User Guide MSeries Plus
User Guide MSeries Plus
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: ___________________________________________________
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.
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GRAND RAPIDS MN 55744-8029
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Please complete the following or register online at: [Link]
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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
Quickstart Guide
Flexible Tubing
Power Supply
AC Power Cord
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.
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.
1.3.3 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.
le
x
Medical
Equipment Note Filter Area
(on bottom) Accessory
Module
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.
Exhalation
Device Exhalation Mask's
Connector
Port
Circuit Flexible
Tubing Tubing
Connector
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.
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.
SYMBOL DEFINITION
DC Power
Electrostatic Discharge
Canadian/US Certification
C-Flex
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 +
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
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.
Note: See Chapter 7, Cleaning and Maintenance, for information on how to clean or
replace the air filters.
Detachable
Swivel
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
Exhalation
Device
Flexible
Tubing
Connector
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.
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.
Warning: Inspect the power cord often for any signs of damage. Replace a dam-
aged power cord immediately.
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.
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.
V 1.0
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 +
Note: The FOSQ option only appears if a SmartCard is inserted or a modem is con-
nected to the device.
15.0 cmH2O
C-Flex Setting
1 2 3
C-Flex Setting
FLEX comfort has been
disabled on this unit.
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 +
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.
– FOSQ Setup +
Press +
1 2 3
Feature: ON 1 2 3
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.
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.
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
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.
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.
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.
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.
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.
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.
Filter Area
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.
7.4 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.
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.
DISPOSAL
Dispose of the device in accordance with local regulations.
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.