Vest Airway Clearance System Model 105 PDF Instructions

The Vest® Airway Clearance System, Model 105 Instructions for Use Product No. P105 Apply Serial Number Label here or record Serial Number ____________________________ REVISION © 2022 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED. PATENTS / PATENT hillrom.com/patents May be covered by one or more patents. See the Internet address above. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. 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, 64-XXXXX, or 65-XXXXX serial number are manufactured by: HILL-ROM SERVICES PRIVATE LIMITED 1 YISHUN AVENUE 7 SINGAPORE 768923 and EU Importer: WELCH ALLYN LIMITED NAVAN BUSINESS PARK DUBLIN ROAD NAVAN, CO. MEATH C15 AW22, IRELAND Authorized Australian Sponsor: WELCH ALLYN AUSTRALIA PTY. LTD UNIT 4.01, 2-4 LYONPARK ROAD MACQUARIE PARK, NSW 2113 PHONE 1800 650 083 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. The Vest® Airway Clearance System, Model 105 i Instructions for Use (145330 REV 21) 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. This manual (145330) was originally released and supplied in English. For a list of available translations, contact Hill-Rom. Notice to Users and/or Patients in EU—Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Product images and labels are for illustrative purposes only. Actual product and label may vary. Twenty First Edition, 2022-01 First Printing, 2007 3M™ is a trademark of 3M Company. C3® and The Vest® are registered trademarks of Hill-Rom Services PTE Ltd. Hillrom™ is a 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. Viraguard® is a registered trademark of Veridien Corporation. Virex® is a registered trademark of Diversey, Inc. 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 respiratorycare.hill-rom.com. Reference Documents The Vest® Airway Clearance System, Models 104, 105, and 205 Service Manual (183192 – North America; 150754 – International) ii The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Table of Contents Revision........................................................... i Intended Use..................................................... 1 Intended patient population.................................. 1 Intended users............................................... 1 Indications for use............................................ 2 Introduction...................................................... 2 Symbols.......................................................... 3 Document Symbols.......................................... 3 Product Symbols............................................. 3 Safety Instructions................................................ 9 Contraindications............................................ 9 Relative Contraindications.................................... 9 Features......................................................... 15 Control Panel................................................ 15 Main Menu.................................................. 15 Air Hose Connector Ports.................................... 16 Air Hoses.................................................... 16 Remote Control............................................. 16 Inflatable Garment.......................................... 17 Power Cord................................................. 17 Contour Foam (Optional).................................... 17 Instructions for Use.............................................. 18 Setting Up the Unit.......................................... 19 Fitting the Classic Chest Vest............................ 22 Assemble the C3® Washable Garment.................... 23 Fitting the C3® Washable Garment and the Classic Full Vest.................................................... 24 Fitting the Classic Wrap Vest............................. 26 Software Version................................................. 27 Use The Vest® Airway Clearance System, Software Version 1.20.... 28 Normal Mode............................................... 28 Set and Use the New Program Mode......................... 30 Use the Program Mode...................................... 33 Set and Use the New Ramp Mode............................ 35 The Vest® Airway Clearance System, Model 105 iii Instructions for Use (145330 REV 21) Table of Contents Use the Ramp Mode......................................... 38 Check the Hour Meter Reading.............................. 40 Change the Language....................................... 41 Disable the Program Modes (Program and Ramp modes)..... 42 Set Custom Default Settings................................. 43 Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher.................................................. 46 Normal Mode............................................... 46 Set and Use the New Program Mode........................ 48 Use the Program Mode..................................... 52 Set and Use the New Ramp Mode............................ 55 Use the Ramp Mode......................................... 58 Check the Hour Meter Reading.............................. 61 Change the Language....................................... 61 Disable the Program Modes (Program and Ramp modes)..... 62 Set Custom Default Settings................................. 63 Cleaning........................................................ 67 General Cleaning—Air Pulse Generator and Classic Garment Line......................................................... 68 Steam Cleaning—Air Pulse Generator and Classic Garments.. 68 Cleaning Hard to Clean Spots—Air Pulse Generator and Classic Garments............................................ 68 C3® Garment Line Cleaning.................................. 69 Maintenance.................................................... 70 Disposal Instructions............................................ 70 Expected Life.................................................... 71 Service Calls..................................................... 71 Troubleshooting................................................ 72 Air Pulse Generator Does Not Power On...................... 72 No Air Pulses into the Inflatable Garment.................... 72 Screen Shows “Please Call for Service” Message.............. 73 An Air Hose Comes out of the Air Pulse Generator or Inflatable Garment during Operation........................ 73 Screen Shows “Restarting”................................... 73 The Inflatable Garment No Longer Fits....................... 73 Storage and Handling........................................... 74 iv The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Table of Contents Shipping the Unit............................................ 74 Specifications.................................................... 75 Electromagnetic Compatibility Guidance..................... 77 Frequently Asked Questions...................................... 83 The Vest® Airway Clearance System, Model 105 v Instructions for Use (145330 REV 21) Table of Contents NOTES: vi The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Intended Use 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). 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. 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. The Vest® Airway Clearance System, Model 105 1 Instructions for Use (145330 REV 21) Introduction 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. 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. 