Hill-Rom Monarch 1000 User Manual
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Hill-Rom Monarch 1000 User Manual

Airway clearance system
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DRAFT 29-NOV-2016
Monarch™ Airway Clearance System,
Model 1000
User Manual
Product No. PMACS1
Rx Only Federal USA law restrict this device to sale by or on the order of a physician
195292 REV G

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  • Page 1 DRAFT 29-NOV-2016 Monarch™ Airway Clearance System, Model 1000 User Manual Product No. PMACS1 Rx Only Federal USA law restrict this device to sale by or on the order of a physician 195292 REV G...
  • Page 2 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.
  • Page 3 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.hill-rom.com. The Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 4: Table Of Contents

    DRAFT 29-NOV-2016 Table of Contents Document Symbols................. 1 Important Safeguards ................1 Intended Use ..................4 Intended patient population ............4 Intended users ................4 Indications for use .................. 5 Contraindications ................... 5 Relative Contraindications .............. 5 Cleaning....................6 General Cleaning—Garment ............
  • Page 5 DRAFT 29-NOV-2016 Table of Contents Program Therapy—Mobile App ......... 32 Start Therapy ..................37 Run Manual Mode Therapy ............37 Using the Pendant ..............37 Pause Therapy ................37 Using The Mobile App ............38 Run Program Mode—Therapy 1 and Therapy 2 ......42 Using the Pendant ..............42 Using the Mobile App .............44 Isolate POD—Pendant ............46 Device Information ................47...
  • Page 6 Replacement Parts List and Instructions ..........68 Battery Replacement ..............70 Battery Access Panel Replacement ..........70 AC/DC Charger ................70 Specifications.................72 Monarch™ Airway Clearance System User Manual (195292 REV G)
  • Page 7 DRAFT 29-NOV-2016 Table of Contents NOTES: viii Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 8: Document Symbols

    DRAFT 29-NOV-2016 Document Symbols DOCUMENT SYMBOLS This manual contains different typefaces and symbols to make the content easier to read and understand: • Standard text—used for regular data. Boldface text—emphasizes a word or phrase. • NOTE:—sets apart special data or important instruction •...
  • Page 9 Do not use attachments not recommended by the manufacturer. Do not use unauthorized parts or accessories with this device. Use only Hill-Rom authorized garment outer shells to avoid allergic skin reactions. If this product has a damaged Power Cord or plug which is not working properly or damaged, do not operate it.
  • Page 10 • In the USA, call Hill-Rom at 800-426-4224. • Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.hill-rom.com. 21. The potential for electrical shock exists with electrical equipment. Failure to follow protocols may cause death or serious personal injury.

  • Page 11: Intended Use

    DRAFT 29-NOV-2016 Intended Use SAVE THESE INSTRUCTIONS INTENDED USE The Monarch™ Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.

  • Page 12: Indications For Use

    DRAFT 29-NOV-2016 Indications for use The patient should also have the ability to start or stop the therapy physically either via pendant or mobile app buttons or pause/resume control on the garment. INDICATIONS FOR USE The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment.

  • Page 13: Cleaning

    DRAFT 29-NOV-2016 Cleaning • 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 •...

  • Page 14: General Cleaning-Garment

    DRAFT 29-NOV-2016 Cleaning do not use it, and replace that component before the next therapy session. Failure to do so could cause injury. 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 Ingredient...

  • Page 15: Acronyms

    DRAFT 29-NOV-2016 Acronyms Remove the Garment Shell from the Garment. Fasten all the hook and loop straps to each other to limit snagging. Machine wash, or hand wash, in cold cycle only (86°F (30°C) maximum). Non-chlorine bleach may be used as necessary. Hang dry or tumble dry on lowest temperature (120°F (49°C) maximum).
  • Page 16 DRAFT 29-NOV-2016 Features CAUTION: Obey these cautions to help prevent equipment damage: • Use only with the Hill-Rom approved AC/DC power adapter (Hill- Rom Part Number 195500 (MEGMEET model number MANGO120-24CK-HR)). • Use only with the Hill-Rom approved battery (Hill-Rom part number 194566 (Inventus Power, Inc.
  • Page 17 DRAFT 29-NOV-2016 Features Item Image Item Image Backpack Battery Cover Charging Battery Com- Port partment Pause/ Pendant Dock Resume But- Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 18: Pendant

