Hill Rom Services PMACS1NA Airway Clearance System User Manual

Hill Rom Services Pte Ltd Airway Clearance System

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User manual

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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
DRAFT 29-NOV-2016
© 2016 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED.
Manufacturer:
HILL-ROM SERVICES PRIVATE LIMITED
1 YISHUN AVENUE 7
SINGAPORE 768923
Authorized European Union Representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: +33 (0)2 97 50 92 12
No part of this text shall be reproduced or transmitted in any form or by
any means, electronic or mechanical, including photocopying, recording,
or by any information or retrieval system without written permission from
Hill-Rom Services PTE Ltd. Inc. (Hill-Rom).
The information in this manual is confidential and may not be disclosed to
third parties without the prior written consent of Hill-Rom.
The information in this manual is subject to change without notice. HillRom makes no commitment to update or keep current, the information in
this manual.
Hill-Rom reserves the right to make changes without notice in design,
specifications, and models. The only warranty Hill-Rom makes is the
express written warranty extended on the sale or rental of its products.
The Monarch™ Airway Clearance System product may be covered by one
or more patents. For a list of applicable patents, go to www.hillrom.com/patents.
This manual (195292) was originally released and supplied in English. For
a list of available translations, contact Hill-Rom Technical Support.
First Edition, November 2016
First Printing, 2016
Cough Pause® and Hill-Rom® are registered trademarks of Hill-Rom
Services, Inc.
Monarch™ is a trademark 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.
The Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Replace this manual (195292) if it is damaged and/or cannot be read.
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.
ii
The Monarch™ Airway Clearance System User Manual (195292 REV G)
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 ........................................................... 7
Washable Garment Shell ................................................................. 7
Acronyms ............................................................................................... 8
Features ................................................................................................. 8
Pendant ......................................................................................... 11
Product 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
Charge Garment.............................................................. 19
Garment Fitting ............................................................... 21
Size Guide Reference ...................................................... 23
Program the Garment .......................................................................... 25
Program Therapy........................................................................... 25
Treatment Options ................................................................. 25
Program Manual Mode ................................................................. 26
Program Manual Mode—Pendant ......................................... 26
Program Manual Mode—Mobile App .................................... 28
Program Therapy Mode ................................................................ 29
Program Therapy—Pendant .................................................. 29
Monarch™ Airway Clearance System User Manual (195292 REV G)
Table of Contents
DRAFT 29-NOV-2016
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
Set The 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
Expected Life ........................................................................................64
Service Calls ..........................................................................................64
Troubleshooting....................................................................................65
Garment Does Not Power On ........................................................65
Pod(s) Do Not Activate ..................................................................65
Screen Shows “Please Call For Service” Message.......................... 65
The Garment No Longer Fits ..........................................................66
Storage and Handling ...................................................................... 66
Shipping The Unit ..................................................................... 66
Frequently Asked Questions .................................................................67
vi
Monarch™ Airway Clearance System User Manual (195292 E F)
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)
vii
Table of Contents
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NOTES:
viii
Monarch™ Airway Clearance System User Manual (195292 REV G)
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
clarification.
•
WARNING or CAUTION
–
–
A WARNING identifies situations or actions that may have an
effect on patient or user safety. To ignore a warning could
cause patient or user injury.
A CAUTION identifies special procedures or precautions that
persons must obey to help prevent equipment damage.
IMPORTANT SAFEGUARDS
When using electrical products, especially when children are present,
basic safety precautions should always be followed, including the
following important safeguards.
READ ALL INSTRUCTIONS
BEFORE USING
Training shall be provided by a qualified trainer or respiratory therapist
before the user utilizes the product for therapy delivery. The training
should last no more than 60 minutes or until the user is comfortable with
the safe and effective use of the product.
The Monarch™ product is for Single Patient Use (SPU) in the Home Care
Environment.Always unplug this product immediately after using or
charging the battery.
Remove the rechargeable battery pack from the product if the product is
not going to be used for an extended period of time.
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Important Safeguards
WARNING:
To reduce the risk of burns, electrocution, fire, or personal injury, follow
these instructions. Failure to do so could cause personal injury or
equipment damage.
1. Patients that may have difficulty clearing secretions from the upper
airway (such as those with DMD or other advanced neuromuscular or
neurological disorders) may require specialized therapy regiments
involving manually or mechanically assisted coughing or other
techniques in conjunction with Monarch™ Airway Clearance System,
Model 1000 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 a doctor’s 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 parts or accessories with this device.
8. Use only Hill-Rom authorized garment outer shells to avoid allergic
skin reactions.
9. If this product has a damaged Power Cord or plug which is not
working properly or damaged, do not operate it. For examination
and repair, contact Hill-Rom.
