Hill Rom Services PMACS14G Airway Clearance System User Manual 195292 1

Hill Rom Services Pte Ltd Airway Clearance System 195292 1

User Manual_20170316_v1 - (PMACS14G) User manual_195292__1

Monarch™ Airway Clearance System, Model 1000User ManualProduct No. PMACS1195292 REV 1Rx only: Federal USA law restricts this device to sale by or on the order of a physician.
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The Monarch™ Airway Clearance System User Manual (195292 REV 1) i© 2017 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED.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. Hill-Rom makes no commitment to update or keep current, the information in this manual.Hill-Rom reserves the right to make changes without notice in design, specifications, and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products.This manual (195292) was originally released and supplied in English. For a list of available translations, contact Hill-Rom Technical Support.First Edition, March 2017First 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.PATENTS / PATENT www.hill-rom.com/patentsMay 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 LIMITED1 YISHUN AVENUE 7SINGAPORE 768923
ii The Monarch™ Airway Clearance System User Manual (195292 REV 1) 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.
Monarch™ Airway Clearance System User Manual (195292 REV 1) iiiTable of ContentsDocument Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Important Safeguards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Intended Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Intended Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Relative Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Pendant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Product Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Pendant Screen Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Mobile Device Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Protocol for Use and Special Instructions . . . . . . . . . . . . . . . . . . . . . 15Setting Up the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Install Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Charge Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Attaching the Vest Shell. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Garment Fitting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Set Up the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Program the Garment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Turn Garment On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Treatment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Programing Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Program Manual Mode—Pendant . . . . . . . . . . . . . . . . . . . . . . . 29Program Manual Mode—Mobile App . . . . . . . . . . . . . . . . . . . . 31Program Therapy Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Program Therapy—Pendant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Program Therapy—Mobile App. . . . . . . . . . . . . . . . . . . . . . . . . . 37Start Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Run Manual Mode Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Using the Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
iv Monarch™ Airway Clearance System User Manual (195292 REV 1) Table of ContentsUsing the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Run Program Mode—Therapy 1 and Therapy 2. . . . . . . . . . . . . . . 49Using the Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Using the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Isolate PODS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Using the Pendant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Using the Mobile App. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Device Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Using the Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Using the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Set the Language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Using the Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Using the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Manage Bluetooth® Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Turn Bluetooth® On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Connect Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Delete a Paired Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69WiFi. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70LTE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Change Color Themes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Using the Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Using the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76General Cleaning—Garment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Washable Vest Shell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Using the Pendant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Using the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Using the Mobile App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82Critical Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Caution Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Expected Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Monarch™ Airway Clearance System User Manual (195292 REV 1) vTable of ContentsService Calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Garment Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92POD(s) Does Not Activate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Screen Shows “Please Call For Service” Message . . . . . . . . . . . . . . 92The Garment No Longer Fits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Shipping The Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Frequently Asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Replacement Parts List and Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 95Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Battery Access Panel Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . 98POD Cover Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98Shoulder Pad Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Backpack Elastic Cover Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 99Vest Shell Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99AC/DC Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
vi Monarch™ Airway Clearance System User Manual (195292 REV 1) Table of ContentsNOTES:
Monarch™ Airway Clearance System User Manual (195292 REV 1) 1Document SymbolsDOCUMENT SYMBOLSThis 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 SAFEGUARDSWhen using electrical products, especially when children are present, basic safety precautions should always be followed, including the following important safeguards.READ ALL INSTRUCTIONS BEFORE USINGTraining 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.
2 Monarch™ Airway Clearance System User Manual (195292 REV 1) Important SafeguardsWARNING: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.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 3Important Safeguards19. 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
4 Monarch™ Airway Clearance System User Manual (195292 REV 1) Intended UseINTENDED USEThe 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 POPULATIONThe Monarch™ Airway Clearance System, Model 1000 is intended for adolescent to adult population (15 years and older) or as prescribed by a physician.INTENDED USERSThe 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.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 5ContraindicationsCONTRAINDICATIONSWARNING: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 instabilityRELATIVE CONTRAINDICATIONSAccording 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
6 Monarch™ Airway Clearance System User Manual (195292 REV 1) Acronyms• Suspected pulmonary tuberculosis•Lung contusion• Bronchospasm• Osteoporosis or osteomyelitis of the ribs•Coagulopathy• Complaint of chest wall painACRONYMSFEATURESAcronym Meaning HFCWO High Frequency Chest Wall Oscillation POD Pulmonary Oscillating Disc LTE Long Term Evolution (4G) UTC Coordinated Universal Time Item Description Item DescriptionA POD H Shoulder padsB Pause/resume control buttonI Torso Adjustment—Cam buckleC Front opening J Battery access panelD Charging port K Backpack coverE Pendant L HandleF POD cover Power adapter (not shown)G Shoulder strap
Monarch™ Airway Clearance System User Manual (195292 REV 1) 7FeaturesCAUTION:Obey these cautions to help prevent equipment damage:• Use only with the Hill-Rom approved AC/DC power adapter (Hill-Rom Part Number 195500).• Use only with the Hill-Rom approved battery (Hill-Rom part number 194566 (Inventus Power, Inc. model number 194566)). Item Image Item ImageGarment Shoulder Adjust-mentPOD Shoulder PadsFront Closer Torso Adjust-ments—clipVest Shell Torso Adjust-ment—Cam buckle
8 Monarch™ Airway Clearance System User Manual (195292 REV 1) FeaturesBackpack CoverBatteryCharging PortBattery Access Panel and Bat-tery Compart-mentPause/Resume But-tonPendant Dock Item Image Item Image
Monarch™ Airway Clearance System User Manual (195292 REV 1) 9Product SymbolsPENDANTPress 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.PRODUCT SYMBOLSThese symbols are used on your model of Monarch™ Airway Clearance System: Item DescriptionAScreenB ON/OFF buttonC Navigation buttonsD Center buttonEBack buttonSymbol DefinitionType B equipment with an F-type applied part, according to IEC 60601-1NOTE:The external POD covers of the actuator PODs are considered an applied part of this equipment.
10 Monarch™ Airway Clearance System User Manual (195292 REV 1) Product SymbolsWARNING OR CAUTIONFollow the operating instructionsClass II equipment (double insulated), according to EN60601-1Protected 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. E336914ANSI/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 Equip-ment Directive 2012/19/EUDo not iron*Machine wash coldSymbol Definition
Monarch™ Airway Clearance System User Manual (195292 REV 1) 11Product SymbolsNo chlorine bleach*Tumble dry low heat* Catalog numberBatch numberDate of manufactureManufacturerManufacturer and date of manufacturePhysician prescription required (for US only)ACMA RCM compliance markSingle Patient UseSymbol Definition
12 Monarch™ Airway Clearance System User Manual (195292 REV 1) Product SymbolsPENDANT SCREEN SYMBOLSThese symbols are used on your model of Monarch™ Airway Clearance System:Main ScreenPause/Resume control button—press the button to stop therapy and press again to resume therapy**Applicable only for vest shell of the product. Symbol Definition Symbol DefinitionFrequency DurationIntensity 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 bat-tery.The battery is charging. The battery has 50% to 75% charge on the bat-tery.The WiFi is connected. (only available on the WiFi enabled Mon-arch® Systems)The battery has 25% to 50% charge on the bat-tery.The Bluetooth® is con-nected.The battery has 20% to 25% charge on the bat-tery.Symbol Definition
Monarch™ Airway Clearance System User Manual (195292 REV 1) 13Product SymbolsThe LTE is connected. (only available on the LTE enabled Monarch® Systems during trans-mission)The battery charge has under 20% charge on the battery.Front view of the garment with POD locations identified Back view of the garment with POD locations identifiedSymbol Definition Symbol Definition
14 Monarch™ Airway Clearance System User Manual (195292 REV 1) Product SymbolsMOBILE DEVICE SYMBOLSNOTE:The mobile device App images in this manual are examples only. Since mobile device screens may vary by brand, your screen may not look exactly like the images shown. Main Screen Item Description Item Description A Current therapy mode G Frequency setting (5-20 hertz)B Settings menu H Countdown therapy durationC Therapy 2 control I Therapy 1 controlD Intensity setting (1-10) J Manual controlE Duration setting (1-30 minutes)K Monarch™ Airway Clearance battery statusF Start therapy control L Previous screen button
Monarch™ Airway Clearance System User Manual (195292 REV 1) 15Instructions for UseINSTRUCTIONS FOR USEPROTOCOL FOR USE AND SPECIAL INSTRUCTIONSYour physician has prescribed The Monarch™ Airway Clearance System to be used __________ times per day.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 www.respiratorycare.hill-rom.com.
