Respironics REMstar plus, 1005960 User Manual

RESPIRONICS^
vwwv.respironics.com
REMstar!
plus
CPAP
System
User
o
09
o
IMPORTANT!
Fill
in the information
helow
when you receive the
RFMstar
Plus
CPAP
system.
\
REMstar
Plus
Serial
No.:
.(Located
on the
bottom
of the
REMstar
Plus)
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:
Doctor: —
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
REMstar
Plus
CPAP
systems
are the subject of US
patent
#5,239,995.
Other
patents
pending.
REMstar
Plus, Wfiisper Swivel, and Comfort
Flap
are trademarks of Respironics, Inc.
©Respironics,
Inc. 2001
Table
of
Contents
Symbol
Key
:..::.v
2
Intended Use &
Contraindications
3
Specifications 4 Warnings & Cautions
5
System Features 7
First
Time
Setup 8
o Device Settings 10 o Assembling the Circuit 12
Accessories 13
o Adding a Humidifier 13 o Adding Oxygen to the System 13 o Using DC Power 14 o Using an Ultra-fine Filter 14 o Carrying Case 14
Routine
Use 15
o Connecting the Circuit 15 ^
o Adjusting the Circuit 15 o Ramp Button 16 o Turning the System Off 16 o Helpful Hints 16
Traveling with the System 17
Routine
Maintenance 18
O
Filter 18
O
Cleaning 18
o Reordering 19
O
Service 19
Troubleshooting 20 Warranty 21
REMstar
Plus
User
Manual O /
SYMBOLS
Display
Screen
Elevation Ramp Start Pressure
XXX. Humidifier Setting
Hours of Use
I
Button
Ligtits
Number of nights with
more than 4
hours usage
Control
Buttons
6
S
5 5
Pressure
Start/Stop Ramp Humidifier On / Off
REMstar
Plus
Device
Attention,
consult
accompanying documents
A
AC Power DC Power Type BF Applied Part Class II (Double Insulated)
IPXO
Ordinary Equipment Rating
^
^ European CE Declaration of Conformity
0123
/tj\d Body Approval
(f"
^ |r for Standards Compliance
®
Canadian/US Certification
2 O REMstar Plus
User
Manual
Intended Use
Intended Use The
Respironics
REMstar
Plus
system is a
CPAP
(Continuous Positive
Airway
Pressure) device designed for the
treatment
of adult Obstructive
Sleep Apnea only.
The
REMstar
Plus is to be used only on the instruction of a licensed
physician.
Your
home
care provider
will
make the correct pressure settings
according to your physician's prescription.
Several
accessories are available to make your
OSA
treatment
with
the
REMstar
Plus
CPAP
system as convenient and comfortable as possible. To
ensure
that
you receive the safe, effective therapy prescribed for you, use
only
Respironics accessories.
IMPORTANT!
Read and understand the
entire
user's manual
before
operating
this
system.
If
you
have
any
questions
concerning the use
of
this
system,
contact
your
home
care
provider
or
doctor.
Contraindications studies have shown
that
the following pre-existing conditions may
contraindicate the use of positive airway pressure therapy for some patients:
Bullous
Lung
Disease
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
(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 contraindi-
cated 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.
REMstar
Plus
User
Manual O 3
specifications
Device
Size
Product Use, Transport, and Storage
Standards Compliance
Dimensions: Weight:
9
1/2" X 6 7/8" X 4 1/2" (24 x 17 x 12 cm)
<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 standard:
lEC
60601-1 General Requirements for Safety of Medical
Electrical
Equipment
Mode of Operation
Power
Requirements
Type
of Protection
Against
Electric
Shock
Degree of Protection Against
Electric
Shock
Degree of Protection Against
Ingress of Water
Continuous
AC
Power
Consumption:
100 - 240
VAC,
50/60 Hz, 1.0 A max.
DC Power Consumption:
12
VDC,
3.0 A max.
Class
11
Equipment
Type
BF
Applied Part
IPXO
- Ordinary Equipment
Pressure Increments
Pressure Display Accuracy
4 to 20 cm HjO (in 1.0 cm H,0 increments)
+/-
(0.15 + 4% of actual reading)
Maximum
Flow
<30
dB(A)
Sound Pressure
Level
35
LPM
4 O
REMstar
Plus
User
Manual
Warnings
&
Cautions
CAUTION!
us
federal
law restricts this device to sale by or on the order
of
a
physician.
WARNING!
Indicates
the
possihility for
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.
injury to the user or
the operator.
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
{CO,)
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 this device,
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 unit,
discontinue
use and
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 at an incorrect elevation setting could result in
airflow
pressures higher
than
the prescribed setting. Always verify the
elevation setting when traveling or relocating.
CAUTION!
Indicates
the
Tobacco
smoke
may cause tar build-up within the
REMstar
Plus
that
may
result in the
REMstar
Plus malfunctioning.
possihility of damage to
the device.
Unpacking the
System
After
unpacking the system, check to make sure you have everything shown
here:
IMPORTANT! if
any
of
the
above
parts
are
missing,
contact
your
home
care
provider.
6 O REMstar Plus
User
Manual
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