10. Store and keep Power Cord out of reach from toddlers and young
children to prevent strangulation risks.
11. Keep the unit, battery, the AC/DC adapter and its Power Cord away
from heated surfaces.
12. Do not use the device near to any heat source such as a fireplace or
radiant heater.
13. Do not use the device in a dusty environment.
14. Do not use the device in a heavy moisture environment.
15. When removing product from storage conditions, let the
Monarch™ Airway Clearance System return to its recommended
operating temperature range before using the product.
16. 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.
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016Important Safeguards
17. Machine wash and dry the external garment shell monthly or when
visibly soiled.
18. If conditions exist that prohibit using Monarch™ Airway Clearance
System, do not use the unit. Death or serious injury could occur.
19. Federal USA law restricts this device to sale by or on the order of a
physician.
20. Only authorized personnel should service Monarch™ Airway
Clearance System. Servicing by unauthorized personnel could cause
personal injury or equipment damage.
NOTE:
If service is necessary, use this contact information:
•
In the USA, call Hill-Rom at 800-426-4224.
•
Outside of the USA, contact your distributor or local Hill-Rom
representative, or go to 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.
22. 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.
23. Do not expose the unit to excessive moisture or immerse it in water.
24. If the 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
equipment damage could occur.
26. Before cleaning, unplug the unit from its power source and remove
the battery. Failure to do so could cause personal injury or equipment
damage.
27. You are recommended to remove the external garment shell for
machine wash on a monthly basis or when it is dirty.
Do not expose the unit to excessive moisture or immerse it in water.
28. Do not use harsh cleansers, solvents, or detergents. Equipment
damage could occur.
29. Retain the original packaging material. If shipping is required, the
original packing material provides the best protection for 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.
Monarch™ Airway Clearance System User Manual (195292 REV G)
Intended Use
DRAFT 29-NOV-2016
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.
This manual includes instructions for setup, use, and cleaning of the
Monarch™ Airway Clearance System, Model 1000. It is to be used as a
reference guide. Please review all the sections carefully before you use the
system.
INTENDED PATIENT POPULATION
The Monarch™ Airway Clearance System, Model 1000 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 expected to operate the device to self-administer therapy treatment,
handle the setup, cleaning, and storage of the device.
The users of the Monarch™ product include patients in the home care
environment. Users should have the ability to read and understand
western Arabic numerals and the native language used in the manual. We
recommend that the users of the device have an education level
comparable to that of an 8th grader. We recommend that patients who do
not meet this education level get assistance from clinical trainers or
respiratory therapists while using this device for therapy.
Monarch™ Airway Clearance System User Manual (195292 REV G)
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. It is indicated for patients
having difficulty with secretion clearance, or the presence of atelectasis
caused by mucus plugging.
The Monarch™ Airway Clearance System is intended to be used in the
Home Care environment by patients, 15 years and older.
CONTRAINDICATIONS
WARNING:
If the patient conditions exist that cause the use of Monarch™ Airway
Clearance System to present a risk to the patient, do not use the unit
except as directed by a physician. Death or serious injury could occur.
Monarch™ Airway Clearance System is contraindicated if these
conditions are present:
•
Head and/or neck injury that has not yet been stabilized
•
Active hemorrhage with hemodynamic instability
RELATIVE CONTRAINDICATIONS
•
•
•
•
•
•
•
According to the American Association for Respiratory Care
(AARC) Guidelines for Postural Drainage Therapy, the decision to
use the unit for Airway Clearance Therapy requires careful
consideration and assessment of the individual patient’s case if
the following conditions exist:
Intracranial pressure (ICP) greater than 20 mm Hg
Recent spinal surgery or acute spinal injury
Bronchopleural fistula
Pulmonary edema associated with congestive heart failure
Large pleural effusions or empyema
Pulmonary embolism
Monarch™ Airway Clearance System User Manual (195292 REV G)
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
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
Suspected pulmonary tuberculosis
Lung contusion
Bronchospasm
Osteoporosis or osteomyelitis of the ribs
Coagulopathy
Complaint of chest wall pain
CLEANING
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 after therapy or charging
the battery. Failure to do so could cause personal injury or
equipment damage.
•
Do not expose the unit to excessive moisture. Injury or
equipment damage could occur.
•
Failure to use cleaning products in accordance with the
manufacturer’s instructions could cause equipment damage.
•
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,
Monarch™ Airway Clearance System User Manual (195292 REV G)
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
Quaternary
ammonium chloride
Didecyl dimethyl ammonium chloride
Alkyl dimethyl benzyl ammonium chloride
Quaternary
ammonium chloride
Alkyl dimethyl benzyl ammonium chloride
Alkyl dimethyl ethylbenzyl ammonium chloride
Phenolic
Ortho-Phenylphenol
Ortho-Benzyl-para-Chlorophenol
Alcohol
Isopropyl alcohol
GENERAL 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 Clearance System
in water or any solution.
