The MetaNeb System PMN4 User Manual Rev 4

© 2013 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED. Manufactured by: HILL-ROM SERVICES PRIVATE LIMITED 1 YISHUN AVENUE 7 SINGAPORE 768923 No part of this text shall be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information or retrieval system without written permission from Hill-Rom Services, Inc. (Hill-Rom). This manual (174432) was originally released and supplied in English. For a list of available translations, contact Hill-Rom Technical Support. Product may be covered by one or more patents. Please consult listing at www.hill-rom.com/patents for any patent(s). The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill-Rom. Second Edition, October 2013 First Printing, 2013 Dispatch® is a registered trademark of The Clorox Company. Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. MetaNeb® is a registered trademark of Comedica, Inc. MetaTherapy® is a registered trademark of Comedica, Inc. Viraguard® is a registered trademark of Veridien Corp. Virex® is a registered trademark of Diversey, Inc. Wex-Cide™ is a trademark of Wexford Labs, Inc. The information contained in this manual is subject to change without notice. Hill-Rom makes no commitment to update or keep current, the information contained in this manual. Hill-Rom reserves the right to make changes without notice in design, specifications, and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products. Replace this manual (174432) if it is damaged and/or can not be read. For product support or to order additional copies of this manual (174432), contact your distributor, local Hill-Rom representative, or go to www.hill-rom.com.

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Reference Documents MetaNeb® System Service Manual (174508) MetaNeb® System-Unpacking Instructions (174434)

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The MetaNeb® System User Manual (174432 REV 2)

Table of Contents Document Symbols... 1 Indications... 2 Indications for Use... 2 Patient Population... 2 Absolute Contraindications... 2 Relative Contraindications... 2 Possible Adverse Reactions... 2 Precautions... 3 Introduction... 4 Description... 4 Theory of Operation... 4 Features... 7 Controller... 7 Circuit... 8 Assemble the Controller System... 9 Stand Assembly... 9 Controller Assembly... 9 Assemble the Circuit... 10 Typical Mouthpiece Configuration... 10 Other Configurations... 10 Pre-Use Check... 12 MetaTherapy® Treatment Protocol... 13 Frequency... 13 Procedure... 13 Assessment of Outcome... 14 Re-Evaluation... 15 The MetaNeb® System In-Line with Ventilator Protocol... 16 Frequency... 16 Procedure... 16 Assessment of Outcome... 17 Re-Evaluation... 17 The MetaNeb® System User Manual (174432 REV 2)

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Move the Stand... 18 Cleaning... 19 Cleaning the Controller and Stand... 20 Cleaning the Circuit... 20 Troubleshooting and Maintenance... 22 Troubleshooting... 22 Maintenance... 23 Shipping and Packaging... 23 Product symbols... 24 Specifications... 26 Classification and Standards... 29 Technical Specification for Performance-Breathing Simulator... 30 Bench Performance Checks-Breathing Simulator... 32 Circuit Part Numbers... 36

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Document Symbols This manual contains different typefaces and symbols to make the content easier to read and understand: • Standard text-used for regular data. • Boldface text-emphasizes a word or phrase. • NOTE:-sets apart special data or important instruction clarification. • WARNING or CAUTION

–

A WARNING identifies situations or actions that may have an effect on patient or user safety. To ignore a warning could cause patient or user injury.

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A CAUTION identifies special procedures or precautions that persons must obey to help prevent equipment damage.

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Indications Indications for Use The MetaNeb® System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

Patient Population • Adult and children over the age of 2

Absolute Contraindications • Untreated tension pneumothorax • Untrained or unskilled operator

Relative Contraindications • History of pneumothorax • Pulmonary air leak • Recent pneumonectomy • Pulmonary hemorrhage • Myocardial infarction • Vomiting

Possible Adverse Reactions • Hyperventilation • Gastric distension • Decreased cardiac output • Increased intracranial pressure • Increased air trapping • Hyperoxygenation • Pneumothorax • Pulmonary air leak • Pulmonary hemorrhage

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The MetaNeb® System User Manual (174432 REV 2)

