The Vest Airway Clearance System Model P205 User Manual Rev 12

© 2016 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED. Units with a 51-XXXXX serial number are manufactured by: HILL-ROM, INC. 4349 CORPORATE ROAD CHARLESTON, SC 29405 Units with 52-XXXXX or 53-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 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. Product may be covered by one or more patents. Please consult listing at www.hill-rom.com/patents for any patent(s). This manual (140643) was originally released and supplied in English. For a list of available translations, contact Hill-Rom. Twelfth Edition, May 2016 First Printing, 2006 Cough Pause® and Hill-Rom®, are registered trademarks of Hill-Rom Services, Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc. The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

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The Vest® is a registered trademark of Hill-Rom Services PTE Ltd. Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories Inc. Replace this manual (140643) if it is damaged and/or can not be read. For product support or to order additional copies of this manual (140643), 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 (150754)

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The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

Table of Contents Document Symbols... 1 Precautions... 2 Intended Use... 4 Introduction... 4 Contraindications... 5 Relative Contraindications... 6 Features... 7 Air Pulse Generator... 7 Push Bar... 7 Remote Control... 8 Height Adjustment Release Lever... 8 Locking Casters... 8 Stand... 8 Storage Basket... 8 Air Hose Connector Ports... 8 Air Hoses... 8 Control Panel... 8 Assembly... 9 Instructions for Use... 10 Put on the Disposable, Single-Patient Use (SPU) Vests . . . 10 Wrap SPU Vest... 10 Full SPU Vest... 11 Connect the Air Hoses... 11 Set Up the Air Pulse Generator... 14 Software Version... 14 Use The Vest® Airway Clearance System, software version 1.20... 15 Setting and Using a New Program Mode... 18 Using the Program Mode... 20 Setting and Using a New Ramp Mode... 22 Using the Ramp Mode... 25

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Check the Hour Meter Reading... 27 Change the Language... 27 Disable the Program Modes (Program and Ramp)... 28 Set Facility Custom Default Settings... 29 Use The Vest® Airway Clearance System, software version 1.22... 32 Normal Mode... 32 Set and Use the New Program Mode... 34 Use the Program Mode... 39 Set and Use the New Ramp Mode... 42 Use the Ramp Mode... 45 Check the Hour Meter Reading... 48 Change the Language... 48 Disable the Program Modes (Program and Ramp Modes) . . 49 Set Custom Default Settings... 51 Move the Air Pulse Generator... 55 Raise or Lower the Air Pulse Generator... 56 Cleaning... 57 General Cleaning... 58 Steam Cleaning... 59 Cleaning Hard to Clean Spots... 59 Disinfecting... 59 Maintenance... 59 Expected Life... 60 Disposable Garments and Replacement Parts... 60 Size the Disposable Garments... 62 Service Calls... 63 Troubleshooting... 63 Air Pulse Generator Does Not Power On... 63 No Air Pulses into the Disposable Garments... 64 Screen Shows “Please Call for Service” Message... 64 An Air Hose Comes out of the Air Pulse Generator or Disposable Garments during Operation... 64

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The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

Screen Shows “RESTARTING”... 64 Product Symbols... 65 Specifications... 70 Classification and Standards... 71 Frequently Asked Questions... 76

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The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

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.

• ELECTRICAL SHOCK HAZARD WARNING

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Precautions • Federal USA law restricts this device to sale by or on the order of a physician. • Unplug this system immediately after you use it. • Do not use the system near flammable chemicals or products, including flammable anaesthetics. To do so could cause personal injury or equipment damage. • Adult supervision is required to use the therapy on children. • Use close supervision when this system is used by or near children or patients with physical limitations or impaired cognitive abilities. • Keep the hoses and power cord away from children to avoid strangulation. • Do not store or use the device around pets, pests, or unsupervised children. • Use this system only for its intended use. Use only those attachments that are specified by the manufacturer. • Do not use unauthorized parts or accessories with this device. • Use only Hill-Rom authorized hoses and vests to avoid allergic skin reactions. • Do not use the device near to any heat source such as a fireplace or radiant heater. • Do not use the device in a dusty environment. • Do not use the device in a heavy moisture environment. • 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 205 therapy. Please consult your physician to determine if additional therapy is appropriate. • To help prevent cross-contamination, replace the single-patient use, disposable garment between patients. • Only authorized persons should service the unit. • If service is necessary, use this contact information: – 2

In the USA, call Hill-Rom at 800-426-4224. The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

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

• Do not operate the Air Pulse Generator without the disposable garment and Air Hoses attached. Equipment damage could occur. • If it is difficult to connect the Air Hoses to the Air Pulse Generator or disposable garment, 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. • Do not eat or drink during a therapy session. To do so could cause a choking hazard. • Do not leave the garment on a patient for extended periods of time without a cloth barrier between the patient and the garment. • 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. • 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. • Discard The Vest® Airway Clearance System product in accordance with your local government regulations. • 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.

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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.

KEEP THESE INSTRUCTIONS

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Intended Use The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician’s choice or 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. The Vest® Airway Clearance System, Model 205 was developed to provide effective Airway Clearance Therapy. The system consists of a disposable garment attached to an Air Pulse Generator that rapidly inflates and deflates the disposable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process 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).

Introduction This manual includes instructions for setup, use, and maintenance of The Vest® Airway Clearance System, Model 205. It is to be used as a reference guide. Please review all sections carefully before you use the system. The Vest® Airway Clearance System, Model 205 is intended for use as prescribed by a physician.

