The Vest Airway Clearance System Model P105 User Manual Rev 13

© 2016 by Hill-Rom Services PTE Ltd. 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, 63-XXXXX, or 64-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 PTE Ltd. (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. 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

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The Vest Airway Clearance System, Model 105 User Manual (145330 REV 13)

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Hill-Rom makes is the express written warranty extended on the sale or rental of its products. Product may be covered by one or more patents. Please consult listing at www.hill-rom.com/patents for any patent(s). This manual (145330) was originally released and supplied in English. For a list of available translations, contact Hill-Rom. Thirteenth Edition, January 2016 First Printing, 2007 Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc. Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories, Inc. ®

C3® and The Vest are registered trademarks of Hill-Rom Services PTE Ltd. Replace this manual (145330) if it is damaged and/or can not be read. For product support or to order additional copies of this manual (145330), contact Hill-Rom: •

In the USA, call Hill-Rom at 800-426-4224.

•

Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.hill-rom.com. Reference Documents ®

The Vest Airway Clearance System, Models 104, 105, and 205 Service Manual (183192 – North America; 150754 – International) ii

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The Vest Airway Clearance System, Model 105 User Manual (145330 REV 13)

Table of Contents Document Symbols... 1 Important Safeguards... 2 Intended Use... 6 Intended patient population... 6 Intended users... 7 Indications for use... 7 Contraindications... 8 Relative Contraindications... 8 Cleaning... 10 General Cleaning-Air Pulse Generator and Classic Garment Line... 11 Steam Cleaning-Air Pulse Generator and Classic Garments... 12 Cleaning Hard to Clean Spots-Air Pulse Generator and Classic Garments... 12 C3® Garment Line Cleaning... 12 Acronyms... 13 Features... 14 Air Pulse Generator... 14 Control Panel... 14 Air Hose Connector Ports... 15 Air Hoses... 15 Remote Control... 15 Inflatable Garment... 16 Power Cord... 16 Product Symbols... 17 Instructions for Use... 24 Protocol for Use and Special Instructions... 24 ®

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Setting Up the Unit...25 Fitting the Classic Chest Vest...29 Fitting the C3® Washable Garment and the Classic Full Vest...30 Fitting the Classic Wrap Vest...33 Software Version...34 Use The Vest® Airway Clearance System, Software Version 1.20...35 Normal Mode...35 Set and Use the New Program Mode...38 Use the Program Mode...41 Set and Use the New Ramp Mode...44 Use the Ramp Mode...48 Check the Hour Meter Reading...51 Change the Language...51 Disable the Program Modes (Program and Ramp modes)...52 Set Custom Default Settings...54 Use The Vest® Airway Clearance System, Software Version 1.22 or 2.02...57 Normal Mode...57 Set and Use the New Program Mode...60 Use the Program Mode...65 Set and Use the New Ramp Mode...68 Use the Ramp Mode...73 Check the Hour Meter Reading...75 Change the Language...76 Disable the Program Modes (Program and Ramp modes)...77 Set Custom Default Settings...79 iv

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The Vest Airway Clearance System, Model 105 User Manual (145330 REV 13)

Maintenance... 83 Expected Life... 83 Service Calls... 84 Troubleshooting... 84 Air Pulse Generator Does Not Power On... 85 No Air Pulses into the Inflatable Garment... 85 Screen Shows “Please Call for Service” Message... 86 An Air Hose Comes out of the Air Pulse Generator or Inflatable Garment during Operation... 86 Screen Shows “Restarting”... 86 The Inflatable Garment No Longer Fits... 87 Storage and Handling... 87 Shipping the Unit... 88 Frequently Asked Questions... 88 Specifications... 90

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The Vest Airway Clearance System, Model 105 User Manual (145330 REV 13)

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, DANGER, or CAUTION:

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A WARNING or DANGER identifies situations or actions that may have an effect on patient or user safety. To ignore a warning or danger 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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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. Adult supervision is required to use the therapy on children. 3. Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities.

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4. Keep the hoses and power cord away from children to avoid strangulation. 5. Do not store or use the device around pets, pests, or unsupervised children. 6. 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. 7. Use this product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer. 8. Do not use unauthorized parts or accessories with this device. 9. Use only Hill-Rom authorized air hoses and garments to avoid allergic skin reactions. 10. 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. 11. Keep the unit and its Power Cord away from heated surfaces. 12. Do not use the device near to any heat source such as a fireplace or radiant heater. 13. Do not use the device in a dusty environment. 14. Do not use the device in a heavy moisture environment. 15. Never drop or insert any inappropriate object into any opening on the unit. 16. 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. ®

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17. If conditions exist that prohibit using The Vest Airway Clearance System, do not use the unit. Death or serious injury could occur. 18. 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. ®

19. 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 necessary, use this contact information: •

In the USA, call Hill-Rom at 800-426-4224.

