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User Guide MSeries Plus

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0% found this document useful (0 votes)
179 views64 pages

User Guide MSeries Plus

Uploaded by

Peter Williams
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

USER MANUAL

1016438
JH 9/12/05
IMPORTANT! Fill in the information below when you receive the REMstar®
Plus M Series system.
Serial No.: _______________________________ (located on the bottom of the device)
System Prescribed for: __________________________________________
Date of Purchase or Rental: ______________________________________
Pressure Setting: _____ cm H2O
Mask Type: __________________________________________________
Mask Size: ___________________________________________________

If you have any questions concerning the system, contact:


• Home Care Company: _______________________________________
Telephone Number: _________________________________________
• Health Care Professional: _____________________________________
Telephone Number: _________________________________________
• Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania
15668-8550 USA
Customer Service
Telephone Number: 1-724-387-4000

The REMstar® Plus M Series with C-Flex™ system is covered by one or more of the following patents:
5,148,802; 5,313,937; 5,433,193; 5,632,269; 5,803,065; 6,029,664; 6,305,374; 6,539,940, 5,535,738;
5,794,615; 6,105,575; 6,609,517; 6,629,527; 6,622,724; and 6,427,689. Other patents pending.
REMstar, Whisper Swivel, Encore Pro, and Encore Pro SmartCard are trademarks of Respironics, Inc.
NOTE: The C-Flex mark is used under license.
© 2005 Respironics, Inc. All rights reserved.
reply_card1.pdf 9/19/05 [Link] AM

CM

MY

CY

CMY

FIRST-CLASS MAIL PERMIT NO. 231 GRAND RAPIDS MN

PO BOX 7014
GRAND RAPIDS MN 55744-8029
reply_card2.pdf 9/19/05 [Link] AM

C
Please complete the following or register online at: [Link]
M
Product Identification Information Model #:
Y (Numbers located on the bottom
of the device) Serial #:
CM

Name
MY

CY Address
CMY
City State Zip
K

Phone ( )

E-mail

Where did you first hear about your M Series device?

Homecare Provider Sleep Lab Internet/Website Tradeshow Friend/Colleague

Other (please specify)

Would you like to receive information regarding new products from Respironics?
Yes No

If Yes, Preferred Method?


Direct Mail Phone Email
An application to join the American Sleep Apnea Association should be attached here.
If it is not, you can contact the American Sleep Apnea Association at 1-202-293-3650.

Name ______________________________________________ Phone No. ( ) ___________________________

Address _________________________________ City ____________________ State _________ Zip ___________

Please check: _____$1000 _____$500 _____$250 _____$100 _____$50 _____$25 annual membership*
All memberships include a one year subscription to the newsletter. Membership and contributions are deductible for income tax
purposes within IRS rules. Membership includes a free medical alert necklace or bracelet.

_____I would like to become a member of the ASAA.


Please send me a free medical alert _____bracelet or _____necklace.
_____I am undecided, but please send me a free copy of the newsletter.
_____I would like to know if there is an A.W.A.K.E. group near me.
PLEASE SEND TO:
American Sleep Apnea Association
1424 K Street NW, Suite 302, Washington D.C. 20005

Respironics, Inc. provided a grant to and is recognized as a founding sponsor of the American Sleep Apnea Association. As a
non-profit organization, the American Sleep Apnea Association does not endorse or recommend any company or product.

*For addresses outside the United States, the minimum contribution is U.S. $50.00.
Join the American Sleep Apnea Association

As a member of the American Sleep Apnea Association, you will receive a newsletter, WAKE-UP CALL,
six times each year. This newsletter will inform you about the latest in medical advances, new technology,
human interest stories of individual accomplishment, home care tips, and legislative affairs. Also, you will
receive a medical alert identification bracelet.

You are also invited to participate in the A.W.A.K.E. (Alert, Well And Keeping Energetic) Network, which
is a nationwide system of local mutual help/support groups. A.W.A.K.E. meetings provide the opportunity
to share information and support with others who have been affected by sleep apnea.

G O A L S
To reduce disability and
death from Sleep
Apnea and other
breathing disorders
To improve the clinical
care of Sleep Apnea by
educating the public and
medical profession
To provide Sleep
Apnea sufferers with
information about new
advances in the treatment
To establish and
nurture mutual
help/support groups
for apnea sufferers
To raise money for
and to sponsor
research on the
causes and treatment
during sleep. about the disorder. of Sleep Apnea. and their families. of Sleep Apnea.
TABLE OF CONTENTS
Chapter 1: Introduction ..................................................................................................................1-1
1.1 System Contents ........................................................................................................1-1
1.2 Intended Use ...............................................................................................................1-2
1.3 Warnings, Cautions, and Contraindications .....................................................1-2
1.3.1 Warnings ...........................................................................................................1-2
1.3.2 Cautions ............................................................................................................1-4
1.3.3 Contraindications ..........................................................................................1-4
1.4 System Overview .......................................................................................................1-5
1.4.1 Breathing Circuit Overview........................................................................1-7
1.5 Glossary .........................................................................................................................1-8
1.6 Symbol Key ..................................................................................................................1-9
1.7 How to Contact Respironics ............................................................................... 1-10
Chapter 2: Device Controls and Displays .................................................................................2-1
2.1 Controls and Displays ..............................................................................................2-1
2.1.1 Control Panel Inactivity ...............................................................................2-2
2.2 Rear Panel .....................................................................................................................2-3
Chapter 3: Setup................................................................................................................................3-1
3.1 Installing the Air Filters ............................................................................................3-1
3.2 Where to Place the Device......................................................................................3-2
3.3 Connecting the Breathing Circuit .......................................................................3-2
3.4 Supplying Power to the Device ............................................................................3-5
3.4.1 Using AC Power .............................................................................................3-5
3.4.2 Using DC Power .............................................................................................3-6
3.5 Complete Assembly Example ...............................................................................3-7
Chapter 4: Device Operation ........................................................................................................4-1
4.1 Starting the Device ...................................................................................................4-1
4.2 Using the Ramp and C-Flex Features .................................................................4-3
4.2.1 Ramp Feature..................................................................................................4-3
4.2.2 C-Flex Comfort Feature ...............................................................................4-4
[Link] C-Flex Enabled....................................................................................4-4
[Link] C-Flex Disabled ..................................................................................4-4

REMSTAR PLUS M SERIES USER MANUAL i


4.3 Changing the Device Settings .............................................................................. 4-5
4.3.1 Navigating the Display Screens ............................................................... 4-5
[Link] Viewing Data on the Patient Data Screens............................... 4-5
[Link] Viewing and Modifying Patient Setup Screens ...................... 4-7
4.4 Completing the FOSQ Questionnaire ..............................................................4-10
4.5 Patient Reminder Screen ......................................................................................4-11
Chapter 5: Alerts and Troubleshooting ..................................................................................... 5-1
5.1 Device Alerts ............................................................................................................... 5-1
5.2 Troubleshooting......................................................................................................... 5-4
Chapter 6: Accessories .................................................................................................................... 6-1
6.1 Adding a Humidifier ................................................................................................. 6-1
6.2 Using the SmartCard .............................................................................................. 6-2
6.3 Adding Supplemental Oxygen ............................................................................. 6-2
Chapter 7: Cleaning and Maintenance ..................................................................................... 7-1
7.1 Cleaning the Device ................................................................................................. 7-1
7.2 Cleaning or Replacing the Filters ......................................................................... 7-1
7.3 Cleaning the Tubing ................................................................................................. 7-3
7.4 Service ........................................................................................................................... 7-3
7.5 Traveling with the System ...................................................................................... 7-4
7.5.1 International Travel ....................................................................................... 7-4
Chapter 8: Specifications................................................................................................................ 8-1
Appendix A: EMC Information .....................................................................................................A-1

ii REMSTAR PLUS M SERIES USER MANUAL


CHAPTER 1: INTRODUCTION
This chapter provides information on:
• REMstar Plus M Series system contents
• Intended Use
• Warnings, cautions, and contraindications
• System overview
• Glossary and symbol key
• How to contact Respironics

1.1 SYSTEM CONTENTS


Your REMstar Plus M Series system includes the following items:
Carrying Case
User Manual

Quickstart Guide
Flexible Tubing

Power Supply

Reusable Gray Foam


Filter
Disposable Ultra-fine
Filter

AC Power Cord

REMstarPlus M Series Device

FIGURE 1–1 SYSTEM CONTENTS

Note: If your system includes a humidifier, you will receive additional items with your
package. See the instructions included with your humidifier for more informa-
tion.

