Respironics C-Flex M Series User manual

M Series with C-Flex™

e REMstar® Auto 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; 6,564,797; 6,427,689; 5,645,035; 6,286,508;
6,550,478; 6,752,150, and 6,932,084. Other patents pending. REMstar, Whisper Swivel, Encore Pro, and
Encore Pro SmartCard are trademarks of Respironics, Inc. NOTE: e C-Flex trademark is used under
license.
© 2008 Respironics, Inc. and its affiliates. All rights reserved.
IMPORTANT! Fill in the information below when you receive the REMstar
Auto 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:
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Telephone Number: _________________________________________
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Telephone Number: _________________________________________
tRespironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania
15668-8550 USA
Customer Service
Telephone Number: 1-724-387-4000
 t 3FTQJSPOJDT%FVUTDIMBOE
Gewerbestrasse 17
82211 Herrsching Germany
Customer Service
Telephone Number: [phone]

iREMSTAR AUTO 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........................................................................1-6
1.5 Glossary.........................................................................................................................1-7
1.6 Symbol Key ..................................................................................................................1-8
1.7 How to Contact Respironics ..................................................................................1-8
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.....................................................................................................................2-2
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............................................................................3-4
3.4.1 Using AC Power .............................................................................................3-4
3.4.2 Using DC Power .............................................................................................3-5
3.5 Complete Assembly Example ...............................................................................3-6
Chapter 4: Device Operation ........................................................................................................4-1
4.1 Available Therapies...................................................................................................4-1
4.2 Starting the Device ...................................................................................................4-1

ii REMSTAR AUTO M SERIES USER MANUAL
4.3 Using the Ramp and C-Flex Features..................................................................4-3
4.3.1 Ramp Feature..................................................................................................4-3
4.3.2 C-Flex Comfort Feature ...............................................................................4-3
4.3.2.1 C-Flex Enabled....................................................................................4-3
4.3.2.2 C-Flex Locked...................................................................................... 4-4
4.3.2.3 C-Flex Disabled ..................................................................................4-4
4.4 Changing the Device Settings ..............................................................................4-4
4.4.1 Navigating the Display Screens................................................................4-5
4.4.1.1 Viewing Data on the Patient Data Screens...............................4-5
4.4.1.2 Viewing and Modifying Patient Setup Screens ...................... 4-7
4.5 Completing the FOSQ Questionnaire ................................................................4-9
4.6 Patient Reminder Screen ......................................................................................4-10
Chapter 5: Device 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 Humidier ................................................................................................. 6-1
6.2 Using the SmartCard ..............................................................................................6-1
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 ................................................................................................. 7-2
7.4 Service ...........................................................................................................................7-2
7.5 Traveling with the System ......................................................................................7-2
7.5.1 International Travel.......................................................................................7-2
Chapter 8: Specications................................................................................................................ 8-1
Appendix A: EMC Information......................................................................................................A-1

1-1REMSTAR AUTO M SERIES USER MANUAL
CHAPTER 1: INTRODUCTION
is chapter provides information on:
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1.1 SYSTEM CONTENTS
Your REMstar Auto M Series system includes the following items:
Device
Flexible Tubing
Reusable Gray Foam
Filter
Disposable Ultra-ne
Filter
Power Supply
AC Power Cord
Carrying Case
User Manual
Flex
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 AUTO M SERIES USER MANUAL
1.2 INTENDED USE
e Respironics REMstar Auto 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.
e device is to be used only on the instruction of a licensed physician. e system can deliver
CPAP therapy or Auto-CPAP therapy, both with and without C-Flex. Your home care provider
will make the correct pressure settings according to your health care professional’s prescription.
When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep and
automatically adjust the pressure to meet your needs. When in CPAP therapy, the system will
deliver a continuous, set pressure during the night.
Several accessories are available to make your OSA treatment with the REMstar Auto 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
1.3.1 WARNINGS
A warning indicates the possibility of injury to the user or the operator.
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sede the health care professional’s instructions regarding the use of the device.
tThe operator should read and understand this entire manual before using the device.
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t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.
As with most CPAP devices, at low CPAP pressures, some exhaled gas (CO2) may remain in
the mask and be rebreathed.

1-3REMSTAR AUTO M SERIES USER MANUAL
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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.
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of an open flame.
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with the patient circuit. Failure to use the pressure valve could result in a fire hazard.
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with oxygen or air, or in the presence of nitrous oxide.
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tions can increase the temperature of the air coming out of the device.
tContact your health care professional if symptoms of sleep apnea recur.
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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.
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only. Unauthorized service could cause injury, invalidate the warranty, or result in costly
damage.
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Discontinue use and replace if damaged.
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in any fluids.
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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 AUTO M SERIES USER MANUAL
1.3.2 CAUTIONS
A Caution indicates the possibility of damage to the device.
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to room temperature before starting therapy. Condensation may damage the device.
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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:
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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)
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 AUTO M SERIES USER MANUAL
1.4 SYSTEM OVERVIEW
e REMstar Auto M Series device, shown in Figure 1–2, is a CPAP (Continuous Positive Air-
way Pressure) device designed for the treatment of Obstructive Sleep Apnea (OSA). It can deliver
CPAP therapy or Auto-CPAP therapy.
When prescribed for you, the device provides several special features 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.
Additionally, the C-Flex comfort feature provides you with pressure relief when you exhale during
therapy.
Several accessories are also available for use with your REMstar Auto M Series device. Contact
your home care provider to purchase any accessories not included with your system.
FIGURE 1–2 REMSTAR AUTO M SERIES DEVICE
Figure 1–3 illustrates many of the device features, described in the table below.
Ramp Button Start/Stop
Button C-Flex
Button Power Inlet
Filter Area
Air Outlet
Accessory
Module
Medical
Equipment Note
(on bottom)
Display Screen
(under door)
lex
FIGURE 1–3 REMSTAR AUTO M SERIES SYSTEM OVERVIEW