Dilute the cleaning solution as specified on the manufacturer’s label.
WASHABLE GARMENT SHELL
To remove difficult spots or stains, we recommend that you 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 garment shell monthly or when visibly
soiled.
Note: Only the Garment Shell can be machine washed. Shoulder Strap
Pads, Backpack Cover, and POD covers should be wiped clean with an
approved cleaner.
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Acronyms
1.
2.
3.
4.
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).
NOTE:
Do not iron any parts on the device.
ACRONYMS
Acronym
Meaning
High Frequency Chest Wall
Oscillation
HFCWO
FEATURES
Item
Description
Item Description
Pod
Pendant
Front opening
Charging port
Cam buckle—waist
adjustment
Pause/resume control button
Garment Shell
Battery access panel
Backpack cover
Shoulder Strap
Shoulder pads
Handle
Pod cover
Power adapter (not shown)
Monarch™ Airway Clearance System User Manual (195292 REV G)
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 (HillRom 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. model number 194566)).
Item
Image
Item
Garment
Shoulder Adjustment
Pod
Shoulder Pads
Front Closer
Waist Adjustments
Garment
Shell
Waist Adjustment—cam
buckle
Monarch™ Airway Clearance System User Manual (195292 REV G)
Image
Features
Item
DRAFT 29-NOV-2016
Image
Item
Backpack
Cover
Battery
Charging
Port
Battery Compartment
Pause/
Resume Button
Pendant Dock
10
Image
Monarch™ Airway Clearance System User Manual (195292 REV G)
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™ Airway Clearance
System:
Symbol
Definition
Type B equipment with an F-type applied
part, according to IEC 60601-1
NOTE:
The external pod covers of the actuator
pods are considered as applied part of this
equipment.
Monarch™ Airway Clearance System User Manual (195292 REV G)
11
Product Symbols
Symbol
DRAFT 29-NOV-2016
Definition
WARNING OR CAUTION
Follow the operating instructions
Class II equipment (double insulated),
according to EN60601-1
Protected against ingress of solid foreign 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 Equipment Directive 2012/19/EU
12
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Symbol
Product Symbols
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)
13
Product Symbols
DRAFT 29-NOV-2016
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.
PENDANT SCREEN SYMBOLS
These symbols are used on your model of Monarch™ Airway Clearance
System:
Main Screen
Item
Description
Item
Description
Frequency setting
Intensity setting
Duration setting
14
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Symbol
Definition
Symbol
Product Symbols
Definition
The unit is plugged
into power and not
running off the battery.
Recovery of error list is in
progress (icon will
rotate)
WiFi connected
The battery has 75% to
100% charge on the battery.
Bluetooth® connected
The battery has 50% to
75% charge on the battery.
Battery is charging
The battery has 25% to
50% charge on the battery.
The battery charge has
under 20% charge on
the battery.
The battery has 20% to
25% charge on the battery.
Frequency
Duration
Intensity
Front view of the garment with POD
locations identified
Back view of the garment with pod
locations identified
Monarch™ Airway Clearance System User Manual (195292 REV G)
15
Product Symbols
DRAFT 29-NOV-2016
MOBILE DEVICE SYMBOLS
Main Screen
Item
Description
Item
Description
Current therapy Mode
Settings
Therapy 2 control
Intensity setting
Duration setting
Start therapy control
Frequency setting
Countdown therapy duration
Therapy 1 control
Manual control
Monarch™ Airway Clearance
battery status
Previous screen button
16
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Instructions for Use
INSTRUCTIONS FOR USE
PROTOCOL FOR USE AND SPECIAL INSTRUCTIONS
Your 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.hill-rom.com.
SETTING UP THE UNIT
WARNING:
To help prevent injury and/or equipment damage, obey these
warnings:
•
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
Monarch™ Airway Clearance System User Manual (195292 REV G)
17
Instructions for Use
•
DRAFT 29-NOV-2016
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.
NOTE:
If your physician has prescribed aerosol therapy to be used during the
treatment, set up the appropriate equipment.
Getting Started
Install Battery
1.
2.
3.
4.
Lift the battery access panel.
Align the battery so the battery latch
is toward the top of the garment.
Insert the bottom of the battery into
the battery panel first.
Slide the latch then proceed to insert
the top of the battery until the
battery locks into place.
NOTE:
The images show how to confirm the battery is locked into place. If you
see an orange color in the latch area, then the battery is not fully locked
into place. Press down on the battery until the orange color is no longer
visible.
