The Vest Airway Clearance System Model 104 User Manual Rev 3

© 2007 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED. Manufactured by: HILL-ROM 4349 CORPORATE ROAD CHARLESTON, SC 29405 UNITED STATES Authorised 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. Third Edition First Printing 2004 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, Inc. ®

Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories Inc. Velcro® is a registered trademark of Velcro Industries, BV (a Dutch Corporation). 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.

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To order additional copies of this manual (USR150), 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 1 2 3

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Pages Affected

Date November 2004 September 2005 September 2007

All All

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The Ves t Airway Clearance System, Model 104 User Manual (USR150 REV 3)

Table of Contents Document Symbols... 1 Safety Tips... 2 Contraindications... 5 Relative Contraindications... 5 Cleaning... 7 General Cleaning... 8 Home Care Environment... 8 Acute Care Environment... 8 Steam Cleaning... 9 Cleaning Hard to Clean Spots... 9 Disinfecting... 9 Intended Use... 9 Introduction... 11 Features... 12 Air Pulse Generator... 12 Air Outlets... 12 Display and Controls... 12 Remote Control and Air Hoses... 13 Power Cord... 13 Inflatable Vests... 14 Product Symbols... 15 Specifications... 18 Classification and Standards... 19 Electromagnetic Compatibility... 20 Instructions for Use... 24 Protocol for Use and Special Instructions for the Home Care Patient... 24 Set Up the Unit... 25 Put on the Inflatable Vest... 29 Reusable Chest Vest (Home Care Environment)... 29 ®

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Reusable Full Vest (Home Care Environment)... 31 Disposable Wrap SPU Vest (Acute Care Environment)... 32 Disposable Full SPU Vest (Acute Care Environment)... 33 Use The Vest® Airway Clearance System, Model 104... 34 Maintenance... 38 Service Calls... 39 Replacement Parts... 40 Troubleshooting... 42 Air Pulse Generator Does Not Power On... 42 Inflatable Vest No Longer Fits (Home Care Environment)... 42 No Air Pulses into the Inflatable Vest... 42 Display Alternates between “Please Call for Service” and “Device Error X” Messages... 43 An Air Hose Comes Out of the Air Pulse Generator or Inflatable Vest during Operation... 43 Storage and Handling... 44 Storage Bag (Home Care Environment)... 44 Shipping the Unit... 44 Frequently Asked Questions... 45 Display Messages... 47

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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-emphasises 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

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Safety Tips When you use electrical products, always obey safety precautions and these important safety tips:

READ ALL INSTRUCTIONS BEFORE PRODUCT USE WARNING: To reduce the risk of electrocution, obey these instructions. Failure to do so could cause personal injury or equipment damage. • Unplug this system immediately after you use it. WARNING: Do not use the system near flammable anaesthetics. To do so could cause personal injury or equipment damage. • Do not use this system near flammable anaesthetics. WARNING: To reduce the risk of burns, electrocution, fire, or personal injury, obey these instructions. Failure to do so could cause personal injury or equipment damage. • 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 104 therapy. Please consult your physician to determine if additional therapy is appropriate.

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• Use close supervision throughout the treatment when this system is used by or near children or patients with physical limitations or impaired cognitive abilities. • Use this system only for its intended use. Use only those attachments that are specified by the manufacturer. • If this system has a damaged Power Cord or plug, does not operate correctly, or has been dropped or damaged; do not operate it. For test and repair, call Hill-Rom Technical Support. For contact information, refer to the back cover. • Keep the unit and its Power Cord away from heated surfaces. • Never drop or insert inappropriate objects into any opening on the unit. • Plug this system into a known-good outlet only. • Read and obey all instructions for setup, use, and maintenance of the unit. Failure to do so could cause patient injury or equipment damage. • If the patient has a condition that prevents the use of the unit, do not use the system. Death or serious injury could occur. • 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 may cause patient injury. • To help prevent cross-contamination, replace the single-patient use inflatable vest between patients. Failure to do so could cause patient injury or equipment damage. • Only authorized persons should service the unit. Service by unauthorized persons could cause personal injury or equipment damage.