16 Monarch™ Airway Clearance System User Manual (195292 REV 1) Instructions for UseSETTING UP THE UNITWARNING:To help prevent injury and/or equipment damage, obey these: • Inspect the garment and accessories 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. • If the garment is wet or damp, do not plug it into a power source or use it.• Use the supplied battery charger only. Failure to do so may cause a fire, which may result in personal injury and property damage.CAUTION:Do not open, crush, puncture, incinerate, immerse in water, or heat over 140°F (60°C) the battery.NOTE:If your physician has prescribed aerosol therapy to be used during the treatment, set up the appropriate equipment. Getting StartedInstall BatteryCAUTION:Obey these cautions to help prevent equipment damage: • Use only with the Hill-Rom approved battery (Hill-Rom part number 194566 (Inventus Power, Inc. model number 194566)).• Fully charge the battery to 100% before first time use.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 17Instructions for Use1. Lift the battery access panel.2. Align the battery so the battery latch is toward the top of the garment.3. Insert the bottom of the battery into the battery panel first (1).4. Slide the latch, then proceed to insert the top of the battery until the battery locks into position (2).Fully Locked Not Fully LockedNOTE:These images show how to confirm the battery is locked into position. If you see an orange color in the latch area, then the battery is not fully locked into position. Press down on the battery until the orange color is no longer visible.
18 Monarch™ Airway Clearance System User Manual (195292 REV 1) Instructions for UseCharge BatteryCAUTION:Use only with the Hill-Rom approved AC/DC power adapter (Hill-Rom part number 195500 (MEGMEET model number MANGO120-24CK-HR)) to prevent equipment damage.1. Plug the power adapter into the garment.2. Plug the power adapter into the power cable.3. Plug the power cord into an applicable power outlet.CAUTION:If the battery charge is below 20%, you may not be able to complete your therapy session.NOTE:The Power Cord required for your country may be different than shown.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 19Instructions for UseAttaching the Vest Shell1. Lay the garment on a flat surface.2. Lay the right and left vest shell panels, colored side up, on a flat surface.3. Align and put one side of the vest shell on to the garment. For the left vest shell, slide the pendant dock through the slots on the vest shell.Vest shell panels Pendant dock4. Snap the three snaps along the side of the vest shell closest to the zipper.5. Attach the hook and loop fastener straps around the cam buckle to secure the bottom of the vest shell to the cam buckle. 6. Attach the hook and loop fastener straps around the shoulder strap on the garment to secure the top of the vest shell. 7. Repeat for the other side of the garment.NOTE:Machine wash and dry the vest shell as needed (see “General Cleaning—Garment” on page 77).
20 Monarch™ Airway Clearance System User Manual (195292 REV 1) Instructions for UseGarment FittingSIZE GUIDE REFERENCE1. Measure from point A to B, see the image below.2. Measure the circumference around point C, the mid-chest of the patient. Size Guide Measurements Item Description A and B Ideal POD contact pointC Circumference measure point
Monarch™ Airway Clearance System User Manual (195292 REV 1) 21Instructions for UseShoulder Strap AdjustmentMeasure the patient’s shoulder height with a flexible tape measure. Place the end of the flexible tape measure in position A and pull the tape measure taunt over the shoulder to position B. Write the shoulder height in the Shoulder Measurement field below. Use the table to determine the adjustment needed to the shoulder strap.Shoulder Measurement: ___________ Measurement Hook and Loop Adjustment Line10" (25.4 cm) All of the orange lines are covered by the shoulder strap.11" (27.9 cm) 1 orange line is visible12" (30.5 cm) 2 orange lines are visible 13" (33.0 cm) 3 orange lines are visible14" (35.6 cm) 4 orange lines are visible
22 Monarch™ Airway Clearance System User Manual (195292 REV 1) Instructions for UseTorso AdjustmentMeasure the patient’s mid chest with a flexible tape measure. Place the end of the tape measure on the patient’s side, below the bust line. Pull the tape measure taunt around the mid chest as shown in the image on page 20 for position C.Write the mid chest circumference in the field below. Use the table to determine the adjustment needed to the torso clip.Mid Chest Measurement: ___________Measurement Torso Clip Adjustment22" - 24" (55.9 - 61 cm) 1 (closest to the back panel or smallest fitting)25" - 27" (63.5 - 68.6 cm) 228" - 30" (71.1 - 76.2 cm) 331" - 33" (78.7 - 83.8 cm) 434" - 36" (86.4 - 91.4 cm) 537" - 39" (94 - 99.1 cm) 640" - 42" (101.6 - 106.7 cm) 743" - 45" (109.2 -114.3 cm) 846" - 48" (116.8 - 121.9 cm) 949" - 50" (124.5 - 127 cm) 10 (furthest from the back panel or larg-est fitting)Back panel Front panel
Monarch™ Airway Clearance System User Manual (195292 REV 1) 23Instructions for UseSHOULDER ADJUSTMENT1. Open the shoulder pad, and remove the pad from the garment to free the shoulder straps for adjustment. 2. Slide the top stretchable band over to access the adjustable strap. 3. Separate and adjust the shoulder strap to fit the patient’s shoulder height. See “Garment Fitting” on page 20.4. Once the strap is set to the correct orange line, firmly press the shoulder strap together to engage the hook and loop fastener.5. Slide the top stretchable band over the adjustable shoulder strap.6. Put the cushion of the shoulder pad under the shoulder straps. 7. Wrap the shoulder pad panels around the shoulder straps. 8. Firmly press the shoulder pad panels together to engage the hook and loop fastener.9. Repeat on the other shoulder strap.The PODs should rest comfortably on the upper chest and back of the patient. If the garment does not rest comfortably on the chest and back, repeat the shoulder adjustments.TORSO ADJUSTMENTS10. Slide the clip into the appropriate slot to accommodate the patient’s mid-chest measurement. See “Garment Fitting” on page 20.
24 Monarch™ Airway Clearance System User Manual (195292 REV 1) Instructions for UseCONFIRM GARMENT SIZING ADJUSTMENTS11. Put on the garment one shoulder at a time like you are putting on a backpack.12. Fully zip the front zipper closure. 13. Close the cam buckle on both sides. •To close—hold and pull the cam buckle in the direction of the arrow (A) to close the cam buckle (B). See the image below.•To open—hold and pull the cam buckle in the opposite direction of the arrow to open the cam buckle.NOTE:The garment should fit snug against the body but not make it difficult to breathe.If the garment is either too tight or loose in the torso, adjust the torso band. If the PODs are not fitting comfortably against the body, adjust the shoulder straps to either be longer or shorter.NOTE:First disengage the cam buckles, and then unzip the garment. Remove one shoulder at a time, like you are removing a backpack.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 25Set Up the Mobile AppSET UP THE MOBILE APPNOTE:For assistance with the installation of the mobile application (app) to a device, contact Hill-Rom: in the USA, call 800-426-4224; outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.respiratorycare.hill-rom.com.1. From your mobile device, go to your device’s app store.2. In the Search box, enter “Monarch System” to find the app.3. Choose to get or download the Monarch System app, and follow the guided instruction to load the free app to your mobile device.4. Tap the Monarch app icon to open the app on your mobile device. 5. When you first open the Monarch app, you will have two options to choose from:a. I have a Monarchorb. Take Me to Demo Mode6. If you choose to demo the app without connecting to a Monarch device, tap Take Me to Demo Mode.NOTE:In Demo Mode, all screens are in gray to show no connectivity to a Monarch device.