Note: If any of the above items are missing, contact your home care provider.

REMSTAR PLUS M SERIES USER MANUAL 1-1


1.2 INTENDED USE
The Respironics REMstar Plus M Series system is a CPAP (Continuous Positive Airway Pressure)
device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing
patients weighing >30 kg.
The device is to be used only on the instruction of a licensed physician. Your home care provider
will make the correct pressure settings according to your health care professional’s prescription.
Several accessories are available to make your OSA treatment with the REMstar Plus M Series
system as convenient and comfortable as possible. To ensure that you receive the safe,
effective therapy prescribed for you, use only Respironics accessories.

1.3 WARNINGS, CAUTIONS, AND CONTRAINDICATIONS


Caution: U.S. federal law restricts this device to sale by or on the order of a physician.

1.3.1 WARNINGS
A warning indicates the possibility of injury to the user or the operator.
• This manual serves as a reference. The instructions in this manual are not intended to super-
sede the health care professional’s instructions regarding the use of the device.

• The operator should read and understand this entire manual before using the device.
• This device is not intended for life support.
• The device should be used only with masks and connectors recommended by Respironics
or with those recommended by the health care professional or respiratory therapist. A mask
should not be used unless the device is turned on and operating properly. The exhalation
port(s) associated with the mask should never be blocked.
Explanation of the Warning: The device is intended to be used with special masks or con-
nectors that have exhalation ports to allow continuous flow of air out of the mask. When the
device is turned on and functioning properly, new air from the device flushes the exhaled air
out through the mask exhalation port. However, when the device is not operating, enough
fresh air will not be provided through the mask, and exhaled air may be rebreathed. Re-
breathing of exhaled air for longer than several minutes can in some circumstances lead to
suffocation.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not
in use.
Explanation of the Warning: When the device is not in operation and the oxygen flow is left
on, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygen
accumulated in the device enclosure will create a risk of fire.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence
of an open flame.

1-2 REMSTAR PLUS M SERIES USER MANUAL


• When using oxygen with this system, a Respironics Pressure Valve (Part Number 302418)
must be placed in-line with the patient circuit. Failure to use the pressure valve could result
in a fire hazard.
• Do not use the device in the presence of a flammable anaesthetic mixture in combination
with oxygen or air, or in the presence of nitrous oxide.
• Do not use this device if the room temperature is warmer than 95° F (35° C). If the device is
used at room temperatures warmer than 95° F (35° C), the temperature of the airflow may
exceed 106° F (41° C). This could cause irritation or injury to your airway.
• Do not operate the device in direct sunlight or near a heating appliance because these condi-
tions can increase the temperature of the air coming out of the device.
• Contact your health care professional if symptoms of sleep apnea recur.
• If you notice any unexplained changes in the performance of this device, if it is making un-
usual or harsh sounds, if the device or the power supply are dropped or mishandled, if water
is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your
home care provider.
• Repairs and adjustments must be performed by Respironics-authorized service personnel
only. Unauthorized service could cause injury, invalidate the warranty, or result in costly
damage.
• Periodically inspect electrical cords, cables, and the power supply for damage or signs of wear.
Discontinue use and replace if damaged.
• To avoid electric shock, unplug the device before cleaning it. DO NOT immerse the device
in any fluids.
• Using this device at an incorrect elevation setting could result in airflow pressures higher than
the prescribed setting. Always verify the elevation setting when traveling or relocating.
• Pins of connectors identified with the ESD warning symbol ( )should not be touched.
Connections should not be made to these connectors unless ESD precautionary procedures
are used. Precautionary procedures include methods to prevent build-up of electrostatic
discharge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic
clothing), discharging one’s body to the frame of the equipment or system or to earth or a
large metal object, and bonding oneself by means of a wrist strap to the equipment or system
or to earth.

REMSTAR PLUS M SERIES USER MANUAL 1-3


1.3.2 CAUTIONS
A Caution indicates the possibility of damage to the device.
• The device may only be operated at temperatures between 41° F (5° C) and 95° F (35° C).
• If this device has been exposed to either very hot or very cold temperatures, allow it to adjust
to room temperature before starting therapy. Condensation may damage the device.
• Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter.
• A properly installed, undamaged reusable foam inlet filter is required for proper operation.
• Tobacco smoke may cause tar build-up within the device, which may result in the device
malfunctioning.
Note: Additional warnings, cautions, and notes are located throughout this manual.

1.3.3 CONTRAINDICATIONS
When assessing the relative risks and benefits of using this equipment, the clinician should
understand that this device can deliver pressures up to 20 cm H2O. In the event of certain fault
conditions, a maximum pressure of 30 cm H2O is possible. Studies have shown that the following
pre-existing conditions may contraindicate the use of CPAP therapy for some patients:
• Bullous Lung Disease
• Pathologically Low Blood Pressure
• Bypassed Upper Airway
• Pneumothorax
• Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pres-
sure. Caution should be used when prescribing CPAP for susceptible patients such as those
with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of
head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)
The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit
signs of a sinus or middle ear infection. Not for use with patients whose upper airways are by-
passed. Contact your physician if you have any questions concerning your therapy.

1-4 REMSTAR PLUS M SERIES USER MANUAL


1.4 SYSTEM OVERVIEW
The REMstar Plus M Series device, shown in Figure 1–2, is a sleep apnea system that
delivers Continuous Positive Airway Pressure (CPAP). CPAP maintains a constant level of pres-
sure throughout the breathing cycle.
When prescribed for you, the device provides several special features to help make your therapy
more comfortable. The ramp function allows you to lower the pressure when you are trying to fall
asleep. The air pressure will gradually increase until your prescription pressure is reached. You also
have the option of not using the ramp feature at all.
Additionally, the C-Flex comfort feature provides you with pressure relief during the expiratory
phase of breathing.
Several accessories are also available for use with your REMstar Plus M Series device. Contact
your home care provider to purchase any accessories not included with your system.

FIGURE 1–2 REMSTAR PLUS M SERIES DEVICE

REMSTAR PLUS M SERIES USER MANUAL 1-5


Figure 1–3 illustrates many of the device features, described in the table below.
Start/Stop
Ramp Button Button
C-Flex
Button
Power Inlet
Display Screen Air Outlet
(under door)

le
x
Medical
Equipment Note Filter Area
(on bottom) Accessory
Module

FIGURE 1–3 SYSTEM OVERVIEW

DEVICE FEATURE DESCRIPTION


Accessory Module If applicable, insert optional accessory module here.
Air Outlet Connect the flexible tubing here.
C-Flex Button This button allows you to change the C-Flex comfort
setting, if C-Flex is prescribed for you. See Chapter 4
for more information about C-Flex.
Display Screen Shows therapy settings, patient data, instructions,
and error messages.
Filter Area A reusable, gray foam filter must be placed in the
filter area to screen out normal household dust and
pollens. An optional, white ultra-fine filter can also
be used for more complete filtration of very fine
particles.

Medical Equipment Note For ease at airport security stations, there is a note
on the bottom of the device stating that it is medical
equipment. It may help if you also take this manual
with you when you travel.
Power Inlet Connect the power cord here.
Ramp Button This button starts or restarts the ramp cycle.
Start/Stop Button This button starts or stops the airflow.

1-6 REMSTAR PLUS M SERIES USER MANUAL


1.4.1 BREATHING CIRCUIT OVERVIEW
The patient breathing circuit, shown in Figure 1–4, consists of the following:
• Circuit tubing to deliver air from the device to your interface (e.g., mask)
• A mask or other patient interface device to deliver the prescribed pressure to your nose or
nose and mouth, depending on which interface has been prescribed for you
• An exhalation device to vent exhaled air from the circuit
Patient Interface

Exhalation
Device Exhalation Mask's
Connector
Port
Circuit Flexible
Tubing Tubing
Connector

Circuit with Separate Circuit with Mask with


Exhalation Device Integrated Exhalation Port

FIGURE 1–4 TYPICAL BREATHING CIRCUITS

Note: The exhalation port may be part of the interface or may be part of a separate
exhalation device, but is required to minimize the potential for CO2 rebreathing.