CAUTION:
Fully charge the battery to 100% before first time use.
18
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Instructions for Use
Charge Garment
1.
2.
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.
Attaching the Garment Shell
1.
Lay the garment on a flat surface.
2.
3.
Lay right and left garment shell panels on a flat surface.
Align and put one side of the garment shell on to the garment. For
the left garment shell, slide the pendant dock through the slots on
the garment shell.
Monarch™ Airway Clearance System User Manual (195292 REV G)
19
Instructions for Use
DRAFT 29-NOV-2016
4.
Snap the three snaps along the side of the garment shell closest to
the zipper.
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 the garment shell.
7.
Repeat for the other side of the garment.
20
Monarch™ Airway Clearance System User Manual (195292 REV G)
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
1.
2.
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.
3.
Adjust the hook and loop to
accommodate the patient’s shoulder
height. See “Size Guide Reference” on
page 23.
4.
Firmly press the shoulder strap together to engage the hook and
loop fastener.
5.
Slide the cable assembly cover over the shoulder strap.
Monarch™ Airway Clearance System User Manual (195292 REV G)
21
Instructions for Use
DRAFT 29-NOV-2016
6.
Put the shoulder pad on the shoulder strap assembly and firmly
press together to engage the hook and loop.
7.
Repeat on the other shoulder strap.
The garment pods should rest comfortably on the upper chest and back
when the garment is fastened. If the garment does not rest comfortably
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.
Fitting the garment on the body—put on the garment one
shoulder at a time like you are putting on a backpack.
10. Fully zip the front zipper closure.
11. Engage the cam buckle on both sides.
NOTE:
The garment should fit snug against the body but not hinder normal
breathing.
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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
1.
2.
Measure from point A to B, see the figure under “Size Guide
Measurements” on page 23.
Measure the circumference around point C of the ribs.
Size Guide Measurements
Item
Description
A&B
Ideal POD contact point
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Instructions for Use
DRAFT 29-NOV-2016
Item
Description
Circumference measure point
Shoulder Strap Adjustment
Shoulder Measurement:
(inches)
Measurement (inches)
Hook Loop Hash Line
10
0 (no hash line visible)
11
12
13
14
Torso Adjustment
Mid Chest Measurement:
(inches)
Measurement (inches)
Hook Loop Hash Line
22 - 24
24 - 26
27 - 29
30 - 32
33 - 35
36 - 38
39 - 41
42 - 44
45 - 47
48 - 50
10
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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 pendant dock when the pendant is not in use.
PROGRAM THERAPY
1.
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 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 the screen normal brightness.
The Monarch™ Airway Clearance System will shut down after 10 minutes of no activity.
Treatment Options
Mode of Operation
Description
Manual mode
Manual mode uses one frequency and intensity for a set time of the entire therapy session.
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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 session can have up to eight (8) steps. You can
also set a cough pause (reminder to cough)
in these therapy sessions.
PROGRAM MANUAL MODE
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.
The timer starts from the total duration and counts down to zero.
Program Manual Mode—Pendant
1.
Press the Up or Down navigation buttons to
select Manual therapy.
2.
Press the Center button to confirm selection.
3.
Press the Up navigation button to select the
manual therapy settings.
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4.
5.
6.
7.
8.
9.
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.
Press the Up or Down navigation button to
select the intensity value.
Press the Center button to set the intensity
value.
10. Press the Right navigation button to select
therapy duration.
11. Press the Up or Down on the navigation
buttons to select the treatment time.
12. Press the Center button to set the duration
time.
13. Press the Back button to return to the previous
menu screen or press the Down navigation
button to the select Start.
14. See “Start Therapy” on page 37 to learn how to
start therapy.
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DRAFT 29-NOV-2016
Program the Garment
Program Manual Mode—Mobile App
1.
From the mobile phone, tap
Request Control.
2.
Tap the Frequency to select
the frequency to change,
swipe up or down until the
frequency value needed is
highlighted.
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3.
Tap the Intensity to select the
intensity to edit, swipe up or
down until the intensity value
needed is highlighted
4.
Tap the Duration to select the
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.
PROGRAM THERAPY MODE
Program Therapy—Pendant
1.
From the Home screen, select Menu.
2.
Press the Up or Down navigation buttons to
select Therapy Settings.
Press the Center button.
3.
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DRAFT 29-NOV-2016
Program the Garment
5.
Select Edit Therapy 1 or Edit Therapy 2 to
change a pre-programed therapy.
Press the Center button.
6.
By default, Cough Interval is selected.
7.
8.
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.
9.
Press the Center button to confirm the Cough Interval frequency.
4.
10. Press the Down navigation button to select
Cough Duration.