2 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Symbols SYMBOLS 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: – A WARNING 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. – A CAUTION identifies special procedures or precautions that persons must obey to help prevent equipment damage. PRODUCT SYMBOLS These symbols may or may not be used on your model of The Vest® Airway Clearance System: Symbol Definition Type B equipment with an F-type applied part, according to EN 60601-1. (The Vest garment is the applied part and the maximum temperature on it will not exceed 107.1°F (41.7°C) under operating conditions.) Dangerous voltage within the device may constitute a risk of electrical shock (Not applicable to units compliant with ANSI/AAMI ES60601-1(2005) +AMD (2012).) ON ON button—starts the Air Pulse Generator (starts therapy, inflates the inflatable garment, starts the unit after being paused). OFF OFF button—stops the Air Pulse Generator (stops therapy, pauses therapy). The Vest® Airway Clearance System, Model 105 3 Instructions for Use (145330 REV 21) Symbols Symbol Definition Frequency setting Pressure setting Time setting Up arrow button—increases the Frequency, Pressure, or Time setting. Down arrow button—decreases the Frequency, Pressure, or Time setting. Remote Control port Attention: Consult accompanying documents. (Applicable to UL60601-1 compliant units.) Class II equipment (double insulated), according to EN60601-1. Protected against ingress of an object of diameter 12.0 mm and vertically falling water drops. Read the operating instructions. 4 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Symbols Symbol Definition Medical— General Medical Equipment as to Electrical Shock, Fire, and Mechanical Hazards Only in Accordance with: ANSI/AAMI ES60601-1(2005) +AMD (2012) CAN/CSA-C22.2 No. 60601-1:14 E336914 Devices with serial numbers 61-XXXXX and 62-XXXXX are in compliance with these standards: Medical Equipment with respect to electrical shock, fire, mechanical, and other specified hazards only in accordance with UL/EN/IEC 60601-1 and CAN/CSA C22.2 No. 601.1. The Vest® Airway Clearance System, Model 105 conforms to the European Medical Device Directive 93/42/EEC. Identifies a replaceable fuse link in an electronic circuit. Environmental Protection: Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your Local Authority or a retailer for recycling advice. Do not spray. Cool iron only. Do not machine wash. Machine wash in cold water only. The Vest® Airway Clearance System, Model 105 5 Instructions for Use (145330 REV 21) Symbols Symbol Definition No chlorine bleach. Tumble dry. Bladder removal procedure (child small through adult sizes). Bladder installation procedure (child extra small size). Catalog number Batch number Serial number Medical Device 6 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Symbols Symbol Definition Authorized Representative in the European Community Unique Device Identification Temperature for transport and storage Relative humidity for transport and storage Atmospheric pressure for transport and storage Fragile This way up Keep Dry Stacking limit. The maximum number of identical packages which may be stacked on the bottom package. Date of manufacture Manufacturer The Vest® Airway Clearance System, Model 105 7 Instructions for Use (145330 REV 21) Symbols Symbol Definition Manufacturer and date of manufacture Non sterile For multiple use on a single patient Physician prescription required (for US only). (Only for products to the Federative Republic of Brazil) InMetro Net Connection Corporation (NCC) logo Tear open here (Only for products to the People's Republic of China) China RoHS2 (Standard No SJ/T 11364-2014) This product does not contain any hazardous substances exceeding concentration limits and is a green environmentally friendly product which can be recycled. 8 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Safety Instructions SAFETY INSTRUCTIONS CONTRAINDICATIONS WARNING: 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. 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 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 The Vest® Airway Clearance System, Model 105 9 Instructions for Use (145330 REV 21) Safety Instructions 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 READ ALL INSTRUCTIONS BEFORE USING NOTE: When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following important safeguards. WARNING: Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: Warning—Always unplug this product immediately after using. Warning—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. Warning—Adult supervision is required to use the therapy on children. Warning—Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities. Warning—Keep the hoses and power cord away from children to avoid strangulation. Warning—Do not store or use the device around pets, pests, or unsupervised children. 10 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: Warning—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. Warning—Use this product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer. Warning—Do not use unauthorized parts or accessories with this device. Warning—Use only Hill-Rom authorized air hoses and garments to avoid allergic skin reactions. Warning—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. Warning—Keep the unit and its Power Cord away from heated surfaces. Warning—Do not use the device near to any heat source such as a fireplace or radiant heater. Warning—Do not use the device in a dusty environment. Warning—Do not use the device in a heavy moisture environment. Warning—Never drop or insert any inappropriate object into any opening on the unit. Warning—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. Warning—If conditions exist that prohibit using The Vest® Airway Clearance System, do not use the unit. Death or serious injury could occur. Warning—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. The Vest® Airway Clearance System, Model 105 11 Instructions for Use (145330 REV 21) Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: Warning—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 respiratorycare.hill-rom.com. Warning—The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury. Warning—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. Warning—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. Warning—If the display on the Air Pulse Generator is faulty, do not use the unit. Warning—Do not use The Vest® Airway Clearance System on a conductive floor. Warning—Wait at least 2 to 4 hours after a meal before you use The Vest® Airway Clearance System. Warning—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. Warning—Before cleaning, unplug the unit from its power source. Failure to do so could cause personal injury or equipment damage. Warning—Do not expose the unit to excessive moisture or immerse it in water. 