REMSTAR PLUS M SERIES USER MANUAL 1-7


1.5 GLOSSARY
The following terms and acronyms appear throughout this manual:

TERM/ACRONYM DEFINITION
Active State The state of the device when power is applied, the airflow is on, and
the device is providing therapy.
Apnea A condition marked by the cessation of spontaneous breathing.
Auto-Off When this feature is enabled, the device automatically discontinues
therapy whenever the mask is removed.
Auto-On With this feature, the device automatically initiates therapy when you
begin breathing on the device. This feature is always enabled.
BPM Breaths Per Minute
C-Flex A therapy feature that provides pressure relief during exhalation, if
enabled by your home care provider.
CPAP Continuous Positive Airway Pressure
FOSQ Functional Outcomes of Sleep Questionnaire – A “quality of life” ques-
tionnaire designed specifically for people with sleep disorders. The
results allow health care professionals to assess how CPAP therapy has
improved the quality of their patients’ lives.
LPM Liters Per Minute
OSA Obstructive Sleep Apnea
Patient Data Menu The display mode in which you can view certain stored information,
such as therapy usage hours.
Patient Setup Menu The display mode in which you can change patient-adjustable device
settings, such as the ramp starting pressure.
Ramp A feature that may increase patient comfort when therapy is started.
The ramp feature reduces pressure and then gradually increases the
pressure to the prescription setting so you can fall asleep more com-
fortably.
Safe State The state in which the device does not provide therapy. The device
enters this state if an error is detected.
Standby State The state of the device when power is applied but the airflow is
turned off.

1-8 REMSTAR PLUS M SERIES USER MANUAL


1.6 SYMBOL KEY
The following symbols appear on the device and power supply:

SYMBOL DEFINITION

Consult accompanying instructions for use.

DC Power

Type BF Applied Part

Class II (Double Insulated)

IPX1 Drip Proof Equipment

Electrostatic Discharge

European Declaration of Conformity

Canadian/US Certification

Notified Body Approval for Standards Compliance

TUV Safety Standard Compliance

UL Recognized for Canada and the United States

No User Serviceable Parts

REMSTAR PLUS M SERIES USER MANUAL 1-9


1.7 HOW TO CONTACT RESPIRONICS
To have your device serviced, contact your home care provider. If you need to contact
Respironics directly, call the Respironics Customer Service department at 1-800-345-6443 or
1-724-387-4000. You can also use the following address:

Visit Respironics web site at: [Link]

1-10 REMSTAR PLUS M SERIES USER MANUAL


CHAPTER 2: DEVICE CONTROLS AND DISPLAYS
This chapter describes the device’s control buttons and displays, patient circuit connections, and
rear panel connections.

2.1 CONTROLS AND DISPLAYS


Figure 2–1 shows the three primary control buttons on the REMstar Plus M Series device.

C-Flex

FIGURE 2–1 PRIMARY CONTROL BUTTONS


These buttons are described below.

BUTTON DESCRIPTION
Ramp – When the airflow is on, this button allows you to
activate or restart the ramp function. Ramp lowers the
airflow pressure and then gradually increases it, allowing
you to fall asleep more easily.
Start/Stop – This button starts the device’s airflow and
places the device in the Active state, or stops the airflow,
and places the device in Standby. You can also press this
button to exit any setting screen.
C-Flex C-Flex – This button adjusts the C-Flex comfort setting.
If you do not want to modify the settings that your home care provider has set for you, you only
need these three buttons to start and stop therapy and do not need to use the display buttons lo-
cated under the device cover door.
Figure 2–2 shows the device display and navigation buttons that are under the cover door.

– FOSQ Setup +

FIGURE 2–2 DISPLAY BUTTONS

REMSTAR PLUS M SERIES USER MANUAL 2-1


The display buttons are described below:

BUTTON DESCRIPTION
Allows you to access the Data screens. Also allows you to
navigate to the previous screen when in the Data, FOSQ, or
Setup menu.
Allows you to access the Data screens. Also allows you to
navigate to the next screen when in the Data, FOSQ, or Setup
menu.
Allows you to enter the FOSQ screens. Also allows you to
decrease the settings on the patient setup screens.
Allows you to enter the Setup screens. Also allows you to
increase the settings on the patient setup screens.
The device’s display screen shows the set pressure, patient data, instructions, and error messages.
See Chapter 4 for instructions on navigating the display screens.
Figure 2–3 provides a view of the entire device control panel, with the cover door open.
Placement Area
for Optional Quick
Reference Label

Cover Door

Previous Next
Screen Screen
Button Button

Decrease Increase
Button Button
C-Flex

Ramp
Button Start/Stop C-Flex
Button Button

FIGURE 2–3 DEVICE CONTROL PANEL

2.1.1 CONTROL PANEL INACTIVITY


Some screens have time-out periods. The screen’s timer starts when the screen is initially displayed
and is restarted whenever a button is pressed. The screen times out after one minute if there is no
activity and returns to the Standby screen.

2-2 REMSTAR PLUS M SERIES USER MANUAL


2.2 REAR PANEL
Figure 2–4 shows the REMstar Plus M Series device’s rear panel (without a humidifier).
DC Power Inlet

Air Outlet Port

Accessory Slot Filter Area

FIGURE 2–4 REAR PANEL


The rear panel contains the following:
• An accessory slot for optional accessories such as the SmartCard or modem (see Chapter 6,
Accessories, for more information).
• A filter area where the filter(s) supplied with your device should be inserted.
• A DC power inlet where the power cord is connected (see Chapter 3, Setup, for complete
information on supplying power to the device).
• The air outlet port where the breathing circuit’s flexible tubing is attached.

REMSTAR PLUS M SERIES USER MANUAL 2-3


2-4 REMSTAR PLUS M SERIES USER MANUAL
CHAPTER 3: SETUP
This chapter provides instructions on how to:
• Install the air filters
• Position the device
• Connect the breathing circuit
• Supply power to the device

3.1 INSTALLING THE AIR FILTERS


Caution: A properly installed, undamaged foam filter is required for proper opera-
tion.

The device uses a gray foam filter that is washable and reusable, and an optional white ultra-fine
filter that is disposable. The reusable filter screens out normal household dust and pollens, while
the optional ultra-fine filter provides more complete filtration of very fine particles. The gray
reusable filter must be in place at all times when the device is operating. The ultra-fine filter is
recommended for people who are sensitive to tobacco smoke or other small particles.
Two reusable gray foam filters and one disposable ultra-fine filter are supplied with the device.
If your filters are not already installed when you receive your device, you must at least install the
reusable gray foam filter before using the device.
To install the filter(s):
1. If you are using the white disposable ultra-fine filter, insert it into the filter area first, mesh-
side facing in, towards the device.
2. Insert the gray foam filter into the filter area as shown in Figure 3–1.
Note: If you are not using the white disposable filter, simply insert the gray foam filter
into the filter area.

REMSTAR PLUS M SERIES USER MANUAL 3-1


Filter Area

Disposable Ultra-Fine Reusable Gray


Filter (optional) Foam Filter
(required)

FIGURE 3–1 INSTALLING THE AIR FILTER

Note: See Chapter 7, Cleaning and Maintenance, for information on how to clean or
replace the air filters.

3.2 WHERE TO PLACE THE DEVICE


Place the device on a firm, flat surface somewhere within easy reach of where you will use it. Make
sure the filter area on the back of the device is not blocked by bedding, curtains, or other items.
Air must flow freely around the device for the system to work properly. Make sure the device is
away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).

3.3 CONNECTING THE BREATHING CIRCUIT


To use the system, you will need the following accessories in order to assemble the recommended
circuit:
• Respironics interface (e.g, nasal mask) with integrated exhalation port (or Respironics inter-
face with a separate exhalation device such as the Whisper Swivel® II)
• Respironics 1.83 m (6 ft.) flexible tubing (with optional swivel)
• Respironics headgear (for the patient interface)
Warning: If the device is used by multiple persons (e.g., rental devices), a low-
resistance, main flow bacteria filter should be installed in-line between
the device and the circuit tubing to prevent contamination.

3-2 REMSTAR PLUS M SERIES USER MANUAL


To connect your breathing circuit to the device, complete the following steps:
1. Connect the flexible tubing to the air outlet on the back of the device, as shown in
Figure 3–2. You can use the optional, detachable swivel that is provided with your device and
already attached to the tubing (shown in Figure 3–2), or you can remove the swivel and con-
nect the tubing directly to the air outlet.

Detachable
Swivel

FIGURE 3–2 CONNECTING THE FLEXIBLE TUBING

Note: If required, connect a bacteria filter to the device air outlet, and then connect
the flexible tubing to the outlet of the bacteria filter.
2. Connect the tubing to the mask:
a. If you are using a mask with a built-in exhalation port, connect the mask’s connector to
the flexible tubing, as shown in Figure 3–3.