    DRAFT 29-NOV-2016 Product Symbols PENDANT Press the power button for 3 seconds to activate the pendant. The pendant allows for features and functions of the garment to be activated, edited, and deactivated. Item Description Screen ON/OFF button Navigation buttons Center button Back button PRODUCT SYMBOLS These symbols are used on your model of Monarch™...
  • Page 19 DRAFT 29-NOV-2016 Product Symbols Symbol Definition WARNING OR CAUTION Follow the operating instructions Class II equipment (double insulated), according to EN60601-1 Protected against ingress of solid for- eign objects ≥ 1.0 mm in diameter and dripping water (at 15° tilt). Read the operating instructions Medical—General Medical Equipment as to Electrical Shock, Fire, and Mechanical...
  • Page 20 DRAFT 29-NOV-2016 Product Symbols Symbol Definition Do not iron* Machine wash cold No chlorine bleach* Tumble dry low heat* Catalog number Batch number Date of manufacture Manufacturer Manufacturer and date of manufacture Physician prescription required (for US only) Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 21: Pendant Screen Symbols

    DRAFT 29-NOV-2016 Product Symbols Symbol Definition ACMA RCM compliance mark Single Patient Use Pause/Resume control button—press the button to stop therapy and press again to resume therapy *Applicable only for external shell of the product. ENDANT CREEN YMBOLS These symbols are used on your model of Monarch™ Airway Clearance System: Main Screen Item...
  • Page 22 DRAFT 29-NOV-2016 Product Symbols Symbol Definition Symbol Definition The unit is plugged Recovery of error list is in into power and not progress (icon will running off the battery. rotate) WiFi connected The battery has 75% to 100% charge on the bat- tery.
  • Page 23 DRAFT 29-NOV-2016 Product Symbols OBILE EVICE YMBOLS Main Screen Item Description Item Description Current therapy Mode Frequency setting Settings Countdown therapy duration Therapy 2 control Therapy 1 control Intensity setting Manual control Monarch™ Airway Clearance Duration setting battery status Start therapy control Previous screen button Monarch™...

  • Page 24: Instructions For Use

    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.hill-rom.com. ETTING WARNING: To help prevent injury and/or equipment damage, obey these warnings: •...

  • Page 25: Getting Started

    DRAFT 29-NOV-2016 Instructions for Use component, do not use it, and replace that component before the next therapy session. Failure to do so could cause injury. • If the garment is wet or damp, do not plug it into a power source or use it.

  • Page 26: Attaching The Garment Shell

    DRAFT 29-NOV-2016 Instructions for Use Charge Garment Plug the power adapter to into the garment. Plug the power cord into an applicable power outlet if the battery is not fully charged. NOTE: The power cord required for your country may be different than shown. CAUTION: The battery must be at a minimum 25% charge to start a therapy session.
  • Page 27 DRAFT 29-NOV-2016 Instructions for Use Snap the three snaps along the side of the garment shell closest to the zipper. Attach the hook and loop around the cam buckle to secure the bottom garment shell to the cam buckle. Attach the hook and loop straps around the shoulder strap on the garment to secure the top of the garment shell.

  • Page 28: Garment Fitting

    DRAFT 29-NOV-2016 Instructions for Use NOTE: Machine wash and dry the garment shells as needed see “General Cleaning—Garment” on page 7. Garment Fitting SHOULDER ADJUSTMENT Open the hook and loop to the top shoulder pad and remove. Slide over the cable assembly to expose the hook and loop shoulder straps.
  • Page 29 DRAFT 29-NOV-2016 Instructions for Use Put the shoulder pad on the shoulder strap assembly and firmly press together to engage the hook and loop. Repeat on the other shoulder strap. The garment pods should rest comfortably on the upper chest and back when the garment is fastened.