Precautions • Federal law restricts this device to sale by or on the order of a physician. • Circuits are for single patient use, multiple treatment sessions. • Do not occlude entrainment orifices. • Do not use on uncooperative patients. • Read the User Manual before use. • Use only with the supplied nebulizer. • To be used only by individuals familiar with its use. • Failure to discard the circuit in accordance with facility protocol could cause patient injury due to cross-contamination. • Care should be taken to appropriately suction secretions as they mobilize into the upper airways. • Use only with hospital grade 50 psi oxygen sources that meet local, state, and government regulations. • Continuous Positive Expiratory Pressure (CPEP) is a therapy and is never to be used for life support. • Monitor the patient, patient lines, and circuit lines during therapy and/or bed articulation. • Make sure you connect the nebulizer to the nebulizer tubing only. • Only persons trained to use the The MetaNeb® System and ventilators should perform therapy on ventilated patients. • Unlock the brake casters during transport. Lock the brake casters during therapy or when not being transported. • Let the unit stabilize to room conditions for 1 hour after storage or transport in a cold or humid environment. • Keep away from all ignition sources. • Do not use near flammable anesthetics.

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Introduction The MetaNeb® System supplies a therapy that enhances secretion removal and helps prevent or resolve patchy atelectasis.

Description The MetaNeb® System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: • CHFO (Continuous High Frequency Oscillation)-a pneumatic form of chest physiotherapy that delivers medicated aerosol while oscillating the airways with continuous pulses of positive pressure. • CPEP (Continuous Positive Expiratory Pressure)-supplies medicated aerosol combined with continuous positive pressure to help hold open and expand the airways. • Aerosol-for the delivery of aerosol only. In this mode CHFO and CPEP are not available. The MetaNeb® System supplies a platform from which both CHFO and CPEP can be administered contiguously. This composite therapy is referred to as "MetaTherapy® Treatment." MetaTherapy® Treatment is a combination therapy that seamlessly alternates between CPEP and CHFO modes. CPEP is a therapy and is never to be used for life support. There are three major components to The MetaNeb® System: • Circuit-includes a mouthpiece, handset, nebulizer, tubing, and biofilter/tri-connector. It is a single patient use, latex-free assembly that is intended for multiple treatment sessions. • Controller-contains the controls to select the three different modes. It also has a manometer to monitor pressure. Power is supplied by a hose connected to a 50 psi oxygen source. • Stand-lets you easily move the The MetaNeb® System from room to room.

Theory of Operation Normal Mucus Clearance

Normal mucus clearance in the lungs is accomplished in three unique ways. It must be understood that these mechanisms complement each other and none are mutually exclusive. The three mechanisms are: 4

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1. Mucociliary Escalator 2. Cough 3. Autocephalad Flow Mucociliary Escalator

The respiratory tract consists of approximately twenty-four generations, each lined with a mucus secretion that has two layers. The top layer is a hydrated gel layer. The bottom layer is a thin, less viscous sol layer. Cilia line the entire surface of the respiratory tract down to the terminal bronchiole (16th generation). These cilia beat continuously at a rate of approximately 10-20 times per second and propel mucus in a cephalad fashion 1-3 mm per second. The mucus with any entrapped particles is swallowed or coughed to the atmosphere. Cough

A cough can be voluntary or stimulated as part of a reflex and is an effective way to remove even large quantities of secretions from the upper airways (6th-7th generations). This is accomplished by creating high velocity flow rates at high lung volumes through the generation of intrapleural pressures >100 mmHg, then releasing this pressure explosively to the atmosphere. Air can be expelled in excess of 100 miles per hour. These high airflows create shear forces, which in turn, cause mucus to be expelled. Past the 6th generation, airways begin to lose their cartilaginous support, and at the high pressures the small airways tend to collapse, which prevents secretion removal. Thus, the rationale behind the HUFF cough and FET maneuvers is that when you teach patients to cough at lower lung volumes, high pressures are minimized and small airway collapse is reduced. Autocephalad Flow

When gas flows over a thickly lined mucus layer, a shear force directly proportional to the velocity of the gas is produced. If this airflow velocity is maintained and exceeds the cohesive forces of the mucus, the mucus will move in the direction of the gas flow. Essentially, autocephalad flow is comparable to a cough, except that lower gas velocities are generally present. To further understand, it is helpful to examine normal tidal breathing. During normal inspiration the diaphragm contracts and is displaced caudally. Concomitantly, the intercostal muscles contract to lift the ribs. These actions together increase the anterior-posterior dimension (volume) of the thoracic cavity which causes a decrease in alveolar pressure as compared to atmospheric. This pressure gradient causes a flow of gas into the lungs.