Exhalation Port
Mask's
Connector
Flexible
Tubing
Connector

FIGURE 3–3 CONNECTING A MASK WITH BUILT-IN EXHALATION PORT

REMSTAR PLUS M SERIES USER MANUAL 3-3


b. If you are using a mask with a separate exhalation device, connect the open end of the
flexible tubing to the exhalation device as shown in Figure 3–4. Position the exhalation
device so that the vented air is blowing away from your face. Connect the mask’s connec-
tor to the exhalation device.

Exhalation
Device

Flexible
Tubing
Connector

FIGURE 3–4 CONNECTING A MASK WITH A SEPARATE EXHALATION DEVICE

Warning: The exhalation device (e.g., Whisper Swivel II) or exhalation port (on
masks with an integrated exhalation port) is designed to exhaust CO2
from the patient circuit. Do not block or seal the ports on the exhala-
tion device.

Warning: If you are using a full face mask (i.e., a mask covering both your mouth
and your nose), the mask must be equipped with a safety (entrain-
ment) valve.
3. Attach the headgear to the mask. See the instructions that came with your headgear.

3-4 REMSTAR PLUS M SERIES USER MANUAL


3.4 SUPPLYING POWER TO THE DEVICE
You can power the device using AC or DC power.
Caution: If this device has been exposed to either very hot or very cold temperatures,
allow it to adjust to room temperature before beginning the following
setup procedures.

Warning: Route the wires to avoid tripping.

Warning: This device is activated when the power cord is connected. Pressing
the button turns the airflow on or off.

Important! If you are using your device with a humidifier, refer to the Quickstart
Guide included with your device or the instructions included with your
humidifier for details on how to power the device and humidifier.

3.4.1 USING AC POWER


Complete the following steps to operate the device using AC power.
1. Plug the socket end of the AC power cord into the power supply, as shown in Figure 3–5.

FIGURE 3–5 CONNECTING THE POWER CORD TO THE POWER SUPPLY


2. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by
a wall switch.
3. Plug the power supply cord’s connector into the power inlet on the back of the device, as
shown in Figure 3–6.

REMSTAR PLUS M SERIES USER MANUAL 3-5


FIGURE 3–6 CONNECTING THE POWER SUPPLY CORD TO THE DEVICE
4. Ensure that all connections are secure.
Important! To remove AC power, disconnect the power supply cord from the elec-
trical outlet.

Warning: Inspect the power cord often for any signs of damage. Replace a dam-
aged power cord immediately.

3.4.2 USING DC POWER


The Respironics DC Power Cord (Reorder Number 1001956) can be used to operate this device
in a stationary recreational vehicle, boat, or motor home. The Respironics DC Battery Adapter
Cable (Reorder Number 532209), when used with the DC Power Cord, enables the device to be
operated from a 12 VDC free-standing battery.
Caution: When DC power is obtained from a vehicle battery, the device should not
be used while the vehicle’s engine is running. Damage to the vehicle or the
device may occur.

Caution: Only use a Respironics DC Power Cord and Battery Adapter Cable. Use of
any other system may cause damage to the device or vehicle.

Refer to the instructions supplied with the DC Power Cord and adapter cable for information on
how to operate the device using DC power.

3-6 REMSTAR PLUS M SERIES USER MANUAL


3.5 COMPLETE ASSEMBLY EXAMPLE
Figure 3–7 shows an example of how a complete assembly will look, with breathing circuit con-
nected and power applied to the device.

FIGURE 3–7 FINAL ASSEMBLY EXAMPLE (SHOWN WITH OPTIONAL ACCESSORY MODULE)
Figure 3–8 shows an example of how you should route your tubing and situate your device on
your nightstand for the best setup possible. This will help prevent the device from falling off your
nighstand or table.

FIGURE 3–8 RECOMMENDED DEVICE AND TUBING PLACEMENT

REMSTAR PLUS M SERIES USER MANUAL 3-7


3-8 REMSTAR PLUS M SERIES USER MANUAL
CHAPTER 4: DEVICE OPERATION
This chapter explains how to start the device and change the settings.

4.1 STARTING THE DEVICE


1. Plug the device in to an AC or DC power source. The three primary buttons light up and the
Software Version screen momentarily appears, shown in Figure 4–1.

V 1.0

FIGURE 4–1 SOFTWARE VERSION SCREEN

Note: Version 1.0 shown in Figure 4–1 is an example. Your device may have a different
software version installed.
2. The next screen to appear is the Standby screen, shown in Figure 4–2. You can access the
FOSQ questionnaire or patient settings and data from this screen. See Section 4.3 for in-
structions on how to navigate the display screens.

– FOSQ Setup +

FIGURE 4–2 STANDBY SCREEN

Note: The FOSQ option only appears if a SmartCard is inserted or a modem is con-
nected to the device.

REMSTAR PLUS M SERIES USER MANUAL 4-1


3. Press the button to turn on the airflow. The Active Display screen appears, shown in
Figure 4–3.

15.0 cmH2O

FIGURE 4–3 ACTIVE DISPLAY (WITH SMARTCARD)


The Active Display screen shows the set pressure.
Symbols also appear on the Active Display screen or Standby screen to indicate when certain
conditions are turned on or detected. These symbols are described below:
SYMBOL DESCRIPTION
Ramp – You can initiate the ramp feature by pressing the Ramp button.
The ramp symbol displays on the Active Display screen when the ramp
function is active.
Mask Mask Leak Alert – This flashing text displays on the Active Display screen
Leak if the Mask Alert setting is enabled and the device detects an excessive
mask leak.
Auto Auto-Off – This flashing text displays on the Standby screen if the Auto-
Off Off setting is enabled and the device detects a mask disconnect.
SmartCard – This symbol appears if a SmartCard is inserted in the device.
If the SmartCard is inserted incorrectly, this symbol will flash intermit-
tently.
Modem – This symbol appears if a modem is connected to the device.
(Note: This symbol will vary in appearance depending on the type of
modem being used.)
4. Put on your mask assembly when the air starts to flow.
5. Make sure that no air is leaking from your mask into your eyes. If it is, adjust the mask and
headgear until the air leak stops. See the instructions provided with your mask for more
information.
Note: A small amount of mask leak is normal and acceptable. Correct large mask
leaks or eye irritation from an air leak as soon as possible.
6. If you are using the device while sleeping, try placing the tubing from the device over your
headboard. This may reduce tension on the mask.
Note: If you are having trouble with your mask, refer to the instructions supplied with
the mask.

4-2 REMSTAR PLUS M SERIES USER MANUAL


4.2 USING THE RAMP AND C-FLEX FEATURES
You can press the (Ramp) button to activate the Ramp feature, or the C-Flex button to
change the C-Flex setting, if your provider has enabled these features.

4.2.1 RAMP FEATURE


The device is equipped with an optional ramp feature that your home care provider can enable or
disable. This feature reduces the air pressure when you are trying to fall asleep and then gradually
increases (ramps) the pressure until your prescription setting is reached, allowing you to fall asleep
more comfortably.
If ramp is enabled on your device, after you turn on the airflow, press the button on the top of
the device. You can use the Ramp button as often as you wish during the night.
Note: If the ramp feature is disabled, nothing will happen when you press the but-
ton.

REMSTAR PLUS M SERIES USER MANUAL 4-3


4.2.2 C-FLEX COMFORT FEATURE
The C-Flex comfort feature allows you to adjust the level of air pressure relief that you feel when
you exhale during therapy. Your home care provider can enable or disable this feature.
[Link] C-FLEX ENABLED
When your provider enables C-Flex, a C-Flex level will already be set for you on the device. If this
is not comfortable for you, you can increase or decrease the setting.
To change the C-Flex setting, press the C-Flex button. The screen shown in Figure 4–4 appears,
with an arrow above the current C-Flex setting.

C-Flex Setting

1 2 3

FIGURE 4–4 C-FLEX SETTING SCREEN


The setting of 1 provides a small amount of pressure relief, with higher numbers providing ad-
ditional relief. To change the pressure relief, press the + or – buttons to increase or decrease the
setting.
Note: You can also view and change the C-Flex setting by navigating to the C-Flex Set-
ting screen from the Patient Setup menu (see Section 4.3).
[Link] C-FLEX DISABLED
If C-Flex has not been prescribed for you and your provider has disabled the C-Flex feature, the
following screen appears when you press the C-Flex button, and you cannot enable or adjust the
setting.

C-Flex Setting
FLEX comfort has been
disabled on this unit.