11. Press the Center button to edit the Cough
Duration.
12. Press the Up or Down navigation buttons to
increase or decrease the pause of the Cough
Duration time.
13. Press the Center to confirm the Cough
Duration time.
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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.
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 Intensity.
19. Press Up or Down navigation buttons until the
prescribed intensity is shown.
20. Press the Right button to select the Frequency.
21. Press Up or Down navigation buttons until the
prescribed time is shown.
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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.
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.
26. Press the Back button to go back to the previous screen.
27. See “Start Therapy” on page 37 to learn how to start therapy.
Program Therapy—Mobile App
1.
From the mobile phone, tap
Request Control.
2.
Tap the Settings icon on the
top right of the app.
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3.
Tap Therapy Setting.
4.
Tap Edit Therapy 1 or Edit
Therapy 2 to select the
programmed therapy to
change.
5.
Tap the Cough Interval to
select the interval.
6.
Swipe up or down until the
Cough Interval value needed
is highlighted.
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DRAFT 29-NOV-2016
Program the Garment
7.
Tap the Cough Duration to
select the duration.
8.
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.
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9.
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.
12. Tap the Duration to select the
duration for editing, swipe up
or down until the duration
value needed is highlighted.
NOTE:
The maximum number of steps is 8.
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DRAFT 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. Click Save to save the change
or click Cancel to discard the
changes.
16. See “Start Therapy” on page 37 to learn how to start therapy.
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Start Therapy
START THERAPY
RUN MANUAL MODE THERAPY
Using the Pendant
1.
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
2.
Select Pause and the Center button or press the
Pause/Resume control button on the garment.
3.
Press the Center button to resume therapy or
press the Pause/Resume button on the
garment.
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Start Therapy
DRAFT 29-NOV-2016
4.
If the therapy has been paused for 8 minutes, this
screen will appear. Select Resume or Stop and
press the Center button.
5.
If Stop is selected, an Incomplete Therapy
screen will show.
6.
When the therapy session is complete, the
following screen will show.
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.
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. Press OK to allow Notifications.
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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.
1.
Tap Accept.
2.
Tap Accept.
3.
Tap OK to allow Notifications.
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Start Therapy
DRAFT 29-NOV-2016
Start Therapy
1.
From the 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.
40
Tap Resume to resume the therapy.
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DRAFT 29-NOV-2016
6.
If 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.
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Start Therapy
41
Start Therapy
8.
DRAFT 29-NOV-2016
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.
RUN PROGRAM MODE—THERAPY 1 AND THERAPY 2
Using the Pendant
1.
See “Program Therapy Mode” on page 29 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.
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3.
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.
4.
To pause the therapy, select Pause and press
the Center button.
5.
To resume the therapy, select Resume and
press the Center button.
6.
When the therapy is complete, the screen will
show Therapy Complete and the percussion
will stop.
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Start Therapy
DRAFT 29-NOV-2016
Using the Mobile App
1.
From the mobile phone, tap Request
Control. Also, tap “Allow Control” on
the pendant
2.
Tap Therapy 1 or Therapy 2 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 therapy by
tapping Pause.
5.
Tap Resume to resume the therapy.
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6.
If the therapy has been paused for 8
minutes, this screen will appear.
Select Resume or Stop and press the
Center button.
7.
If Stop is selected, an Incomplete
Therapy screen will show.
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Start Therapy
45
Start Therapy
8.
DRAFT 29-NOV-2016
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
1.
From the Home screen, select Menu.
2.
Press the Center button.
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3.
Select the Isolate Pods menu.
4.
A colored circle around the pod shows which
pod is selected. Select the pod that is to be
turned on or off.
Device Information
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.
NOTE:
The system will not allow all pods to be in an off state.
DEVICE INFORMATION
1.
From the Home screen, select Menu.
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Device Information
DRAFT 29-NOV-2016
2.
Press the Center button.
3.
Select the Device Information menu.
4.
Select the General menu.
5.
Select the Software Information menu.
6.
The following general information will show:
•
MCB (Master Control Board) APP Software
•
MCB BL (battery level) Software
•
Pendant APP Software
•
Pendant Software
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7.
Select the System Information menu.
8.
The following general information will show:
•
Software Revision
•
Total Therapy Hours
9.
Select the System Clock and Date menu.
Device Information
10. The time and date information will display.
11. Press the Back button on the pendant to return to the previous
screen.
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`
DRAFT
Device Information
REGULATORY
1.
From the Home screen, select Menu.
2.
Select the Regulatory menu.
3.
View regulatory information.
Press BACK button to return.
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Set The Language
DRAFT 29-NOV-2016
SET THE LANGUAGE
1.
From the Home screen, select Menu.
