The Vest Airway Clearance System Model 205 User Manual Rev 6

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 © 2010 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED. Units with a 51-XXXXX serial number are manufactured by: HILL-ROM, INC. 4349 CORPORATE ROAD CHARLESTON, SC 29405 Units with a 52-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. Sixth Edition First Printing 2006 Printed in the USA 3M® is a registered trademark of Minnesota Mining and Manufacturing Company. Citris II® is a registered trademark of Beaumont Products, Inc. Dispatch® is a registered trademark of Caltech Industries, Inc. Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. Matar® is a registered trademark of Huntington Laboratories, Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc. The Vest® is a registered trademark of Hill-Rom Services PTE Ltd. Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories Inc.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

i

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 Velcro® is a registered trademark of Velcro Industries, BV (a Dutch corporation). Viraguard® is a registered trademark of Veridien Corp. Virex® is a registered trademark of S. C. Johnson & Son, Inc. Wex-Cide™ is a trademark of Wexford Labs, 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 (140643), 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

ii

Pages Affected All All All All All

Date July 2006 September 2007 January 2008 April 2008 September 2008 February 2010

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

Table of Contents Document Symbols... 1 Precautions... 2 Intended Use... 4 Introduction... 4 Contraindications... 4 Relative Contraindications... 5 Features... 6 Air Pulse Generator... 6 Push Bar... 6 Remote Control... 7 Height Adjustment Release Lever... 7 Locking Casters... 7 Stand... 7 Storage Basket... 7 Air Hose Connector Ports... 7 Air Hoses... 7 Control Panel... 7 Assembly... 8 Instructions for Use... 9 Put on the Disposable, Single-Patient Use (SPU) Vests... 9 Wrap SPU Vest... 9 Full SPU Vest... 10 Connect the Air Hoses... 10 Set Up the Air Pulse Generator... 12 Software Version... 12 Use The Vest® Airway Clearance System, software version 1.20... 13 Setting and Using a New Program Mode... 15 Using the Program Mode... 18 Setting and Using a New Ramp Mode... 19 Using the Ramp Mode... 23

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

iii

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 Change the Language... 24 Disable the Program Modes (Program and Ramp)... 25 Set Facility Custom Default Settings... 26 Use The Vest® Airway Clearance System, software version 1.22... 30 Normal Mode... 30 Set and Use the New Program Mode... 32 Use the Program Mode... 37 Set and Use the New Ramp Mode... 40 Use the Ramp Mode... 44 Change the Language... 46 Disable the Program Modes (Program and Ramp modes)... 47 Set Custom Default Settings... 48 Move the Air Pulse Generator... 52 Raise or Lower the Air Pulse Generator... 53 Cleaning... 54 General Cleaning... 55 Steam Cleaning... 55 Cleaning Hard to Clean Spots... 55 Disinfecting... 55 Maintenance... 56 Disposable Garments and Replacement Parts... 57 Size the Disposable Garments... 58 Service Calls... 58 Troubleshooting... 58 Air Pulse Generator Does Not Power On... 59 No Air Pulses into the Disposable Garments... 59 Screen Shows “Please Call for Service” Message... 59 An Air Hose Comes out of the Air Pulse Generator or Disposable Garments during Operation... 59 Screen Shows “RESTARTING”... 60 Product Symbols... 61 Specifications... 64 iv

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 Classification and Standards... 65 Frequently Asked Questions... 70

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

v

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

vi

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

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.

• CAUGHT HAZARD WARNING

• CHEMICAL HAZARD WARNING

• ELECTRICAL SHOCK HAZARD WARNING

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

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

1

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

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. • Use close supervision when this system is used by or near children or patients with physical limitations. • Use this system only for its intended use. Use only those attachments that are specified by the manufacturer. • 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, call Hill-Rom Technical Support. For contact information, refer to the back cover. For countries not listed on the back cover, contact your distributor. • 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. • Frequent exposure to Matar® germicidal detergent may discolor the Air Pulse Generator.

2

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 • When you use Dispatch® disinfectant or CSI disinfectant spray, make sure you wipe the unit dry. Failure to do so could result in the build-up of residue or equipment damage. • 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.

KEEP THESE INSTRUCTIONS

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

3

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

Intended Use 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.

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

4

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 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

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

5

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

Features J

A B

I C H

D G

F E

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.

6

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 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.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

7

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

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.

8

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.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10

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 Velcro® 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.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

9

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 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 Velcro® 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 Velcro® fasteners to attach the front flaps of the Full SPU Vest to each other.

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.

Adjust the Velcro® 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.

10

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.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 2.

Connect the Air Hoses to the disposable garment:

For a Wrap SPU Vest, do as follows: a.

Remove the tear label from the disposable garment.

b.

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

c.

Use the Velcro® loops on the side of the disposable garment to hold the Air Hoses in position.

For a 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.

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)

11

PROPRIETARY AND CONFIDENTIAL DRAFT 12-FEB-10 Set Up the Air Pulse Generator 1.

Install the Remote Control into the Air Pulse Generator.

NOTE: Use of the Remote Control is optional.

2.

Plug the Power Cord into the power inlet on the back of the Air Pulse Generator.

3.

Plug the Power Cord into a grounded, three-pronged outlet.

Software Version The software version is displayed on the opening screen when the unit is connected to AC power. To use the 1.20 software, go to “Use The Vest® Airway Clearance System, software version 1.20” on page 13. To use the 1.22 software, go to “Use The Vest® Airway Clearance System, software version 1.22” on page 30.

12

The Vest® Airway Clearance System, Model 205 User Manual (140643 REV 6)