  • Page 30: Size Guide Reference

    DRAFT 29-NOV-2016 Instructions for Use If the garment is either too tight or loose in the waist, then adjust the waist band. Too Loose Too Tight NOTE: First disengage the cam buckles and then unzip the garment. Size Guide Reference Measure from point A to B, see the figure under “Size Guide Measurements”...
  • Page 31 DRAFT 29-NOV-2016 Instructions for Use Item Description Circumference measure point Shoulder Strap Adjustment Shoulder Measurement: (inches) Measurement (inches) Hook Loop Hash Line 0 (no hash line visible) Torso Adjustment Mid Chest Measurement: (inches) Measurement (inches) Hook Loop Hash Line 22 - 24 24 - 26 27 - 29 30 - 32...

  • Page 32: Program The Garment

    DRAFT 29-NOV-2016 Program the Garment PROGRAM THE GARMENT The pendant is used to select and start the therapy. The pendant dock is located on the front of the garment. Place the pendant in the pen- dant dock when the pendant is not in use. ROGRAM HERAPY Slide the pendant up and away from the garment to remove the...

  • Page 33: Program Manual Mode

    D RAFT 29-NOV-2016 Program the Garment Mode of Operation Description 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 (8) steps. You can also set a cough pause (reminder to cough) in these therapy sessions.
  • Page 34 DRAFT 29-NOV-2016 Program the Garment Press the Center button. Set frequency will be selected by default. Press the Up or Down navigation buttons to select the frequency value. Press the Center button to set the frequency value. Press the Right navigation button to select Intensity.

  • Page 35: Program Manual Mode-Mobile App

    D RAFT 29-NOV-2016 Program the Garment Program Manual Mode—Mobile App From the mobile phone, tap Request Control. Tap the Frequency to select the frequency to change, swipe up or down until the frequency value needed is highlighted. Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 36: Program Therapy Mode

    DRAFT 29-NOV-2016 Program the Garment Tap the Intensity to select the intensity to edit, swipe up or down until the intensity value needed is highlighted Tap the Duration to select the duration to edit, swipe up or down until the duration value needed is highlighted.
  • Page 37 D RAFT 29-NOV-2016 Program the Garment Select Edit Therapy 1 or Edit Therapy 2 to change a pre-programed therapy. Press the Center button. By default, Cough Interval is selected. Press the Center button to edit the Cough Interval. Press the Up or Down navigation buttons to increase or decrease the frequency of the Cough Interval.
  • Page 38 DRAFT 29-NOV-2016 Program the Garment 14. Press the Up or Down navigation buttons to select the therapy step to edit. 15. Press the Center button. NOTE: The step number will show on the top of the screen. This screen shows that you are on step one of eight. Press the down navigation button to the next step.

  • Page 39: Program Therapy-Mobile App

    D RAFT 29-NOV-2016 Program the Garment 22. Press the Down navigation button to select the next step or Add New Step. 23. Repeat Step 4 through Step 22 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.
  • Page 40 DRAFT 29-NOV-2016 Program the Garment Tap Therapy Setting. Tap Edit Therapy 1 or Edit Therapy 2 to select the programmed therapy to change. Tap the Cough Interval to select the interval. Swipe up or down until the Cough Interval value needed is highlighted.
  • Page 41 D RAFT 29-NOV-2016 Program the Garment Tap the Cough Duration to select the duration. Swipe up or down until the Cough Duration needed is highlighted. NOTE: The steps are labeled by X/X meaning current step out of the total steps. Example: 2/6 means it is the second step out of a total of 6 steps.
  • Page 42 DRAFT 29-NOV-2016 Program the Garment Tap the step you want to edit. 10. Tap the Frequency to select the frequency for editing, swipe up or down until the frequency value needed is highlighted. 11. Tap the Intensity to select the intensity for editing, swipe up or down until the intensity value needed is highlighted.
  • Page 43 D RAFT 29-NOV-2016 Program the Garment 13. To add a step, swipe to the bottom of the steps list and tap Add New Step. 14. To delete a step, swipe the step you want to delete to the left and tap Delete. 15.

  • Page 44: Start Therapy

    DRAFT 29-NOV-2016 Start Therapy START THERAPY ANUAL HERAPY Using the Pendant Press the navigation buttons to select Start and press the Center button. NOTE: The therapy settings can be adjusted while the therapy session is in progress. Pause Therapy Select Pause and the Center button or press the Pause/Resume control button on the garment.