12 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: Warning—Do not run the Air Pulse Generator without the inflatable garment and Air Hoses attached. Warning—Do not use harsh cleansers, solvents, or detergents. Warning—Retain the original packaging material. If shipping is required, the original packing material provides the best protection for The Vest® Airway Clearance System. Warning—Do not eat or drink during a therapy session. To do so could cause a choking hazard. Warning—Discard The Vest® Airway Clearance System product in accordance with your local government regulations. Warning—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. Warning—This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm. Warning—The Vest® Airway Clearance System, Model 105 is MR Unsafe. Do not expose the system to any magnetic resonance (MR) environment. NOTES: The system may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core. The system may not function properly due to the strong magnetic and radio frequency fields generated by the MR equipment. Warning—Some patients with seizure history may experience seizure during or after the therapy. The Vest® Airway Clearance System, Model 105 13 Instructions for Use (145330 REV 21) Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: Warning—Some patients may experience nausea, dizziness or headache when using the therapy. It is recommended that patients refrain from doing any therapy for a period of time after eating. If patients experience these symptoms, it is recommended that they take breaks during therapy. Warning—Patients that have external ports or equipment (for example, catheters, feeding tubes, tracheostomy tubes) should take care to cushion the site and/or support the equipment before initiating therapy. Warning—For patients with breast implants, make sure that you follow the doctor's prescriptions and exercise caution before you conduct the therapy. SAVE THESE INSTRUCTIONS 14 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Features FEATURES Air Pulse Generator A Air Pulse Generator D Remote Control B Air Hose Connection Ports E Control Panel C Air Hoses 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. MAIN MENU The Main Menu is shown when the Air Pulse Generator is powered on and ready for therapy or options selection. The Vest® Airway Clearance System, Model 105 15 Instructions for Use (145330 REV 21) Features AIR HOSE CONNECTOR PORTS The Air Hoses connect to the Air Pulse Generator at the two Air Hose Connector Ports on the face of the Air Pulse Generator. AIR HOSES The Air Hoses connect the inflatable garment to the Air Pulse Generator. NON LOCKING LOCKING REMOTE CONTROL The Remote Control is optional and can be used instead of the ON/OFF control to pause or resume the Air Pulse Generator. 16 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Features INFLATABLE GARMENT The garment that you have will look like one of these: Chest Vest Full Vest Wrap Vest Chest When connected to the Air Pulse Generator by the Air Hoses, the inflatable garment is controlled by the Air Pulse Generator to provide pulsations to the chest wall. The most appropriate size garment will be provided to you with the Air Pulse Generator and other accessories. NOTE: Full Chest The non-washable garments are referred to as the Classic Line, and the washable garments are referred to as the C3® Garment Line. Extra Small Full Wrap POWER CORD The Power Cord plugs into the Air Pulse Generator and a power outlet. NOTE: The Power Cord required for your country may be different than shown. CONTOUR FOAM (OPTIONAL) The contour foam (P/N 300177000) is an optional accessory. The foam helps provide comfort for the patient who has a Hickman catheter, portacath, and/or G-tube. The Vest® Airway Clearance System, Model 105 17 Instructions for Use (145330 REV 21) Instructions for Use INSTRUCTIONS FOR USE WARNING: Warning—Changing prescribed settings, an unadjusted or ill-fitting garment may cause an ineffective therapy or lead to patient injury. Protocol for Use and Special Instructions Your physician has prescribed The Vest® Airway Clearance System to be used __________ times per day. NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment to prevent static charge build-up. Additional Instructions: _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ NOTES: _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ If you have any questions or concerns, 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 respiratorycare.hill-rom.com. 18 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Instructions for Use SETTING UP THE UNIT 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. NOTE: If your physician has prescribed aerosol therapy to be used during the treatment, set up the appropriate equipment. WARNING: Warning—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. 1. Make sure the Air Pulse Generator is not wet or damp. 2. Put the Air Pulse Generator in a location that is stable and convenient. 3. Plug the Power Cord into the back of the Air Pulse Generator. 4. Plug the Power Cord into an applicable power outlet. NOTE: The Power Cord required for your country may be different than shown. The Vest® Airway Clearance System, Model 105 19 Instructions for Use (145330 REV 21) Instructions for Use NOTE: Once the unit is plugged in or the ON button is pressed, the following will show on the screen: a. The Model number. b. The total number of hours the device has been used. c. The software revision. NOTE: To temporarily illuminate the backlight on the display, press any one of the six Up or Down arrow buttons. CAUTION: Caution—Do not run the Air Pulse Generator without the inflatable garment and Air Hoses attached. Equipment damage could occur. 5. Connect each Air Hose as follows: Non-Locking Hose a. Connect the Air Hose to the Air Hose Connector Port on the front of the Air Pulse Generator. b. Slightly twist the Air Hose into the Air Hose Connector Port to help secure the Air Hose in position. Locking Hose a. Align the mark on the Air Hose with the corresponding mark on the Air Hose Connector Port on the front of the Air Pulse Generator. b. Turn the Air Hose to the locked position. 6. 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: 20 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Instructions for Use NOTE: The contour foam is not sterile. a. Cut out a center hole to form a “donut” shape in the foam. b. Put the open hole of the “donut” directly over the port site. 7. Fit the inflatable garment: NOTE: The Vest® Airway Clearance System can be used with the patient in a sitting, lying down, or standing position. Chest Vest—refer to “Fitting the Classic Chest Vest” on page 22. Full Vest—refer to “Fitting the C3® Washable Garment and the Classic Full Vest” on page 24. Wrap Vest—refer to “Fitting the Classic Wrap Vest” on page 26. The Vest® Airway Clearance System, Model 105 21 Instructions for Use (145330 REV 21) Instructions for Use 8. Connect the Air Hoses to the ports on the inflatable garment. 9. Slightly twist the Air Hoses into the Air Hose Connector Ports to help secure the Air Hoses in position. NOTE: The connection of the Air Hoses to the Ports is the same for the locking and the non-locking hoses. 10. To use the optional Remote Control instead of the ON button, plug the Remote Control into the port on the front of the Air Pulse Generator. Fitting the Classic Chest Vest NOTE: It is recommended that a single layer of cotton clothing be worn beneath the inflatable garment to prevent static charge build-up. 1. Unfasten the back panel tabs from the main hook-and-loop fastener, and separate the front and back panels of the Chest Vest. 2. Turn the Chest Vest so the Air Hose Connector Ports are in front, and slide the Chest Vest over the head. NOTE: The Chest Vest can also be worn with the Air Hose Connector Ports in the back. 3. With the Chest Vest deflated, temporarily attach both back panel tabs of the Chest Vest to the front panel. 22 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Instructions for Use 4. Adjust the hook-and-loop fasteners on the shoulder straps so the bottom of each arm opening of the Chest Vest is comfortably close to the underarm. 5. Detach both back panel tabs from the front of the Chest Vest. 6. For the best fit, inhale deeply, and then secure both back panel tabs to the front panel. You should be able to fit a flat hand between the Chest Vest and the body. 7. Make sure the Chest Vest fits close to the body without being uncomfortably snug. To tighten the fit at the bottom edge, angle the back panel tabs upward. To loosen the fit at the bottom edge, angle the back panel tabs downward. 