Hill-Rom MetaNeb System User Manual

The MetaNeb® System
User Manual
Product No. PMN4
174432 REV 7
REVISION
© 2016 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED.
Manufactured by:
HILL-ROM SERVICES PRIVATE LIMITED 1 YISHUN AVENUE 7 SINGAPORE 768923
Authorized European Union Representative:
Authorized Brazilian Representative:
VR MEDICAL—MEDICAL DEVICES IMPORTER & DISTRIBUTOR, LTDA. 391 BATATAES STREET CJ 11-13, 8TH FLOOR SÃO PAULO, SP-BRAZIL CNJP: 04.718.143/0001-94
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).
The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill-Rom.
The information in this manual is subject to change without notice. Hill­Rom makes no commitment to update or keep current, the information 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.
The MetaNeb® System may be covered by one or more patents. For a list of applicable patents, go to www.hill-rom.com/patents.
This manual (174432) was originally released and supplied in English. For a list of available translations, contact Hill-Rom Technical Support.
Seventh Edition, August 2016
First Printing, 2013
The MetaNeb® System User Manual (174432 REV 7) i
Hill-Rom® is a registered trademark of Hill-Rom Services, Inc.
MetaNeb® and MetaTherapy® are registered trademarks of Comedica, Inc.
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.hill­rom.com.
Reference Documents
MetaNeb® System Service Manual, North America (174508)
MetaNeb® System Service Manual, International (187293)
183808 (Stand) Assembly (182920)
ii The MetaNeb® System User Manual (174432 REV 7)
Table of Contents
Table of Contents
Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Normal Mucus Clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Mucociliary Escalator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Autocephalad Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
The MetaNeb® System and Bronchial Hygiene. . . . . . . . . 6
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Assemble the Controller System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Stand Assembly and Controller Installation. . . . . . . . . . . . . . . 10
Connect the Oxygen Hose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Assemble the Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Typical Mouthpiece Configuration . . . . . . . . . . . . . . . . . . . . . . . 11
Other Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Mask. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Tracheostomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
In-Line with Ventilator Circuit. . . . . . . . . . . . . . . . . . . . . . . . 12
Add Medication to the Nebulizer. . . . . . . . . . . . . . . . . . . . . . . . . 13
Pre-Use Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Pre-Use Check For In-Line Use with a ventilator . . . . . . . . . . . . . . . . . . . 15
The MetaNeb® System User Manual (174432 REV 7) 1
Table of Contents
MetaTherapy® Treatment Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Assessment of Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Re-Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
The MetaNeb® System In-Line with Ventilator Protocol . . . . . . . . . . . 18
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Assessment of Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Re-Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Move the Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Cleaning the Controller and Stand. . . . . . . . . . . . . . . . . . . . . . . 21
Cleaning the Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Troubleshooting and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Shipping and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Product symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Controller Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Stand Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Classification and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Technical Specification for Performance—Breathing Simulator . . . 31
CHFO Pulses—Airway Pressure Reading . . . . . . . . . . . . . 32
CPEP—Airway Pressure Reading . . . . . . . . . . . . . . . . . . . . 32
Hi Pressure CHFO Pulses—Airway Pressure Reading . 33
Hi Pressure CPEP—Airway Pressure Reading. . . . . . . . . 33
Bench Performance Checks—Breathing Simulator. . . . . . . . . . . . . . . . 34
Nebulizer Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Circuit Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Particle Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2 The MetaNeb® System User Manual (174432 REV 7)

Document Symbols

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.
A CAUTION identifies special procedures or precautions that
persons must obey to help prevent equipment damage.
The MetaNeb® System User Manual (174432 REV 7) 1

Indications

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
2 The MetaNeb® System User Manual (174432 REV 7)
Indications

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.
This device is not suitable for use with anesthetic breathing systems.
The MetaNeb® System User Manual (174432 REV 7) 3

Introduction

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 minimum 50 psi oxygen source.
Stand—lets you easily move the The MetaNeb® System from room to room.
4 The MetaNeb® System User Manual (174432 REV 7)
Introduction

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:
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.
The MetaNeb® System User Manual (174432 REV 7) 5
Introduction

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.
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.
6 The MetaNeb® System User Manual (174432 REV 7)
Introduction
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.
The MetaNeb® System User Manual (174432 REV 7) 7

Features

FEATURES

Controller

H
G
F
B
A
C
E
D
Item Description Item Description A Pressure manometer E CPEP flow adjuster B Higher/lower switch F Master on/off switch C Mode selector G Oxygen gas connector D Circuit tri-connector
port
H Mount bracket
8 The MetaNeb® System User Manual (174432 REV 7)
Features

Circuit

Item Description Item Description A Mouthpiece G Orifice indicators B Selector ring H Adapter, 22 mm x 15 mm C Handset I Adapter, 22 mm x 22 mm D Circuit tri-connector/
J Occlusion ring
bio-filter E Tubing K Silicon adapter F Nebulizer L Nebulizer tubing
The MetaNeb® System User Manual (174432 REV 7) 9
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