Page 1

PRESENTS

THE SINUSOIDAL BRONCHOTRON

INSTRUCTIONS FOR USE

THE SINUSOIDAL BRONCHOTRON PERCUSSIONATOR® MODEL F00038-1


2

THE SINUSOIDAL BRONCHOTRON® PERCUSSIONATOR® F00038-1 WITH ACCESSORY UNIVERSAL MONITRON® F00007-B Invented and Patented by Dr. Forrest M. Bird, M.D., Ph.D., Sc.D. for Cardio-respiratory lung recruitment therapy


3 TABLE OF CONTENTS PAGE Table of Contents ....................................................................................... 3 Description of unit ...................................................................................... 4 Primary Claims ........................................................................................... 4 Indications for use...................................................................................... 4 Contraindications for use .......................................................................... 4 Potential Effects ......................................................................................... 4 Suggested Neonatal/Pediatric Invasive or Noninvasive Programming . 5 Intrahospital Neonatal Ventilation .................................................. Low PaO2 ......................................................................................... Elevated PaO2 .................................................................................. Suggested Large Pediatric/Adult Patient Programming .........................

5 6 7 7

Appendices Storage……………………………………………………………………. 9 Disposal of Equipment…………………………………………………. 9 Shipping Information ....................................................................... 9 Glossary of Symbols ....................................................................... 10 Cleaning and Decontamination Procedures.................................. 11


4

THE SINUSOIDAL BRONCHOTRON® PERCUSSIONATOR® MODEL F00038-1 DESCRIPTION OF UNIT A totally independent Therapeutic Recruitment and Lung Stabilization Percussionator® using a standard medical oxygen or air supply source to cycle the ventilator and ventilate the patient with proven reliability “equal to or better than” any other existing pulmonary ventilatory device. Requires NO batteries.

THE PRIMARY SINUSOIDAL BRONCHOTRON CLAIMS ARE: A PROVEN THERAPEUTIC RECRUITMENT AND LUNG STABILIZATION PERCUSSIONATOR® PROVIDING FOR AUTOCYCLED® HIGHER FREQUENCY PERCUSSIVE SINUSOIDAL MECHANICAL VENTILATION, THUS ALLOWING PROFESSIONAL CIVIL OR MILITARY CARDIOPULMONARY CLINICIANS TO VENTILATE ALL NEONATAL, PEDIATRIC OR ADULT LUNGS CAPABLE OF BEING MECHANICALLY VENTILATED, INVASIVELY OR NON-INVASIVELY, DURING LAND, SEA OR AIR TRANSPORT TO AND THEN WITHIN THE MEDICAL FACILITY

INDICATIONS FOR USE Use of the Percussionaire® Sinusoidal Bronchotron® Percussionator® is indicated for the mobilization and raising of endobronchial secretions, bronchodilation, reducing mucosal edema and the resolution of diffuse patchy atelectasis in all patient populations.

CONTRAINDICATIONS FOR USE Contraindications for use include but are not limited to: Untreated tension pneumothorax Lack of adequate, skilled supervision

POTENTIAL EFFECTS OF THE SINUSOIDAL BRONCHOTRON® The Sinusoidal Bronchotron has inherent risks similar to all positive pressure breathing devices. These risks include but are not limited to under/over ventilation, under/over humidification, pneumothorax, and pneumomediastinum, PIE, pneumoperitoneum, and hemoptysis. Individuals attempting to operate the Sinusoidal Bronchotron® must understand warnings and cautions contained in user’s manual to prevent bodily injury or equipment failure.

CAUTION

If the Sinusoidal Bronchotron is used on a patient with an indwelling airway (i.e. endotracheal or tracheotomy tube), a clinician must be present so that a one to one relationship exists. This device enhances secretion clearance. Patients must be assessed pre and post treatment for a reduced vital capacity/FRC or the need for assistance in clearing airway secretions. A patient cannot breathe through an obstructed airway! If an artificial airway is in place, a special gated aerosol generator must be used to relieve any transient/unwanted pressure rises.


5

SUGGESTED NEONATAL/PEDIATRIC INVASIVE OR NON INVASIVE PROGRAMMING OF THE SINUSOIDAL BRONCHOTRON® F00038-1 For intra-hospital neonatal ventilation: 1. Securely attach Sinusoidal Bronchotron F00038-1 to pole stand. 2. 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.


6 3. Interconnect NEONATAL RESPIRATORY BREATHING CIRCUIT A50209-A with green Percussionator® body and three channel interfacing harness with (white, yellow and red) tubing’s to the Sinusoidal Bronchotron® service sockets. 4. 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. 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


7 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. 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).


8 7. Activate OPERATIONAL GAS SOURCE (turn ON). 8. Select OPERATIONAL PRESSURE. Neonatal- 20 psig. Pediatric- 30 psig. Adult- 40 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. 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.


9

STORAGE The Percussionaire® units should be stored in a clean environment and covered when not in use. Temperature should be maintained between -40°C to +40°C. (-40°F to +104°F) Humidity range is 0- 95% non-condensing.

DISPOSAL OF EQUIPMENT At the end of useful life of a unit, disposal should be in accordance with local, state, federal and international laws. The unit may also be packaged according to instructions found within this manual and shipped to authorized maintenance centers below for disposal.