26 Monarch™ Airway Clearance System User Manual (195292 REV 1) Set Up the Mobile App7. If you want to connect to your Monarch device, tap I Have a Monarch.NOTE:Make sure that Bluetooth® is enabled on your mobile device before you select I Have a Monarch.8. Enter the serial number of your Monarch device. See “Device Information” on page 59 for the serial number location.9. The Monarch app needs to have specific parameters enabled to operate successfully with different mobile devices. You will see one or two pop-up messages asking for permissions to be allowed on your mobile device. Tap Accept on these messages.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 27Set Up the Mobile App10. If Bluetooth® is not enabled, the Monarch app will notify you. Tap Turn on, and follow the on-screen instructions.11. Tap OK to allow Notifications.CAUTION:The first time you launch the mobile application a Notification screen will show. Press OK to allow notifications.NOTE:Notifications allow the Monarch app to send information to your phone (via pop-up messages) even when the app is running in the background.
28 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the GarmentPROGRAM THE GARMENTThe pendant is used to program the gar-ment and start the therapy.The pendant dock is on the front of the gar-ment. Place the pendant in the pendant dock when the pendant is not in use.TURN GARMENT ON1. Slide the pendant up and away from the garment to remove the pendant from the pendant dock. 2. Press and hold the Power button for up to 5 seconds to power the pendant. You will see the Monarch System startup screen momentarily. This screen shows the software version and the hour meter reading.NOTE:The pendant screen will dim after 3 minutes if there are no user inputs when using the battery. Any button press will return the screen to normal brightness.The Monarch™ Airway Clearance System will shut down after 10 min-utes of no activity.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 29Program the GarmentTreatment OptionsPROGRAMING MANUAL MODEMode of Operation Description Manual mode Manual mode uses one frequency and inten-sity for a set time of the entire therapy ses-sion. Program modes Therapy 1 and Therapy 2 are programmed therapy sessions. Each program is a quick start therapy session. A single therapy ses-sion can have up to eight steps. You can also set cough pauses (reminders to cough) in these therapy sessions.Manual Mode will run one frequency and one intensity for a set amount of time. The therapy settings can be changed at any time during therapy. The treatment continues while the user adjusts different frequencies, intensities, and duration values. You can program the Monarch™ Airway Clearance System through the pendant or a mobile device.Program Manual Mode—Pendant1. Press the Up or Down navigation buttons to select Manual therapy, and press the Center button to confirm selection.2. Press the Up navigation button to select the manual therapy settings.
30 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the Garment3. Press the Center button. Frequency will be selected by default.4. Press the Up or Down navigation buttons to select the frequency value.5. Press the Right navigation button to select Intensity. 6. Press the Up or Down navigation button to select the intensity value.7. Press the Right navigation button to select Duration. 8. Press the Up or Down navigation buttons to select the therapy duration.9. Press the Center button to confirm the therapy settings.10. Press the Back button to return to the previous menu screen, or press the Down navigation button to the select Start. 11. See “Start Therapy” on page 42 to learn how to start therapy.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 31Program the GarmentProgram Manual Mode—Mobile AppSee “Set Up the Mobile App” on page 25 for steps on how to download the Monarch app.1. After you turn on the Monarch garment from the pendant, open the Monarch app on your mobile device.2. From the mobile device, tap Request Control.NOTE:The Monarch app will automatically pair with the Monarch garment during the first two minutes after the Monarch garment is powered on. After the first two minutes, the Monarch garment must be manually paired with the Monarch app by going into the pendant menu. See “Manage Bluetooth® Connections” on page 67.3. From the pendant, press the Center button to select Allow. NOTE:The pendant screen will show a message that your mobile device is controlling the Monarch garment.
32 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the Garment4. From the mobile device, tap Go to Therapy.5. Tap the Frequency to select and change the frequency; swipe up or down until the frequency value needed is highlighted. Tap the selected number to confirm the frequency setting.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 33Program the GarmentPROGRAM THERAPY MODEProgram Therapy—Pendant6. Tap the Intensity to select and change the intensity; swipe up or down until the intensity value needed is highlighted. Tap the selected number to confirm the intensity setting.7. Tap the Duration to select and change the duration; swipe up or down until the duration value needed is highlighted. Tap the selected number to confirm the duration setting.8. See “Start Therapy” on page 42 to learn how to start therapy.1. From the Main screen, select Menu.2. Press the Up or Down navigation buttons to select Therapy Settings, and press the Center button.
34 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the Garment3. Select Edit Therapy 1 or Edit Therapy 2 to change a programmed therapy, and press the Center button.Cough Interval will be selected by default.4. Press the Center button to edit the Cough Interval. 5. Press the Up or Down navigation buttons to increase or decrease the frequency of the cough pause.NOTE:To remove the cough pause, set the Cough Interval to zero.6. Press the Center button to confirm the Cough Interval frequency.7. Press the Down navigation button to select Cough Duration.8. Press the Center button to edit the Cough Duration.9. Press the Up or Down navigation buttons to increase or decrease the cough duration time. 10. Press the Center button to confirm the Cough Duration time.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 35Program the GarmentNOTE:The therapy steps are labeled by X/X meaning current step out of total steps. Example: 1/8 means it is the first step out of a total of 8 steps. The maximum number of steps allowed is 8 steps. Each therapy step can have a different Frequency, Intensity, and Duration setting.11. Press the Up or Down navigation buttons to select the therapy step to edit.12. Press the Center button to edit the selected step.13. Press the Center button to edit the Frequency. 14. Press the Up or Down navigation buttons to select the frequency value.15. Press the Right navigation button to edit the Intensity. 16. Press the Up or Down navigation buttons to select the intensity value.17. Press the Right navigation button to edit the therapy duration. 18. Press the Up or Down navigation buttons to select the therapy duration.
36 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the Garment19. Press the Center button to confirm the step settings.20. Press the Down navigation button to select the next step or Add New Step. 21. Repeat Step 3 through Step 20 until all steps in the therapy are programmed as prescribed by the physician.NOTE:To eliminate a step and all the steps that follow, set the duration to 0. 22. Press the Back button to go back to the previous screen. You will be prompted to save your settings, if any changes were made. 23. Select Yes or No to save the changes made to the therapy settings.24. Press the Back button to go back to the previous screen. 25. See “Start Therapy” on page 42 to learn how to start therapy.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 37Program the GarmentProgram Therapy—Mobile AppSee “Set Up the Mobile App” on page 25 for steps on how to download the Monarch app.1. After you turn on the Monarch from the pendant, open the Monarch app on your mobile device.2. From your mobile device, tap Request Control.NOTE:The Monarch app will automatically pair with the Monarch garment during the first two minutes after the Monarch garment is powered on. After the first two minutes, the Monarch garment must be manually paired with the Monarch app by going into the pendant menu. See “Manage Bluetooth® Connections” on page 67.3. From the pendant, press the Center button to select Allow. NOTE:The pendant screen will show a message that your mobile device is controlling the Monarch garment.
38 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the Garment4. From your mobile device, tap Go to Therapy.5. Tap the Settings icon on the top right of the app.6. Tap Therapy Settings.7. Tap Edit Therapy 1 or Edit Therapy 2 to select the programmed therapy to change.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 39Program the Garment8. Tap the Cough Interval to select the interval.9. Swipe up or down until the Cough Interval value needed is highlighted. Tap the selected number to confirm the cough interval setting.10. Tap the Cough Duration to select the duration.