FIGURE 4–5 C-FLEX DISABLED SCREEN

4-4 REMSTAR PLUS M SERIES USER MANUAL


4.3 CHANGING THE DEVICE SETTINGS
You can view the set pressure on the Active Display screen, and the following information on the
Patient Data screens:
• Therapy usage hours
• Number of sessions greater than 4 hours
Additionally, you can view and modify the following settings on the Patient Setup screens:
• C-Flex (if enabled by your home care provider)
• Altitude
• Ramp starting pressure (if enabled by your home care provider)
• Mask alert (enable/disable)
• Auto off (enable/disable)

4.3.1 NAVIGATING THE DISPLAY SCREENS


Use the button to navigate to the next screen and the button to navigate to the previous
screen.

Use the + and — buttons to adjust the settings on the Patient Setup screens.
[Link] VIEWING DATA ON THE PATIENT DATA SCREENS
Figure 4–6 shows how to navigate the Patient Data screens.

Press Press

– FOSQ Setup +

Sessions > 4 Therapy Usage


Hrs/Night
7 Days: 5 Sessions 7 Day Avg: 5:00
30 Days: 8 Sessions 30 Day Avg: 8:00

FIGURE 4–6 NAVIGATING THE PATIENT DATA SCREENS

REMSTAR PLUS M SERIES USER MANUAL 4-5


Press the button to scroll forward through the data screens, or press the button to scroll
through the screens in the reverse order. The Patient Data screens are described below.

1. Standby Screen
The Standby screen appears when you first apply power to the
device. You can access the Patient Data menu from this screen by
– FOSQ Setup + pressing the or buttons.
Note: You can also access the Patient Setup screens by pressing
the + button, and the FOSQ questionnaire by pressing the
— button, as described later in this chapter.
Note: The FOSQ option only appears if a SmartCard is inserted or
a modem is connected to the device.
Therapy Usage
2. Therapy Usage Screen
Hrs/Night
This screen displays the number of hours that the device provided
7 Day Avg:
30 Day Avg:
5:00
8:00
therapy, as 7-day and 30-day averages. The maximum value that can
be displayed for both averages is 24 hours.
Note: This screen is only for reference. Your home care
provider may periodically ask you for this information.
Sessions > 4 3. Sessions Greater than 4 Hours Screen
This screen displays the number of device therapy sessions that
7 Days: 5 Sessions
30 Days: 8 Sessions exceeded 4 hours in 7-day and 30-day periods. The maximum value
for the 7-day period is 35 sessions, while the maximum value for the
30-day period is 150 sessions.
Note: This screen is only for reference. Your home care
provider may periodically ask you for this information.

4-6 REMSTAR PLUS M SERIES USER MANUAL


[Link] VIEWING AND MODIFYING PATIENT SETUP SCREENS
Figure 4–7 shows how to navigate the Patient Setup screens.

– FOSQ Setup +

Press +

Press C-Flex Setting Press

1 2 3

Auto Off Altitude

Feature: ON 1 2 3

Mask Alert Ramp Start Pres

Feature: ON 4.0 cmH2O

FIGURE 4–7 NAVIGATING THE PATIENT SETUP SCREENS

REMSTAR PLUS M SERIES USER MANUAL 4-7


The Patient Setup screens are described below.

1. Standby Screen
The Standby screen appears when you first apply power to the
device. You can access the Patient Setup menu from this screen by
– FOSQ Setup + pressing the + button. Once inside the Setup menu, press the
or buttons to cycle through the screens.

C-Flex Setting
2. C-Flex Setting Screen
This screen displays the C-Flex level set by your home care
1 2 3 provider. This setting allows you to adjust the level of air pressure
relief that you feel when you exhale during therapy. Your home
care provider will either enable, lock, or disable C-Flex.
– If C-Flex is enabled and the setting is not comfortable for you,
you can increase or decrease the setting by pressing the + or
– buttons. The setting of 1 provides a small amount of pres-
sure relief, with higher numbers providing additional relief.
Press the + or – buttons to increase or decrease the setting.
C-Flex Setting
– If your provider has disabled C-Flex, you cannot enable or ad-
just the setting. The screen shown at left displays to indicate
FLEX comfort has been
disabled on this unit.
that C-Flex is disabled.

Altitude
3. Altitude Setting Screen
This screen allows you to modify the altitude adjustment setting.
1 2 3 Press the + or – buttons to increase or decrease the setting by
increments of 1:
• 1 = less than 2500 ft. (<762 m)
• 2 = 2500 to 5000 ft. (762 m to 1524 m)
• 3 = 5001 to 7500 ft. (1525 m to 2286 m)
Note: Elevations over 7500 ft. (2286 m) may affect the accuracy
of the pressure.
Warning: If you incorrectly set the manual altitude setting, the
pressure may be too high or too low, depending on
your location.
4. Ramp Starting Pressure Screen
Ramp Start Pres
You can increase or decrease the ramp starting pressure in 0.5 cm
4.0 cmH2O H2O increments by pressing the + or – buttons. The default setting
is 4 cm H2O. You can adjust the setting from 4 cm H2O to the CPAP
pressure setting.
Note: This screen will not display if your provider has not en-
abled Ramp on your device.

4-8 REMSTAR PLUS M SERIES USER MANUAL


5. Mask Alert Screen
Mask Alert
You can enable or disable the mask alert setting by pressing the +
Feature: ON or – buttons to select OFF or ON. If this feature is enabled, then the
words Mask Leak appear on the Active display screen if a signifi-
cant mask leak is detected, and an audible alert sounds.
Note: If your physician indicates that the Mask Alert is neces-
sary for you, do not disable it.
Auto Off
6. Auto Off Screen
You can enable this feature if you want the device to automati-
Feature: ON cally turn the airflow off whenever you remove the interface (e.g.,
mask) from your airway.
Press the + or – buttons to select OFF or ON. If this feature is en-
abled, then the words Auto Off appear on the Standby screen if
the device detects that you have removed your mask. The airflow
shuts off, and the Auto Off message continues to appear on the
Standby screen until the condition is corrected.

After you have finished modifying the Patient Setup screens, press the button to return to the
Standby screen.
Note: The Setup menu automatically times out and returns to the Standby screen
after one minute of inactivity.

REMSTAR PLUS M SERIES USER MANUAL 4-9


4.4 COMPLETING THE FOSQ QUESTIONNAIRE
Note: The FOSQ option only appears on the Standby screen if a SmartCard is
inserted or a modem is connected to the device.

From the Standby screen, you can access the FOSQ questionnaire by pressing the – button. The
FOSQ test is a ‘quality of life’ questionnaire designed specifically for people with sleep disorders.
The results allow health care professionals to see how therapy has improved the quality of your
life. By completing the questionnaire periodically, you can provide valuable information about
the effectiveness of your treatment. The device can record your answers on the SmartCard or via a
wired or wireless modem for later review by the health care professional. Contact your home care
provider for further instructions.
Note: If your health care professional or home care provider instructs you to
complete the questionnaire, he or she will provide you with the ques-
tions, and you can enter your answers into the device. Make sure a
SmartCard or modem is installed before answering the questions. The

ENGLISH
FOSQ screens will not display if a SmartCard or modem is not present
and able to store data.
To answer the FOSQ questionnaire, complete the following steps:
1. Make sure that the SmartCard or modem is properly installed. Answers to the questionnaire
are saved onto the SmartCard or sent to the health care professional via a wired or wireless
modem (when available). If you are using a SmartCard, a SmartCard symbol ( ) appears
in the upper right corner of the Active Display screen. The symbol will flash if the SmartCard
is inserted incorrectly, and the FOSQ questionnaire will not be available.
2. From the Standby screen, press the – button to access the first FOSQ screen, shown in Figure
4–9.
FOSQ 1/30

0 1 2 3 4

FIGURE 4–9 FOSQ SCREEN 1 OF 30


Press the + or – button to select your answer to the first question, and an arrow appears over
your answer:
– 0 indicates that you choose 0 as the answer to the question.
– 1 indicates that you choose 1 as the answer to the question.
– 2 indicates that you choose 2 as the answer.
– 3 indicates that you choose 3 as the answer.
– 4 indicates that you choose 4 as the answer.

REMSTAR PLUS M SERIES USER MANUAL 4-11


3. After you answer the first question, press the button to access the next FOSQ screen and
continue answering each question. If you need to go back to a previous screen, press the
button.
4. There are 30 FOSQ questions. Once you have reached the last question, press the button
to save your answers and exit the questionnaire.

