Respironics REMstar Plus with C-Flex User Manual
REMstar Plus with C-Flex User Manual ❍ 1
Table of Contents
Symbol Key................................................................................... 2
Intended Use & Contraindications ............................................. 3
Specifications ............................................................................... 4
Warnings ....................................................................................... 5
Cautions ........................................................................................ 6
Unpacking the System................................................................. 6
System Features .......................................................................... 7
First Time Setup ........................................................................... 8
❍ Installing the Filter .................................................................. 9
❍ Device Settings .................................................................... 10
❍ Assembling the Circuit ......................................................... 15
Accessories ................................................................................ 16
❍ Adding a Humidifier .............................................................. 16
❍ Adding Oxygen to the System.............................................. 16
❍ Using DC Power with the System ........................................ 16
Routine Use ................................................................................ 17
❍ Connecting the Circuit.......................................................... 17
❍ Adjusting the Circuit ............................................................. 17
❍ Ramp Button ........................................................................ 18
❍ Turning the System Off ........................................................ 18
❍ Helpful Hints......................................................................... 18
Routine Maintenance ................................................................. 19
❍ Cleaning the Filter ................................................................ 19
❍ Cleaning the System ............................................................ 19
❍ Reordering ........................................................................... 20
❍ Service ................................................................................. 20
Traveling with the System ......................................................... 20
Troubleshooting ......................................................................... 21
EMC Requirements .................................................................... 23
Warranty...................................................................................... 26
2 ❍ REMstar Plus with C-Flex User Manual
Symbols
REMstar Plus with C-Flex CPAP systems are the subject of the following U.S. patents: #5239995 and #6105575.
Other patents pending.
REMstar, Whisper Swivel and Encore are registered trademarks of Respironics, Inc.
©Respironics, Inc. 2003
0123
!
REMstar Plus with C-Flex User Manual ❍ 3
The Respironics REMstar Plus with C-Flex system is a CPAP (Continuous
Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only.
The REMstar Plus with C-Flex is to be used only on the instruction of a
licensed health care professional. Your home care provider will make the
correct pressure settings according to your health care professional’s
prescription.
Several accessories are available to make your OSA treatment with the
REMstar Plus with C-Flex CPAP system as convenient and comfortable as
possible. To ensure that you receive the safe, effective therapy prescribed
for you, use only Respironics accessories.
Read and understand the entire user manual before operating this system.
If you have any questions concerning the use of this system, contact your
home care provider or health care professional.
IMPORTANT!
Intended Use
Studies have shown that the following pre-existing conditions may
contraindicate the use of positive airway pressure therapy for some patients:
• Bullous Lung Disease
• Bypassed Upper Airway
• Pneumothorax
• Pathologically Low Blood Pressure
• 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 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.
Contact your health care professional if you have any questions concerning
your therapy.
Contraindications
Intended Use
4 ❍ REMstar Plus with C-Flex User Manual
Specifications
Dimensions: 9 1/2” x 6 7/8” x 4 1/2” (24 x 17 x 12 cm)
Weight: <4.0 lbs. (<1.8 kg)
Operation Transport & Storage
Temperature: 41 to 95° F (5 to 35° C) -4 to 140° F (-20 to 60° C)
Humidity: 15 to 95%
Non-condensing
15 to 95%
Non-condensing
Atmospheric Pressure: 76.7 to 102 kPascals N/A
This device is designed to conform to the following standards:
IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment
IEC/EN 60601-1-2:2001 (2nd Edition) Immunity for Medical Electrical Equipment
EN ISO 17510-1 Sleep Apnea Breathing Therapy Devices
Continuous
100 - 240 VAC, 50/60 Hz, 1.0 A max.
12 VDC, 3.0 A max.
Class II Equipment
Type BF Applied Part
IPX0 - Ordinary Equipment
4 to 20 cm H2O (in 1 cm H2O increments)
4 to 20 cm H2O (±1.0 cm H2O)
Measured in accordance with EN ISO 17510 @ 6.6, 13.2, & 20 cm H
2
O @ 500 ml with BPM set to 10, 15, & 20
BPM performed at 23° C (±2° C), 50% RH (±5%), and an atmospheric pressure of 101.54 kPascals.
<30 dB(A)
Measured in accordance with EN ISO 17510 @ 10 cm H2O at the patient circuit. This measurement
applies to the CPAP device with or without the optional REMstar Heated Humidifier.
35 LPM
Measured in accordance with EN ISO 17510 @ 6.6, 13.2, & 20 cm H
2
O @ 500 ml with BPM set to 10, 15, & 20
BPM performed at 23° C (±2° C), 50% RH (±5%), and an atmospheric pressure of 101.54 kPascals.
±(0.15 + 4% of actual reading)
Device Size
Product Use,
Transport, and
Storage
Standards
Compliance
AC Power Consumption
Type of Protection
Against Electric Shock
Degree of Protection
Against Electric Shock
Degree of Protection
Against Ingress of Water
Pressure Range
Mode of Operation
Pressure Stability
Sound Pressure Level
Maximum Flow
DC Power Consumption
Pressure Display Accy.
REMstar Plus with C-Flex User Manual ❍ 5
• The instructions in this manual are not intended to supersede established
medical protocols.
• This device is intended for adult use only.
• This device is not intended for life support.
•CPAP devices have the potential to allow rebreathing of exhaled air.
To reduce this potential, observe the following:
- Use Respironics circuit accessories.
- Do not wear the mask and headgear for more than a few minutes
while the device is not operating.
- Do not block or try to seal the vent holes in the exhalation port.
As with most CPAP devices: At low CPAP pressures, some exhaled gas
(CO2) may remain in the mask and be rebreathed.
• Do not use this device if the room temperature is warmer than 95° F (35° C).