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NOTE: If service is necessary, call Hill-Rom Technical Support. For contact information, refer to the back cover. For countries not listed on the back cover, contact your distributor. • The potential for electrical shock exists with electrical equipment. Failure to follow electrical use protocols may cause death or serious personal injury. • 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. • Use a known-good electrical outlet only. Do not use the Air Pulse Generator with an extension cord or multiple-use electrical outlet adapter. Death, serious injury, or equipment damage could occur. • Before you clean the system, unplug it from its power source. Failure to do so could cause personal injury or equipment damage. • Do not expose the system to excessive moisture or immerse it in water. Personal injury or equipment damage could occur. • Do not operate the Air Pulse Generator without the inflatable vest and Air Hoses attached. Equipment damage could occur. • If it is difficult to connect the Air Hose to the Air Pulse Generator or inflatable vest, do not use lubricant. Equipment damage could occur. • If it is difficult to connect the Remote Control to the Air Pulse Generator, do not use lubricant. Equipment damage could occur. • Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur. • Frequent exposure to phenol-based germicidal detergent may discolor the Air Pulse Generator. • If you use bleach-based (NaOCI) disinfectants or quarternary ammonium-based disinfectant cleaners, make sure you wipe the unit dry. Failure to do so could cause the build-up of residue or equipment damage. • If shipping is necessary, the original packing material is designed to protect the unit during shipment. Keep the original packing material so it can be used if it is necessary to ship the system.

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Contraindications WARNING: If the patient has a condition that prevents the use of The Vest Airway Clearance System, Model 104, do not use the system. Death or serious injury could occur.

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Do not use The Vest Airway Clearance System, Model 104 if the patient has one or more of these conditions: ®

• Head and/or neck injury that has not been stabilised • Active hemorrhage with hemodynamic instability

Relative Contraindications If the patient has one or more of the conditions below, before you use The Vest Airway Clearance System, carefully consider and assess the patient’s case, in accordance with the American Association for Respiratory Care (AARC) Guidelines for Postural Drainage: ®

• Intracranial pressure (ICP) >20 mm Hg, or patients in whom increased intracranial pressure is to be avoided • 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 • Distended abdomen • Recent esophageal surgery • Active or recent gross hemoptysis • Uncontrolled airway at risk for aspiration such as Air Hose feeding or a recent meal • Subcutaneous emphysema ®

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• Recent epidural spinal infusion or spinal anesthesia • Burns, open wounds, and skin infections on the thorax • Transvenous or subcutaneous pacemaker • Hemodynamic instability • Suspected pulmonary tuberculosis • Lung contusion • Bronchospasm • Osteoporosis or osteomyelitis of the ribs • Coagulopathy • Complaint of chest wall pain

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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 electrical use protocols may cause death or serious personal injury. SHOCK HAZARD: Unplug the unit from its power source before you clean it. Failure to do so could cause personal injury or equipment damage. SHOCK HAZARD: Do not expose the unit to excessive moisture. Personal injury or equipment damage could occur. CAUTION: Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur.

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The Vest Airway Clearance System, Model 104 has been tested for compatibility with these detergents: ®

CAUTION: Frequent exposure to phenol-based germicidal detergent may discolor the Air Pulse Generator. • Phenol-based germicidal detergent • Alcohol-based disinfectants. CAUTION: If you use bleach-based (NaOCI) disinfectants or quarternary ammonium-based disinfectant cleaners, make sure you wipe the unit dry. Failure to do so could cause in the build-up of residue or equipment damage. • Bleach-based disinfectants • Quarternary ammonium-based disinfectant cleaner

General Cleaning Home Care Environment We recommend that you clean the Air Pulse Generator and inflatable vest with a soft cotton cleaning pad that is slightly moist from detergent and warm water. Do not use excessive liquid or harsh cleansers. Do not put The Vest Airway Clearance System, Model 104 in water or let liquids enter the Air Pulse Generator. ®

After you clean the system, wipe it dry. Acute Care Environment WARNING: To help prevent cross-contamination, replace the single-patient use inflatable vest and Air Hoses between patients. Failure to do so could cause patient injury or equipment damage. NOTE: In the Acute Care environment, the inflatable vests and Air Hoses are single-patient use, latex-free, disposable products for use on individual patients over multiple treatment sessions. Clean The Vest Airway Clearance System, Model 104 between patients, or when visibly soiled if used on the same patient. Replace the inflatable vest and Air Hoses between patients or when it is damaged. ®

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We recommend that you clean the Air Pulse Generator and Remote Control with a soft cotton cleaning pad that is slightly moist from detergent and warm water. Do not use excessive liquid or harsh cleansers. Do not immerse The Vest Airway Clearance System, Model 104 in water or allow liquids to enter the Air Pulse Generator. ®

After you clean the system, wipe it dry.

