation 130 McGhee Rd., Ste. 109 Sandpoint, ID 83864 USA Telephone: 208.263.2549 Fax: 208.263.0577 Percussionaire® Corp. 2009 www.percussionaire.com US and Foreign Patents Issued and Pending

MDSS GmbH Schiffgraben 41 30175 Hannover, Germany

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Document ID: F-032209 REV D

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