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Product Symbols

DRAFT 29-NOV-2016

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
Hazards Only in Accordance with
Control No. E336914
ANSI/AAMI ES60601-1 (2005) + AMD
(2012)
CAN/CSA-C22.2 No. 60601-1 (2008) +
(2014)

Monarch™ Airway Clearance System,
Model 1000 conforms to the European
Medical Device Directive 93/42/EEC.

Manufacturer or distributor complies with
the Waste Electric and Electronic Equip-
ment Directive 2012/19/EU

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

Содержание Monarch 1000

Страница 1: ...DRAFT 29 NOV 2016 Monarch Airway Clearance System Model 1000 User Manual ProductNo PMACS1 195292REVG Rx Only Federal USA law restrict this device to sale by or on the order of a physician...

Страница 2: ...l 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...

Страница 3: ...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 representat...

Страница 4: ...Symbols 11 Pendant Screen Symbols 14 Instructions for Use 17 Protocol for Use and Special Instructions 17 Setting Up The Unit 17 Getting Started 18 Install Battery 18 Attaching the Garment Shell 19 Ch...

Страница 5: ...e Language 50 Bluetooth Devices 51 Turn Bluetooth on or off 51 Connect Device 52 Delete Device 53 WiFi 54 Change Color Themes 56 Support 57 Errors 58 Critical Errors 60 Caution Errors 61 Service 64 Ex...

Страница 6: ...Replacement Parts List and Instructions 68 Battery Replacement 70 Battery Access Panel Replacement 70 AC DC Charger 70 Specifications 72 Monarch AirwayClearanceSystemUserManual 195292REV G vii...

Страница 7: ...TableofContents DRAFT 29 NOV 2016 NOTES viii Monarch AirwayClearanceSystemUserManual 195292REV G...

Страница 8: ...When using electrical products especially when children are present basic safety precautions should always be followed including the following important safeguards READALL INSTRUCTIONS BEFORE USING T...

Страница 9: ...office or at home with a clinical trainer 6 Use this product only for its intended use as described in this manual Do not use attachments not recommended by the manufacturer 7 Do not use unauthorized...

Страница 10: ...display on the Monarch pendant is faulty do not use the unit 25 If Monarch Airway Clearance System is wet or damp do not plug it into a power source or use it Patient injury personal injury or equipme...

Страница 11: ...odel 1000 in intended for adolescent to adult population 15 years and above or as prescribed by a physician INTENDED USERS The users of the system are patients in the home care environments They are e...

Страница 12: ...e of Monarch Airway Clearance System to present a risk to the patient do not use the unit exceptasdirectedbyaphysician Deathorseriousinjurycouldoccur Monarch AirwayClearanceSystemiscontraindicatedifth...

Страница 13: ...est wall pain CLEANING Obeyallwarningsthroughoutthemanualandalsothewarningsbelow Failureto doso couldcause injury and or equipment damage The potential for electrical shock exists with electrical equi...

Страница 14: ...L CLEANING GARMENT We recommend that you wipe clean the garment with recommended cleaning solutions and warm water Do not use excessive liquid or harsh cleansers and do not submerge The Monarch Airway...

Страница 15: ...owest temperature 120 F 49 C maximum NOTE Do not iron any parts on the device ACRONYMS Acronym Meaning HFCWO HighFrequencyChestWall Oscillation FEATURES Item Description Item Description A Pod H Batte...

Страница 16: ...195500 MEGMEET model number MANGO120 24CK HR Use only with the Hill Rom approved battery Hill Rom part number 194566 Inventus Power Inc model number 194566 Item Image Item Image Garment ShoulderAdjust...

Страница 17: ...Features DRAFT 29 NOV 2016 Item Image Item Image Backpack Cover Battery Charging Port Battery Com partment Pause Resume But ton PendantDock 10 Monarch AirwayClearanceSystemUserManual 195292REV G...

Страница 18: ...tion A Screen B ON OFF button C Navigationbuttons D Center button E Back button PRODUCT SYMBOLS These symbols are used on your model of Monarch Airway Clearance System Symbol Definition Type B equipme...

Страница 19: ...ing instructions Medical General Medical Equipment as to Electrical Shock Fire and Mechanical Hazards Only in Accordance with Control No E336914 ANSI AAMI ES60601 1 2005 AMD 2012 CAN CSA C22 2 No 6060...

Страница 20: ...on 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 onl...

