Monarch Airway Cleatance System Model 1000 User Manual Rev 1

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© 2017 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED.

PATENTS / PATENT www.hill-rom.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. Manufacturer: HILL-ROM SERVICES PRIVATE LIMITED 1 YISHUN AVENUE 7 SINGAPORE 768923 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. 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. The information in this manual is subject to change without notice. HillRom makes no commitment to update or keep current, the information in this manual. Hill-Rom reserves the right to make changes without notice in design, specifications, and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products. This manual (195292) was originally released and supplied in English. For a list of available translations, contact Hill-Rom Technical Support. First Edition, March 2017 First Printing, 2017 Cough Pause® and Hill-Rom® are registered trademarks of Hill-Rom Services, Inc. Monarch™ and VisiView® are trademarks of Hill-Rom Services PTE Ltd. Bluetooth® is a registered trademark of Bluetooth Sig, Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc. Replace this manual (195292) if it is damaged and/or cannot be read.

The Monarch™ Airway Clearance System User Manual (195292 REV 1)

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For product support or to order additional copies of this manual (195292), contact Hill-Rom: • In the USA, call Hill-Rom at 800-426-4224 • Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.respiratorycare.hill-rom.com.

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The Monarch™ Airway Clearance System User Manual (195292 REV 1)

Table of Contents Document Symbols... 1 Important Safeguards... 1 Intended Use... 4 Intended Patient Population... 4 Intended Users... 4 Contraindications... 5 Relative Contraindications... 5 Acronyms... 6 Features... 6 Pendant... 9 Product Symbols... 9 Pendant Screen Symbols... 12 Mobile Device Symbols... 14 Instructions for Use... 15 Protocol for Use and Special Instructions... 15 Setting Up the Unit... 16 Getting Started... 16 Install Battery... 16 Charge Battery... 18 Attaching the Vest Shell... 19 Garment Fitting... 20 Set Up the Mobile App... 25 Program the Garment... 28 Turn Garment On... 28 Treatment Options... 29 Programing Manual Mode... 29 Program Manual Mode-Pendant... 29 Program Manual Mode-Mobile App... 31 Program Therapy Mode... 33 Program Therapy-Pendant... 33 Program Therapy-Mobile App... 37 Start Therapy... 42 Run Manual Mode Therapy... 42 Using the Pendant... 42 Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Table of Contents

Using the Mobile App... 44 Run Program Mode-Therapy 1 and Therapy 2... 49 Using the Pendant... 49 Using the Mobile App... 51 Isolate PODS... 56 Using the Pendant... 56 Using the Mobile App... 57 Device Information... 59 Using the Pendant... 59 Using the Mobile App... 62 Regulatory... 64 Set the Language... 64 Using the Pendant... 64 Using the Mobile App... 65 Manage Bluetooth® Connections... 67 Turn Bluetooth® On or Off... 67 Connect Device... 68 Delete a Paired Device... 69 WiFi... 70 LTE... 72 Change Color Themes... 73 Using the Pendant... 73 Using the Mobile App... 74 Cleaning... 76 General Cleaning-Garment... 77 Washable Vest Shell... 77 Support... 78 Using the Pendant... 78 Using the Mobile App... 79 Errors... 80 Using the Mobile App... 82 Critical Errors... 85 Caution Errors... 86 Service... 90 Expected Life... 91 iv

Monarch™ Airway Clearance System User Manual (195292 REV 1)

Table of Contents

Service Calls... 91 Troubleshooting... 92 Garment Does Not Power On... 92 POD(s) Does Not Activate... 92 Screen Shows “Please Call For Service” Message... 92 The Garment No Longer Fits... 92 Storage and Handling... 93 Shipping The Unit... 93 Frequently Asked Questions... 94 Replacement Parts List and Instructions... 95 Battery Replacement... 97 Battery Access Panel Replacement... 98 POD Cover Replacement... 98 Shoulder Pad Replacement... 99 Backpack Elastic Cover Replacement... 99 Vest Shell Replacement... 99 AC/DC Power Adapter... 100 Specifications... 101

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Table of Contents

NOTES:

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Monarch™ Airway Clearance System User Manual (195292 REV 1)

Document Symbols

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.

IMPORTANT SAFEGUARDS When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following important safeguards.

READ ALL INSTRUCTIONS BEFORE USING Training shall be provided by a Hill-Rom qualified trainer or respiratory therapist before the user uses the product for therapy delivery. The training may last 60 minutes or until the user is comfortable with the safe and effective use of the product. The Monarch™ product is intended for Single Patient Use (SPU) in the Home Care environment. Always unplug this product immediately after use or after you charge the battery. Remove the rechargeable battery pack from the product if the product is not going to be used for an extended period of time.

Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Important Safeguards

WARNING: To reduce the risk of burns, electrocution, fire, or personal injury, follow these instructions. Failure to do so could cause personal injury or equipment damage. 1. Patients that may have difficulty clearing secretions from the upper airway (such as those with DMD or other advanced neuromuscular or neurological disorders) may require specialized therapy regiments involving manually or mechanically assisted coughing or other techniques in conjunction with Monarch™ Airway Clearance System therapy. Please consult your physician to determine if additional therapy is appropriate. 2. It is recommended that a single layer of cotton clothing be worn beneath the wearable garment. 3. Close supervision throughout the treatment is necessary when this product is used by patients with physical limitations or impaired cognitive abilities. 4. Do not store or use the device around pets, pests, or unsupervised children. 5. We recommend your first use of this product be in a supervised setting such as at home with a clinical trainer or in a doctor’s office. 6. Use this product only for its intended use as described in this manual. 7. Do not use attachments not recommended by the manufacturer. 8. Do not use unauthorized parts or accessories with this device. 9. Use only Hill-Rom authorized garment vest shells to avoid allergic skin reactions. 10. If this product has a damaged Power Cord or plug, or the product does not operate correctly, do not use it. For examination and repair, contact Hill-Rom. 11. Store and keep the Power Cord out of reach from toddlers and young children to prevent strangulation risks. 12. Keep the unit, battery, AC/DC power adapter, and Power Cord away from heated surfaces. 13. Do not use the device near to any heat source such as a fireplace or radiant heater. 14. Do not use the device in a dusty environment. 15. Do not use the device in a heavy moisture environment. 16. When you remove the product from storage conditions, let the Monarch™ Airway Clearance System return to its recommended operating temperature range before you use the product. 17. Read and follow all instructions for setup, use, and cleaning of Monarch™ Airway Clearance System. Failure to do so could cause patient injury or equipment damage. 18. Machine wash and dry the vest shell monthly or when visibly soiled.

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Monarch™ Airway Clearance System User Manual (195292 REV 1)

Important Safeguards

19. If conditions exist that prohibit use of the Monarch™ Airway Clearance System, do not use the unit. Death or serious injury could occur. 20. Federal USA law restricts this device to sale by or on the order of a physician. 21. Only authorized persons should service Monarch™ Airway Clearance System. NOTE: If service is necessary, use this contact information: • In the USA, call Hill-Rom at 800-426-4224. • Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.respiratorycare.hill-rom.com. 22. The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury. 23. Make sure the position of the Monarch™ Airway Clearance System is such that you can quickly, without obstruction, disconnect the power cord from the main power supply if necessary. 24. Do not expose the unit to excessive moisture or immerse it in water. 25. If the display on the Monarch™ pendant is faulty, do not use the unit. 26. If the Monarch™ Airway Clearance System is wet or damp, do not plug it into a power source or use it. 27. Before cleaning, unplug the unit from its power source and remove the battery. 28. Do not use harsh cleansers, solvents, or detergents. 29. Retain the original packaging material. If shipping is required, the original packing material provides the best protection for the Monarch™ Airway Clearance System. 30. Do not eat or drink during a therapy session. To do so could cause a choking hazard. 31. Discard Monarch™ Airway Clearance System product in accordance with your local government regulations. 32. This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm. 33. The maximum temperature of the Monarch™ Airway Clearance System applied parts will not exceed 109° F (43°C) under all conditions. 34. Do not allow metallic conductive objects to contact the battery terminals. Do not short circuit a battery or throw it into a fire; it can explode and cause severe personal injury. 35. Improper battery use may result in a fire, explosion, or other hazard. 36. Risk of fire and burns: do not open, crush, or heat the battery above 140°F (60°C).

SAVE THESE INSTRUCTIONS Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Intended Use

INTENDED USE The Monarch™ Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.

This manual includes instructions for setup, use, and cleaning of the Monarch™ Airway Clearance System, Model 1000. It is to be used as a reference guide. Please review all the sections carefully before you use the system.

INTENDED PATIENT POPULATION The Monarch™ Airway Clearance System, Model 1000 is intended for adolescent to adult population (15 years and older) or as prescribed by a physician.

