Hillrom Monarch 1000 User manual

DRAFT 29-NOV-2016
Monarch™ Airway Clearance System,
Model 1000
User Manual
Product No. PMACS1
195 9 REV G
Rx Only Federal USA law restrict this device to sale by or on the order of a physician

DRAFT 29-NOV-2016
© 016 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED.
Manufacturer:
HILL-ROM SERVICES PRIVATE LIMITED
1 YISHUN AVENUE 7
SINGAPORE 7689 3
Authorized European Union Representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]
No part of this text shall be reproduced or transmitted in any form or by
any means, electronic or mechanical, including photocopying, recording,
or by any information or retrieval system without written permission from
Hill-Rom Services PTE Ltd. Inc. (Hill-Rom).
The information in this manual is confidential and may not be disclosed to
third parties without the prior written consent of Hill-Rom.
The information in this manual is subject to change without notice. Hill-
Rom makes no commitment to update or keep current, the information in
this manual.
Hill-Rom reserves the right to make changes without notice in design,
specifications, and models. The only warranty Hill-Rom makes is the
express written warranty extended on the sale or rental of its products.
The Monarch™ Airway Clearance System product may be covered by one
or more patents. For a list of applicable patents, go to www.hill-
rom.com/patents.
This manual (195 9 ) was originally released and supplied in English. For
a list of available translations, contact Hill-Rom Technical Support.
First Edition, November 016
First Printing, 016
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 ) i

DRAFT 29-NOV-2016
Replace this manual (195 9 ) if it is damaged and/or cannot be read.
For product support or to order additional copies of this manual (195 9 ),
contact Hill-Rom:
• In the USA, call Hill-Rom at 800-4 6-4 4
• 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 )

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 ............................................................... 1
Size Guide Reference ...................................................... 3
Program the Garment .......................................................................... 5
Program Therapy ........................................................................... 5
Treatment Options ................................................................. 5
Program Manual Mode ................................................................. 6
Program Manual Mode—Pendant ......................................... 6
Program Manual Mode—Mobile App .................................... 8
Program Therapy Mode ................................................................ 9
Program Therapy—Pendant .................................................. 9
Monarch™ Airway Clearance System User Manual (195292 REV ) v

Table of Contents
DRAFT 29-NOV-2016
Program Therapy—Mobile App ......................................... 3
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 ............................4
Using the Pendant ..................................................................4
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 ..............................................................................5
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.................................................................................7
Monarch™ Airway Clearance System User Manual (195292 REV ) vii

Table of Contents
DRAFT 29-NOV-2016
NOTES:
viii Monarch™ Airway Clearance System User Manual (195292 REV )

DRAFT 29-NOV-2016
Document Symbols
DOCUMENT SYMBO S
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 A 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 ) 1

Important Safeguards
DRAFT 29-NOV-2016
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.
. 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.
1 . 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.
2 Monarch™ Airway Clearance System User Manual (195292 REV )

DRAFT 29-NOV-2016
Important 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.
0. 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 800-4 6-4 4.
• Outside of the USA, contact your distributor or local Hill-Rom
representative, or go to www.hill-rom.com.
1. The potential for electrical shock exists with electrical equipment.
Failure to follow protocols may cause death or serious personal injury.
. 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 .
3. Do not expose the unit to excessive moisture or immerse it in water.
4. If the display on the Monarch™ pendant is faulty, do not use the unit.
5. 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.
6. Before cleaning, unplug the unit from its power source and remove
the battery. Failure to do so could cause personal injury or equipment
damage.
7. 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.
8. Do not use harsh cleansers, solvents, or detergents. Equipment
damage could occur.
9. 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.
3 . 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 ) 3

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.
I NTENDED PATIENT POPU ATION
The Monarch™ Airway Clearance System, Model 1000 in intended for
adolescent to adult population (15 years and above) or as prescribed by a
physician.
I NTENDED 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.
4 Monarch™ Airway Clearance System User Manual (195292 REV )

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
R E ATIVE C ONTRAINDICATIONS
• 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 0 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 ) 5

Cleaning
DRAFT 29-NOV-2016
• 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
C EANING
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,
6 Monarch™ Airway Clearance System User Manual (195292 REV )

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
G ENERA C EANING —G ARMENT
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.
W ASHAB E G ARMENT S HE
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 ) 7

Acronyms
DRAFT 29-NOV-2016
1. Remove the Garment Shell from the Garment.
. Fasten all the hook and loop straps to each other to limit snagging.
3. Machine wash, or hand wash, in cold cycle only (86°F (30°C)
maximum). Non-chlorine bleach may be used as necessary.
4. Hang dry or tumble dry on lowest temperature (1 0°F (49°C)
maximum).
NOTE:
Do not iron any parts on the device.
ACRONYMS
Acronym Meaning
HFCWO
High
Fr
equency
Chest
Wall
Oscillation
FEATURES
Item
Descri
ption
Item
Descri
ption
A
P
od
H
Battery
access
panel
B Pendant I Backpack cover
C Front opening J Shoulder Strap
D Charging port K Shoulder pads
E
C
am
buckle
—
waist
adjustment
L Handle
F
Pause
/r
esume
cont
r
ol
but
-
ton
M Pod cover
G Garment Shell Power adapter (not shown)
8 Monarch™ Airway Clearance System User Manual (195292 REV )

DRAFT 29-NOV-2016
Features
CAUTION:
Obey these cautions to help prevent equipment damage:
• Use only with the Hill-Rom approved AC/DC power adapter (Hill-
Rom Part Number 195500 (MEGMEET model number
MANGO1 0- 4CK-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
Shoulder
Ad
j
u
st
-
ment
Pod Shoulder Pads
Front Closer
W
aist
Adjust
-
ments
Garment
Shell
Wa
is
t
Adjust
-
ment—cam
buckle
Monarch™ Airway Clearance System User Manual (195292 REV ) 9

Features
DRAFT 29-NOV-2016
Item
Image
Item
Image
Backpack
Cover
Battery
Ch
ar
g
i
ng
Port
Battery
Com
-
partment
Pause
/
Resume But-
ton
Pendant Dock
10 Monarch™ Airway Clearance System User Manual (195292 REV )

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
Descri
ption
A
Sc
r
een
B ON/OFF button
C Navigation buttons
D Center button
E Back button
PRODUCT SYMBO S
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 ) 11

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 ( 005) + AMD
( 01 )
CAN/CSA-C . No. 60601-1 ( 008) +
( 014)
Monarch™ Airway Clearance System,
Model 1000 conforms to the European
Medical Device Directive 93/4 /EEC.
Manufacturer or distributor complies with
the Waste Electric and Electronic Equip-
ment Directive 01 /19/EU
12 Monarch™ Airway Clearance System User Manual (195292 REV )

DRAFT 29-NOV-2016
Product Symbols
Symbol Definition
Do not iron*
Machine wash cold
No chlorine bleach*
Tumble dry low heat*
Catalog number
Batch number
Date of manufacture
Manufacturer
Manufacturer and date of manufacture
Physician prescription required (for US
only)
Monarch™ Airway Clearance System User Manual (195292 REV ) 13