8. Adjust the shoulder straps so that the bottom of each arm opening of the inflatable garment is comfortably close to the underarm. Assemble the C3® Washable Garment The C3® Washable Garment will arrive to you in two pieces and will need to be assembled as follows. The Classic Full Vest does not need to be assembled, For the Classic Full Vest, go to “Fitting the C3® Washable Garment and the Classic Full Vest” on page 24. To assemble the Child Small through Adult Sizes: 1. Lay the outer garment flat. 2. Open the zipper on the bottom of the outer garment. 3. Put the inflatable bladder into the outer garment. 4. Put the air duct pipes through the outer garment. 5. Press the studs to attach the bladder to the outer garment. The Vest® Airway Clearance System, Model 105 23 Instructions for Use (145330 REV 21) Instructions for Use 6. Close the zipper on the bottom of the outer garment. To assemble the Child Extra Small Size: 1. Lay the outer garment flat. 2. Open the flap on the bottom of the outer garment. 3. Put the inflatable bladder into the outer garment. 4. Put the air duct pipes through the outer garment. Fitting the C3® Washable Garment and the Classic Full Vest Fitting the Child Small through Adult Sizes NOTE: It is recommended that a single layer of cotton clothing be worn beneath the inflatable garment. 1. Put the garment on so the closures are in front. NOTE: The garment can also be worn with the Air Hose Connector Ports in the back. 2. Connect the closures so the garment fits loosely over the chest. NOTE: You should be able to fit a fist between the garment and the body before you inflate the garment. 3. Adjust the shoulder straps so the arm opening is just beneath the patient’s underarms. 24 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Instructions for Use 4. Using the front closures, adjust the garment to fit close to the body without being uncomfortably snug: To tighten the front closures, hold the buckle, and pull the end of the strap to the patient’s right. To loosen the front closures, gently lift the back of the buckle, and lengthen the strap. 5. If any excess material is under the front closures, fold it under itself to make sure the garment fits correctly: a. Loosen the front closures. b. Fold the top flap under itself. c. Tighten the front closures. Fitting the Child Extra Small Size It is recommended that a single layer of cotton clothing be worn beneath the inflatable garment. 1. Put the garment on so the Air Hose Connector Ports are in the front. 2. Connect the closures so the garment fits loosely over the chest: NOTE: You should be able to fit a flat hand between the garment and the body before you inflate the garment. 3. Adjust the shoulder straps so the arm opening is just beneath the patient’s underarms. The Vest® Airway Clearance System, Model 105 25 Instructions for Use (145330 REV 21) Instructions for Use 4. Adjust the garment to fit close to the body without being uncomfortably snug: To tighten the fit at the bottom edge, angle the front panel tabs upward. To loosen the fit at the bottom edge, angle the front panel tabs downward. Fitting the Classic Wrap Vest NOTE: It is recommended that a single layer of cotton clothing be worn beneath the inflatable garment. 1. With the garment deflated, put the garment so it is perpendicular with the patient’s torso. 2. Put the garment in position just beneath the patient’s underarms, and centered around the nipple line and continue to pull the garment around the patient’s torso. 3. Pull both ends of the garment around the patient’s chest, and use the hook and loop fasteners to temporarily attach both ends to each other. NOTE: The garment can be worn with the Air Hose Connector Ports anywhere around the chest that is comfortable. 4. Have the patient inhale deeply, and then attach the ends of the garment so it fits close to the body, but is not uncomfortable. You should be able to fit a flat hand between the garment and the body. 26 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Software Version SOFTWARE VERSION The software version is displayed on the start screen when the unit is connected to AC power. Software Version Instructions 1.20 X.XX is the software version; (XX) is the software revision. Go to “Use The Vest® Airway Clearance System, Software Version 1.20” on page 28. 1.22 or 2.00 and higher VER: X.XX (XX) is the software version; REV: XX is the software revision. Go to “Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher” on page 46. The Vest® Airway Clearance System, Model 105 27 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 USE THE VEST® AIRWAY CLEARANCE SYSTEM, SOFTWARE VERSION 1.20 Make sure the unit is set up correctly. Once power is connected, the unit will show a blank screen for up to 15 seconds. Then it will show the model number and the total therapy hours for the unit. This screen shows for 10 seconds or until you press the ON button. NOTE: To show the total therapy hours, press the OFF button when the Main menu is shown. NORMAL MODE The Normal mode is using one Frequency, Pressure, and Time settings for the entire therapy session. 1. Press the Up arrow button above NORMAL for the standard operation mode. The screen will show the previously programmed Frequency, Pressure, and treatment Time settings (either factory settings or settings programmed by your clinical trainer based on your doctors prescription). 2. Confirm the settings on the screen. If the settings match the prescribed treatment, continue to step 3. Otherwise, adjust the settings to match the prescription. a. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed treatment shows on the screen. The 28 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 Frequency or Hertz (Hz) may be set between 5 and 20 cycles per second. b. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen. The Pressure may be set between 1 and 10. c. To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen. The treatment Time may be set between 1 and 60 minutes. NOTE: It is not necessary to stop the treatment to adjust the settings. 3. Press the ON button. The inflatable garment will inflate. NOTE: If the unit is left in this mode for 10 minutes, it will turn off. 4. Press the ON button again to begin the treatment. The set treatment Time shows as it counts down to zero. 5. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. b. To resume treatment, press the ON button or the Remote Control again. 6. If it is necessary to end the treatment session The Vest® Airway Clearance System, Model 105 29 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 7. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the main screen. 8. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 9. Unplug the system from its power source. 10. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 11. Remove the inflatable garment. SET AND USE THE NEW PROGRAM MODE The New Program mode allows the programming of up to eight (8) different Programming Points, each with its own combination of Frequency, Pressure, and treatment Time. WARNING: Warning—Consult your physician prior to changing prescribed settings. Failure to do so can cause personal injury. 1. Press the ON button. 30 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 2. Press the UP arrow button above OPTIONS. 