Respironics REMstar M Series User manual

1016452
AM 2/09/06

e REMstar® M Series system is covered by the following patent: 6,622,724. Other patents pending.
REMstar and Whisper Swivel are trademarks of Respironics, Inc.
© 2006 Respironics, Inc. and its affiliates. All rights reserved.
Important! Fill in the information below when you receive the
REMstar®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: 1-800-345-6443 or 1-724-387-4000

PO BOX 7014 GRAND RAPIDS MN 55744-8029
FIRST-CLASS MAIL PERMIT NO. 231 GRAND RAPIDS MN
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Name Address City State Zip 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
Product Identification Information (Numbers located on the bottom of the device)
Model #: Serial #:
Please complete the following or register online at: www.mseries.respironics.com
®
If Yes, Preferred Method?
Direct Mail Phone Email
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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.
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.

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, WellAnd 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
during sleep.
To improve the clinical
care of Sleep Apnea by
educating the public and
medical profession
about the disorder.
To establish and
nurture mutual
help/support groups
for apnea sufferers
and their families.
To raise money for
and to sponsor
research on the
causes and treatment
of Sleep Apnea.
Join the American Sleep Apnea Association
To provide Sleep
Apnea sufferers with
information about new
advances in the treatment
of Sleep Apnea.

iREMstaR M sERiEs UsER ManUal
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 ..................................................................................................................1-8
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...............................................................................2-3
2.2 Rear Panel.....................................................................................................................2-3
Chapter 3: Setup3-1
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 Feature..........................................................................................4-2
4.3 Changing the Device Settings ..............................................................................4-3
4.3.1 Navigating the Display Screens................................................................4-4
4.3.1.1 Viewing the Patient Data Screens ...............................................4-4
4.3.1.2 Viewing and Modifying Patient Setup Screens ......................4-6
4.4 Reporting Your Therapy By Phone ......................................................................4-8

ii REMstaR M sERiEs UsER ManUal
Chapter 5: Alerts and Troubleshooting..................................................................................... 5-1
5.1 Device Alerts ...............................................................................................................5-1
5.2 Troubleshooting......................................................................................................... 5-2
Chapter 6: Accessories .....................................................................................................................6-1
6.1 Adding a Humidier .................................................................................................6-1
6.2 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: Specications................................................................................................................ 8-1
Environmental...........................................................................................................8-1
Physical........................................................................................................................ 8-1
Standards Compliance........................................................................................... 8-1
Electrical...................................................................................................................... 8-1
Pressure ....................................................................................................................... 8-2
Disposal....................................................................................................................... 8-2
Appendix A: EMC Information.......................................................................................................A-1

1-1REMstaR M sERiEs UsER ManUal
ChaptER 1: intRodUCtion
is chapter provides information on:
• System contents
• Intended use
• Warnings, cautions, and contraindications
• System overview
• Glossary and symbol key
• How to contact Respironics
1.1 systEM ContEnts
Your REMstar M Series system includes the following items:
REMstar M Series Device
Flexible Tubing
Reusable Gray Foam
Filter
Disposable Ultra-fine
Filter
Power Supply
AC Power Cord
Carrying Case
User Manual
Quickstart Guide
figURE 1–1 systEM ContEnts
Note: If your system includes a humidier, you will receive additional items with your
package. See the instructions included with your humidier for more informa-
tion.
Note: If any of the above items are missing, contact your home care provider.

1-2 REMstaR M sERiEs UsER ManUal
1.2 intEndEd UsE
e Respironics REMstar 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 more than 66 lbs (30 kg).
e 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.
1.3 WaRnings, CaUtions, and ContRaindiCations
Caution: US 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.
• is manual serves as a reference. e 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.
• is device is not intended for life support.
•e 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. e exhalation
port(s) associated with the mask should never be blocked.
Explanation of the Warning: e 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.
• 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.
• 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.

1-3REMstaR M sERiEs UsER ManUal
• 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). is 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.

1-4 REMstaR M sERiEs UsER ManUal
1.3.2 CaUtions
A Caution indicates the possibility of damage to the device.
•e 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.
• Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter.
• Condensation may damage the device. Always allow the device to reach room temperature
before use.
• 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 follow-
ing 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
Pressure. 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 his-
tory of head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)
e 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.

