The Vest Airway Clearance System Model 105 User Manual Rev 7

PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10

PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10

© 2010 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED. Units with a 61-XXXXX serial number are manufactured by: HILL-ROM, INC. 4349 CORPORATE ROAD CHARLESTON, SC 29405 Units with a 62-XXXXX serial number are manufactured by: HILL-ROM SERVICES PRIVATE LIMITED 1 YISHUN AVENUE 7 SINGAPORE 768923 Authorized European Union Representative: HILL-ROM SAS B.P. 14 - Z.I. DU TALHOUET 56330 PLUVIGNER FRANCE TEL: +33 (0)2 97 50 92 12

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. Seventh Edition First Printing 2007 Printed in the USA Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc. The Vest® is a registered trademark of Hill-Rom Services PTE Ltd. The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

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PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10

Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories, 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. To order additional copies of this manual (145330), refer to the back cover for contact information. For countries not listed on the back cover, contact your distributor. NOTE:

The back cover is a comprehensive list of Technical Support contact information for Hill-Rom. The product discussed in this manual may not be available in all of the countries listed.

Revision Original Issue 2 3 4 5 6 7

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Pages Affected All All All All All All

Date February 2007 March 2007 September 2007 December 2007 April 2008 September 2008 February 2010

The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10

Table of Contents Document Symbols... 1 Important Safeguards... 2 Contraindications... 5 Relative Contraindications... 5 Cleaning... 7 GENERAL CLEANING-Air Pulse Generator and Classic Garment Line... 7 Steam Cleaning-Air Pulse Generator and Classic Garments... 8 Cleaning Hard to Clean Spots-Air Pulse Generator and Classic Garments... 8 Disinfecting-Air Pulse Generator and Classic Garments... 8 C3™ Garment line Cleaning and disinfecting... 8 Acronyms... 9 Intended Use... 10 Introduction... 11 Features... 12 Air Pulse Generator... 12 Control Panel... 12 Air Hose Connector Ports... 13 Air Hoses... 13 Remote Control... 13 Inflatable garment... 14 Power Cord... 14 Product Symbols... 15 Instructions for Use... 19 Protocol for Use and Special Instructions... 19 Setting Up the Unit... 20 Fitting the Chest Vest... 23 Fitting the Full VEST... 25 Fitting the Wrap Vest... 26 The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 7)

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PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10 Software version... 26 Use The Vest® Airway Clearance System, software version 1.20... 27 Normal Mode... 27 Set and Use the New Program Mode... 31 Use the Program Mode... 35 Set and Use the New Ramp Mode... 37 Use the Ramp Mode... 41 Change the Language... 44 Disable the Program Modes (Program and Ramp modes)... 45 Set Custom Default Settings... 47 Use The Vest® Airway Clearance System, software version 1.22... 51 Normal Mode... 51 Set and Use the New Program Mode... 54 Use the Program Mode... 60 Set and Use the New Ramp Mode... 64 Use the Ramp Mode... 68 Change the Language... 70 Disable the Program Modes (Program and Ramp modes)... 72 Set Custom Default Settings... 74 Maintenance... 79 Service Calls... 79 Troubleshooting... 80 Air Pulse Generator Does Not Power On... 80 No Air Pulses into the inflatable garment... 81 Screen Shows “Please Call for Service” Message... 81 An Air Hose Comes out of the Air Pulse Generator or inflatable garment During Operation... 81 Screen Shows “RESTARTING”... 82 The inflatable garment No Longer Fits... 82 Storage and Handling... 83 iv

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 7)

PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10 Shipping the Unit... 83 Frequently Asked Questions... 84 Specifications... 86

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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 information. • Boldface text-emphasizes a word or phrase. • NOTE:-sets apart special data or important instruction clarification. • WARNING or CAUTION:

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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.

• ELECTRICAL SHOCK HAZARD WARNING:

NOTE: These document symbols may or may not be used in this manual.

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IMPORTANT SAFEGUARDS When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following important safeguards.