3. Press the Down arrow button below New Pgm to create a new program. The screen will show the Frequency, Pressure, and treatment Time settings for the first Programming Point. NOTE: All the settings can be adjusted. 4. For Programming Point 1, if the settings match the prescribed treatment, continue to step 3. Otherwise, adjust the settings to match the prescription by pressing the Up and Down arrow buttons associated with Frequency, Pressure, and treatment Time. 5. Once you have set Programming Point 1, proceed to Programming Point 2 by pressing the ON button (to move to a previous Programming Point, press the OFF button). Adjust the settings to match the prescription and repeat for all 8 Programming Points. NOTE: If the prescription does not call for all 8 Programming Points, after programming the last prescribed programming point, set the Time to 0 MIN for the following segment. Once you change the Programming Point Time to 0 MIN and press the ON button, it will take you to the start of the program to begin therapy. 6. Press the ON button. The inflatable garment will inflate. 7. Press the ON button again to begin the treatment program. The set treatment Time shows as it counts down to zero for each Programming Point. The Vest® Airway Clearance System, Model 105 31 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 8. Therapy will automatically end after it has gone through each Programming Point. 9. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. b. To resume treatment, press the ON button or the Remote Control again. 10. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 11. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the Program and Ramp main screen. 32 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 12. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 13. Unplug the system from its power source. 14. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 15. Remove the inflatable garment. USE THE PROGRAM MODE Runs a previously created New Program mode. See “Set and Use the New Program Mode” on page 30. WARNING: Warning—Consult your physician prior to changing prescribed settings. Failure to do so can result in personal injury. 1. Press the ON button. 2. Press the UP arrow button above OPTIONS. 3. Press the Up arrow button above PGM to run the previously created program, or selected default program. 4. Press the ON button. The inflatable garment will inflate. The Vest® Airway Clearance System, Model 105 33 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 5. Press the ON button again to begin the treatment program. The set treatment Time shows as it counts down to zero for each Programming Point. 6. The therapy will automatically end after it has gone through each of the Programming Points. 7. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. b. To resume treatment, press the ON button or the Remote Control again. 8. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 9. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must 34 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 press the ON button to continue to the Program and Ramp main screen. 10. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 11. Unplug the system from its power source. 12. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 13. Remove the inflatable garment. SET AND USE THE NEW RAMP MODE Creates a new Ramp Program to ease the patient from a lower setting to a higher setting during a limited period of the therapy session. WARNING: Warning—Consult your physician if not using the prescription as provided. Failure to do so can result in personal injury. 1. Press the ON button. 2. Press the UP arrow button above OPTIONS. 3. Press the Down arrow button below New Ramp to adjust the program settings. The Vest® Airway Clearance System, Model 105 35 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 4. Look at the settings on the screen. Ramp Time Percent is the portion of the treatment Time required to increase from the initial settings (Ramp Start) to the final settings (Ramp End). To adjust the percent to the prescribed therapy, press the right Up or Down arrow buttons. 5. Press the ON button to advance to the next screen. 6. Review the settings for Frequency and Pressure for the initial setting, Ramp Start. a. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed treatment shows on the screen. The Frequency (or Hertz (Hz)) may be set between 5 and 20 cycles per second. b. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen. Pressure may be set between 1 and 10. 7. Press the ON button to advance to the next screen. 8. Review the settings on the screen. Frequency and Pressure for the final setting, Ramp End, are shown as treatment Time. a. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed setting shows on the screen. Frequency or Hertz (Hz) may be set between the Ramp Start setting and 20 cycles per second. b. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed setting shows on the screen. Pressure may be set between the Ramp Start setting and 10. 36 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 c. To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen. The treatment Time may be set between 1 and 60 minutes. 9. Press the ON button to advance to the next screen. This screen shows the summary of the ramp program you have just created. 10. Press the ON button. The inflatable garment will inflate. 11. Press the ON button again to begin the therapy. The screen will show the word “Ramping” during the ramp portion of the program. The total treatment Time shows as it counts down to zero. NOTE: Therapy settings can not be changed during Ramping stage. 12. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. b. To resume treatment, press the ON button or the Remote Control again. 13. If it is necessary to end the treatment session before it is complete, press the OFF button twice. The Vest® Airway Clearance System, Model 105 37 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 NOTE: Pressing the OFF button does not turn off the screen. 14. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press ON to continue to the main screen. 15. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 16. Unplug the system from its power source. 17. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 18. Remove the inflatable garment. USE THE RAMP MODE Runs a previously created Ramp Program. See “Set and Use the New Ramp Mode” on page 35. WARNING: Warning—Consult your physician if not using the prescription as provided. Failure to do so can result in personal injury. 1. Press the ON button. 38 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 2. Press the UP arrow button above OPTIONS. 3. Press the Up arrow button above RAMP to run the previously created ramp program. 4. The programmed points will be shown. Press the ON button to advance to the next screen. 5. Press the ON button. The inflatable garment will inflate. 6. Press the ON button again to begin the program. The screen will show the word “Ramping” during the ramp portion of the program. The total treatment Time shows as it counts down to zero. NOTE: Therapy settings can not be changed during Ramping stage. 7. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. The Vest® Airway Clearance System, Model 105 39 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 b. To resume treatment, press the ON button or the Remote Control again. 8. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 9. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the main screen. 10. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 11. Unplug the system from its power source. 12. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 13. Remove the inflatable garment. CHECK THE HOUR METER READING The Hour Meter Reading will show on the screen when you first plug your device in. You can also access the Hour Meter Reading as follows: With the device plugged in, press the On button and then press the Off button. The Hour Meter Reading will show on the screen. 40 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 CHANGE THE LANGUAGE 1. Press the ON button. 2. Press the Up arrow button above NORMAL. The Normal mode screen shows. 3. Press the two -outside Down arrow buttons at the same time for a minimum of 3 seconds (or until the screen changes). 4. Press the middle Down arrow button until the desired language shows in all capital letters. 5. To accept the change, press the far right Down arrow button. 6. Once you have accepted the change, the system will automatically re-boot and go back to the main screen in the applicable language. The Vest® Airway Clearance System, Model 105 41 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 DISABLE THE PROGRAM MODES (PROGRAM AND RAMP MODES) Disable the Program modes allows the unit to operate in Normal mode only, and removes access to custom modes by the user. 1. Press the ON button. 2. Press the left Up arrow button above NORMAL. The Normal mode screen shows. 3. Press the two outside arrow buttons at the same time for a minimum of 3 seconds, or until the screen changes. 4. Press the right Up arrow button above Programs. 5. Press the right Up arrow button above pgm disable (it will turn to PGM DISABLE). 6. To accept the change, press the right Down arrow below ACCEPT. 7. To accept all changes and exit out of the menu, press the right Down arrow button below ACCEPT. 42 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 8. Once you have accepted the change, the system will automatically re- boot and go to the main screen of NORMAL mode. You will no longer be able to see the Program or Ramp mode programs. 9. To switch back to Program mode, repeat the steps starting at step 2. NOTE: Press the Up arrow button above pgm enable at step 4 to enable the Program mode (it will change pgm enable to PGM ENABLE). SET CUSTOM DEFAULT SETTINGS Allows the user to set the default settings for the modes of operation. These settings will be the initial settings for all users. 1. Press the ON button. 2. Press the Up arrow button above NORMAL. The Normal mode screen shows. 3. Press the two outside Down arrows for a minimum of 3 seconds, or until the screen changes. 4. Press the left Up arrow button above Defaults. 5. Press the right Up arrow button above default (Defaults will change to DEFAULTS). The Vest® Airway Clearance System, Model 105 43 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 6. To accept the change, press the right Down arrow button below ACCEPT. 7. To adjust the Maximum Run Time use the Up and Down arrow buttons above and below MIN and then press the ON button. 8. To set default Frequency, Pressure, and Time settings for Normal mode, adjust each by using the respective Up and Down arrow buttons and press the ON button. 9. To adjust the default settings for Program mode, set each Program Point sequentially. Press the ON button to advance to the next Programming Point. 10. Adjust Frequency, Pressure, and Time for each Program Point (1 through 8) or change the time to zero, after the last desired Program Point, to make the previous point the last point. 11. Press the ON button to advance to the next default setting. 44 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.20 12. Adjust the Ramp Time Percent for the Default Ramp mode using the right Up and Down arrow buttons, and press the ON button. 13. Adjust the Ramp Start Frequency, and Pressure settings for default Ramp mode by using the left and middle Up and Down arrow buttons, and press the ON button. 14. Adjust the Ramp End settings for default Ramp Mode Frequency, Pressure, and Time settings using the Up and Down arrow buttons, and press the ON button. 15. To accept all of the changes, press the right Down arrow below ACCEPT. 16. Once you have accepted the change, it will automatically re-boot the system and go back to the main screen. 17. To switch back to previous patient default mode, repeat the steps and select prev pt instead of default. The Vest® Airway Clearance System, Model 105 45 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher USE THE VEST® AIRWAY CLEARANCE SYSTEM, SOFTWARE VERSION 1.22 OR 2.00 AND HIGHER Make sure the unit is set up correctly. Once power is connected, the unit will show a blank screen for up to 15 seconds. Then it will show the model number and the total therapy hours for the unit. This screen shows for 10 seconds or until you press the ON button. NOTE: To show the total therapy hours, press the OFF button when the Main menu is shown. NORMAL MODE The Normal mode is using one Frequency, Pressure, and Time settings for the entire therapy session. 1. Press the Up arrow button above NORMAL for the standard operation mode. The screen will show the previously programmed Frequency, Pressure, and treatment Time settings (either factory settings or settings programmed by your clinical trainer based on your doctors prescription). 2. Confirm the settings on the screen. If the settings match the prescribed treatment, continue to step 3. Otherwise, adjust the settings to match the prescription. a. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed treatment shows on the screen. The 46 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Frequency or Hertz (Hz) may be set between 5 and 20 cycles per second. b. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen. The Pressure may be set between 1 and 10. c. To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen. The treatment Time may be set between 1 and 60 minutes. NOTE: It is not necessary to stop the treatment to adjust the settings. 3. Press the ON button. The inflatable garment will inflate. NOTE: If the unit is left in this mode for 10 minutes, it will turn off. 4. Press the ON button again to begin the treatment. The set treatment Time shows as it counts down to zero. 5. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. The Vest® Airway Clearance System, Model 105 47 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher b. To resume treatment, press the ON button or the Remote Control again. 6. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 7. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the main screen. 8. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 9. Unplug the system from its power source. 10. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 11. Remove the inflatable garment. SET AND USE THE NEW PROGRAM MODE The New Program mode allows the programming of Program A and Program B modes, each with up to eight (8) points with various settings within a single therapy session. It also allows the programming of the Cough Pause feature (reminder to cough). NOTE: All the settings can be adjusted. You can program up to 8 different Programming Points, each with its own combination of Frequency, Pressure, and treatment Time. 48 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher WARNING: Warning—Consult your physician prior to changing prescribed settings. Failure to do so can cause personal injury. 1. Press the ON button. 2. Press the UP arrow button above CUSTOM. 3. Do one of these: a. To program the Ramp mode, press the Down arrow under RAMP NEW and go to “Set and Use the New Ramp Mode” on page 55. b. To program Program A or Program B, press the Down arrow button below PGM A NEW, or PGM B NEW and go to step 4. 