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Contraindications WARNING: If patient conditions exist that cause the use of The Vest® Airway Clearance System, Model 205 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 205 is contraindicated if these conditions are present: • Head and/or neck injury that has not yet been stabilized • Active hemorrhage with hemodynamic instability

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Relative Contraindications If the patient has one or more of the conditions below, carefully consider and assess the patient’s case before you decide to use The Vest® Airway Clearance System, Model 205. • Intracranial pressure (ICP) >20 mm Hg, or patients in whom increased intracranial pressure is to be avoided • Uncontrolled hypertension • Hemodynamic instability • Pulmonary edema associated with congestive heart failure • Bronchopleural fistula • Subcutaneous emphysema • Large pleural effusions or empyema • Recent esophageal surgery • Active or recent gross hemoptysis • Pulmonary embolism • Uncontrolled airway at risk for aspiration such as tube feeding or recent meal • Distended abdomen • Bronchospasm • Suspected pulmonary tuberculosis • Recently placed transvenous pacemaker or subcutaneous pacemaker • Recent epidural spinal infusion or spinal anesthesia • Recent spinal surgery or acute spinal injury • Rib fractures, with or without flail chest • Surgical wound, healing tissue, recent skin grafts, or flaps on thorax • Burns, open wounds, and skin infections on the thorax • Lung contusion • Osteomyelitis of the ribs • Osteoporosis • Coagulopathy • Complaint of chest wall pain

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The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

Features

D

Alternate Stand

A B C D E

Air Pulse Generator Push Bar Remote Control Height Adjustment Release Lever Four Locking Casters

F G H I

Stand Storage Basket Air Hose Connector Ports Air Hoses

J

Control Panel

Air Pulse Generator When correctly connected, the Air Pulse Generator controls the disposable garment and supplies pulsations to the chest wall.

Push Bar Permits the unit to be moved around a room or from room to room.

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Remote Control Can be used instead of the ON/OFF button to pause or resume the Air Pulse Generator.

Height Adjustment Release Lever Used to raise or lower the Air Pulse Generator to a comfortable working height.

Locking Casters Keeps the stand and Air Pulse Generator from unintentionally moving.

Stand Holds the Air Pulse Generator.

Storage Basket Can be used to store disposable garments.

Air Hose Connector Ports Air Hoses connect to the Air Hose Connector Ports on the front of the Air Pulse Generator.

Air Hoses Connect the disposable garment to the Air Pulse Generator.

Control Panel Shows the modes, system settings, and system messages.

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The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

Assembly 1.

Align the two posts on the rubber mat with the holes in the top of the stand.

2.

Align the holes on the bottom of the Air Pulse Generator with the posts on the rubber mat.

NOTE: The screen on the Air Pulse Generator faces the side of the stand that the basket is on. 3.

Install the four screws to attach the Air Pulse Generator to the stand.

4.

Tighten, but not overtighten, the four screws with the supplied wrench.

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Instructions for Use Put on the Disposable, Single-Patient Use (SPU) Vests NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment. Wrap SPU Vest 1.

Turn the patient towards you.

2.

With the Wrap SPU Vest deflated, begin to lay it flat on the bed so it is perpendicular with the patient’s torso.

3.

Roll the patient away from you and on the open portion of the Wrap SPU Vest.

4.

Put the Wrap SPU Vest in position just beneath the patient’s underarms, and continue to pull the Wrap SPU Vest around the patient’s torso.

5.

Roll the patient to a supine position.

6.

Pull both ends of the Wrap SPU Vest around the patient’s chest, and use the hook-andloop fasteners to temporarily attach both ends to each other.

Have the patient inhale deeply, and then attach the ends of the Wrap SPU Vest so it fits close to the body, but is not uncomfortable. You should be able to fit a flat hand between the Wrap SPU Vest and the body.

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The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

Full SPU Vest NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment. 1.

Separate the front flaps of the Full SPU Vest at the hook-and-loop fasteners.

2.

Turn the Full SPU Vest so the front flaps will meet in front of the patient. Then put the patient’s arms through the arm openings in the Full SPU Vest.

3.

With the Full SPU Vest deflated, use the hook-and-loop fasteners to attach the front flaps of the Full SPU Vest to each other. You should be able to fit a fist between the Full SPU Vest and the body before you inflate the garment.

4.

Make sure there is approximately 3" to 4" (8 cm to 10 cm) between the bottom edge of the front of the Full SPU Vest and the patient.

5.

Adjust the hook-and-loop fasteners at the shoulder straps so the bottom edge of the Full SPU Vest is level with the top of the patient’s hip bone.

Connect the Air Hoses 1.

Connect each Air Hose as follows: Slide one end of each Air Hose into each Air Hose Connector Port on the front of the Air Pulse Generator. Use a slight twist motion as you push the Air Hose to help keep it in position.

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NOTE: If the patient has a Hickman catheter, portacath, and/or G-tube, for the patient’s comfort, it may help to use contour foam (P/N 300177000) around the port site. Install the foam as follows: NOTE: The contour foam is not sterile. 2.

Cut out a center hole to form a “donut” shape in the foam.

3.

Put the open hole of the “donut” directly over the port site.

4.

Connect the Air Hoses to the disposable garment: Wrap SPU Vest a.

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Remove the tear label from the disposable garment.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 12)

b.

Slide the other end of each Air Hose into the disposable garment Air Hose slits at least 2" (5 cm).

c.

Use the hook-and-loop loops on the side of the disposable garment to hold the Air Hoses in position.

NOTE: The garment can be worn with the Air Hose Connector Ports anywhere around the chest that is comfortable. Full SPU Vest Slide the other end of each Air Hose over the disposable garment Air Hose Ports. To help keep the Air Hoses in position, slightly twist the Air Hoses as you push them over the Full SPU Vest Air Hose Ports.

NOTE: The Vest® Airway Clearance System can be use with patient in a sitting, lying down, or standing position.

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