2.
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.
5.
Select the Center button.
6.
Press the Back button on the pendant to return to the previous
screen.
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Bluetooth® Devices
BLUETOOTH® DEVICES
TURN BLUETOOTH® ON OR OFF
1.
From the Home screen, select Menu.
2.
Press the Center button.
3.
Select Device Settings menu.
4.
Press the Center button.
5.
Select the Wireless menu.
6.
Press the Center button.
7.
Select the Bluetooth® feature. Use the Left and
Right navigation buttons to turn on or off
Bluetooth® feature.
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Bluetooth® Devices
DRAFT 29-NOV-2016
CONNECT DEVICE
8.
Select the Device List menu.
9.
A list of Paired Devices and Other Devices will
show.
10. Select the device to connect.
11. Press the Center button.
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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.
DELETE DEVICE
1. Do Step 1 through Step 8 of “Bluetooth® Devices” on page 51.
2.
Select the device to delete.
3.
Press the Center button.
4.
5.
Select Delete.
Press the Center button.
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WiFi
DRAFT 29-NOV-2016
The device will no longer be listed under Paired
Devices.
6.
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
1.
From the Home screen, select Menu.
2.
Press the Center button.
3.
Select Device Settings.
4.
Press the Center button.
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5.
Select Wireless.
6.
Press the Center button.
7.
Select the WiFi feature. Use the Left and Right
navigation buttons to turn on or off Bluetooth®
feature.
8.
Select Network 1 for your primary WiFi
connection.
WiFi
9.
Use the navigation buttons on the pendent to
select the letter or number to enter your
network password.
10. Press the Center button to accept each
character.
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DRAFT 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
1.
From the Home screen, select Menu.
2.
Press the Center button.
3.
Select the Device Settings menu.
4.
Press the Center button.
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5.
Select the Color Themes menu.
6.
Press the Center button.
7.
Select the desired color.
8.
Press the Center button.
Support
SUPPORT
1. From the Home screen, select Menu.
2.
Press the Center button.
3.
Select the Device Information menu.
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DRAFT 29-NOV-2016
Errors
4.
Press the Center button.
5.
Select the Support menu.
6.
The Support screen will show a phone number
to contact Hill-Rom.
ERRORS
1.
From the Home screen, select Menu.
2.
Press the Center button.
3.
Select Device Information menu.
4.
Press the Center button.
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5.
Select Errors to review system error codes.
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 system had.
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Errors
59
Errors
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CRITICAL ERRORS
Error
Pendant
Mobile App
Loss of Battery
Communication—battery lost
communication and will not
charge.
1. Remove the battery and
reinstall. See “Battery
Replacement” on page 70.
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 unit in to
power.
3. If error is not resolved, contact Hill-Rom at 800-426-4224. If outside
of the
USA, contactisyour
distributor or local Hill-Rom
Faulty
Driver—power
interrupted between main control
board and the pod drivers.
Contact Hill-Rom at 800-4264224.
Outside of the USA, contact your
distributor or local Hill-Rom representative, or go to www.hillrom.com.
Loss of Communication—
pendant lost the communication
with the main control board.
Contact Hill-Rom at 800-4264224.
Outside of the USA, contact your
distributor or local Hill-Rom representative, or go to www.hillrom.com.
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Error
Pendant
Mobile App
Pendant
Mobile App
Errors
Product Overheat—
temperature exceeds the
garments operating
temperature.
1. Press Okay to terminate the
therapy to allow the system
to cool for 15 minutes.
2. If error is not resolved,
contact Hill-Rom at 800-4264224. If outside of the USA,
contact your distributor or
local Hill-Rom
representative, or go to
www.hill-rom.com.
CAUTION ERRORS
Error
Pod 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
one or more of the pods is not
working.
Contact Hill-Rom at 800-4264224 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. Plug the system in to
power.
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Errors
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Error
Pendant
Mobile App
Low battery—Plug the system
in to power.
Pod Isolation—One pod must
be active for therapy.
Stuck button—Make sure that a
button is not inadvertently
pressed or held close.
Contact Hill-Rom at 800-4264224.
Not applicable
WiFi—Reconnect to the WiFi
communication, see “WiFi” on
page 54.
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Error
Pendant
Errors
Mobile App
Bluetooth®—Reconnect to the
Bluetooth® communication, see
“Bluetooth® Devices” on page 51.
Battery Communication—
1. Remove the battery 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 unit in
to power.
Data storage—Contact HillRom at 800-426-4224.
Unauthorized USB—
Remove the USB device
from the system
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Service
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SERVICE
WARNING:
Only authorized person should service The Monarch™ Airway Clearance
System. Servicing by unauthorized person 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.hill-rom.com.