40 Monarch™ Airway Clearance System User Manual (195292 REV 1) Program the Garment11. Swipe up or down until the Cough Duration needed is highlighted. Tap the selected number to confirm the cough duration setting.NOTE:The therapy steps are labeled by X/X meaning current step out of total steps. Example: 1/8 means it is the first step out of a total of 8 steps. The maximum number of steps allowed is 8 steps. Each therapy step can have a different Frequency, Intensity, and Duration setting.12. Tap the step you want to edit.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 41Program the Garment13. Tap the Frequency to select and change the frequency; swipe up or down until the frequency value needed is highlighted. Tap the selected number to confirm the frequency setting.14. Tap the Intensity to select and change the intensity; swipe up or down until the intensity value needed is highlighted. Tap the selected number to confirm the intensity setting.15. Tap the Duration to select and change the duration; swipe up or down until the duration value needed is highlighted. Tap the selected number to confirm the therapy duration setting.NOTE:The maximum number of steps is 8.16. To add a step, swipe to the bottom of the steps list and tap Add New Step.
42 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start TherapySTART THERAPY RUN MANUAL MODE THERAPYUsing the Pendant17. To delete a step, swipe the step you want to delete to the left and tap Delete.18. Tap Save to save the changes, or tap Cancel to discard the changes.19. See “Start Therapy” on page 42 to learn how to start therapy.1. Press the navigation buttons to select Start, and press the Center button. NOTES:• The therapy settings can be adjusted while the therapy session is in progress.• The timer starts from the total duration and counts down to zero.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 43Start Therapy2. To pause therapy, do these:a. Select Pause, and the Center button or press the Pause/Resume control button on the garment.b. Press the Center button to resume therapy, or press the Pause/Resume button on the garment.c. If the therapy has been paused for 8 minutes, this screen will show. Use the Up and Down navigation buttons to select Stop or Resume, and press the Center button.d. If Stop is selected, an Incomplete Therapy screen will show. Use the Up and Down navigation buttons to select Stop or Resume, and press the Center button.
44 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start TherapyUsing the Mobile App3. When the therapy session is complete, the Therapy Complete screen will show. Press the Center button to return to the main screen.NOTE:The pendant screen will dim after 3 minutes of no active therapy or inputs. The system will completely shut down after 10 minutes when used with the battery pack.1. Press and hold the power button on the pendant for 5 seconds.2. From your mobile device, tap the Monarch app to open the app. 3. Tap Request Control.NOTE:The Monarch app will automatically pair with the Monarch garment during the first two minutes after the Monarch garment is powered on. After the first two minutes, the Monarch garment must be manually paired with the Monarch app by going into the pendant menu. See “Manage Bluetooth® Connections” on page 67.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 45Start Therapy4. From the pendant, select Allow, and press the Center button.5. Tap Go to Therapy.6. From the mobile device, tap Manual on the top menu bar.
46 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start Therapy7. Tap Start.NOTE:The timer starts from the total duration and counts down to zero.8. To pause therapy, do these:a. Tap Pause during therapy.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 47Start Therapyb. Tap Resume to start the therapy.c. If the therapy has been paused for 8 minutes, a pop-up screen will show to allow you to choose to Stop or Resume the therapy. Tap Stop or Resume.
48 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start Therapyd. If Stop is selected, an Incomplete Therapy screen will show. Tap Stop or Resume.9. When the therapy session is complete, the Therapy Complete screen will show. Press Done to return to the Main screen.NOTES:• The Monarch™ Airway Clearance System will dim the screen after 3 minutes of no active therapy or inputs. The system will completely shut down after 10 minutes on battery power.• If the Monarch System is powered by the AC/DC power adapter, the device will not shutdown.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 49Start TherapyRUN PROGRAM MODE—THERAPY 1 AND THERAPY 2Using the Pendant1. See “Program Therapy Mode” on page 33 to set up and save a therapy program as prescribed by a physician.2. Select Therapy 1 or Therapy 2, and press the Center button.3. To start the therapy, select Start, and press the Center button.Notes:• The total therapy time shows on the pendant. The timer will countdown during the therapy session.• The therapy settings can be adjusted while a therapy session is in progress. 4. To pause therapy, do these: a. Select Pause, and press the Center button.b. To resume the therapy, select Resume, and press the Center button.
50 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start Therapyc. If the therapy has been paused for 8 minutes, this screen will show. Use the Up and Down navigation buttons to select Stop or Resume, and press the Center button.5. If Stop is selected, an Incomplete Therapy screen will show. Use the Up and Down navigation buttons to select Stop or Resume, and press the Center button.6. The cough timer screen will show at each cough interval. Either wait for the timer to run out of time, or select Resume and press the Center button to continue with your therapy session.7. When the therapy is complete, the Therapy Complete screen will show. Press the Center button to return to the Main screen.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 51Start TherapyUsing the Mobile App1. Press and hold the power button on the pendant for 5 seconds.2. From your mobile device, tap the Monarch app to open the app. 3. Tap Request Control.NOTE:The Monarch app will automatically pair with the Monarch garment during the first two minutes after the Monarch garment is powered on. After the first two minutes, the Monarch garment must be manually paired with the Monarch app by going into the pendant menu. See “Manage Bluetooth® Connections” on page 67.4. From the pendant, select Allow, and press the Center button.
52 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start Therapy5. Tap Go to Therapy.NOTE:The pendant screen will show a message that your mobile device is controlling the Monarch garment.6. Tap Therapy 1 or Therapy 2 on the top menu bar.7. Tap Start.NOTE:The timer starts from the total duration and counts down to zero.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 53Start TherapyNOTE:You can change the settings during therapy by tapping on the setting you want to change.8. To pause the therapy, do these: a. You can pause during the therapy by tapping Pause.b. Tap Resume to start the therapy.
54 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start Therapyc. If the therapy has been paused for 8 minutes, this screen will show. Tap Stop or Resume.9. The cough timer screen will show at each cough interval. Either wait for the timer to run out of time, or select Resume to continue with your therapy session.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 55Start Therapy10. If Stop is selected, an Incomplete Therapy screen will show. Tap Stop or Resume to continue.11. When the therapy session is complete, the Therapy Complete screen will show. Press Done to return to the Main screen.NOTES:• The Monarch™ Airway Clearance System will dim the screen after 3 minutes of no active therapy or inputs. The system will completely shut down after 10 minutes on battery power.• If the Monarch System is powered by the AC/DC power adapter, the device will not shutdown.
56 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start TherapyIsolate PODSUsing the Pendant1. From the Main screen, select Menu, and press the Center button.2. Select the Therapy Settings menu.3. Use the Down navigation button to select the ISOLATE PODS menu. Press the Center button to view the ISOLATE PODS screen.4. Use the Navigation button to select different PODs. A colored circle around the POD shows which POD is selected. Select the POD that is to be turned on or off.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 57Start TherapyUsing the Mobile App5. Press the Center button to turn the POD on or off.NOTE:White indicates that the POD will be active. Gray indicates that the POD is off. A defective POD is shown with a red cross icon.6. Press the Back button to return to the previous screen.NOTE:The system will not allow all PODs to be in inactive. At least one POD must be active for the Monarch System to deliver therapy.1. Tap the Settings icon on the top right of the app.
58 Monarch™ Airway Clearance System User Manual (195292 REV 1) Start Therapy2. Tap Therapy Settings.3. Tap Isolate Pods.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 59Device InformationDEVICE INFORMATIONUSING THE PENDANT4. Tap on the POD(s) to be turned on or off. NOTE:A green checked POD means the POD is active. A gray POD means the POD is inactive. A red POD means a defective POD which does not function.5. Swipe from right to left to see the other side of the garment.6. Tap Save, on the top right, to save the changes or tap Cancel, on the top left, to discard the changes.NOTE:The system will not allow all PODs to be inactive. At least one POD must be active for the Monarch System to deliver therapy.1. From the Main screen, select Menu, and press the Center button.