4.5 PATIENT REMINDER SCREEN


Your home care provider may set a patient reminder that will appear periodically to alert you
to take certain actions, such as replacing your mask. A message will appear whenever the device
transitions from the Active Display to the Standby state if the period of time specified by your
provider has expired.
You can acknowledge the message by pressing any of the display buttons (+, –, or ). If you
do not acknowledge the message within six minutes of it appearing on the screen, it will time
out and disappear. The message will continue to display for three consecutive days whenever the
device transitions from Active to Standby until it is acknowledged. If, after three days, you still
have not acknowledged the message, then the reminder period will reset and no more reminders
will display until the next time the patient reminder setting expires.
Figure 4–9 shows an example of a patient reminder message.
Attention

Check your mask. A replacement


may be available.
Call (XXX) XXX-XXXX.

FIGURE 4–9 PATIENT REMINDER SCREEN

REMSTAR PLUS M SERIES USER MANUAL 4-11


4-12 REMSTAR PLUS M SERIES USER MANUAL
CHAPTER 5: ALERTS AND TROUBLESHOOTING
This chapter describes the device alerts and also provides troubleshooting information for issues
you may run into when using the device.

5.1 DEVICE ALERTS


The device provides two alert levels, high and medium priority.
• High Priority – These alerts require immediate operator response. The alert signal consists
of a high priority sound, which is a continuous two-beep pattern (indicated in the following
table as: • • • •). Additionally, the backlights on the buttons will provide a high priority
flashing pattern consisting of a continuous, bright-to-off, two-flash pattern (indicated in the
following table as: ◊◊ ◊◊ ◊◊).
• Medium Priority – These alerts require prompt operator response. The alert signal consists of
a medium priority sound, which is a continuous one-beep pattern (indicated in the following
table as: • •). Additionally, the backlights on the buttons will provide a medium priority
flashing pattern consisting of a continuous, bright-to-dim, one-flash pattern (indicated in the
following table as: ◊ ◊ ◊).

REMSTAR PLUS M SERIES USER MANUAL 5-1


ALERT SUMMARY TABLE
The following table summarizes the high and medium priority alerts.

ALERT AUDIBLE VISUAL DEVICE ACTION POSSIBLE CAUSE PATIENT ACTION


INDICATOR INDICATOR
System Error •• •• Backlights: The device enters the Device failure Press any of the display
◊◊ ◊◊ ◊◊ “Safe state” in which screen buttons to silence
the device power the alert. Remove the
Screen displays the remains on, but the power supply cord from
following message: airflow is disabled. the device to remove
power. Plug the cord back
Service Required into the device’s power
inlet to restore power. If the
alert continues to occur,
contact your home care
provider.
SmartCard • • Backlights: The device continues A problem exists Remove the SmartCard
Error ◊ ◊ ◊ to operate and with the Smart- to clear the alert. Confirm
provide therapy., but Card inserted in that the card is properly
Screen displays the data logging is un- the accessory oriented, with the arrow
following flashing available and FOSQ slot. The card may pointing towards the de-
error symbol: is deactivated. be improperly in- vice, as shown below, and
serted or the data reinsert the SmartCard.
may be corrupt.

If the alert continues to


occur, remove the Smart-
Card from the device and
contact your home care
provider. The card may be
corrupt and need to be
replaced.

5-2 REMSTAR PLUS M SERIES USER MANUAL


ALERT AUDIBLE VISUAL DEVICE ACTION POSSIBLE CAUSE PATIENT ACTION
INDICATOR INDICATOR
Mask Leak • • Backlights: The device continues The breathing Check your breathing
◊ ◊ ◊ to operate. circuit is discon- circuit connections and re-
nected or there is connect the tubing if it has
The words Mask a large air leak. come loose. Press any of
Leak flash on the the display buttons to clear
Active Display the alarm. Make sure your
screen. mask is on properly before
you press the button to
restart the airflow.

If the alert continues to


occur, disable the mask
alert setting following the
instructions in Chapter 4,
and continue your therapy
overnight. Contact your
home care provider the
next morning to have your
mask checked. You may
need a mask refitting.
Auto Off None The words Auto The airflow shuts The mask has Put your mask back on
Off flash on the off and the device been removed. and press the button
Standby screen, enters the Standby to turn the airflow on and
indicating that a state approximately resume therapy.
mask disconnect 45-60 seconds after
has been detected. a mask disconnect is
detected.
Patient None Backlights: The device continues Your home care Press any of the display
Reminder ◊ ◊ ◊ to operate. provider may buttons to acknowledge
set a patient the message and clear it. If
Screen displays reminder sched- you do not acknowledge
a customized uled to pop up at the reminder, it will disap-
reminder message a particular time pear after 6 minutes, and
whenever the de- to remind you then reappear for three
vice transitions from to replace your consecutive days whenever
the Active state to mask, change the device transitions from
the Standby state. your filters, etc. the Active state to the
Standby state. If you still do
not acknowledge the mes-
sage, the reminder period
will reset and the message
will not reappear until
the next time the Patient
Reminder setting expires.

REMSTAR PLUS M SERIES USER MANUAL 5-3


5.2 TROUBLESHOOTING
The table below lists some of the problems you may experience with your device or mask and pos-
sible solutions to those problems.

PROBLEM WHY IT HAPPENED WHAT TO DO


Nothing happens when There’s no power If you are using AC power, check the outlet
you apply power to at the outlet or power and verify that the device is properly
the device. The audible the device is un- plugged in. Make sure the AC power cord is
indicator does not sound plugged. connected correctly to the power supply and
and the backlights on the the power supply cord is securely connected to
buttons do not light. the device’s power inlet. If the problem contin-
ues to occur, contact your home care provider.
Return both the device and power supply to
your provider, so they can determine if the
problem is with the device or power supply.

If you are using DC power, make sure your DC


power cord and battery adaptor cable con-
nections are secure. Check your battery. It may
need recharged or replaced. If the problem
persists, check the DC cord’s fuse following the
instructions supplied with your DC cord. The
fuse may need to be replaced. If the problem
still occurs, contact your home care provider.

If you are using a humidifier, make sure you


follow the instructions for applying power that
are provided with your humidifier.

The device does not op- There may be a Make sure the device is powered correctly, fol-
erate when you press the problem with the lowing the instructions on the previous page.
button. The airflow blower. If the audible indicator sounds and the button
does not turn on. backlights turn on when you apply power, but
the airflow does not turn on, there may be a
problem with your device. Contact your home
care provider for assistance.

Note: When the device is functioning cor-


rectly, after you press the button,
the device beeps and the airflow turns
on after a slight delay. This brief delay
is normal.

5-4 REMSTAR PLUS M SERIES USER MANUAL


PROBLEM WHY IT HAPPENED WHAT TO DO
The device’s display is The device or Unplug the device and the power supply.
erratic. power supply has Reapply power to the device. If the problem
been dropped continues, relocate the device to an area with
or mishandled, lower EMI emissions (e.g., away from electronic
or the device or equipment such as cellular phones, cordless
power supply is in phones, computers, TVs, electronic games, hair
an area with high dryers, etc.).
Electromagnetic
Interference (EMI) If the problem still occurs, contact your home
emissions. care provider for assistance.
Device Resets/Reboots: The device comes Such a reset poses no danger to the patient
installed with and assures that the patient receives pre-
The device shuts down troubleshooting scribed therapy throughout the night. If there
and restarts automati- software that auto- is a possibility of damage to the device, the
cally during therapy. matically monitors device will shut down permanently. The prod-
(This is unlikely to occur.) performance. uct will then display the following system error
alert to indicate that the device be returned to
the home care provider for service:
Service Required

The Ramp feature does Your home care If Ramp has not been prescribed for you, dis-
not work when you press provider did not cuss this feature with your home care provider
the Ramp button prescribe Ramp for to see if they will change your prescription.
( ). you, or your CPAP
pressure is already If your provider has enabled Ramp, but the fea-
set to the mini- ture still does not work, check the CPAP setting
mum setting. on your Active Display screen. If CPAP is set to
the minimum setting (4.0 cm H2O), the Ramp
feature will not work.

REMSTAR PLUS M SERIES USER MANUAL 5-5


PROBLEM WHY IT HAPPENED WHAT TO DO
The device has fallen off The device may Always make sure your device is placed on
your table or nightstand. not have been a hard, flat surface so the rubber feet on the
properly seated bottom of the device can adhere to the surface
on the nightstand, (make sure there is no fabric under the device).
or the placement The device (and humidifier, if using) must be
of the tubing may level for proper operation.
have caused the
device to fall. Also, place the device away from the edge of
the nightstand or table, so it doesn’t acciden-
tally get knocked off the table.

If you are using a humidifier with the device,


make sure that the device and humidifier are
placed below your head and mask, so that any
condensation in the tubing drains back into
the water chamber.