  • Page 45: Using The Mobile App

    NOTE: A trainer will install the mobile application to your device. For assistance with an installation to a device, contact Hill-Rom 800-426-4224. Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.hill-rom.com. CAUTION: The first time you launch the mobile application, Notifications screens will appear.
  • Page 46 DRAFT 29-NOV-2016 Start Therapy Notification Screens Notifications allow the Monarch™ app to send information to your phone (via pop up message) even when the app is not in use. Tap Accept. Tap Accept. Tap OK to allow Notifications. Monarch™ Airway Clearance System User Manual (195292 REV G)
  • Page 47 DRAFT 29-NOV-2016 Start Therapy Start Therapy From the mobile phone, Tap Request Control. Also, tap “Allow Control” on the pendant Tap Manual on the top menu bar. Tap Start. You can Pause during the therapy by tapping Pause. Tap Resume to resume the therapy. Monarch™...
  • Page 48 DRAFT 29-NOV-2016 Start Therapy If the therapy has been paused for 8 minutes, this screen will appear. Select Resume or Stop. If Stop is selected, an Incomplete Therapy screen will show and press the center button. Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 49: Using The Pendant

    DRAFT 29-NOV-2016 Start Therapy When the therapy session is complete, the following screen will appear. NOTE: The Monarch™ Airway Clearance System will go into standby mode after 5 minutes of no active therapy or inputs. The system will completely shut down after 10 minutes. —T ROGRAM HERAPY...
  • Page 50 DRAFT 29-NOV-2016 Start Therapy Use the navigation buttons to select Start and press the Center button. NOTE: The therapy settings can be adjusted while a therapy session is in progress. To pause the therapy, select Pause and press the Center button. To resume the therapy, select Resume and press the Center button.

  • Page 51: Using The Mobile App

    DRAFT 29-NOV-2016 Start Therapy Using the Mobile App From the mobile phone, tap Request Control. Also, tap “Allow Control” on the pendant Tap Therapy 1 or Therapy 2 on the top menu bar. Tap Start. NOTE: You can change the settings during therapy by tapping on the setting you want to change.
  • Page 52 DRAFT 29-NOV-2016 Start Therapy If the therapy has been paused for 8 minutes, this screen will appear. Select Resume or Stop and press the Center button. If Stop is selected, an Incomplete Therapy screen will show. Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 53: Isolate Pod-Pendant

    DRAFT 29-NOV-2016 Start Therapy When the therapy session is complete, the following screen will appear. NOTE: The Monarch™ Airway Clearance System will go into standby mode after 5 minutes of no active therapy or inputs. The system will completely shut down after 10 minutes. Isolate POD—Pendant From the Home screen, select Menu.

  • Page 54: Device Information

    DRAFT 29-NOV-2016 Device Information Select the Isolate Pods menu. A colored circle around the pod shows which pod is selected. Select the pod that is to be turned on or off. NOTE: White indicates that the pod will be active. Grey indicates that the pod is not active.
  • Page 55 DRAFT 29-NOV-2016 Device Information Press the Center button. Select the Device Information menu. Select the General menu. Select the Software Information menu. The following general information will show: • MCB (Master Control Board) APP Software • MCB BL (battery level) Software •...
  • Page 56 DRAFT 29-NOV-2016 Device Information Select the System Information menu. The following general information will show: • Software Revision • Total Therapy Hours Select the System Clock and Date menu. 10. The time and date information will display. 11. Press the Back button on the pendant to return to the previous screen.
  • Page 57 DRAFT Device Information REGULATORY From the Home screen, select Menu. Select the Regulatory menu. View regulatory information. Press BACK button to return. Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 58: Set The Language

    DRAFT 29-NOV-2016 Set The Language SET THE LANGUAGE From the Home screen, select Menu. Select the Device Settings menu and press the Center button. Select the Language menu and press the Center button. Use Up or Down navigation buttons to select the language.