60 Monarch™ Airway Clearance System User Manual (195292 REV 1) Device Information2. Select the Device Information menu.3. Select the General menu.4. Select the Software Information menu.5. The following general information will show: • MCB (Master Control Board) APP Software• MCB BL (bootloader) Software• Pendant APP Software•Pendant Software
Monarch™ Airway Clearance System User Manual (195292 REV 1) 61Device Information6. Press the Back button to return to the previous screen or select the System Information menu.7. The following general information will show: • Serial Number• Total Therapy Hours8. Press the Back button to return to the previous screen, or select the System Clock and Date menu.9. The time and date information will show. Time is in 24 hour format. Date is in MM/DD/YYYY format.NOTE:The clock and date will be set at Hill-Rom before shipment and will show the current Coordinated Universal Time (UTC) to correctly synchronize the use data with the VisiView™ Health Portal. The time and date cannot be adjusted by the user, only viewed for confirmation of the settings.10. Press the Back button on the pendant to return to the previous screen.
62 Monarch™ Airway Clearance System User Manual (195292 REV 1) Device InformationUSING THE MOBILE APP1. Tap the Settings icon on the top right of the app.2. Tap General.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 63Device Information3. Tap Device Info.4. The following information will show for Device Info: • Serial Number• Total Therapy hours for this Monarch device•FCC ID
64 Monarch™ Airway Clearance System User Manual (195292 REV 1) RegulatoryREGULATORYSET THE LANGUAGEUSING THE PENDANT1. From the Main screen, select Menu, and press the Center button.2. Select the Regulatory menu, and press the Center button.3. View the regulatory information. Press the Back button to return to the previous screen. 1. From the Main screen, select Menu, and press the Center button.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 65Set the LanguageUSING THE MOBILE APP2. Select the Device Settings menu, and press the Center button.3. Select the Language menu, and press the Center button. 4. Use Up or Down navigation buttons to select the language you want shown on the Monarch pendant, and press the Center button.5. Press the Back button to return to the previous screen.1. Tap the Settings icon on the top right of the app.
66 Monarch™ Airway Clearance System User Manual (195292 REV 1) Set the Language2. Tap Language.3. Tap the Language you want shown on the Monarch app and pendant. NOTE:A check by the language shows the active language. 4. Tap Save, on the top right, to save the changes, or tap Cancel, on the top left, to discard the changes.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 67Manage Bluetooth® ConnectionsMANAGE BLUETOOTH® CONNECTIONSTURN BLUETOOTH® ON OR OFF 1. From the Main screen, select Menu, and press the Center button.2. Select the Device Settings menu, and press the Center button.3. Select the Wireless menu, and press the Center button.4. Select the Bluetooth® feature. Use the Left and Right navigation buttons to turn on or off the Bluetooth® feature. Press the Center button to connect to the device.
68 Monarch™ Airway Clearance System User Manual (195292 REV 1) Manage Bluetooth® ConnectionsCONNECT DEVICE5. Select the Device List menu. The Monarch System will automatically start scanning for Bluetooth® enabled devices.6. A list of Paired Devices and Other mobile devices available will show. 7. Use the navigation buttons to select the mobile device to connect to from either the Paired list or Other list.8. Press the Center button to confirm the mobile device selected.NOTE:If the device was previously paired, an option to Connect or Delete will show.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 69Manage Bluetooth® Connections9. This screen will show to indicate the system is trying to connect with the device.10. Once Paired, the device will show under Paired.DELETE A PAIRED DEVICENOTE:The mobile device’s Bluetooth® must be enabled in order to delete a device from the of Paired Devices on the pendant.1. Do Step 1 through Step 6 of “Manage Bluetooth® Connections” on page 67.2. Select the device to delete, and press the Center button.3. Select Delete, and press the Center button.
70 Monarch™ Airway Clearance System User Manual (195292 REV 1) WiFiWIFIThe device will no longer be listed under Paired Devices.4. Press the Back button on the pendant to return to the previous screen.The Monarch™ Airway Clearance System must be within about 33 feet (10 meters) of the Bluetooth® device with no obstructions.1. From the Main screen, select Menu, and press the Center button.2. Select Device Settings, and press the Center button.3. Select Wireless, and press the Center button.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 71WiFi4. Select the WiFi feature. Use the Left and Right navigation buttons to turn on or off the WiFi feature. 5. Select Network 2 for your primary WiFi connection. 6. Use the navigation buttons on the pendant to select the letter or number to enter your network password. Click SHOW TEXT to view the password.7. Press the Center button to accept each character. 8. Once your password is entered, select Okay and then press the Center button.
72 Monarch™ Airway Clearance System User Manual (195292 REV 1) LTELTE9. The screen will show that the system is searching for the network.1. From the Main screen, select Menu, and press the Center button.2. Select Device Settings, and press the Center button.3. Select Wireless, and press the Center button.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 73Change Color ThemesCHANGE COLOR THEMESUSING THE PENDANT4. Select the LTE feature. Use the Left and Right navigation buttons to turn on or off the LTE feature. The LTE Status information screen shows:• Carrier Name• Mobile Equipment Identifier (MEID)•SIM card ID1. From the Main screen, select Menu and press the Center button.2. Select the Device Settings menu, and press the Center button.
74 Monarch™ Airway Clearance System User Manual (195292 REV 1) Change Color ThemesUSING THE MOBILE APP3. Select the Color Themes menu, and press the Center button.4. Select the desired color, and press the Center button.1. Tap the Settings icon on the top right of the app.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 75Change Color Themes2. Tap Color Themes.3. Tap the color you want. 4. Tap Save to save the changes, or tap Cancel to discard the changes.
76 Monarch™ Airway Clearance System User Manual (195292 REV 1) CleaningCLEANINGWARNING:Obey all warnings throughout the manual and also the warnings below. Failure to do so could cause injury and/or equipment damage:• The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury.• Unplug the unit from its power source.• Do not expose the unit to excessive moisture. • Use cleaning products in accordance with the manufacturer’s instructions.• Inspect the product 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. CAUTION:Do not use harsh cleansers, solvents, or detergents. Equipment damage could occur.The Monarch™ Airway Clearance System has been tested for compatibility with cleaning solutions containing the following active ingredients:Chemical Class Active IngredientQuaternary ammonium chloride Didecyl dimethyl ammonium chlorideAlkyl dimethyl benzyl ammonium chlorideQuaternary ammonium chloride Alkyl dimethyl benzyl ammonium chloride Alkyl dimethyl ethylbenzyl ammonium chloridePhenolic Ortho-PhenylphenolOrtho-Benzyl-para-ChlorophenolAlcohol Isopropyl alcohol
Monarch™ Airway Clearance System User Manual (195292 REV 1) 77CleaningGENERAL CLEANING—GARMENTWe recommend to wipe clean the garment with the recommended cleaning solutions and warm water. Do not use excessive liquid or harsh cleansers, and do not submerge The Monarch™ Airway Clearance System in water or any solution.Dilute the cleaning solution as specified on the manufacturer’s label.WASHABLE VEST SHELLTo remove difficult spots or stains, use standard laundry cleaner and either hand wash or machine wash in cold water. Then either line dry or tumble dry in the dryer with low heat. To loosen heavy, dried-on soil, you may first need to saturate the spot. Machine wash and dry the external vest shell monthly or when visibly soiled.NOTE:Only the Vest Shell can be machine washed. The Shoulder Strap Pads, Backpack Cover, and POD Covers should be wiped clean with an approved cleaner.1. Remove the Vest Shell from the Garment.2. Fasten all the hook and loop fastener straps to each other to limit snagging.3. Machine wash, or hand wash, in cold cycle only (86°F (30°C) maximum). Non-chlorine bleach may be used as necessary. 4. Hang dry or tumble dry on lowest temperature (120°F (49°C) maximum).NOTE:Do not iron any parts on the device.
