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