Страница 21: ...p therapy and press again to resume therapy Applicable only for external shell of the product PENDANT SCREEN SYMBOLS These symbols are used on your model of Monarch Airway Clearance System Main Screen...

Страница 22: ...t tery Bluetooth connected The battery has 50 to 75 charge on the bat tery Batteryischarging The battery has 25 to 50 charge on the bat tery The battery charge has under 20 charge on the battery The b...

Страница 23: ...herapy Mode G Frequencysetting B Settings H Countdown therapy duration C Therapy 2 control I Therapy 1 control D Intensity setting J Manual control E Duration setting K Monarch Airway Clearance batter...

Страница 24: ...n 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 SETTING UP THE UNIT WARNING Tohelppreventinjury and orequ...

Страница 25: ...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 4 Slide the latch then proceed to insert the top...

Страница 26: ...erent than shown CAUTION The battery must be at a minimum 25 charge to start a therapy session Attaching the Garment Shell 1 Lay the garment on a flat surface 2 Lay right and left garment shell panels...

Страница 27: ...r 5 Attach the hook and loop around the cam buckle to secure the bottom garment shell to the cam buckle 6 Attach the hook and loop straps around the shoulder strap on the garment to secure the top of...

Страница 28: ...shoulderpadandremove 2 Slide over the cable assembly to expose the hook and loop shoulder straps 3 Adjust the hook and loop to accommodate the patient s shoulder height See Size Guide Reference on pa...

Страница 29: ...ly on the chest and back repeat the shoulder adjustments WAIST ADJUSTMENTS 8 Slide the waist clip into the appropriate slot to accommodate the patient s waist See Size Guide Reference on page 23 9 Fit...

Страница 30: ...irst disengage the cam buckles and then unzip the garment Size Guide Reference 1 Measure from point A to B see the figure under Size Guide Measurements on page 23 2 Measure the circumference around po...

Страница 31: ...surement inches Measurement inches Hook Loop Hash Line 10 0 no hash line visible 11 1 12 2 13 3 14 4 Torso Adjustment Mid Chest Measurement inches Measurement inches Hook Loop Hash Line 22 24 1 24 26...

Страница 32: ...t from the pendant dock 2 Press and hold the Power button for 3 seconds to power the pendant NOTE The pendant screen will dim after 3 minutes if there are no user inputs Any button press will return t...

Страница 33: ...ne 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...

Страница 34: ...gation button to select the intensity value 9 Press the Center button to set the intensity value 10 Press the Right navigation button to select therapyduration 11 Press the Up or Down on the navigatio...

Страница 35: ...Program Manual Mode Mobile App 1 From the mobile phone tap RequestControl 2 TaptheFrequencytoselect thefrequencytochange swipe up or down until the frequencyvalueneededis highlighted 28 Monarch Airway...

Страница 36: ...e duration to edit swipe up or down until the duration value needed is highlighted 5 See Start Therapy on page 37 to learn how to start therapy PROGRAMTHERAPY MODE ProgramTherapy Pendant 1 From the Ho...

Страница 37: ...ttons to increase or decrease the frequency of the Cough Interval 9 Press the Center button to confirm the Cough Interval frequency 10 Press the Down navigation button to select Cough Duration 11 Pres...

Страница 38: ...igationbuttontothenextstep 16 Press the Center button to select the Frequency 17 Press Up or Down navigation buttons until the prescribed frequency is shown 18 Press the Right button to select the Int...

Страница 39: ...to 0 24 Press the Center or Back button to go back a menu and you will be prompted to save your settings if any changes were made 25 Select Yes or No to save the changes made to the therapy settings 2...

Страница 40: ...4 Tap EditTherapy 1 or Edit Therapy 2 to select the programmed therapy to change 5 TaptheCoughIntervalto select the interval 6 Swipe up or down until the Cough Interval value needed is highlighted Mo...

Страница 41: ...duration 8 Swipe up or down until the CoughDurationneeded 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...

Страница 42: ...alueneededis highlighted 11 Tap the Intensity to select the intensity for editing swipe up or down until the intensity value needed is highlighted 12 TaptheDurationtoselectthe duration forediting swip...

Страница 43: ...list and tap AddNewStep 14 To delete a step swipe the step you want to delete to the leftand tapDelete 15 Click Save to save the change orclickCanceltodiscardthe changes 16 See Start Therapy on page...