78 Monarch™ Airway Clearance System User Manual (195292 REV 1) SupportSUPPORTUSING THE PENDANT1. From the Main screen, select Menu and press the Center button.2. Select the Device Information menu, and press the Center button.3. Select the Support menu. 4. The Support screen will show a phone number to contact Hill-Rom.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 79SupportUSING THE MOBILE APP1. Tap the Settings icon on the top right of the app.2. Tap Contact Us.
80 Monarch™ Airway Clearance System User Manual (195292 REV 1) ErrorsERRORS3. Tap the phone number to place a call.1. From the Main screen, select Menu and press the Center button.2. Select the Device Information menu, and press the Center button.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 81Errors3. Select Errors to review system error codes, and press the Center button.4. Select Reset to remove the error information, and press the Center button.5. Select No or Ye s to reset the error list, and press the Center button.6. Once Ye s is selected, the pendant will show no errors.
82 Monarch™ Airway Clearance System User Manual (195292 REV 1) ErrorsUSING THE MOBILE APP1. Tap the Settings icon on the top right of the app.2. Tap General.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 83Errors3. Tap Device Info.4. Tap Errors to view a list of errors.
84 Monarch™ Airway Clearance System User Manual (195292 REV 1) Errors5. Tap Reset to clear the error list.6. Tap Ye s to clear the error list.7. Tap the back arrow to return to the previous screen.NOTE:The reset of errors will erase the current list being shown on the pendant. The system will continue to store errors collected on the device even though they are not viewable on the pendant.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 85ErrorsCRITICAL ERRORSNOTE:If the solution is to contact Hill-Rom or the solution provided does not resolve the error, 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.Error Pendant Mobile AppLoss of Battery Communication—the battery lost communication and will not charge. 1. Remove the battery and reinstall. See “Battery Replacement” on page 97.2. Press the button on the battery, confirm that a battery indicator light is lit on the front of the battery. If there is no light or a flashing light, charge the Monarch’s battery. Faulty Driver—power is inter-rupted between the main con-trol board and the POD drivers.Contact Hill-Rom.
86 Monarch™ Airway Clearance System User Manual (195292 REV 1) ErrorsCAUTION ERRORSNOTE:If the solution is to contact Hill-Rom or the solution provided does not resolve the error, 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.comLoss of Communication—the pendant lost communication with the main control board.Contact Hill-Rom.Product Overheat—the temperature exceeds the garments operating temperature. Press Okay to terminate the therapy to allow the Monarch garment to cool for 15 minutes. Error Pendant Mobile AppPOD Not Working—one or more of the therapy PODs is not working. The location of the POD will be identified in the caution statement. Therapy can continue if at least one of the PODs is working.Contact Hill-Rom.Error Pendant Mobile App
Monarch™ Airway Clearance System User Manual (195292 REV 1) 87ErrorsBattery under 25%—the battery charge is less than 25%. Charge the battery or use the AC/DC power adapter to plug into a wall outlet. Or, you may continue the therapy with the understanding that the battery charge may run out before the therapy set time.Low battery—plug the system into power.POD Isolation—one POD must be active for therapy.Stuck button—make sure that a button is not accidentally being pressed during startup or for an extended period of time. Put the pendant in its holder to prevent any accidental contact. Not applicableError Pendant Mobile App
88 Monarch™ Airway Clearance System User Manual (195292 REV 1) ErrorsWiFi—reconnect to the WiFi communication, see “WiFi” on page 70.Bluetooth®—reconnect to the Bluetooth® communication, see “Manage Bluetooth® Connec-tions” on page 67.LTE Communication—move to a location where the LTE signal strength increases. Make sure that you have LTE access at this time and that the device is correctly configured for the LTE.Battery Communication—1. Remove the battery, and then install the battery.See “Battery Replacement” on page 97.Error Pendant Mobile App
Monarch™ Airway Clearance System User Manual (195292 REV 1) 89Errors2. Press the button on the battery, confirm that a battery indicator light is lit on the front of the battery. If there is no light or a flashing light, plug the unit into power. Data storage—contact Hill-Rom.Unauthorized USB—remove the unauthorized USB device from Monarch device.Maximum Therapy—sixty min-utes is the maximum therapy time allowed per therapy ses-sion.Error Pendant Mobile App
90 Monarch™ Airway Clearance System User Manual (195292 REV 1) ServiceSERVICEThe Monarch™ Airway Clearance System is a HFCWO therapeutic device that is used to aid mobilization of secretions from the airways and help improve airway health. This is achieved by advanced microprocessor control of 8 PODS which oscillate against the chest wall. The PODs provide a targeted kinetic energy to the lungs which thin mucus and generate airflow to move the mucus from the small airways to the large airways where it can be coughed out or suctioned.No user initiated calibration is required during the service life of the Monarch™ Airway Clearance System.WARNING:Only authorized person should service the Monarch™ Airway Clearance System. Service by unauthorized persons could cause personal injury or equipment damage.The Monarch™ Airway Clearance System does not require periodic preventive maintenance.The product shall not be serviced or cleaned while in use by a patient.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. WIFI Router—check the router cables and reconnect with the WIFI router, see “WiFi” on page 70.Error Pendant Mobile App
Monarch™ Airway Clearance System User Manual (195292 REV 1) 91Expected LifeEXPECTED LIFE The expected service life for the Monarch garment is five years from date of purchase.The expected service life of the battery is one year from date of purchase.Hill-Rom will repair or replace a defective unit as part of a warranty package specified at the time of purchase of the Monarch garment.NOTE:For proper disposal, make sure to follow your local, state, or country electronic and battery regulations to safely discard or recycle the Monarch™ Airway Clearance System, parts, and batteries.SERVICE CALLSWhen you contact Hill-Rom about the Monarch™ Airway Clearance System, be prepared to give the serial number The serial number can be found via the pendant (see “Device Information” on page 59), or the serial number can be found on the product identification label. The product identification label is under the backpack cover just over the battery compartment.NOTE:The serial number of the Monarch™ Airway Clearance System may be found on the inside of the front cover of this User Manual. If the serial number is not there, the user can record it there for easy reference.When you give the serial number, the Hill-Rom representative can identify your unit and give you the information you need more quickly.
92 Monarch™ Airway Clearance System User Manual (195292 REV 1) TroubleshootingTROUBLESHOOTINGWARNING:Only authorized persons should service the Monarch™ Airway Clearance System, Model 1000. Service by unauthorized persons could cause personal injury or equipment damage.WARNING:Do not modify this device without the authorization of the manufacturer. To do so could cause personal injury or equipment damage.GARMENT DOES NOT POWER ON1. Make sure the DC connector from the AC/DC power adapter is securely plugged into the charging port on the bottom of the Monarch™ garment. Make sure the battery is fully charged and is properly seated in its location on the garment. If necessary, unplug the DC connector from the garment, and then reconnect.2. If the problem still exists, contact Hill-Rom.POD(S) DOES NOT ACTIVATE1. Use the pendant to get to the Isolate PODS screen (see “Isolate PODS” on page 56). Confirm that all PODs are white to indicate that the PODs are active for therapy.2. If the problem still exists, contact Hill-Rom.SCREEN SHOWS “PLEASE CALL FOR SERVICE” MESSAGEThe system has experienced an unexpected event. Do as follows:1. Follow the steps on the screen.2. If the problem still exists, contact Hill-Rom.THE GARMENT NO LONGER FITSAdjust the garment to accommodate growth:• To adjust the fit of garment, refer to “Garment Fitting” on page 20.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 93Storage and HandlingSTORAGE AND HANDLINGTo store or transport the Monarch™ Airway Clearance System, do as follows: 1. Place the garment in the carry case.2. Insert the AC/DC power adapter, power cord, battery, and other accessories into the compartments above the garment in the carry case.3. Close the carry case to secure the garment inside.SHIPPING THE UNITWARNING:To help prevent injury and/or equipment damage, obey these: • Do not ship the battery with over a 30% charge.• Do not store the battery at temperatures above 140°F (60°C), such as inside of a car on a hot day or in direct sunlight. CAUTION:If shipping is required, the original packing material provides the best protection for The Monarch™ Airway Clearance System. Retain the original packing material. Failure to do so could cause equipment damage.If shipping is required, ship the unit in its original packing material.