EXPECTED LIFE
The expected 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 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™
Airway Clearance System, parts and batteries.
SERVICE CALLS
When you contact Hill-Rom about The Monarch™ Airway Clearance System, be
prepared to give the serial number from the product identification label. The
product identification label is located under the backpack cover just over the
battery compartment.
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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.
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 ON
1.
2.
Make sure the DC connector from the AC adapter is securely 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 connector from
the garment, and then reconnect.
If the problem still exists, contact Hill-Rom.
POD(S) DO NOT ACTIVATE
1.
2.
Use the pendent to get to the Localize screen (see “Start Therapy” on
page 37). Confirm that all pods are white to indicate that the pods are
active for therapy.
If the problem still exists, contact Hill-Rom.
SCREEN SHOWS “PLEASE CALL FOR SERVICE” MESSAGE
The 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.
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Storage and Handling
THE GARMENT NO LONGER FITS
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:
1. Place the garment in the roller bag.
2. Insert the AC/DC adapter, power cord, and other accessories into 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 over 30% charge or injury and/or
equipment damage may occur.
CAUTION:
If shipping is required, the original packing material provides the best
protection for The Monarch™ Airway Clearance System. Retain the original
packaging material. Failure to do so could cause equipment damage.
If shipping is required, ship the unit in its original packing material.
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quently Asked Questions
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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.
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 G)
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DRAFT 29-NOV-2016
Replacement Parts List and Instructions
REPLACEMENT PARTS LIST AND INSTRUCTIONS
Symbol
68
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
198685
Washable garment shell, green
198686
Washable garment shell, pink
198687
Washable garment shell, red
Monarch™ Airway Clearance System User Manual (195292 REV G)
arts List and Instructions
DRAFT 29-NOVRep-la2cem0en1t P6
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)
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DRAFT 29-NOV-2016
Replacement Parts List and Instructions
BATTERY REPLACEMENT
NOTES:
•
Consult your local regulations to safely discard or recycle the
batteries.
•
Do not return the battery unless specifically requested by
customer service.
•
Remove the battery before returning the main garment for
repairs.
WARNING:
Do not ship the battery with over 30% charge or injury and/or
equipment damage may occur.
1.
2.
3.
4.
Lift the battery access
panel.
Slide and hold the latch
down to unlock battery.
Pull on the top battery
while the latch is unlocked.
Remove the bottom of the
battery from the garment.
BATTERY ACCESS PANEL REPLACEMENT
1.
2.
3.
4.
5.
Open the battery access panel by lifting the bottom of the panel and
lifting up.
Grip the battery access panel close to the hinge and slowly pull away
from the backpack to remove the hinge.
Grip the new battery access panel with the logo facing away from the
backpack.
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 CHARGER
Only use a Hill-Rom approved Monarch AC/DC Charger.
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arts List and Instructions
DRAFT 29-NOVRep-la2cem0en1t P6
Monarch™ Airway Clearance System User Manual (195292 REV G)
71
DRAFT 29-NOV-2016
Specifications
The 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. 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.
SPECIFICATIONS
Feature
Dimension
Monarch™ weight (with battery)
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
Polyester
Electrical Requirements
Nominal voltage: 24V DC +/- 1.5 V DC
Nominal Power Consumption: ~65 W
max
A/C Power Supply
Model MANGO120-24CK
Input: 100-240 V, 50/60 Hz 1.0-2.0A
Lithium-ion Battery
Part number: 194566
Output: 24 V DC +/- 1.5 V DC,
Capacity : 2700mAh
Fuse requirement
Power adapter/cord only
Environmental Conditions for Transport and Storage
Condition
Range
Temperature
-4°F to 140°F (-20°C to 60°C)
Relative humidity
15% to 90%, non-condensing
Atmospheric pressure
50 kPa to 106 kPa
Environmental Conditions for Use
Condition
Temperature
72
Range
41°F to 95°F (5°C to 35°C)
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Condition
Specifications
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. The Monarch™ Airway Clearance System also features an optional WiFi module to export device use data in home care environments.
Feature
Dimension
Bluetooth ® Specification (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 shift keying
Frequency hopping spectrum
Wi-Fi (Optional Configuration)
WLAN
Frequency
IEEE 802.11a, 802.11b, 802.11g, 802.11n
2412 – 2462 MHz,
5180 – 5240 MHz,
5745 – 5825 MHz
Transmit Power
(+/- 2dBm)
17.5 dBm for 802.11b DSSS
17.5 dBm for 802.11g/n OFDM
12 dBm for 802.11a/g/n OFDM
Receive Sensitivity
(+/- 2dBm)
1Mbps -95.5 dBm (< 10% PER)
54 Mbps -74.5 dBm (< 10% PER)
MCS7(20MHz) -71.5 dBm (< 10% PER)
MCS7(40MHz) -68 dBm (< 10% PER)
Security
Authentication/Encryption
WPA/WPA2-Personal, WEP 64/128bits
73
Monarch™ Airway Clearance System User Manual (195292 REV G)
DRAFT 29-NOV-2016
Classification and Standards
Technical and Quality Assurance
ANSI/AAMI ES60601-1
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
External pod cover 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
Maximum Sound Pressure
Level
65 dBA
Not for use with flammable anesthetics.