  • Page 59: Bluetooth® Devices

    DRAFT 29-NOV-2016 Bluetooth® Devices BLUETOOTH® DEVICES ® LUETOOTH ON OR OFF From the Home screen, select Menu. Press the Center button. Select Device Settings menu. Press the Center button. Select the Wireless menu. Press the Center button. Select the Bluetooth® feature. Use the Left and Right navigation buttons to turn on or off Bluetooth®...

  • Page 60: Connect Device

    DRAFT 29-NOV-2016 Bluetooth® Devices ONNECT EVICE Select the Device List menu. A list of Paired Devices and Other Devices will show. 10. Select the device to connect. 11. Press the Center button. Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 61: Delete Device

    DRAFT 29-NOV-2016 Bluetooth® Devices 12. This screen will show to indicate the system is trying to connect with the device. 13. Once Paired, the device will show under Paired Devices. ELETE EVICE 1. Do Step 1 through Step 8 of “Bluetooth® Devices” on page 51. Select the device to delete.

  • Page 62: Wifi

    DRAFT 29-NOV-2016 WiFi The device will no longer be listed under Paired Devices. 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. WIFI From the Home screen, select Menu.
  • Page 63 DRAFT 29-NOV-2016 WiFi Select Wireless. Press the Center button. Select the WiFi feature. Use the Left and Right navigation buttons to turn on or off Bluetooth® feature. Select Network 1 for your primary WiFi connection. Use the navigation buttons on the pendent to select the letter or number to enter your network password.

  • Page 64: Change Color Themes

    D RAFT 29-NOV-2016 Change Color Themes 11. Once your password is entered, select Okay and then press the Center button. 12. The screen will show that the system is searching for the network. CHANGE COLOR THEMES From the Home screen, select Menu. Press the Center button.

  • Page 65: Support

    DRAFT 29-NOV-2016 Support Select the Color Themes menu. Press the Center button. Select the desired color. Press the Center button. SUPPORT 1. From the Home screen, select Menu. Press the Center button. Select the Device Information menu. Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 66: Errors

    DRAFT 29-NOV-2016 Errors Press the Center button. Select the Support menu. The Support screen will show a phone number to contact Hill-Rom. ERRORS From the Home screen, select Menu. Press the Center button. Select Device Information menu. Press the Center button.
  • Page 67 DRAFT 29-NOV-2016 Errors Select Errors to review system error codes. Select Reset list to remove the error information. Select No or Yes to reset the error list and press the center button. Once Yes is selected, the screen will show the last ten errors the system had.

  • Page 68: Critical Errors

    If the lights are flashing or no light is observed, plug the unit in to power. If error is not resolved, contact Hill-Rom at 800-426-4224. If outside of the USA, contact your distributor or local Hill-Rom Faulty Driver—power is inter- rupted between main control board and the pod drivers.

  • Page 69: Caution Errors

    Contact Hill-Rom at 800-426- 4224 or if outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.hill-rom.com. Battery under 25%—There might not be enough battery charge to complete the therapy session.
  • Page 70 Stuck button—Make sure that a Not applicable button is not inadvertently pressed or held close. Contact Hill-Rom at 800-426- 4224. WiFi—Reconnect to the WiFi communication, see “WiFi” on page 54. Monarch™ Airway Clearance System User Manual (195292 REV G)
  • Page 71 DRAFT 29-NOV-2016 Errors Error Pendant Mobile App Bluetooth®—Reconnect to the Bluetooth® communication, see “Bluetooth® Devices” on page 51. Battery Communication— Remove the battery and reinstall. After pressing the push button on the battery, confirm that a battery indicator light is lit on the front of the battery.

  • Page 72: Service

    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 device. Note: For proper disposal make sure to follow your local, state or country electronic and battery regulations to safely discard or recycle Monarch™...

  • Page 73: Troubleshooting

    Troubleshooting When you give the serial number, the Hill-Rom representative can identify your unit and give you the information you need more quickly. TROUBLESHOOTING WARNING: Only authorized personnel should service The Monarch™ Airway Clearance System, Model 1000. Servicing by unauthorized personnel could cause personal injury or equipment damage.