94 Monarch™ Airway Clearance System User Manual (195292 REV 1) Frequently Asked QuestionsFREQUENTLY ASKED QUESTIONS• How does the Monarch™ Airway Clearance System effectively treat areas of my lungs?– The system is designed to oscillate the chest wall to create airflow by applying percussion to the lung area to treat the lobes of the lung.• How long should my Airway Clearance Therapy treatment session last?– Common prescriptions specify a treatment session Time to be between 10 and 30 minutes. Prescribed treatment session times may be different. Refer to the physician’s order.• How often should my treatment sessions be given?– The Frequency of treatment sessions depends on your underlying disease, age, and state of health. Your physician will prescribe a schedule for your individual needs.• Is chest physiotherapy still necessary?– Refer to the physician’s order.• Is postural drainage still necessary?– Refer to the physician’s order.• What will happen if I miss a treatment session?– One missed treatment session of the system may or may not affect your health. However, the key to help maintain your health is consistent, effective therapy. Try to follow the physician’s care plan as closely as possible. Consult your physician if a treatment session is missed.• Is there a best time to do a therapy with The Monarch™ Airway Clearance System?– Establish a schedule that works for you and your family, and lets you do the therapy consistently. • Do all patients receive the same benefits from The Monarch™ Airway Clearance System?– The overall benefit depends on many factors, which include the underlying disease, patient’s age, and present state of health.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 95Replacement Parts List and InstructionsREPLACEMENT PARTS LIST AND INSTRUCTIONSSymbol Part Number Description197811 Shoulder pads195499 Back cover198221M07774POD coverPOD cover (set of 4)198457S Pendant clip198413S Panel hinge kit
96 Monarch™ Airway Clearance System User Manual (195292 REV 1) Replacement Parts List and Instructions198683 Washable vest shell, orange198684 Washable vest shell, blue198685 Washable vest shell, green198686 Washable vest shell, pink198687 Washable vest shell, red198678 Battery access panel, green 198679 Battery access panel, red198680 Battery access panel, pink198681 Battery access panel, blue198682 Battery access panel, orange 194566S Battery198656 Carry case195500 AC/DC power adapter Symbol Part Number Description
Monarch™ Airway Clearance System User Manual (195292 REV 1) 97Replacement Parts List and InstructionsBATTERY REPLACEMENTNOTES:• Consult your local regulations to safely discard or recycle the battery. • Do not return the battery unless specifically requested by customer service.• Remove the battery before you return the main garment for repairs.WARNING:Do not ship the battery with over a 30% charge or injury and/or equipment damage may occur.M07437 Power cord, NA_Canada (NEMA1-15P)1. Lift the battery access panel.2. Slide and hold the latch down to unlock battery.3. Pull on the top of the battery while the latch is unlocked. 4. Remove the bottom of the battery from the garment.Symbol Part Number Description
98 Monarch™ Airway Clearance System User Manual (195292 REV 1) Replacement Parts List and InstructionsBATTERY ACCESS PANEL REPLACEMENTPOD COVER REPLACEMENT1. Lift the battery access panel.2. Hold the battery access panel close to the hinges, and slowly pull the access panel away from the backpack to remove the hinges from the backpack.3. Hold the new battery access panel with the logo facing away from the backpack.4. Insert the left hinge of the access panel on to the backpack until it clicks, and then insert the right hinge until it clicks.5. Press on the access panel until it clicks closed.1. Lay the garment on a flat surface.2. Unzip the garment, and open it so that you can get access to the inside of it.3. From the inside of the garment, hold the POD cover with one hand, and gently squeeze the cover while you pull it straight away from the garment to remove the cover. 4. Hold the new POD cover so that the larger recess in the inner cover aligns with its mate on the internal ring of the POD. The three outer recesses should align with their respective screws.5. Press the POD cover gently into the POD ring and over the POD. Press the cover fully in position such that all sides of the cover touch the garment.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 99Replacement Parts List and InstructionsSHOULDER PAD REPLACEMENTBACKPACK ELASTIC COVER REPLACEMENTVEST SHELL REPLACEMENT1. Disengage the shoulder pad’s hook and loop fastener, and then remove the pad from the garment.2. Put the new pad into position on the garment, and firmly press the shoulder pad together to engage the hook and loop fastener.1. Lay the garment on a flat surface.2. Remove the battery access panel. See “Battery Access Panel Replacement” on page 98.3. Start at the bottom of the backpack, and lift the elastic skirt out from under the edge of the backpack.Continue up both sides of the backpack elastic cover to fully remove it from the backpack.4. Align the new cover with the backpack, and then do the removal procedure in reverse order. Make sure that the stretchable skirt is secured completely around the edge of the backpack.See “Attaching the Vest Shell” on page 19.
100 Monarch™ Airway Clearance System User Manual (195292 REV 1) Replacement Parts List and InstructionsAC/DC POWER ADAPTEROnly use a Hill-Rom approved Monarch™ power adapter as the AC/DC adapter.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 101SpecificationsSPECIFICATIONS Environmental Conditions for Transport and Storage Environmental Conditions for UseFeature DimensionMonarch™ weight (with bat-tery)13.2 lb (6 kg)Size guide Fits mid chest circumference of 22" to 50" (55.9 cm to 127 cm)Base garment EVA foamGarment shell PolyesterElectrical Requirements Nominal voltage: 24 V DC +/- 1.5 V DCNominal Power Consumption: ~65 W maxA/C Power Supply Model MANGO120-24CKInput: 100-240 V, 50/60 Hz 1.0-2.0ALithium-ion Battery Part number: 194566Output: 24 V DC +/- 1.5 V DCCapacity: 2700 mAhFuse requirement Power adapter cord onlyCondition RangeTemperature -4°F to 140°F (-20°C to 60°C)Relative humidity 15% to 90%, non-condensingAtmospheric pressure 50 kPa to 106 kPaCondition RangeTemperature 41°F to 95°F (5°C to 35°C)Relative humidity 15% to 90%, non-condensingAtmospheric pressure 70 to 106 kPA
102 Monarch™ Airway Clearance System User Manual (195292 REV 1) Specifications Wireless CommunicationThe Monarch™ Airway Clearance System features a Bluetooth® interface to connect to a smartphone mobile application as a secondary control for the device. The Monarch™ Airway Clearance System also features an optional WiFi module to export device use data in home care environments.Feature DimensionBluetooth® Specification (Built-in)Bluetooth® compliance Bluetooth® V4.0 (BLE Mode)Frequency 2.40 to 2.48 GHzTransmit Power +8 dBm (max) + 0.5 dBmReceive Sensitivity -90 dBm (typical)Modulation Frequency shift keyingFrequency hopping spectrumWiFi (Optional Configuration)WLAN IEEE 802.11a, 802.11b, 802.11g, 802.11nFrequency 2412 MHz - 2462 MHz5180 MHz - 5240 MHz5745 MHz - 5825 MHzTransmit Power (+/- 2 dBm) 17.5 dBm for 802.11b DSSS17.5 dBm for 802.11g/n OFDM12 dBm for 802.11a/g/n OFDMReceive Sensitivity (+/- 2 dBm)1 Mbps - 95.5 dBm (<10% PER)54 Mbps - 74.5 dBm (<10% PER)MCS7 (20 MHz) - 71.5 dBm (<10% PER)MCS7 (40MHz) - 68 dBm (<10% PER)Security Authentica-tion/EncryptionWPA/WPA2-Personal, WEP 64/128 bits
Monarch™ Airway Clearance System User Manual (195292 REV 1) 103Specifications Classification and StandardsThe Monarch™ Airway Clearance System, Model 1000 is a continuous operation device classified with Underwriters Laboratories, Inc.® (UL) in the United States and licensed with Health Canada. LTE 4G (Optional Configuration)Technology FDD-LTE 3G PP Rel. 9+LTE Band Designation Band 4, 13Power Class 3Transmit Power 23 dBm typicalReceive Sensitivity Min -93 dBmData Rates DL 10Mbps, UL 5MbpsAntenna Internal/built-inCat 1IP Services TCPTechnical and Quality Assur-anceANSI/AAMI ES60601-1CAN/CSA-C22.2 No. 60601-1 IEC 60601-1ISO 13485: 2003 Medical Devices Quality Mgt SystemsEN ISO 14971:2012 Safety Class Class II (double insulation)Equipment Classification Percussor, powered electric Class IIPatient Applied Part External POD cover of actuator PODsDegree of Protection Against Electric ShockClass II (double insulation)Classification According to Directive 93/42/EEC: IIaDegree of Protection Against Ingress of Water: IP42Maximum Sound Pressure Level65 dBANot for use with flammable anesthetics.Feature Dimension