4. Press the Up or Down arrow for Cough Pause Reminder duration (time between cough pauses). A zero (0) time will turn off the Cough Pause feature. 5. Press On to go to the next screen. The Vest® Airway Clearance System, Model 105 49 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 6. Press the Up or Down arrow to select the pause duration. This will set the duration the unit pauses for coughs. 7. Press On to go to the next screen. 8. For Programming Point 1, if the settings match the prescribed treatment, continue to step 9. Otherwise, adjust the settings to match the prescription by pressing the Up and Down arrow buttons associated with Frequency, Pressure, and treatment Time. 9. Once you have set Programming Point 1, proceed to Programming Point 2 by pressing the ON button (to move to a previous Programming Point, press the OFF button). Adjust the settings to match the prescription and repeat for all 8 Programming Points. NOTE: If the prescription does not call for all 8 Programming Points, after programming the last prescribed programming point, set the Time to 0 MIN for the following segment. Once you change the Programming Point Time to 0 MIN and press the ON button, it will take you to the start of the program to begin therapy. 10. Press the ON button. The inflatable garment will inflate. 11. Press the ON button again to begin the treatment program. The set treatment Time shows as it counts down to zero for each Programming Point. 12. Therapy will automatically end after it has gone through each Programming Point. 13. If it is necessary to pause the treatment during a session, do as follows: 50 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. b. To resume treatment, press the ON button or the Remote Control again. 14. When the time for a cough pause is reached, these will happen: a. The unit will pause. b. The display will change to show the pause duration timer. c. The garment will deflate. 15. While the pause happens, the patient should cough as prescribed. 16. When the timer reaches zero, the garment will inflate, and therapy will resume. NOTE: If additional time is needed, press the OFF control to pause the unit. To resume therapy before the cough pause timer expires, you can press ON or squeeze the Remote Control. 17. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 18. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must The Vest® Airway Clearance System, Model 105 51 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher press the ON button to continue to the Program and Ramp main screen. 19. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 20. Unplug the system from its power source. 21. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 22. Remove the inflatable garment. USE THE PROGRAM MODE Runs a previously created New Program mode. See “Set and Use the New Program Mode” on page 48. WARNING: Warning—Consult your physician prior to changing prescribed settings. Failure to do so can result in personal injury. 1. Press the ON button. 2. Press the UP arrow button above CUSTOM. 3. Press the Up arrow button above PGM A or PGM B to run the previously created program, or selected default program. 52 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 4. Press the ON button. The inflatable garment will inflate. 5. Press the ON button again to begin the treatment program. The set treatment Time shows as it counts down to zero for each Programming Point. 6. When the time for a cough pause is reached, these will happen: a. The unit will pause. b. The display will change to show the pause duration timer. c. The garment will deflate. 7. While the pause happens, the patient should cough as prescribed. 8. When the timer reaches zero, the garment will inflate, and therapy will resume. NOTE: If additional time is needed, press the OFF control to pause the unit. 9. To resume therapy before the cough pause timer expires, you can press ON or squeeze the Remote Control. 10. The therapy will automatically end after it has gone through each of the Programming Points. 11. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. The Vest® Airway Clearance System, Model 105 53 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher b. To resume treatment, press the ON button or the Remote Control again. 12. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 13. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the Program and Ramp main screen. 14. When the time for a cough pause is reached, these will happen: a. The unit will pause. b. The display will change to show the pause duration timer. c. The garment will deflate. 15. While the pause happens, the patient should cough as prescribed. 16. When the timer reaches zero, the garment will inflate, and therapy will resume. NOTE: If additional time is needed, press the OFF control to pause the unit. To resume therapy before the cough pause timer expires, you can press ON or squeeze the Remote Control. 54 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 17. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. d. Unplug the system from its power source. e. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. f. Remove the inflatable garment. SET AND USE THE NEW RAMP MODE Creates a new Ramp Program to ease the patient from a lower setting to a higher setting during a limited period of the therapy session. WARNING: Warning—Consult your physician if not using the prescription as provided. Failure to do so can result in personal injury. 1. Press the ON button. 2. Press the UP arrow button above CUSTOM. 3. Press the Down arrow button below New Ramp/New to adjust the program settings. The Vest® Airway Clearance System, Model 105 55 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 4. Look at the settings on the screen. Ramp Time Percent is the portion of the treatment Time required to increase from the initial settings (Ramp Start) to the final settings (Ramp End). To adjust the percent to the prescribed therapy, press the right Up or Down arrow buttons. 5. Press the ON button to advance to the next screen. 6. Review the settings for Frequency and Pressure for the initial setting, Ramp Start. a. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed treatment shows on the screen. The Frequency (or Hertz (Hz)) may be set between 5 and 20 cycles per second. b. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen. Pressure may be set between 1 and 10. 7. Press the ON button to advance to the next screen. 8. Review the settings on the screen. Frequency and Pressure for the final setting, Ramp End, are shown as treatment Time. a. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed setting shows on the screen. Frequency or Hertz (Hz) may be set between the Ramp Start setting and 20 cycles per second. b. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed setting shows on the screen. Pressure may be set between the Ramp Start setting and 10. 56 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher c. To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen. The treatment Time may be set between 1 and 60 minutes. 9. Press the ON button to advance to the next screen. This screen shows the summary of the ramp program you have just created. 10. Press the ON button. The inflatable garment will inflate. 11. Press the ON button again to begin the therapy. The screen will show the word “Ramping” during the ramp portion of the program. The total treatment Time shows as it counts down to zero. NOTE: Therapy settings can not be changed during Ramping stage. 12. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. b. To resume treatment, press the ON button or the Remote Control again. 