SHIPPING INFORMATION MAIL AND SHIPPING ADDRESS Percussionaire® Corporation 130 McGhee Rd., Ste. 109 Sandpoint, ID 83864 USA

WEBSITE ADDRESS www.percussionaire.com

ATTENTION! READ THE SAFETY INSTRUCTIONS AND THE ENTIRE INSTRUCTION MANUAL BEFORE USING THIS DEVICE


10

GLOSSARY OF SYMBOLS

ATTENTION! READ THE SAFETY INSTRUCTIONS AND THE ENTIRE INSTRUCTION MANUAL BEFORE USING THIS DEVICE

DANGEROUS VOLTAGE WITHIN THE DEVICE MAY CONSITITUTE A RISK OF ELECTRICAL SHOCK (Impulsator®, IPV®-HT™, Monitron II)

STOP! READ EXTRA CARE PRECAUTIONS

CLASS 1 EQUIPMENT TYPE BF EQUIPMENT

PROTECTIVE EARTH GROUNDING ALTERNATING CURRENT

POWER SWITCH ON

POWER SWITCH OFF YEAR OF MANUFACTURE (xxxx = YEAR)

ELECTRICAL AND ELECTRONIC EQUIPMENT SHOULD NOT BE PLACED IN MUNICIPAL WASTE. PLEASE CHECK LOCAL REGULATIONS FOR DISPOSAL OF ELECTRONIC EQUIPMENT. THE UNIT MAY ALSO BE PACKAGED ACCORDING TO PRECEDING INSTRUCTIONS AND SHIPPED TO AUTHORIZED MAINTENANCE CENTER FOR DISPOSAL.


11

EQUIPMENT CLEANING AND DECONTAMINATION PROCEDURES These cleaning procedures supersede all others prior to July 1st, 2010. All new Percussionaire® products are packaged clean. They should not be considered sterile or decontaminated. Prior to use it is recommended that breathing circuit components be disassembled then cleansed and/or decontaminated. GENERAL CLEANSING PROTOCOLS 1. The devices may be sprayed by aerosolized CITRACE® or similar Hospital Grade Disinfectant. ***DO NOT USE BUTCHER’S QUEST 256, THE USE OF THIS PRODUCT WILL DAMAGE THE MACHINE AND THIS DAMAGE IS NOT COVERED UNDER WARRANTY. 2. The devices after being sprayed down and allowed to dry are re sprayed with hospital wide spectrum aerosol consisting of the same germicidal agents with a timed exposure per labeling. 3. After device has dried it is then mechanically wiped with a similar germicidal agent impregnated in a saturated wiping vehicle and allowed to dry per labeling instructions. 4. Further in-depth mechanical cleansing and rinse is accomplished with CITRACE®. As well as other germicidal household cleansers to remove any grime, dirt or other materials during the disassembly processes. Percussionaire® does not deliver sterile devices, which are appropriately labeled per FDA.

Follow instructions below on how to disassemble Percussionaire® breathing circuits. 1. Mechanically wash and dry all parts completely 2. Process following local institution guidelines. 3. Reassemble circuit.

OTHER TECHNIQUES The decision to use other decontamination techniques should be based upon the following parameters:


12 1. Standard PhasitronÂŽ part # A50007, A50007-1 2. Aerosol Generator part # A50010, A50010-1, A50010-3, A50010-5 The above components can withstand temperatures < 280o Fahrenheit (137.8o Celsius)

The following components are not autoclavable: 1. PhasitronÂŽ Duo part # A50007-10 2. Interface tubing assembly part # A50034 3. These parts can withstand temperatures < 140o Fahrenheit (60o Celsius)

PercussionaireÂŽ medical devices are not submersible.


13

Disassembly of Percussionaire® Phasitron® Part Numbers A50007, A50007-1

Disconnect colored tubing from service sockets. 1. Unscrew Phasitron® end cap part B10914. 2. Withdraw venturi assembly from Phasitron® body by pulling out upon orificed diaphragm part B10918 attached to green or alternative red venturi assembly. 3. Remove opening spring B10916 from around Venturi tube.

Phasitron Body exterior component disassembly steps. 4. 5. 6. 7.

Remove green Inspiratory Failsafe Tee assembly part A50144 by a pulling rotation. Remove red Expiratory Failsafe tee assembly. Remove proximal airway Swivel Tee assembly by a pulling rotation. Remove Phasitron® Outlet Plug loop assembly, from Swivel Tee assembly part A50089-1 by pulling and rotating.


14

Disassembly of PercussionaireÂŽ Aerosol Generator Part Numbers A50010, A50010-1, A50010-2, A50010-3, A50010-5

1. 2.

Disconnect colored tubing from service sockets. Release nebulizer cap part # A50015 by holding aerosol bowl assembly part A50087, then rotating nebulizer cap counterclockwise Âź turn.

Four channel breathing circuit interfacing tubing assemblies: A50034 non-autoclavable tubing assembly


15 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.


16

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

0123

Document ID: F-032109 REV H

Profile for Percussionaire

Bronchotron Manual  

The Sinusoidal Bronchotron instructions for use.

Bronchotron Manual  

The Sinusoidal Bronchotron instructions for use.