READ ALL INSTRUCTIONS BEFORE USING DANGER: To reduce the risk of electrocution, follow these instructions. Failure to do so could cause personal injury or equipment damage. Always unplug this product immediately after using. WARNING: To reduce the risk of burns, electrocution, fire, or personal injury, follow these instructions. Failure to do so could cause personal injury or equipment damage. 1. Patients that may have difficulty clearing secretions from the upper airway (such as those with DMD or other advanced neuromuscular or neurological disorders) may require specialized therapy regiments involving manually or mechanically assisted coughing or other techniques in conjunction with The Vest® Airway Clearance System, Model 105 therapy. Please consult your physician to determine if additional therapy is appropriate. 2. Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities. 3. We recommend your first use of this product be in a supervised setting such as a doctor’s office or at home with a clinical trainer. 2

The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

PROPRIETARY AND CONFIDENTIAL DRAFT 15-FEB-10

4. Use this product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer. 5. If this product has a damaged Power Cord or plug, is not working properly, or has been dropped or damaged, do not operate it. For examination and repair, contact Hill-Rom Customer Service. For contact information, refer to the back cover. 6. Keep the unit and its Power Cord away from heated surfaces. 7. Never drop or insert any inappropriate object into any opening on the unit. 8. Plug this product into a correctly grounded outlet only. 9. Read and follow all instructions for setup, use, and maintenance of The Vest® Airway Clearance System. Failure to do so could cause patient injury or equipment damage. 10. If conditions exist that prohibit using The Vest® Airway Clearance System, do not use the unit. Death or serious injury could occur. 11. Federal USA law restricts this device to sale by or on the order of a physician. Sale by or on the order of unauthorized persons can cause patient injury. 12. Only authorized personnel should service The Vest® Airway Clearance System. Servicing by unauthorized personnel could cause personal injury or equipment damage. NOTE: If service is required in the United States, contact Hill-Rom Customer Service. For contact information, refer to the back cover. Outside of the United States, refer to the back cover for contact information. For countries not listed on the back cover, contact your distributor.

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13. The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury. 14. If the Air Pulse Generator is wet or damp, do not plug it into a power source or use it. Patient injury, personal injury, or equipment damage could occur. 15. Use a correctly grounded electrical outlet only. Failure to do so could cause equipment damage. 16. Before cleaning, unplug the unit from its power source. Failure to do so could cause personal injury or equipment damage. 17. Do not expose the unit to excessive moisture or immerse it in water. Personal injury or equipment damage could occur. 18. Do not run the Air Pulse Generator without the inflatable garment and Air Hoses attached. Equipment damage could occur. 19. Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur. 20. Retain the original packaging material. If shipping is required, the original packing material provides the best protection for The Vest® Airway Clearance System. 21. Do not eat or drink during a therapy session. To do so could cause a choking hazard.

SAVE THESE INSTRUCTIONS

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CONTRAINDICATIONS WARNING: If the patient conditions exist that cause the use of The Vest® Airway Clearance System, Model 105 to present a risk to the patient, do not use the unit except as directed by a physician. Death or serious injury could occur. The Vest® Airway Clearance System, Model 105 is contraindicated if these conditions are present: • Head and/or neck injury that has not yet been stabilized • Active hemorrhage with hemodynamic instability

RELATIVE CONTRAINDICATIONS According to the American Association for Respiratory Care (AARC) Guidelines for Postural Drainage Therapy, the decision to use the unit for Airway Clearance Therapy requires careful consideration and assessment of the individual patient’s case if the following conditions exist: • Intracranial pressure (ICP) greater than 20 mm Hg • Recent spinal surgery or acute spinal injury • Bronchopleural fistula • Pulmonary edema associated with congestive heart failure • Large pleural effusions or empyema • Pulmonary embolism • Rib fractures, with or without flail chest • Surgical wound or healing tissue or recent skin grafts or flaps on the thorax • Uncontrolled hypertension

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• Distended abdomen • Recent esophageal surgery • Active or recent gross hemoptysis • Uncontrolled airway at risk for aspiration such as tube feeding or a recent meal • Subcutaneous emphysema • Recent epidural spinal infusion or spinal anesthesia • Burns, open wounds, and skin infections on the thorax • Recent placement of transvenous or subcutaneous pacemaker • Suspected pulmonary tuberculosis • Lung contusion • Bronchospasm • Osteoporosis or osteomyelitis of the ribs • Coagulopathy • Complaint of chest wall pain