Страница 44: ...eCenterbutton NOTE The therapy settings can be adjusted while the therapy session is in progress Pause Therapy 2 Select Pause and the Center button or press the Pause Resumecontrolbuttononthegarment 3...

Страница 45: ...r 5 minutes of no active therapy or inputs The system will completely shut down after 10 minutes Using The Mobile App NOTE A trainer will install the mobile application to your device For assistance w...

Страница 46: ...creens Notifications allow the Monarch app to send information to your phone via pop up message even when the app is not in use 1 Tap Accept 2 Tap Accept 3 Tap OK to allow Notifications Monarch Airway...

Страница 47: ...mobile phone Tap Request Control Also tap Allow Control on the pendant 2 Tap Manual on the top menu bar 3 Tap Start 4 You can Pause during the therapy by tapping Pause 5 Tap Resume to resume the thera...

Страница 48: ...the therapy has been paused for 8 minutes this screen will appear Select Resume or Stop 7 If Stop is selected an Incomplete Therapy screen will show and press the center button Monarch Airway Clearan...

Страница 49: ...er 5 minutes of no active therapy or inputs The system will completely shut down after 10 minutes RUN PROGRAM MODE THERAPY 1 AND THERAPY 2 Using the Pendant 1 See Program Therapy Mode on page 29 to se...

Страница 50: ...be adjusted while a therapy session is in progress 4 To pause the therapy select Pause and press theCenterbutton 5 Toresume the therapy select Resume and presstheCenterbutton 6 When the therapy is com...

Страница 51: ...ontrol on the pendant 2 TapTherapy1 or Therapy2 on the top menu bar 3 Tap Start NOTE You can change the settings during therapy by tapping on the setting you want to change 4 You can pause during the...

Страница 52: ...If the therapy has been paused for 8 minutes this screen will appear SelectResumeorStopand pressthe Center button 7 If Stop is selected an Incomplete Therapy screen will show Monarch Airway Clearance...

Страница 53: ...r 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 IsolatePOD Pendant 1 From the...

Страница 54: ...NOTE White indicates that the pod will be active Grey indicates that the pod is not active 5 Press the Center button to turn the pod on or off 6 Press the Back button to exit to the previous screen NO...

Страница 55: ...ormationmenu 4 SelecttheGeneralmenu 5 Select theSoftware Informationmenu 6 The following general information will show MCB Master Control Board APP Software MCB BL battery level Software Pendant APP S...

Страница 56: ...general information will show Software Revision Total Therapy Hours 9 Select the System Clock and Date menu 10 The time and date information will display 11 Press the Back button on the pendant to ret...

Страница 57: ...AFT DeviceInformation REGULATORY 1 From the Home screen select Menu 2 SelecttheRegulatorymenu 3 View regulatory information Press BACK button to return Monarch AirwayClearanceSystemUserManual 195292RE...

Страница 58: ...tings 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 5 SelecttheCenterbutton 6 Press the Back button...

Страница 59: ...electMenu 2 PresstheCenterbutton 3 SelectDeviceSettingsmenu 4 PresstheCenterbutton 5 Select the Wireless menu 6 PresstheCenterbutton 7 Select the Bluetooth feature Use the Left and Right navigation bu...

Страница 60: ...T 29 NOV 2016 CONNECTDEVICE 8 Select the DeviceList menu 9 A list of Paired Devices and Other Devices will show 10 Select the device to connect 11 PresstheCenterbutton 52 Monarch AirwayClearanceSystem...

Страница 61: ...ect with the device 13 Once Paired the device will show under Paired Devices DELETE DEVICE 1 Do Step 1 through Step 8 of Bluetooth Devices on page 51 2 Select the device to delete 3 PresstheCenterbutt...

Страница 62: ...t 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 1 FromtheHomescreen selectMenu 2 Pressth...

Страница 63: ...tion buttons to turn on or off Bluetooth feature 8 Select Network 1 for your primary WiFi connection 9 Use the navigation buttons on the pendent to select the letter or number to enter your network pa...

Страница 64: ...and then press the Center button 12 The screen will show that the system is searching for the network CHANGECOLORTHEMES 1 FromtheHomescreen selectMenu 2 PresstheCenterbutton 3 SelecttheDeviceSettings...

Страница 65: ...orThemesmenu 6 PresstheCenterbutton 7 Select the desired color 8 PresstheCenterbutton SUPPORT 1 FromtheHomescreen selectMenu 2 PresstheCenterbutton 3 SelecttheDeviceInformationmenu Monarch Airway Clea...