  • Page 74: The Garment No Longer Fits

    DRAFT 29-NOV-2016 Storage and Handling ARMENT ONGER Adjust the garment to accommodate growth: • To adjust fit of garment, refer to “Garment Fitting” on page 21. STORAGE AND HANDLING To store or transport The Monarch™ Airway Clearance System, do as follows: Place the garment in the roller bag.

  • Page 75: Frequently Asked Questions

    DRAFT 29-NOV-201 F re q uently Asked Questions FREQUENTLY 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.

  • Page 76: Replacement Parts List And Instructions

    29-NOV-2016 Replacement Parts Lis t an d Ins t ruc t ion REPLACEMENT PARTS LIST AND INSTRUCTIONS Symbol Part Number Description 197811 Assembly, padding shoulder 195499 Assembly, back cover 198221 Foam, cover VCA bottom 198457 Cradle, pendant clip 198683 Washable garment shell, orange 198684 Washable garment shell, blue...
  • Page 77 DRAFT 29-NOV a rts List and Instructions Symbol Part Number Description 198678 Lid, back cover_green 198679 Lid, back cover_red 198680 Lid, back cover_pink 198681 Lid, back cover_blue 198682 Lid, back cover_orange 194566 Battery 198656 Carry case 195500 AC/DC adaptor M07437 Powercord, NA_Canada (NEMA1-15P) Monarch™...

  • Page 78: Battery Replacement

    Insert the left hinge on to the backpack until it clicks and insert the right hinge until it clicks. Close the battery access panel until it clicks closed. AC/DC C HARGER Only use a Hill-Rom approved Monarch AC/DC Charger. Monarch™ Airway Clearance System User Manual (195292 REV G)
  • Page 79 DRAFT 29-NOV a rts List and Instructions Monarch™ Airway Clearance System User Manual (195292 REV G)

  • Page 80: Specifications

    DRAFT 29-NOV-2016 Specifications 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 electromechanical actuators (PODS) which oscillate against the chest wall.
  • Page 81 DRAFT 29-NOV-2016 Specifications Condition Range Relative humidity 15% to 90%, non-condensing Atmospheric pressure 70 to 106 kPA Wireless Communication The Monarch™ Airway Clearance System features a Bluetooth® interface to connect to a smartphone mobile application as secondary control for the device.
  • Page 82 Monarch™ Airway Clearance System User Manual (195292 REV G) DRAFT 29-NOV-2016 Classification and Standards Technical and Quality Assur- ANSI/AAMI ES60601-1 ance CAN/CSA-C22.2 No. 60601-1 IEC 60601-1 ISO 13485: 2003 Medical Devices Quality Mgt Systems EN ISO 14971:2012 Safety Class Class II (double insulation) Equipment Classification Percussor, powered electric Class II Patient Applied Part...
  • Page 83 Monarch™ Airway Clearance System User Manual (195292 REV G)
  • Page 84 DRAFT 29-NOV-2016 Specifications Electromagnetic Compatibility Guidance The Monarch™ Airway Clearance System is suitable for the electromagnetic environment of typical home healthcare environment settings. 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™...
  • Page 85 DRAFT 29-NOV-2016 Specifications Guidance and Manufacturer's Declaration—Electromagnetic Emissions The Monarch™ Airway Clearance System is intended for use in the electromagnetic 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 B Environment—Guidance...
  • Page 86 DRAFT 29-NOV-2016 Specifications Guidance and Manufacturer's Declaration B Electromagnetic Immunity The Monarch™ Airway Clearance System is intended for use in the electromagnetic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment.
  • Page 87 DRAFT 29-NOV-2016 Specifications Guidance and Manufacturer's Declaration B Electromagnetic Immunity The Monarch™ Airway Clearance System is intended for use in the electromagnetic environment specified below. The customer or the user of the Monarch™ Airway Clearance System should make sure it is used in such an environment. IEC 60601 Immunity Compliance...
  • Page 88 DRAFT 29-NOV-2016 Specifications ield strengths from fixed transmitters, such as base stations for radio (cellular/cordless) a. F 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 Monarch™...
  • Page 89 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.
  • Page 90 Monarch™ Airway Clearance System User Manual (195292 REV G...
  • Page 91 DRAFT 29-NOV-2016...

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