•

Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.hill-rom.com.

20. The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury. 21. If it is necessary to disconnect/isolate the device from the main power supply, disconnect the power cord plug from the power inlet socket on the back of the air pulse generator or disconnect the plug from the power outlet in the wall. 22. Make sure the position of the air pulse generator is such that you can quickly, without obstruction, disconnect the power cord from the main power supply if necessary. 23. If the display on the Air Pulse Generator is faulty, do not use the unit. ®

24. Do not use The Vest Airway Clearance System on a conductive floor. 25. Wait at least 2 to 4 hours after a meal before you use The Vest Airway Clearance System. ®

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26. 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. 27. Before cleaning, unplug the unit from its power source. Failure to do so could cause personal injury or equipment damage. 28. Do not expose the unit to excessive moisture or immerse it in water. 29. Do not run the Air Pulse Generator without the inflatable garment and Air Hoses attached. Equipment damage could occur. 30. Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur. 31. Retain the original packaging material. If shipping is required, the original packing material provides the best protection for The Vest Airway Clearance System. ®

32. Do not eat or drink during a therapy session. To do so could cause a choking hazard. ®

33. Discard The Vest Airway Clearance System product in accordance with your local government regulations. 34. To protect the patient and caregiver from the total acoustical energy from the use of this device, make sure of these: •

The device is not used by a patient and/or a caregiver more than a total of 12 hours each day.

•

When the device is in use, keep a distance of at least 1.64' (0.5 m) between the device and the patient and caregiver.

SAVE THESE INSTRUCTIONS

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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).

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.

INTENDED PATIENT POPULATION ®

The Vest Airway Clearance System, Model 105 can be used for the pediatric to geriatric population. The system accommodates use across the targeted population by providing a selection of garment sizes which is used along with the air pulse generator. 6

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INTENDED USERS The users of the system can either be designated caregivers or patients in both the acute care and home care environments. Users should have the ability to read and understand western Arabic numerals and the native language used in the manual. We recommend that the users of the device have an education level comparable to that of an 8th grader. We recommend that patients who do not meet this education level get assistance from caregivers or respiratory therapists while using this device for therapy.

INDICATIONS FOR USE The Vest® Airway Clearance System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician’s choice of treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest® Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.

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CONTRAINDICATIONS WARNING: If the patient conditions exist that cause the use of The Vest Airway Clearance System to present a risk to the patient, do not use the unit except as directed by a physician. Death or serious injury could occur. ®

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The Vest Airway Clearance System 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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The Vest Airway Clearance System, Model 105 User Manual (145330 REV 13)

• 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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CLEANING 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. Injury or equipment damage could occur. CAUTION: Failure to use cleaning products in accordance with the manufacturer’s instructions could cause equipment damage. WARNING: Inspect the Air Pulse Generator and Garments before each use. In addition, after each cleaning cycle, visually inspect each component for any wear, tear, or deformity. If you have any concern about a component, do not use it, and replace that component before the next therapy session. Failure to do so could cause injury. CAUTION: Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur.

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The Vest Airway Clearance System has been tested for compatibility with the following cleaning solutions: Chemical Class

Active Ingredient

Quaternary ammonium chloride

Didecyl dimethyl ammonium chloride Alkyl dimethyl benzyl ammonium chloride

Quaternary ammonium chloride

Alkyl dimethyl benzyl ammonium chloride Alkyl dimethyl ethylbenzyl ammonium chloride

Phenolic

Ortho-Phenylphenol Ortho-Benzyl-para-Chlorophenol

Alcohol

Isopropyl alcohol

GENERAL CLEANING-AIR PULSE GENERATOR AND CLASSIC GARMENT LINE NOTE: The non-washable garments are referred to as the Classic Line, and the washable garments are referred to as the C3® 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. ®

Make sure to thoroughly clean the inside and outside of these: •

Ends of the Air Hoses

•

Connection Ports on the reusable garment

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Air Hose Connector Port outlets on the Air Pulse Generator

When there is visible soilage we recommend that you use a standard household, mild anti-bacterial soap or solution to clean the unit. Dilute the cleaning agent as specified on the manufacturer’s label. ®

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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.

C3® GARMENT LINE CLEANING Only the outer piece of the C3® Garment Line can be machine washed. The bladder is cleaned in the same manner as the Classic garment above. Remove the bladder assembly as follows: a. Open up the buckles or hook and loop connections and lay the garment flat on a table. b. Open the zipper or flap at the bottom of the garment. c. If there are snaps that secure the bladder to the outer garment, unfasten the snaps. 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: 12

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The Vest Airway Clearance System, Model 105 User Manual (145330 REV 13)

a. Fasten all buckles, zippers and hook and loop connections. NOTE: The 16" garment has hook and loop connections only. 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

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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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