13. If it is necessary to end the treatment session before it is complete, press the OFF button twice. The Vest® Airway Clearance System, Model 105 57 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher NOTE: Pressing the OFF button does not turn off the screen. 14. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press ON to continue to the main screen. 15. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 16. Unplug the system from its power source. 17. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 18. Remove the inflatable garment. USE THE RAMP MODE Runs a previously created Ramp Program. See “Set and Use the New Ramp Mode” on page 55. WARNING: Warning—Consult your physician if not using the prescription as provided. Failure to do so can result in personal injury. 1. Press the ON button. 58 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 2. Press the UP arrow button above Custom. 3. Press the Up arrow button above RAMP to run the previously created ramp program. 4. The programmed points will be shown. Press the ON button to advance to the next screen. 5. Press the ON button. The inflatable garment will inflate. 6. Press the ON button again to begin the program. The screen will show the word “Ramping” during the ramp portion of the program. The total treatment Time shows as it counts down to zero. NOTE: Therapy settings cannot be changed during Ramping stage. 7. If it is necessary to pause the treatment during a session, do as follows: a. Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. The Vest® Airway Clearance System, Model 105 59 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher b. To resume treatment, press the ON button or the Remote Control again. 8. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. 9. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the main screen. 10. When the treatment session is complete: a. The “Session Complete” message shows. b. The pulsations stop. c. The inflatable garment deflates. 11. Unplug the system from its power source. 12. Remove the Air Hoses from the Air Hose Ports on the inflatable garment. 13. Remove the inflatable garment. 60 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher CHECK THE HOUR METER READING The Hour Meter Reading will show on the screen when you first plug your device in. You can also access the Hour Meter Reading as follows: With the device plugged in, press the ON button and then press the OFF button. The Hour Meter Reading will show on the screen. CHANGE THE LANGUAGE 1. Press the ON button. 2. Press the Up arrow button above NORMAL. The Normal mode screen shows. 3. Press the two outside Down arrow buttons at the same time for a minimum of 3 seconds (or until the screen changes). 4. Press the middle Down arrow button until the desired language shows in all capital letters. The Vest® Airway Clearance System, Model 105 61 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 5. To accept the change, press the far right Down arrow button. 6. Once you have accepted the change, the system will automatically re-boot and go back to the main screen in the applicable language. DISABLE THE PROGRAM MODES (PROGRAM AND RAMP MODES) Disable the Program modes allows the unit to operate in Normal mode only, and removes access to custom modes by the user. 1. Press the ON button. 2. Press the left Up arrow button above NORMAL. The Normal mode screen shows. 3. Press the two outside Down arrow buttons at the same time for a minimum of 3 seconds, or until the screen changes. 4. Press the right Up arrow button above Programs. 62 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 5. Press the right Up arrow button above pgm disable (it will turn to PGM DISABLE). 6. To accept the change, press the right Down arrow below ACCEPT. 7. To accept all changes and exit out of the menu, press the right Down arrow button below ACCEPT. 8. Once you have accepted the change, the system will automatically re- boot and go to the main screen of NORMAL mode. You will no longer be able to see the Program or Ramp mode programs. 9. To switch back to Program mode, repeat the steps starting at step 3. NOTE: Press the Up arrow button above pgm enable at step 4 to enable the Program mode (it will change pgm enable to PGM ENABLE). SET CUSTOM DEFAULT SETTINGS Allows the user to set the default settings for the modes of operation. These settings will be the initial settings for all users. 1. Press the ON button. 2. Press the Up arrow button above NORMAL. The Normal mode screen shows. The Vest® Airway Clearance System, Model 105 63 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 3. Press the two outside Down arrows for a minimum of 3 seconds, or until the screen changes. 4. Press the left Up arrow button above Defaults. 5. Press the right Up arrow button above default (Defaults will change to DEFAULTS). 6. To accept the change, press the right Down arrow button below ACCEPT. 7. To adjust the Maximum Run Time use the Up and Down arrow buttons above and below MIN and then press the ON button. 8. Do one of these: a. To change the default Normal settings, press the Up arrow above NORMAL, and go to step 9. b. To change the default settings of Program A press the Up arrow above PGM A, or press the Down arrow below PGM B, and go to step 10. c. To change the default Ramp settings, press the Down arrow below RAMP, and go to step 18. d. Press ON to accept changes or to advance to the next screen and go to step 21. 64 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 9. To set default Frequency, Pressure, and Time settings for Normal mode, adjust each by using the respective Up and Down arrow buttons, press the ON button and return to step 8. 10. Press the Up or Down arrow for Cough Pause Reminder duration (time between cough pauses). A zero (0) time will turn off the Cough Pause feature. 11. Press On to go to the next screen. 12. Press the Up or Down arrow to select the pause duration. This will set the duration the unit pauses for coughs. 13. Press On to go to the next screen. 14. Press the Down arrow under Yes or No for the Auto Start feature. NOTE: Auto Start resumes therapy after cough pause duration expires. 15. Press On to go to the next screen. 16. Adjust Frequency, Pressure, and Time for each Program Point (1 through 8) or change the time to zero, after the last desired Program Point, to make the previous point the last point. The Vest® Airway Clearance System, Model 105 65 Instructions for Use (145330 REV 21) Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 17. Press the ON button to advance to the next default setting, and return to step 8. 18. Adjust the Ramp Time Percent for the Default Ramp mode using the right Up and Down arrow buttons, and press the ON button. 19. Adjust the Ramp Start Frequency, and Pressure settings for default Ramp mode by using the left and middle Up and Down arrow buttons, and press the ON button. 20. Adjust the Ramp End settings for default Ramp mode Frequency, Pressure, and Time settings using the Up and Down arrow buttons, and press the ON button and return to step 8. 21. To accept all of the changes, press the right Down arrow below ACCEPT. 22. Once you have accepted the change, it will automatically re-boot the system and go back to the main screen. 23. To switch back to previous patient default mode, repeat steps 3 through 5 and select prev pt instead of default. 66 The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21) Cleaning CLEANING

Vest Airway Clearance System Model 105 PDF Instructions

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