If this device is used at room temperatures warmer than 95° F (35° C), the
temperature of the airflow may exceed 106° F (41° C). This could cause
irritation to your airway.
• This equipment is not suitable for use in the presence of a flammable
anaesthetic mixture in combination with oxygen or air, or in the presence of
nitrous oxide.
• If you notice any unexplained changes in the performance of the REMstar
Plus with C-Flex, if it is making unusual or harsh sounds, if it has been
dropped or mishandled, if the enclosure is broken, or if water has entered
the enclosure, disconnect the power cord and discontinue use. Contact your
home care provider.
• To avoid electrical shock, disconnect the power cord before cleaning. DO NOT
immerse the device in any fluids.
• Contact your health care professional if symptoms of sleep apnea recur.
• Using the REMstar Plus with C-Flex at an incorrect elevation setting could
result in airflow pressures higher than the prescribed setting. Always verify
the elevation setting when traveling or relocating.
WARNING!
Indicates the
possibility for
injury to the user
or the operator.
Warnings & Cautions
CAUTION!
• U.S. federal law restricts this device to sale by or on the order of a physician.
6 ❍ REMstar Plus with C-Flex User Manual
After unpacking the system, make sure you have everything shown here:
If any of the above parts are missing, contact your home care provider.
IMPORTANT!
Warnings & Cautions/Unpacking the System
• Tobacco smoke may cause tar build-up within the REMstar Plus with C-Flex
that may result in the REMstar Plus with C-Flex malfunctioning.
• The use of accessories other than those specified, with the exception of
cables sold by the manufacturer of the equipment or system as replacement
parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.
Additional warnings and cautions are located throughout this manual as
they apply.
CAUTION!
Indicates the
possibility of damage
to the device.
REMstar Plus with C-Flex User Manual ❍ 7
System Features
AC Inlet ...............................Connect/disconnect the AC power cord here.
Air Outlet ............................Connect the flexible tubing here.
Communications
Connector ............................ For clinical use with the Encore® Pro Data Management Software or an
IEC 950 approved device. Connect the communications cable here.
DC Inlet ...............................Connect the optional DC power cord here.
Display Screen..................... All system settings, total operating time, and therapy hours will appear
here. Displays the pressure and elevation settings.
Filter Cap & Filters ............ The foam filter screens out normal household dust and pollens. The
optional, ultra-fine filter is also included for more complete filtration of
very fine particles. The filter cap is designed to reduce the noise from
the REMstar Plus with C-Flex.
Humidifier Button ..............This button turns the REMstar heated humidifier on/off and allows the
heat setting to be adjusted. The humidifier is an optional accessory that
may be purchased separately.
Medical Product Note.........For ease at airport security stations, there is a note on the bottom of the
REMstar Plus with C-Flex stating that it is medical equipment. It may
help if you also take this manual with you when you travel.
Pressure Start / Stop
Button ................................This button starts/stops the airflow.
Ramp Button .......................This button starts the ramp cycle or accesses the REMstar Plus with
C-Flex settings.
User Buttons........................These buttons can be used to change some of the system settings.
AC Inlet
DC Inlet
Communications
Connector
Filter and
Filter Cap
Pressure
Start/Stop Button
Air Outlet
Ramp
Button
Humidifier
Button
Display
Screen
Medical
Equipment
Note (on bottom)
User Buttons
8 ❍ REMstar Plus with C-Flex User Manual
Do not use the REMstar Plus with C-Flex system until an appropriate
professional adjusts the settings! To order any accessories not included
with this system, contact your home care provider.
Note to home care provider: Before beginning setup, be sure that you
have available the REMstar Plus with C-Flex Home Care Provider
Setup Instructions. Setup instructions are not provided in this manual.
DO NOT connect any equipment to the REMstar Plus with C-Flex
unless recommended by Respironics or your health care provider.
If the REMstar Plus with C-Flex has been exposed to either very hot
or very cold temperatures, allow it to adjust to room temperature
(approximately 2 hours) before beginning setup.
CAUTION!
First Time Setup
WARNING!
WARNING!
REMstar Plus with C-Flex User Manual ❍ 9
First Time Setup (cont.)
1. Install the filters and filter cap.
The foam filter must be in place at all times when the
REMstar Plus with C-Flex is operating. The white
ultra-fine filter is optional and can be used in
addition to the foam filter. The ultra-fine filter is
recommended for people who are sensitive to tobacco
smoke or other small particles.
a. Place one of the foam filters over the ultra-fine
filter. If you are not using the ultra-fine filter,
simply place the foam filter into the filter area on
the back of the REMstar Plus with C-Flex.
An extra filter is included for your convenience.
b.
Attach the filter cap. Position the cap so that the small opening on the
cap is facing down. Insert the cap’s tabs into the filter area opening.
To remove AC power, disconnect the power cord
from the electrical outlet.
Inspect the power cord often for any signs of
damage. Replace a damaged cord immediately.
The REMstar Plus with C-Flex is activated and ready for use when the
power cord is connected. The pressure start/stop button turns the
blower on/off.
3. Place the REMstar Plus with C-Flex on a firm,
flat surface.
Make sure the REMstar Plus with C-Flex is away
from any heating or cooling equipment (e.g., forced
air vents, radiators, air conditioners). Also make sure that bedding,
curtains, or other items are not blocking the filter or vents of the device.
Air must flow freely around the device for the system to work properly.
Installing the Filter
Power Cord
WARNING!
WARNING!
CAUTION!
CAUTION!
IMPORTANT!
!
!
2. Connect the power cord. Plug the socket end of
the power cord into the AC inlet on the back of
the REMstar Plus with C-Flex. Plug the pronged
end of the power cord into an electrical outlet.
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