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It is important to understand that as the pressure gradient rises, so do the flow rate and the velocity. The highest flow rates can be expected to be in the upper airways during inspiration because the gradient begins at the mouth and ends at the alveoli. During exhalation the process is reversed and the alveolar pressure is greater than atmospheric. The flow gradient is now from the alveoli to the mouth, and therefore, the greatest flow rates will be in the smaller airways. Since the normal I:E (inspiratory to expiratory) ratio is 1:1.5 to 1:2, secretions from these airways are transported to the larger airways by way of asymmetric periodic gas flow. The MetaNeb® System and Bronchial Hygiene

The MetaNeb® System supplies aerosol, CHFO, and CPEP therapy modes. CHFO is a pneumatic form of chest physiotherapy that uses a systematic approach to enhance normal mucus clearance and resolve patchy atelectasis. CHFO- • Supplies aerosolized medication and humidification to relax bronchial smooth muscle so that airway resistance is decreased, and at the same time hydrates thickened retained secretions. • Uses specifically calibrated frequency and I:E ratio to create a mean airway pressure in order to maintain airway caliber, prevent premature closure, and expand collapsed lung regions. • Maintains continuous high frequency oscillation during both inspiration and expiration to form a pressure gradient to the small airways where secretions are trapped. This pressure gradient creates an accelerated expiratory airflow that can be manipulated to help move the secretions to the upper airways. • Aids in the mobilization of retained secretions. CPEP is a therapy which supplies a continuous, clinician-set airway pressure above atmospheric by use of a venturi, a fixed orifice resistor, and flow during both inspiration and expiration. CPEP- • Prevents or reverses atelectasis. • Delivers hyperinflation therapy through positive expiratory pressure that will help patients deeply breathe and cough. • Reduces the incidence of air trapping.

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Features Controller

H

G

F

B A

C

E D

Item A B C D

Description Pressure manometer Higher/lower switch Mode selector Circuit tri-connector port

Item E F G H

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Description CPEP flow adjuster Master on/off switch Oxygen gas connector Mount bracket

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Circuit

L

Item A B C D E F

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Description Mouthpiece Selector ring Handset Circuit tri-connector/ bio-filter Tubing Nebulizer

Item G H I J

Description Orifice indicators Adapter, 22 mm x 15 mm Adapter, 22 mm x 22 mm Occlusion ring

K L

Silicon adapter Nebulizer tubing

The MetaNeb® System User Manual (174432 REV 2)

Assemble the Controller System Make sure you have all the parts that are listed on the contents list.

Stand Assembly 1.

Press the button at the bottom of the pole.

2.

Install the pole, button side down, into the base.

3.

Move the pole as needed so the button comes out of the hole in the base.

Controller Assembly 1.

Loosen the knob on the bracket arm.

2.

Put the controller on to the pole.

3.

Adjust the controller to the applicable height on the pole.

4.

Tighten the knob on the bracket arm.

5.

Attach, and hand tighten, the oxygen hose to the connector on the controller.

6.

Install the applicable hose adapter on the free end of the hose, as necessary for your facility.

7.

Attach, and hand tighten, the free end of the oxygen hose to an oxygen source.

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Assemble the Circuit Typical Mouthpiece Configuration 1.

Put the circuit tri-connector/bio-filter into the tri-connector port on the control unit.

2.

Turn the connector 45° counterclockwise to lock it into position.

3.

Remove the mouthpiece from the package.

4.

Attach the mouthpiece to the handset: insert the mouthpiece at a 45° angle and gently push it in and twist it to the correct orientation.

5.

Remove the nebulizer from the package.

6.

Assemble the nebulizer cup before you attach it to the circuit. Make sure the green cone within the nebulizer stays intact.

7.

Connect the nebulizer to the nebulizer port on the bottom of the handset.

8.

Connect, but do not twist, the nebulizer hose of the tubing to the bottom of the nebulizer. Make sure to push the bushing all the way on to the nebulizer stem.

