Respironics REMstar Auto M Series system User Manual
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e REMstar® Auto M Series with A-Flex™ system is covered by one or more of the following patents:
5,148,802; 5,313,937; 5,433,193; 5,535,738; 5,632,269; 5,645,035; 5,794,615; 5,803,065; 5,970,975;
6,029,664; 6,105,575; 6,286,508; 6,305,374; 6,539,940; 6,550,478; 6,609,517; 6,615,831; 6,752,150;
6,837,260; 6,915,705; 6,920,877; 6,932,084; 7,100,607. Australian Patent Nos. 638054; 661575; 698519;
723681; 734319; 733655; 766227. Canadian Patent Nos. 2,024,477; 2,162,981; 2,259,795. Japanese
Patent Nos. 2137336; 2832812; 2926392; 3566285. EP Patent Nos. EP0425092; EP0714670; EP0612257.
Other Patent Nos. FI 105650; DE 69231157; ES 2146591; IT 24310/BE. Other U.S. and foreign patents
pending. REMstar, Whisper Swivel, Encore Pro, and Encore Pro SmartCard are trademarks of Respironics,
Inc. NOTE: e C-Flex and A-Flex trademarks are used under license. © 2007 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:
• 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 (US and Canada) or 1-724-387-4000
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
4.3 Using the Ramp and 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 Disabled ..................................................................................4-4
ii rEmstar auto m sErIEs usEr manual
4.3.3 A-Flex Comfort Feature ...............................................................................4-4
4.3.3.1 A-Flex Enabled....................................................................................4-4
4.3.3.2 A-Flex Disabled .................................................................................. 4-4
4.4 Changing the Device Settings .............................................................................. 4-5
4.4.1 Navigating the Display Screens................................................................4-5
4.4.1.1 Viewing Data on the Patient Data Screens ...............................4-6
4.4.1.2 Viewing and Modifying Patient Setup Screens ......................4-8
4.5 Completing the FOSQ Questionnaire ..............................................................4-11
4.6 Patient Reminder Screen ......................................................................................4-12
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 Humidier .................................................................................................6-1
6.2 Using the SmartCard ..............................................................................................6-2
6.3 Adding Supplemental Oxygen ............................................................................. 6-2
Chapter 7: Cleaning and Maintenance......................................................................................7-1
7.1 Cleaning the Device .................................................................................................7-1
7.2 Cleaning or Replacing the Filters .........................................................................7-1
7.3 Cleaning the Tubing ................................................................................................. 7-2
7.4 Service ...........................................................................................................................7-2
7.5 Traveling with the System ......................................................................................7-2
7.5.1 International Travel ....................................................................................... 7-2
Chapter 8: Specications ................................................................................................................ 8-1
Appendix A: EMC Information......................................................................................................A-1
1-1rEmstar auto m sErIEs usEr manual
ChaptEr 1: IntroduCtIon
is chapter provides information on:
• REMstar Auto M Series system contents
• Intended Use
• Warnings, cautions, and contraindications
• System overview
• Glossary and symbol key
• How to contact Respironics
1.1 systEm ContEnts
Your REMstar Auto M Series system includes the following items:
REMstar Auto M Series Device
Reusable Gray Foam
Filter
Disposable Ultra-fine
Filter
Power Supply
AC Power Cord
Carrying Case
User Manual
F
le
x
Flexible Tubing
Swivel
(may not be included)
fIgurE 1–1 systEm ContEnts
Note: If your system includes a humidier, you will receive additional items with your
package. See the instructions included with your humidier for more information.
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 >66 lbs (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. For enhanced pressure relief in CPAP mode, the REMstar
Auto M Series can also deliver C-Flex. For enhanced pressure relief in Auto mode, the REMstar
Auto M Series can deliver C-Flex or A-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
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
1.3.1 WarnIngs
A warning indicates the possibility of injury to the user or the operator.
• is manual serves as a reference. e instructions in this manual are not intended to supersede 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 connectors 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. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to
suffocation.
1-3rEmstar auto m sErIEs usEr manual
• 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.
• 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 conditions 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 unusual 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.
• 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 auto 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. Condensation may damage the device.
• Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter.
• Do not place the device in or on any container that can collect or hold water.
• A properly installed, undamaged reusable foam inlet filter is required for proper operation.
• Tobacco smoke may cause tar build-up within the device, which may result in the device
malfunctioning.
Note: Additional warnings, cautions, and notes are located throughout this manual.
1.3.3 ContraIndICatIons
When assessing the relative risks and benefits of using this equipment, the clinician should
understand that this device can deliver pressures up to 20 cm H2O. In the event of certain fault
conditions, a maximum pressure of 30 cm H2O is possible. Studies have shown that the following
pre-existing conditions may contraindicate the use of CPAP therapy for some patients:
• Bullous Lung Disease
• Pathologically Low Blood Pressure
• Bypassed Upper Airway
• Pneumothorax
• Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway 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 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 bypassed. 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 Airway 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 and A-Flex comfort features provide 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
Flex
Button
Power Inlet
Filter Area
Air Outlet
Accessory
Module
Medical
Equipment Note
(on bottom)
Display Screen
(under door)
le
x
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.
Flex Button This button allows you to change the Flex comfort setting, if
Flex is prescribed for you. See Chapter 4 for more information
about 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 bot-
tom 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 airow.
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 CO2 rebreathing.
1-7rEmstar auto 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 airow is on, and the
device is providing therapy.
A-Flex A therapy feature that establishes a level of pressure relief taking place at
the end of inhalation and at the start of exhalation.
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.
Compliance
Check Value
Represents a code used by the home care provider to determine the accuracy of reported data.
CPAP Continuous Positive Airway Pressure
FOSQ Functional Outcomes of Sleep Questionnaire – A “quality of life” question-
naire designed specically 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 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 airow 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
European Declaration of Conformity
Canadian/US Certication
Notied Body Approval for Standards Compliance
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 Respironics
directly, call the Respironics Customer Service department at 1-800-345-6443 or
1-724-387-4000. You can also use the following address:
Visit Respironics web site at: www.respironics.com
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.
Flex
fIgurE 2–1 prImary Control buttons
ese buttons are described below.
button dEsCrIptIon
Ramp – When the airow is on, this button allows you to activate or restart the ramp function. Ramp
lowers the airow pressure and then gradually increases it, allowing you to fall asleep more easily.
Start/Stop – This button starts the device’s airow and places the device in the Active state, or stops the
airow, and places the device in Standby. You can also press this button to exit any setting screen.
Flex
Flex – This button adjusts the 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 located under the device cover door.
Figure 2–2 shows the device display and navigation buttons that are under the cover door.
– FOSQ
+
Setup
fIgurE 2–2 dIsplay buttons
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 menu.
Allows you to access the Data screens. Also allows you to navigate to the next screen when in the
Data or Setup menu.
Allows you to enter the FOSQ screens. Also allows you to decrease the settings on the setup screens.
Allows you to enter the Setup screens. Also allows you to increase the settings on the setup screens.
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