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The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

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CLEANING WARNING: Follow the product manufacturer’s instructions. Failure to do so could cause personal injury or equipment damage. SHOCK HAZARD: The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury. SHOCK HAZARD: Unplug the unit from its power source. Failure to do so could cause personal injury or equipment damage. SHOCK HAZARD: Do not expose the unit to excessive moisture or put it in water or any solution. Personal injury or equipment damage could occur. CAUTION: Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur.

GENERAL CLEANING-Air Pulse Generator and Classic Garment Line We recommend that you wipe clean the Air Pulse Generator and inflatable garment with detergent and warm water. Do not use excessive liquid or harsh cleansers, and do not put The Vest® Airway Clearance System in water or any solution. NOTE: The non-washable garments are referred to as the Classic Line, and the washable garments are referred to as the C3™ Garment Line. The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

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STEAM CLEANING-Air Pulse Generator and Classic Garments Do not use any steam cleaning device on the unit or garments. Excessive moisture can damage mechanisms in this unit or garments.

CLEANING HARD TO CLEAN SPOTS-Air Pulse Generator and Classic Garments To remove difficult spots or stains, we recommend that you use standard household cleansers and a soft bristle brush. To loosen heavy, dried-on soil, you may first need to saturate the spot. Do not put The Vest® Airway Clearance System in water or any solution.

DISINFECTING-Air Pulse Generator and Classic Garments When there is visible soilage, and also between patient use in multi-patient care environments, we recommend that you disinfect the unit. Use an Environmental Protection Agency (EPA) registered (US only), tuberculocidal disinfectant or standard household, mild, anti-bacterial soap or solution. Dilute the disinfectant as specified on the manufacturer's label.

C3™ GARMENT LINE CLEANING AND DISINFECTING Only the outer piece of the C3™ Garment Line can be machine washed. The bladder is cleaned and disinfected in the same manner as the Classic garment above. Remove the bladder assembly as follows: a. Open up the buckles and lay the garment flat on a table. 8

The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

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b. Open the zipper at the bottom of the garment. c. Unfasten the snaps that secure the bladder to the outer garment. d. Remove the two hose connections from the outer garment. e. Remove the bladder from the outer garment. Machine wash the outer piece only as follows: a. Fasten all buckles, zippers and hook and loop connections. b. Machine wash, or hand wash, in cold cycle only (86° F (30° C) maximum). Non-chlorine bleach may be used as necessary. c. Hang dry or tumble dry on lowest temperature (120° F (49° C) maximum). d. Cool iron (250° F (110° C) maximum) as necessary. Do not iron the design. NOTE: Do not machine wash or dry the bladder.

ACRONYMS Acronym AARC AWG CSA HFCWO ICP PVC UL

Meaning American Association for Respiratory Care American Wire Gauge Canadian Standards Association High Frequency Chest Wall Oscillation Intercranial pressure Polyvinyl chloride Underwriters Laboratories Inc.®

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INTENDED USE The Vest® Airway Clearance System, Model 105 was developed to provide effective Airway Clearance Therapy. The system consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).

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The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)

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INTRODUCTION

This manual includes instructions for setup, use, and maintenance of The Vest® Airway Clearance System, Model 105. It is to be used as a reference guide. Please review all the sections carefully before you use the system. The Vest® Airway Clearance System, Model 105 is intended for use as prescribed by a physician.

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FEATURES A E

B

C D A B C

Air Pulse Generator Air Hose Connection Ports Air Hoses

D E

Remote Control Control Panel

AIR PULSE GENERATOR When correctly connected, the Air Pulse Generator controls the inflatable garment and supplies pulsations to the chest wall. CONTROL PANEL Pressing the ON or OFF controls or the 6 Up and Down arrow buttons, activates or deactivates features/functions on the Air Pulse Generator.

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The Vest® Airway Clearance System, Model 105 User Manual (145330 REV 7)