NOTE: A twisted hose could cause the nebulizer bowl to become loose.

Other Configurations Mask

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Tracheostomy

Flex tube adapter not included

In-Line with Ventilator Circuit

“T”connector not included

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Pre-Use Check Do this before to each use: 1.

Connect the gas hose to a 50 psi oxygen source.

2.

Connect the circuit to the controller.

3.

Set the mode to CHFO, and select Higher.

4.

Set the selector ring on the handset to the three-dots position.

5.

Put the master switch in the ON position.

6.

Occlude the patient opening of the handset.

7.

Watch the pressure gauge. The average of pressure fluctuations should not be less than 15 and not more than 30 cm H2O.

Higher

Lower

8.

Set the mode to CPEP.

9.

Turn the CPEP flow dial counterclockwise to full flow.

10. With the selector ring on three dots, occlude the patient opening of the handset and monitor the manometer. Make sure there is a peak pressure occurrence of not less than 20 and not more than 30 cm H2O. 11. If the device is not within the parameters specified above, do not use the unit. Contact Hill-Rom Technical Support to examine and repair the unit.

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MetaTherapy® Treatment Protocol Frequency The common strategy for frequency of MetaTherapy® Treatment, in the acute care setting, ranges from two (2) to four (4) times daily. The patient’s response to the therapy should determine any frequency adjustments.

Procedure 1.

Make sure the unit operates correctly. See “Pre-Use Check” on page 12.

2.

Follow your institutional guidelines for infection control.

3.

Introduce yourself, and explain the procedure to the patient.

4.

The patient should be in an upright and comfortable position, if possible.

5.

The patient should be assessed per institutional guidelines.

6.

Fill the nebulizer with the prescribed medications, if applicable.

7.

Set the mode to CPEP.

High resistance

8.

Turn the CPEP flow dial all the way clockwise to the lowest position.

Medium resistance

9.

Low resistance

Set the selector ring to the one-dot position.

10. Connect The MetaNeb® System to an approved 50 psi oxygen source. 11. Put the master switch in the ON position. 12. Adjust the CPEP flow to observe the aerosol that comes from the patient end of the handset. 13. Attach the mouthpiece to the handset. NOTE: A cushion mask or tracheotomy tube may also be connected to the handset using the appropriate provided adapter. 14. Instruct the patient to inhale normally and exhale slowly (3-4 seconds) through the mouthpiece or facemask.

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15. Adjust the selector ring up to the two-dot setting for higher resistance or three-dot setting for highest resistance as tolerated by the patient. 16. Encourage the patient to exhale slowly (3-4 seconds). 17. Continue CPEP mode approximately 2 ½ minutes, adjusting the flow to achieve a therapy that is comfortable yet challenging for the patient or as otherwise provided in institutional protocol. 18. Instruct the patient that the mode will now change to CHFO. Proceed with changing the mode to CHFO. 19. Move the Higher/Lower switch to Higher 20. During the treatment, the selector ring may be adjusted and the Higher/Lower switch may be moved to Lower. NOTE: The Lower setting on the Higher/Lower switch reduces the percussion rate and the pressure, and may be used as an introductory mode. Subsequently, the switch may be returned to the Higher position for enhanced therapy.

Higher

Lower

21. Encourage the patient to inhale normally and exhale slowly (3-4 seconds) against pulsations, keeping his or her cheeks firm to avoid pressure loss. 22. Continue CHFO mode for approximately 2 ½ minutes. 23. Alternate between CPEP and CHFO for 10 minutes or depending on patient need or as otherwise provided in institutional protocol. 24. When the treatment is complete, turn the unit off, disconnect the circuit, and store the unit for future use. NOTE: When you store the circuit, keep the tubing attached to the bottom of the nebulizer cup and disassemble the top of the nebulizer from the handset.

Assessment of Outcome Therapy will be discontinued per facility protocol or when one of these occur: • Secretion clearance is < 5 cc per treatment for a 24 hr period. • The post therapy chest exam shows an absence of retained secretions and atelectasis. • Breath sounds have become clear or have improved. 14

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Re-Evaluation Patients should be evaluated every 24 hrs while on The MetaNeb® System to make sure that an acute change has not occurred.

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