1-5REMstaR M sERiEs UsER ManUal
1.4 systEM ovERviEW
e REMstar M Series device, shown in Figure 1–2, is a sleep apnea therapy 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 a special feature to help make your therapy more
comfortable. e ramp function allows you to lower the pressure when you are trying to fall
asleep. e air pressure will gradually increase until your prescription pressure is reached. You also
have the option of not using the ramp feature at all.
figURE 1–2 REMstaR M sERiEs dEviCE

1-6 REMstaR M sERiEs UsER ManUal
Figure 1–3 illustrates many of the device features, described in the table below.
Ramp Button Start/Stop
Button
Power Inlet
Filter Area
Air Outlet
Medical
Equipment Note
(on bottom)
Display Screen
(under door)
figURE 1–3 systEM ovERviEW
dEviCE fEatURE dEsCRiption
Air Outlet Connect the exible tubing here.
Display Screen Shows therapy settings and patient data.
Filter Area A reusable, gray foam lter must be placed in the
lter area to screen out normal household dust and
pollens. An optional, white ultra-ne lter can also
be used for more complete ltration of very ne
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 airow.

1-7REMstaR M sERiEs UsER ManUal
1.4.1 bREathing CiRCUit ovERviEW
e 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
Circuit
Tubing
Exhalation
Device
Patient Interface
Circuit with Separate
Exhalation Device
Circuit with Mask with
Integrated Exhalation Port
Flexible
Tubing
Connector
Mask's
Connector
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 CO2rebreathing.

1-8 REMstaR M sERiEs UsER ManUal
1.5 glossaRy
e following terms and acronyms appear throughout this manual:
tERM/aCRonyM dEfinition
Active State The state of the device when power is applied, the airow is on, and the
device is capable of providing therapy.
Altitude Allows the user to modify the altitude setting. Can be set to 1, 2, or 3 cor-
responding to low, medium, and high altitudes, respectively.
Apnea A condition marked by the cessation of spontaneous breathing.
BPM Breaths Per Minute
Compliance
Check Value
Represents a code used by the provider to determine the accuracy of
reported therapy data.
CPAP Continuous Positive Airway Pressure
Hours of
Patient Use
The total amount of time that the blower has been on .
LPM Liters Per Minute
OSA Obstructive Sleep Apnea
Patient Data
Mode
The display mode in which the patient can view certain stored information,
such as session count.
Patient Setup
Mode
The display mode in which the patient 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 patients can fall asleep more comfortably.
Safe State The state in which the device does not provide therapy. The device enters
this state if a fault is detected.
Standby State The state of the device when power is applied but the airow is turned o.
Therapy Hours The total amount of time that the blower is on and patient breathing is
detected.

1-9REMstaR M sERiEs UsER ManUal
1.6 syMbol KEy
e 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 Certication
TUV Safety Standard Compliance
UL Recognized for Canada and the United
States
Notied Body Approval for Standards Compli-
ance
No User Serviceable Parts

1-10 REMstaR M sERiEs UsER ManUal
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 (US and Canada
only) or 1-724-387-4000.
You can also use the following address:
Visit Respironics web site at: www.respironics.com

2-1REMstaR M sERiEs UsER ManUal
ChaptER 2: dEviCE ContRols and displays
is 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 two primary control buttons on the REMstar M Series device.
figURE 2–1 pRiMaRy ContRol bUttons
ese buttons are described below.
bUtton dEsCRiption
Ramp –When the airow is on, this button allows you to
activate or restart the ramp function. Ramp lowers the
airow pressure and then gradually increases it, allowing
you to fall asleep more easily.
Start/Stop –This button starts the device’s airow and
places the device in the Active state, or stops the airow,
and places the device in Standby. You can also press this
button to exit any setting screen.
If you do not want to modify the settings that your home care provider has set for you, you only
need these two buttons to start and stop therapy and do not need to use the display buttons located
under the device cover door.
Figure 2–2 shows the device display and navigation buttons that are under the cover door.
figURE 2–2 display bUttons

2-2 REMstaR M sERiEs UsER ManUal
e 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 or Setup mode.
Allows you to access the Setup screens. Also
allows you to navigate to the next screen
when in the Data or Setup mode.
Allows you to decrease the settings on the
patient setup screens.
Allows you to increase the settings on the
patient setup screens.
e device’s display screen shows the prescribed or ramping pressure and patient data. See Chap-
ter 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.
Cover Door
Previous
Screen
Button
Next
Screen
Button
Decrease
Button
Increase
Button
Ramp
Button Start/Stop
Button
Placement Area
for optional Quick
Reference Label
figURE 2–3 dEviCE ContRol panEl