If the device and humidifier fall and water gets


into the device, drain all water out of the device
and make sure it is completely dry before reap-
plying power.

If the placement of the tubing causes the de-


vice to fall, make sure that you use proper hose
management when setting up your device.
Route the tubing behind the bed’s headboard,
as shown in Chapter 3, Setup.

If the device falls or water gets into the device


upon falling, let the device dry completely be-
fore restarting it. If the device does not operate
correctly after falling, contact your home care
provider.

5-6 REMSTAR PLUS M SERIES USER MANUAL


PROBLEM WHY IT HAPPENED WHAT TO DO
You are having problems You have lost the If you are not using a humidifier, you cannot
connecting the tubing to air outlet port or connect your tubing to the device without the
the device. are traveling and detachable air outlet port, shown below.
forgot to bring the
port with you.

You must have the port attached properly


before connecting your tubing.
You are experiencing The air outlet port Remove the port and reattach it to make sure
excessive air leaks where is not installed cor- it’s properly installed.
the tubing connects to rectly and doesn’t
the device. seal properly. To remove the port:
a. Put your thumb underneath the port
and insert your index finger into the port
opening.
b. Pivoting from the bottom, unsnap the
port and pull it away from the device.

To properly reattach the port:


a. Make sure it is correctly oriented (with the
port opening at the top), and insert the
two latches at the bottom of the port into
the openings on the bottom of the device.
b. Push the top of the port down to snap it
into place.

Reattach your tubing, turn on the airflow, and


check to make sure you do not still feel air com-
ing out of the port area.

REMSTAR PLUS M SERIES USER MANUAL 5-7


PROBLEM WHY IT HAPPENED WHAT TO DO
The air out of the mask is The air filters may Clean or replace the air filters as described in
much warmer than usual. be dirty. Chapter 7.

The device may be The temperature of the air may vary somewhat
operating in direct based on your room temperature. Make sure
sunlight or near a that the device is properly ventilated. Keep
heater. the device away from bedding or curtains that
could block the flow of air around the device.
Make sure the device is away from direct sun-
light and heating equipment.

If the problem continues, contact your home


care provider.
The mask feels uncom- This could be due If you experience any issues with your mask,
fortable to wear, there to improper head- refer to your mask instructions for information
is significant air leakage gear adjustment on proper fitting, etc. If the problem continues,
around the mask, or you or improper mask contact your home care provider.
experience other mask- fitting, etc.
related issues.
You have a runny nose. This is caused by Call your health care professional.
a nasal reaction to
the airflow.
You have throat or nose The air is too dry. Increase the room humidity. Consult with your
dryness. health care professional about using a Respi-
ronics humidifier with the device. If you have
a humidifier, refer to the instructions included
with your humidifier to make sure it is working
properly.
You experience nasal, You may have a Stop using the device and contact your health
sinus, or ear pain. sinus or middle ear care professional.
infection.

5-8 REMSTAR PLUS M SERIES USER MANUAL


CHAPTER 6: ACCESSORIES
Contact your home care provider for additional information on the accessories available for your
REMstar Plus M Series system. When using optional accessories, always follow the instructions
enclosed with the accessories.

6.1 ADDING A HUMIDIFIER


You can use the M Series Heated humidifier or the M Series Passover humidifier with your
device. They are available from your home care provider. A humidifier may reduce nasal dryness
and irritation by adding moisture (and heat, if applicable) to the airflow. Figure 6–1 shows the
humidifier by itself and attached to the REMstar Plus M Series device.
Caution: For safe operation, the humidifier must always be positioned below the
breathing circuit connection at the mask. The humidifier must be level for
proper operation.

Humidifer without Device Humidifer Device Attached

FIGURE 6–1 HUMIDIFIER ALONE AND ATTACHED TO THE DEVICE


Refer to the humidifier’s instructions for complete setup information.

REMSTAR PLUS M SERIES USER MANUAL 6-1


6.2 USING THE SMARTCARD
Some REMstar Plus M Series systems come with a SmartCard accessory module installed in the
accessory slot on the back of the device to record information for the home care provider. Your
home care provider may ask you to periodically remove the SmartCard and send it to him/her for
evaluation.
Note: The SmartCard does not need to be installed for the device to work properly.
The SmartCard records device usage information for use by your home care
provider. Contact your provider if you have any questions about the SmartCard.

6.3 ADDING SUPPLEMENTAL OXYGEN


Oxygen may be added at the mask connection. Please note the warnings listed below when using
oxygen with the device.

WARNINGS
• When using oxygen with this system, the oxygen supply must comply with local regulations
for medical oxygen.
• When using oxygen with this system, a Respironics Pressure Valve (Part number 302418)
must be placed in-line with the patient circuit. Failure to use the pressure valve could result
in a fire hazard.
• Oxygen accelerates fires. Keep the device and the oxygen container away from heat, open
flames, any oily substance, or other sources of ignition. Do not smoke in the area near the
device or the oxygen.
• When using oxygen with this system, turn the device on before turning on the oxygen. Turn
the oxygen off before turning the device off. This will prevent oxygen accumulation in the
device.
• If administering fixed-flow supplemental oxygen, the oxygen concentration may not be con-
stant. The inspired oxygen concentration will vary, depending on the CPAP setting, patient
breathing pattern, and leak rate. Substantial leaks around the mask may reduce the inspired
oxygen concentration to less than the expected concentrations. Appropriate patient monitor-
ing should be implemented.

6-2 REMSTAR PLUS M SERIES USER MANUAL


CHAPTER 7: CLEANING AND MAINTENANCE
This chapter describes how to clean the device and its filters and provides tips on traveling with
your REMstar Plus M Series system.

7.1 CLEANING THE DEVICE


Warning: To avoid electrical shock, always unplug the power cord from the wall
outlet or DC power source before cleaning the device.

Caution: Do not immerse the device in liquid or allow any liquid to enter the
enclosure, inlet filter, or any opening.
1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with
water and a mild detergent. Let the device dry completely before plugging in the power cord.
2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts.

7.2 CLEANING OR REPLACING THE FILTERS


Caution: Operating the device with a dirty filter may keep the system from working
properly and may damage the device.

Under normal usage, you should clean the gray foam filter at least once every two weeks and
replace it with a new one every six months. The white ultra-fine filter is disposable and should be
replaced after 30 nights of use or sooner if it appears dirty. DO NOT clean the ultra-fine filter.
Caution: Dirty inlet filters may cause high operating temperatures that may affect
device performance. Regularly examine the inlet filters as needed for integ-
rity and cleanliness.

1. If the device is operating, stop the airflow by pressing the button. Disconnect the device
from the power source.
2. Remove the filter(s) from the enclosure by gently squeezing the filter in the center and pull-
ing it away from the device, as shown in Figure 7–1.

REMSTAR PLUS M SERIES USER MANUAL 7-1


FIGURE 7–1 REMOVING THE FILTERS
3. Examine the filter(s) for cleanliness and integrity.
4. Wash the gray foam filter in warm water with a mild detergent. Rinse thoroughly to remove
all detergent residue. Allow the filter to air dry completely before reinstalling it. If the foam
filter is torn, replace it. (Only Respironics-supplied filters should be used as replacement
filters.)
5. If the white ultra-fine filter is dirty or torn, replace it.
6. Reinstall the filters, inserting the white ultra-fine filter first if applicable, as shown in Figure
7–2.

Filter Area

Disposable Ultra-Fine Reusable Gray


Filter (optional) Foam Filter
(required)

FIGURE 7–2 REINSTALLING THE FILTERS

Caution: Never install a wet filter into the device. It is recommended that you
clean the filter in the morning and alternate using the two foam
filters provided with the system to ensure sufficient drying time for the
cleaned filter.

7-2 REMSTAR PLUS M SERIES USER MANUAL


7.3 CLEANING THE TUBING
Clean the tubing daily. Disconnect the flexible tubing from the device. Gently wash the tubing in
a solution of warm water and a mild detergent. Rinse thoroughly. Air dry.

7.4 SERVICE
The REMstar Plus M Series device does not require routine servicing.
Warning: If you notice unexplained changes in the performance of this device,
if it is making unusual or harsh sounds, if the device or power supply
have been dropped or mishandled, if the enclosure is broken, or if
water has entered the device, discontinue use, and contact your home
care provider.