Steam Cleaning Do not use any steam cleaning device on the unit. Excessive moisture can damage mechanisms in this unit.

Cleaning Hard to Clean Spots Air Pulse Generator-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 any component of The Vest Airway Clearance System, Model 104 in water. ®

Disinfecting When there is visible soil and between patient use, we recommend that you disinfect the unit with an intermediate level, tuberculocidal disinfectant. Use the disinfectant as specified in the disinfectant manufacturer's instructions.

Intended Use WARNING: Read and obey all of the instructions for setup, use, and maintenance for The Vest Airway Clearance System, Model 104. Failure to do so could cause patient injury or equipment damage. ®

This manual includes instructions for setup, use, and maintenance of The Vest Airway Clearance System, Model 104. Before you use the system, carefully read all of this manual, and make sure you obey the instructions for your safety and to get the best therapeutic benefit. Most importantly, obey all warnings, cautions, and notes in this manual. ®

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NOTE: This manual is not intended as a substitute for information you receive from your physician or other healthcare providers. Use The Vest Airway Clearance System, Model 104 as prescribed by your physician. ®

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Introduction

The Vest Airway Clearance System, Model 104 was developed to help supply effective Airway Clearance Therapy. The system has an inflatable vest attached by Air Hoses to an Air Pulse Generator. The Air Pulse Generator rapidly inflates and deflates the inflatable vest to gently compress and release the chest wall which creates airflow within the lungs. This process, which mimics coughing, moves 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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Features Air Pulse Generator When correctly connected, the Air Pulse Generator controls the inflatable vest and supplies pulsations to the chest wall. Air Outlets

Air outlets

Air Hoses connect at the two air outlets on the front of the Air Pulse Generator. Display and Controls

Item A

Control ON

B and C Frequency Up and Down D and E Pressure Up and Down F and G Treatment Time Up and Down H OFF

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Description Press to fill the inflatable vest and start or pause the Air Pulse Generator. Press to adjust the Frequency setting until the prescribed treatment session Frequency shows on the display. Press to adjust the Pressure setting until the prescribed treatment session Pressure shows on the display. Press to adjust the treatment Time until the prescribed treatment session Time shows on the display. Press to stop the Air Pulse Generator.

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The display shows the current Frequency, Pressure, and treatment Time settings and system messages. NOTE: The display shows its messages in English. For a translation of the messages in your language, refer to “Display Messages” on page 47.

Remote Control and Air Hoses The Remote Control can be used instead of the ON control to start or pause the Air Pulse Generator. The Air Hoses connect the inflatable vest to the Air Pulse Generator.

Power Cord The Power Cord plugs into the Air Pulse Generator and a grounded outlet. NOTE: The Power Cord necessary for your country may be different than the one shown.

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Inflatable Vests For use in the home care environment, these reusable, inflatable vests are available in several standard sizes of these two types: • Chest Vest • Full Vest Reusable Chest Vest Reusable Full Vest For use in an acute care facility, these disposable, single-patient use, inflatable vests are available in several standard sizes of these two types: • Wrap SPU Vest • Full SPU Vest Disposable Wrap SPU Vest

Disposable Full SPU Vest

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The Ves t Airway Clearance System, Model 104 User Manual (USR150 REV 3)

Product Symbols Symbol

Definition Type B equipment with an F-type applied part, according to EN 60601-1.

Dangerous voltage within the device may constitute a risk of electrical shock.

ON OFF

ON control-starts the Air Pulse Generator OFF control-stops the Air Pulse Generator Frequency setting

Pressure setting

treatment Time setting

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