Страница 66: ...the Support menu 6 The Support screen will show a phone number to contact Hill Rom ERRORS 1 FromtheHomescreen selectMenu 2 PresstheCenterbutton 3 Select Device Information menu 4 PresstheCenterbutton...

Страница 67: ...odes 6 Select Reset list to remove the error information 7 Select No or Yes to reset the error list and press the center button 8 Once Yes is selected the screen will show the last ten errors the syst...

Страница 68: ...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 driv...

Страница 69: ...l rom com CAUTION ERRORS Error Pendant Mobile App PodNotWorking oneormore of the therapy pods is not work ing The location of the pod will be identified in the caution state ment Therapy can continue...

Страница 70: ...Pod Isolation One pod must be active for therapy Stuckbutton Makesurethat a button is not inadvertently pressed or held close Contact Hill Rom at 800 426 4224 Not applicable WiFi Reconnect to the WiFi...

Страница 71: ...ry and reinstall 2 After pressing the push button on the battery confirm that a battery indicator light is lit on the front of the battery If the lights are flashing or no light is observed plug the u...

Страница 72: ...ed service life for the 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...

Страница 73: ...curely plugged into the charging port on bottom of the Monarch system garment Make sure the battery is fully charged and is properly seated into its location on the garment If necessary unplug the DC...

Страница 74: ...to the compartments above the garment in the roller bag 3 Close the roller bag to secure the garment inside SHIPPING THE UNIT WARNING Do not ship the battery with over30 charge or injury and or equipm...

Страница 75: ...our 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 se...

Страница 76: ...Assembly paddingshoulder 195499 Assembly back cover 198221 Foam cover VCA bottom 198457 Cradle pendantclip 198683 Washable garment shell orange 198684 Washable garment shell blue 198685 Washable garme...

Страница 77: ...ription 198678 Lid backcover_green 198679 Lid backcover_red 198680 Lid backcover_pink 198681 Lid backcover_blue 198682 Lid backcover_orange 194566 Battery 198656 Carry case 195500 AC DCadaptor M07437...

Страница 78: ...on the top battery while the latch is unlocked 4 Remove the bottom of the battery from the garment BATTERY ACCESS PANEL REPLACEMENT 1 Open the battery access panel by lifting the bottom of the panel...

Страница 79: ...DRAFT 29 NOV Rep la 2 cem 0 en 1 t P6 arts List and Instructions Monarch Airway Clearance SystemUser Manual 195292 REV G 71...

Страница 80: ...System SPECIFICATIONS Feature Dimension Monarch weight with bat tery 13 2 lbs 6 kg Size guide Fits mid chest circumference of 22 inches to 50 inches 56 cm to 127 cm Base garment EVA foam Garment shell...

Страница 81: ...pecification Built in Bluetooth compliance Bluetooth V4 0 BLE Mode Frequency 2 40 to 2 48 GHz Transmit Power 8 dBm max 0 5dBm upper tolerance Receive Sensitivity 90 dBm typical Modulation Frequency sh...

Страница 82: ...over of actuator pods Degree of Protection Against Electric Shock Class II double insulation Classification According to Directive 93 42 EEC IIa Degree of Protection Against Ingress of Water IP42 Maxi...

Страница 83: ...Monarch Airway Clearance SystemUser Manual 195292 REV G 74...

Страница 84: ...his equipment and result in improper operation Guidance and Manufacturer s Declaration Electromagnetic Emissions The Monarch Airway Clearance System is intended for use in the electromagnetic environm...

Страница 85: ...ironment specified below The customer or the user of the Monarch Airway Clearance System should make sure it is used in such an environment ImmunityTest IEC 60601 TestLevel ComplianceLevel Electromagn...

Страница 86: ...90 135 180 225 270 and 315 At0 45 90 135 180 225 270 and 315 home healthcare environment If the user of the Monarch Airway Clearance System requires continued operation during power mains interruption...

Страница 87: ...nded separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 2 1 2 80 MHz to 800 MHz 2 33 800 MHz to 2 7 GHz Where P is the ma...

Страница 88: ...in which radiated RF disturbances are controlled The customer or the user of the Monarch Airway Clearance System prevent electromagnetic interference by maintaining a minimum distance between portabl...

Страница 89: ...lished 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...

Страница 90: ...79 Monarch AirwayClearanceSystemUserManual 195292REV G...

Страница 91: ...DRAFT 29 NOV 2016...

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