1-6 REMSTAR AUTO M SERIES USER MANUAL
DEVICE FEATURE DESCRIPTION
Accessory Module If applicable, insert the optional accessory card here.
Air Outlet Connect the exible tubing here.
C-Flex Button This button allows you to change the C-Flex comfort set-
ting, 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 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.
1.4.1 BREATHING CIRCUIT OVERVIEW
e patient breathing circuit, shown in Figure 1–4, consists of the following:
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nose and mouth, depending on which interface has been prescribed for you
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Circuit
Tubing
Exhalation
Device
Patient Interface
(Typical)
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

1-7REMSTAR AUTO M SERIES USER MANUAL
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.
1.5 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 providing therapy.
Apnea A condition marked by the cessation of spontaneous breathing.
Auto-CPAP Adjusts CPAP pressure automatically to improve patient comfort
based on monitoring of apnea and snoring events.
Auto-O 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 specically 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 pres-
sure to the prescription setting so you can fall asleep more comfortably.
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 airow is
turned o.

1-8 REMSTAR AUTO 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
Compliant with theWaste Electrical and Electronic Equipment/Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic Equipment (WEEE/RoHS) recycling directives.
European Declaration of Conformity
Canadian/US Safety Certication
TUV Safety Standard Compliance
UL Recognized for Canada and the United States
No User Serviceable Parts
1.7 HOW TO CONTACT RESPIRONICS
To have your device serviced, contact your home care provider. If you need to contact Respiron-
ics directly, call the Respironics Customer Service department at 1-724-387-4000 or +49 8152
93060. You can also use one of the following addresses:
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2-1REMSTAR AUTO 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 three primary control buttons on the REMstar Auto M Series device.
C-Flex
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.
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 +
FIGURE 2–2 DISPLAY BUTTONS
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, 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.

2-2 REMSTAR AUTO M SERIES USER MANUAL
e 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.
Cover Door
Previous
Screen
Button
Next
Screen
Button
Decrease
Button
Increase
Button
Ramp
Button Start/Stop
Button
C-Flex
Button
C-Flex
Placement Area
for Optional Quick
Reference Label
FIGURE 2–3 DEVICE CONTROL PANEL
2.1.1 CONTROL PANEL INACTIVITY
Some screens have time-out periods. e screen’s timer starts when the screen is initially displayed
and is restarted whenever a button is pressed. e screen times out after one minute if there is no
activity and returns to the Standby screen.
2.2 REAR PANEL
Figure 2–4 shows the REMstar Auto M Series device’s rear panel (without a humidifier).
Air Outlet Port
Accessory Slot Filter Area
DC Power Inlet
FIGURE 2–4 REAR PANEL
e rear panel contains the following:
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Accessories, for more information).
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information on supplying power to the device).
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3-1REMSTAR AUTO M SERIES USER MANUAL
CHAPTER 3: SETUP
is chapter provides instructions on how to:
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3.1 INSTALLING THE AIR FILTERS
Caution: A properly installed, undamaged foam lter is required for proper operation.
e device uses a gray foam filter that is washable and reusable, and an optional white ultra-fine
filter that is disposable. e reusable filter screens out normal household dust and pollens, while
the optional ultra-fine filter provides more complete filtration of very fine particles. e gray
reusable filter must be in place at all times when the device is operating. e 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 lter, simply insert the gray foam lter
into the lter area.
Filter Area
Disposable Ultra-Fine
Filter (optional)
Reusable Gray
Foam Filter
(required)
FIGURE 3–1 INSTALLING THE AIR FILTER

3-2 REMSTAR AUTO M SERIES USER MANUAL
Note: See Chapter 7, Cleaning and Maintenance, for information on how to clean or
replace the air lters.
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:
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face with a separate exhalation device such as the Whisper Swivel® II)
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Warning: If the device is used by multiple persons (e.g., rental devices), a low-
resistance, main ow bacteria lter should be installed in-line between
the device and the circuit tubing to prevent contamination.
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.
FIGURE 3–2 CONNECTING THE FLEXIBLE TUBING
Note: If required, connect a bacteria lter to the device air outlet, and then connect
the exible tubing to the outlet of the bacteria lter.

3-3REMSTAR AUTO M SERIES USER MANUAL
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.
Flexible
Tubing
Connector
Mask's
Connector
Exhalation Port
FIGURE 3–3 CONNECTING AMASK WITH BUILT-IN EXHALATION PORT
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 AMASK WITH ASEPARATE 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 AUTO 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 tempera-
tures, 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 airow on or o.
Important! If you are using your device with a humidier, refer to the instructions
included with your humidier for details on how to power the device
and humidier.
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.

3-5REMSTAR AUTO M SERIES USER MANUAL
3. Plug the power supply cord’s connector into the power inlet on the back of the device, as
shown in Figure 3–6.
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
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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, Portable Battery Pack, and Battery
Adapter Cable. Use of any other system may cause damage to the device or
vehicle.
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cable for information on how to operate the device using DC power.

3-6 REMSTAR AUTO 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. is will help prevent the device from falling off your
nightstand or table.
FIGURE 3–8 RECOMMENDED DEVICE AND TUBING PLACEMENT