104 Monarch™ Airway Clearance System User Manual (195292 REV 1) Specifications Electromagnetic Compatibility Guidance The Monarch™ Airway Clearance System is suitable for the electromagnetic environment settings specified in the tables that follow.WARNING:The Monarch™ Airway Clearance System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Monarch™ Airway Clearance System should be observed to verify normal operation. If operation is not normal, the Monarch™ Airway Clearance System or the other equipment should be moved.Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.Guidance and Manufacturer's Declaration—Electromagnetic EmissionsThe Monarch™ Airway Clearance System is intended for use in the electromag-netic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment.Emissions Test Compliance Electromagnetic - Environment—GuidanceRF Emissions CISPR 11Group 1 The Monarch™ Airway Clearance System uses RF energy only for its internal func-tions. Therefore, its RF emissions are low and are not likely to cause any interference in nearby electronic equipment.RF Emissions CISPR 11Class B The Monarch™ Airway Clearance System is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low-voltage power supply network that sup-plies buildings used for domestic pur-poses.Harmonic Emis-sions IEC 61000-3-2Class AVoltage Fluctua-tions/Flicker Emissions IEC 61000-3-3Complies
Monarch™ Airway Clearance System User Manual (195292 REV 1) 105SpecificationsElectromagnetic Immunity GuidanceGuidance and Manufacturer's Declaration - Electromagnetic Immunity The Monarch™ Airway Clearance System is intended for use in the electromag-netic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment.Immunity Test IEC 60601Test Level Compliance LevelElectromagnetic - Environment—GuidanceElectrostatic Discharge (ESD)IEC 61000-4-2± 8kV Contact Discharge± 15kV Air Dis-charge± 8kV Contact Discharge± 15kV Air Dis-chargeFloors should be wood, concrete, or ceramic tile. If floors are covered with syn-thetic material, the relative humidity should be at least 30%.Electrical Fast Transient/BurstIEC 61000-4-4± 2 kV for Power Supply Lines± 2 kV for Power Supply LinesMains power quality should be that of a typical home health-care environment.Surge IEC 61000-4-5± 1 kV Line(s) to Line(s)± 1 kV Line(s) to Line(s)Mains power quality should be that of a typical home environ-ment.Voltage Dips, Short Interrup-tions, and Volt-age Variations On Power Sup-ply Input LinesIEC 61000-4-110% UT; 0.5 cycleAt 0, 45, 90, 135, 180, 225, 270 and 3150% UT; 1 cycle and70% UT; 25/30 cyclesSingle Phase: at 00% UT; 250/300 cycle0% UT; 0.5 cycleAt 0, 45, 90, 135, 180, 225, 270 and 3150% UT; 1 cycle and70% UT; 25/30 cyclesSingle Phase: at 00% UT; 250/300 cycleMains power quality should be of a typical home healthcare environment. If the user of the Monarch™ Airway Clearance Sys-tem requires contin-ued operation it is recommended that the Monarch™ Air-way Clearance Sys-tem uninterruptedly power supply or a battery.
106 Monarch™ Airway Clearance System User Manual (195292 REV 1) SpecificationsPower Fre-quency (50/60Hz) Mag-netic FieldIEC 61000-4-830 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical home health-care environment.Note: UT is the AC mains voltage prior to application of the test level.Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Monarch™ Airway Clearance System is intended for use in the electromag-netic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment.Immunity TestIEC 60601Test LevelCompliance LevelElectromagnetic Environment—GuidancePortable and mobile RF communica-tions equipment should be used no closer to any part of the Monarch™ Air-way Clearance System, including cables, than the recommended separa-tion distance calculated from the equa-tion applicable to the frequency of the transmitter.Recommended separation distance:Conducted RFIEC 61000-4-63 V/m150 kHz to 80 MHz3 V/mGuidance and Manufacturer's Declaration - Electromagnetic Immunity The Monarch™ Airway Clearance System is intended for use in the electromag-netic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment.Immunity Test IEC 60601Test Level Compliance LevelElectromagnetic - Environment—Guidance
Monarch™ Airway Clearance System User Manual (195292 REV 1) 107SpecificationsRadiated RF IEC 61000-4-310 V/m80 MHz to 2.7 GHz3 V/m 80 MHz to 800 MHz800 MHz to 2.7 GHzWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufac-turer and d is the recommended sepa-ration in meters (m).Field strengths from fixed RF transmit-ters, as determined by an electromag-netic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with the follow-ing symbol.Note 1: At 80 MHZ and 800 MHz, the higher the frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propa-gation is affected by absorption and reflection from structures, objects and peo-ple.a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PMACS1 is used exceeds the applicable RF compliance level above, the PMACS1 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PMACS1.b. Over the frequency range of 150 kHz to 80 MHz, field strength should be less than 3 V/m.Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Monarch™ Airway Clearance System is intended for use in the electromag-netic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment.Immunity TestIEC 60601Test LevelCompliance LevelElectromagnetic Environment—Guidance
108 Monarch™ Airway Clearance System User Manual (195292 REV 1) SpecificationsRecommended separation distances between portable and mobile RF communications equipment and the Monarch™ Airway Clearance System. The Monarch™ Airway Clearance System is intended for use in an electromag-netic environment in which radiated RF disturbances are controlled. The cus-tomer or the user of the Monarch™ Airway Clearance Systemprevent electromagnetic interference by maintaining a minimum distance between por-table and mobile RF communications equipment (transmitters) and the Mon-arch™ Airway Clearance System as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power oftransmitter, WSeparation distance according to frequency of transmitterm150 kHz to 80 MHzd = 1.2 P80 MHz to800 MHzd = 1.2 P800 MHz to 2.7 GHzd = 2.33 P0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rated at a maximum output power not listed above, the recom-mended separation distance d in metres (m) can be estimated using the equa-tion applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher fre-quency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propa-gation is affected by absorption and reflection from structures, objects and peo-ple.
Monarch™ Airway Clearance System User Manual (195292 REV 1) 109Specifications Federal Communications Commission (FCC) Radiation Exposure StatementThis device complies with Part 15 of the FCC rules and Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.For body worn operation, the device is designed and tested to meet the applicable limits for radio frequency (RF) exposure established by the Federal Communications Commission (U.S.A.) Specific Absorption Rate; (SAR) refers to the rate at which the body absorbs RF energy. To maintain compliance, the device must be used with specified Hill-Rom Holdings, Inc. accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.NOTE:The module must be used in strict accordance with the manufacturer’s instructions as described in the user documentation that comes with the product. Modifications not expressly approved by Hill-Rom could void your authority to operate the equipment.The module must not be co-located or operated in conjunction with any other antenna or transmitter.
110 Monarch™ Airway Clearance System User Manual (195292 REV 1) SpecificationsNOTES:

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