The 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.
There are no user accessible fuses. Refer to the Monarch™ Airway Clearance
System Service Manual (195291)” for fuse ratings and replacement
procedures.
Monarch™ Airway Clearance System User Manual (195292 REV G)
74
Specifications
DRAFT 29-NOV-2016
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™ 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
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
RF
Emissions
CISPR 11
Group 1
The Monarch™ Airway Clearance System uses
RF energy only for its internal functions.
Therefore, its RF emissions are low and are not
likely to cause any interference in nearby
electronic equipment.
RF
Emissions
CISPR 11
Class B
The Monarch™ Airway Clearance System is
suitable for use in all establishments, including
domestic establishments, and those directly
connected to the public low-volt- age power
supply network that supplies buildings used for
domestic purposes.
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Monarch™ Airway Clearance System User Manual (195292 REV G)
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
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
Electromagnetic B Environment—Guidance
Electromagnetic Immunity Guidance
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.
Electromagnetic B
Environment—
Guidance
IEC 60601
Test Level
Compliance Level
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± 8kV Contact Discharge
± 15kV Air Discharge
± 8kV Contact Discharge
± 15kV Air Discharge
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2 kV for Power
Supply Lines
± 2 kV for Power
Supply Lines
Mains power quality
should be that of a typical home healthcare
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 healthcare
environment
Immunity Test
Monarch™ Airway Clearance System User Manual (195292 REV G)
76
Specifications
DRAFT 29-NOV-2016
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.
Immunity Test
Voltage Dips, Short
Interruptions, and
Voltage Variations
On Power Supply
Input Lines
IEC 61000-4-11
Power Frequency
(50/60Hz) Magnetic Field
IEC 61000-4-8
IEC 60601
Test Level
Compliance Level
Electromagnetic B
Environment—
Guidance
0% UT; 0.5
cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0% UT; 0.5
cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
Mains power quality
should be of a typical
home healthcare
environment. If the user
of the Monarch™ Airway
Clearance System
requires continued
operation during power
mains interruption,
0% UT; 1 cycle
and
0% UT; 1 cycle
and
70% UT; 25/30
cycles
Single Phase:
at 0°
70% UT; 25/30
cycles
Single Phase:
at 0°
it is recommended that
the Monarch™ Airway
Clearance System be
powered from an
uninterruptedly power
supply or a battery.
0% UT; 250/300
cycle
0% UT; 250/300
cycle
30 A/m
30 A/m
Power frequency magnetic fields should be at
levels characteristic of a
typical location in a typical home healthcare
environment
Note: UT is the AC mains voltage prior to application of the test level.
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Monarch™ Airway Clearance System User Manual (195292 REV G)
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.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment—
Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Monarch™ Airway Clearance
System, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Conducted
RF
IEC 61000-4-6
3 V/m
150 kHz to
80 MHz
3 V/m
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
3 V/m
Recommended separation distance:
= 1.2√
= 1.2√
= 2.33√
80 MHz to 800 MHz
800 MHz to 2.7 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer and d is the
recommended separation in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey , should be less than the compliance
level in each frequency range .
Interference may occur in the vicinity of
equipment marked with the following 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 propagation is
affected by absorption and reflection from structures, objects and people.
Monarch™ Airway Clearance System User Manual (195292 REV GF)
78
Specifications
DRAFT 29-NOV-2016
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 Monarch™ Airway
Clearance System is used exceeds the applicable RF compliance level above, the
Monarch™ Airway Clearance System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Monarch™ Airway Clearance System .
b. Over the frequency range of 150 kHz to 80 MHz, field strength should be less than 3 V/m.
Recommended 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 electromagnetic
environment 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 portable and mobile RF communications
equipment (transmitters) and the Monarch™ Airway Clearance System as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter, W
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d = 1.2√
√P
80 MHz to800 MHz
d = 1.2√
√P
800 MHz to 2.7 GHz
d = 2.33√
√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation 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 frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Monarch™ Airway Clearance System User Manual (195292 REV G)
79
Federal Communications Commission (FCC) Radiation Exposure
Statement
This 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.
79
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DRAFT 29-NOV-2016
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