INTENDED USERS The users of the system are patients in the home care environments. They are expected to operate the device to self-administer therapy treatment, handle the setup, cleaning, and storage of the device. 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 8th grade education level or comparable. We recommend that patients who do not meet this education level get assistance from Hill-Rom qualified trainers before using this device for therapy. The patient should also have the ability to start or stop the therapy physically either via the pendant, mobile app buttons, or pause/resume control on the garment. 4

Monarch™ Airway Clearance System User Manual (195292 REV 1)

Contraindications

CONTRAINDICATIONS WARNING: If any patient conditions exist that could cause the use of Monarch™ 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. Monarch™ 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 • Recent placement of transvenous or subcutaneous pacemaker

Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Acronyms

• • • • • •

Suspected pulmonary tuberculosis Lung contusion Bronchospasm Osteoporosis or osteomyelitis of the ribs Coagulopathy Complaint of chest wall pain

ACRONYMS

Acronym

Meaning

HFCWO

High Frequency Chest Wall Oscillation Pulmonary Oscillating Disc Long Term Evolution (4G) Coordinated Universal Time

POD LTE UTC

FEATURES

Item A B C D E F G

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Description POD Pause/resume control button Front opening Charging port Pendant POD cover Shoulder strap

Item Description H Shoulder pads I Torso Adjustment-Cam buckle J Battery access panel K Backpack cover L Handle Power adapter (not shown)

Monarch™ Airway Clearance System User Manual (195292 REV 1)

Features

CAUTION:

Obey these cautions to help prevent equipment damage: • •

Use only with the Hill-Rom approved AC/DC power adapter (HillRom Part Number 195500). Use only with the Hill-Rom approved battery (Hill-Rom part number 194566 (Inventus Power, Inc. model number 194566)).

Item Garment

Image

Item Image Shoulder Adjustment

POD

Shoulder Pads

Front Closer

Torso Adjustments-clip

Vest Shell

Torso Adjustment-Cam buckle

Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Features

Item Backpack Cover

Image

Item Battery

Charging Port

Battery Access Panel and Battery Compartment

Pause/ Resume Button

Pendant Dock

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Image

Monarch™ Airway Clearance System User Manual (195292 REV 1)

Product Symbols

PENDANT Press the power button for 3 seconds to activate the pendant. The pendant allows for features and functions of the garment to be activated, edited, and deactivated.

Item A B C D E

Description Screen ON/OFF button Navigation buttons Center button Back button

PRODUCT SYMBOLS These symbols are used on your model of Monarch™ Airway Clearance System: Symbol

Definition Type B equipment with an F-type applied part, according to IEC 60601-1 NOTE: The external POD covers of the actuator PODs are considered an applied part of this equipment.

Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Product Symbols

Symbol

Definition WARNING OR CAUTION

Follow the operating instructions

Class II equipment (double insulated), according to EN60601-1 Protected against ingress of solid foreign objects ≥0.04" (1.0 mm) in diameter and dripping water (at 15° tilt).

Medical-General Medical Equipment as to Electrical Shock, Fire, and Mechanical Hazards Only in Accordance with Control No. E336914 ANSI/AAMI ES60601-1 (2005) + AMD (2012) CAN/CSA-C22.2 No. 60601-1 (2008) + (2016) Manufacturer or distributor complies with the Waste Electric and Electronic Equipment Directive 2012/19/EU

Do not iron*

Machine wash cold

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Monarch™ Airway Clearance System User Manual (195292 REV 1)

Product Symbols

Symbol

Definition No chlorine bleach*

Tumble dry low heat*

Catalog number

Batch number

Date of manufacture

Manufacturer

Manufacturer and date of manufacture

Physician prescription required (for US only) ACMA RCM compliance mark

Single Patient Use

Monarch™ Airway Clearance System User Manual (195292 REV 1)

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Product Symbols

Symbol

Definition Pause/Resume control button-press the button to stop therapy and press again to resume therapy*

*Applicable only for vest shell of the product.

PENDANT SCREEN SYMBOLS These symbols are used on your model of Monarch™ Airway Clearance System: Main Screen Symbol

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Definition

Symbol

Definition

Frequency

Duration

Intensity

The recovery of the error list is in progress. (icon will rotate)

The unit is plugged into power and not running off the battery.

The battery has 75% to 100% charge on the battery.

The battery is charging.

The battery has 50% to 75% charge on the battery.

The WiFi is connected. (only available on the WiFi enabled Monarch® Systems)

The battery has 25% to 50% charge on the battery.

The Bluetooth® is connected.

The battery has 20% to 25% charge on the battery.

Monarch™ Airway Clearance System User Manual (195292 REV 1)