REMSTAR PLUS M SERIES USER MANUAL 7-3


7.5 TRAVELING WITH THE SYSTEM
When traveling, the carrying case is for carry-on luggage only. The carrying case will not protect
the system if it is put through checked baggage.
For your convenience at security stations, there is a note on the bottom of the device stating that
it is medical equipment. It may be helpful to bring this manual along with you to help security
personnel understand the REMstar Plus M Series device.
If you typically use a humidifier with your device, but leave the humidifier home when traveling,
make sure you attach the air outlet port to your device when you remove the humidifier from the
device. You need the port to connect the tubing directly to your device. Figure 7–3 illustrates how
to remove the humidifier from the device and attach the air outlet port.

Remove the Device


From the Humidifier

Attach Air Outlet Port


to the Device

FIGURE 7–3 ATTACHING THE AIR OUTLET PORT TO THE DEVICE

7.5.1 INTERNATIONAL TRAVEL


If you are traveling to a country with a line voltage different than the one you are currently using,
a different power cord or an international plug adaptor may be required to make your power cord
compatible with the power outlets of the country to which you are traveling. Contact your home
care provider for additional information.

7-4 REMSTAR PLUS M SERIES USER MANUAL


CHAPTER 8: SPECIFICATIONS

ENVIRONMENTAL

OPERATING STORAGE
TEMPERATURE 41° F (5° C) to 95° F (35° C) -4° F (-20° C) to 140° F (60° C)
RELATIVE HUMIDITY 15 to 95% (non-condensing) 15 to 95% (non-condensing)
ATMOSPHERIC PRESSURE 77 to 101kPa (0 - 7500 ft) N/A

PHYSICAL
Dimensions: 7.5” L x 5.0” W x 3.125” H (19 x 12.7 x 7.9 cm)
Weight: Approximately 2.2 lbs. (without a humidifier)

STANDARDS COMPLIANCE
This device is designed to conform to the following standards:
– IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment
– EN ISO 17510-1 Sleep Apnea Breathing Therapy Devices

ELECTRICAL
AC Power Consumption: 100 – 240 VAC, 50/60 Hz, 1.0 A max.
DC Power Consumption: 12 VDC, 3.0 A max.
Type of Protection Against Electric Shock: Class II Equipment
Degree of Protection Against Electric Shock: Type BF Applied Part
Degree of Protection against Ingress of Water: Device: Drip Proof, IPX1
AC Power Supply: (Reorder number 1015642):
Drip Proof, IPX1
Mode of Operation: Continuous
Electromagnetic Compatibility: The device meets the requirements of EN 60601-
1-2, 2nd edition.
Fuses: There are no user-replaceable fuses.

REMSTAR PLUS M SERIES USER MANUAL 8-1


PRESSURE
Pressure Increments: 4.0 to 20.0 cm H2O (in 0.5 cm H2O increments)
Pressure Stability:
4.0 to 20 cm H2O (±1.0 cm H2O)
Measured in accordance with EN ISO 17510-1 @ 1/3, 2/3, and Pmax with BPM set to 10, 15,
and 20 BPM @ 20° C (±5° C), 50% RH (±5%).
Maximum Flow: 35 LPM
Measured in accordance with EN ISO 17510-1 @ 1/3, 2/3, and Pmax with BPM set to 10, 15,
and 20 BPM @ 23° C (±2° C), 50% RH (±5%).

DISPOSAL
Dispose of the device in accordance with local regulations.

8-2 REMSTAR PLUS M SERIES USER MANUAL


APPENDIX A: EMC INFORMATION

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS


This device is intended for use in the electromagnetic environment specified below. The user of
this device should make sure it is used in such an environment.

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUID-


ANCE

RF emissions Group 1 The device uses RF energy only for


CISPR 11 its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions Class B The device is suitable for use in all
CISPR 11 establishments, including domestic
Harmonic emissions Class A establishments and those directly
IEC 61000-3-2 connected to the public low-voltage
power supply network.
Voltage fluctuations/Flicker Complies
emissions
IEC 61000-3-3

REMSTAR PLUS M SERIES USER MANUAL A-1


GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
This device is intended for use in the electromagnetic environment specified below. The user of
this device should make sure it is used in such an environment.

IMMUNITY TEST IEC 60601 TEST COMPLIANCE LEVEL ELECTROMAGNETIC


LEVEL ENVIRONMENT -
GUIDANCE
Electrostatic ±6 kV contact ±6 kV contact Floors should be
Discharge (ESD) wood, concrete or
±8 kV air ±8 kV air ceramic tile. If floors
IEC 61000-4-2 are covered with
synthetic material,
the relative humid-
ity should be at least
30%.
Electrical fast ±2 kV for power sup- ±2 kV for supply Mains power quality
Transient/burst ply lines mains should be that of a
typical home or hos-
±1 kV for input-out- ±1 kV for input/out- pital environment.
IEC 61000-4-4 put lines put lines
Surge ±1 kV differential ±1 kV differential Mains power quality
IEC 61000-4-5 mode mode should be that of a
typical home or hos-
±2 kV common mode ±2 kV for common pital environment.
mode
Voltage dips, short <5% UT <5% UT Mains power qual-
interruptions and (>95% dip in UT) for (>95% dip in UT) for ity should be that
voltage variations on 0.5 cycle 0.5 cycle of a typical home
power supply input 40% UT 40% UT or hospital environ-
lines (60% dip in UT) for (60% dip in UT) for 5 ment. If the user of
5 cycles cycles the device requires
IEC 61000-4-11 70% UT (30% dip in 70% UT (30% dip in continued operation
UT) for 25 cycles UT) for 25 cycles during power mains
<5% UT (>95% dip in <5% UT (>95% dip in interruptions, it is rec-
UT) for 5 sec UT) for 5 sec ommended that the
device be powered
from an uninterrupt-
ible power supply or
a battery.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

A-2 REMSTAR PLUS M SERIES USER MANUAL


GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
This device is intended for use in the electromagnetic environment specified below. The user of
this device should make sure it is used in such an environment.

IMMUNITY TEST IEC 60601 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT -


TEST LEVEL LEVEL GUIDANCE
Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should be
Hz) magnetic field at levels characteristic of a typical location in a
typical hospital or home environment.
IEC 61000-4-8
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.

Conducted RF 3 Vrms 3 Vrms Recommended separation distance


IEC 61000-4-6 150 kHz to 80 d = 1.2 P
MHz
d = 1.2 P 80 MHz to 800 MHz
Radiated RF 3 V/m 3 V/m d = 2.3 P 800 MHz to 2.5 GHz
IEC 61000-4-3 80 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in meters (m).

Field strengths from fixed RF transmitters, as


determined by an electromagnetic site surveya,
should be less than the compliance level in
each frequency range.b

Interference may occur in the vicinity of equip-


ment marked with the following
symbol:

NOTE 1 At 80 MHz and 800 MHz, 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.
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 device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.

REMSTAR PLUS M SERIES USER MANUAL A-3


RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THIS DEVICE
The device is intended for use in an electromagnetic environment in which radiated RF distur-
bances are controlled. The customer or the user of this device can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communica-
tions equipment (transmitters) and this device as recommended below, according to the maxi-
mum output power of the communications equipment.

RATED MAXIMUM SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER


POWER OUTPUT OF M
TRANSMITTER 150 KHZ TO 80 MHZ 80 MHZ TO 800 MHZ 800 MHZ TO 2.5 GHZ
W d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 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 meters (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 ap-
plies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is af-
fected by absorption and reflection from structures, objects, and people.

A-4 REMSTAR PLUS M SERIES USER MANUAL


LIMITED WARRANTY
Respironics, Inc. warrants that the system shall be free from defects of workmanship and materials
and will perform in accordance with the product specifications for a period of two (2) years from
the date of sale by Respironics, Inc. to the dealer. If the product fails to perform in accordance
with the product specifications, Respironics, Inc. will repair or replace – at its option – the defec-
tive material or part. Respironics, Inc. will pay customary freight charges from Respironics, Inc. to
the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse,
alteration, and other defects not related to material or workmanship.
Respironics, Inc. disclaims all liability for economic loss, loss of profits, overhead, or consequen-
tial damages which may be claimed to arise from any sale or use of this product. Some states do
not allow the exclusion or limitation of incidental or consequential damages, so the above limita-
tion or exclusion may not apply to you.
This warranty is given in lieu of all other express warranties. In addition, any implied warranties
– including any warranty of merchantability or fitness for the particular purpose – are limited
to two years. Some states do not allow limitations on how long an implied warranty lasts, so the
above limitation may not apply to you. This warranty gives you specific legal rights, and you may
also have other rights which vary from state to state.
To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer
or contact Respironics, Inc. at:
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8550
1-724-387-4000

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