3B RESmart CPAP User manual

RESmart®CPAP and Auto-CPAP
User Manual
Solutions in Sleep Therapy™
www.3Bproducts.com

Table of Contents
Symbols ............................................................................................................. 1
Indications for Use .......................................................................................... 2
Warning! ........................................................................................................... 3
Specifications .................................................................................................. 5
Unpacking the System .................................................................................. 7
Available Therapies ....................................................................................... 8
System features ............................................................................................... 9
First Time Setup (Patient) ............................................................................. 10
Install the Filter.................................................................. 10
Connect Power Cord..................................................... 10
Patient Menu Set-Up....................................................... 12
Selecting Patient Device Settings ................................ 13
Assembling the Circuit.................................................... 18
Adding a Humidifier........................................................ 19
Using Oxygen with Device............................................. 20
Routine use (Patient) ................................................................................... 21
Connecting the Circuit .................................................. 21
Adjusting the Circuit ....................................................... 21
Using the Ramp Button................................................... 21
Turning the System OFF .................................................. 22
Helpful Hints...................................................................... 23
Routine Maintenance ................................................................................. 24
Replacing the Filter......................................................... 24
Cleaning the System ...................................................... 24
Reordering........................................................................ 25
Service............................................................................... 25
Traveling with RESmart
®
.............................................................................. 26
Troubleshooting ............................................................................................ 27
EMC Requirements ...................................................................................... 28
Glossary ........................................................................................................... 32
Limited Warranty .......................................................................................... 34
iCode® is a trademark of BMC Medical Co., Ltd.
3B and Solutions in Sleep Therapy™are trademarks of 3B Products, LLC.
RESmart®is a registered trademark of BMC Medical Co., Ltd.

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RESmart®CPAP and Auto-CPAP User Manual
Symbols
CONTROL BUTTONS
PressureStartIStop
Ramp Start
Humidifier On I Off ( iCode® )
User Button
User Button
DEVICE
Attention, Consult Accompanying Documents
Type BF Applied Part
Class II (Double Insulated)
AC Power
IPX1 Drip-Proof, Vertical
SN Serial Number of the Product
Manufacturer

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RESmart®CPAP and Auto-CPAP User Manual
IMPORTANT!
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.
CAUTION!
Federal law restricts this device to the sale by or on the order of a
physician.
Indications for Use
The RESmart®CPAP and Auto-CPAP systems are intended to deliver
positive pressure for the treatment of Obstructive Sleep Apnea. The
optional integrated humidifier is indicated for the humidification
and warming of air from the flow generator device. These devices
are intended for single patient use by prescription in the home or
hospital/ institutional environment on adult patients.
Contraindications
TheRESmart
®
CPAPandAuto-CPAP device areNOTintendedforlife
support. Studies haveshown 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 beused 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.

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RESmart®CPAP and Auto-CPAP User Manual
Warning!
Indicates the possibility for Injury to the user or the operator
• 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.
• Contact your health care professional if symptoms of sleep apnea
recur.
• Using the RESmart
®
CPAP and Auto-CPAP at an incorrect elevation
setting could result in airflow pressures higher than the prescribed
setting. Always verify the elevation setting when traveling or relocating.
To reduce this potential, observe the following:
• Use BMC 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
(C0
2
) may remain in the mask and be rebreathed.
• If the room temperature is warmer than 95 ℉ (35 ℃ ), the airflow
produced by the RESmart
®
device may exceed 106 ℉ (41 ℃ ). The room
temperature must be kept below 95 ℉ (35 ℃ ) while the patient uses the
device.
• This equipment is not suitable for use in the presence of a flammable
anesthetic 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
RESmart
®
CPAP and Auto-CPAP. 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.
• To remove AC power, disconnect the power cord from the electrical
outlet.
• The use of accessories other than those specified or recommended by
the manufacturer may adversely impact performance of the device.
• Inspect the power cord often for any signs of damage. Replace a
damaged cord immediately.
• DO NOT use the RESmart
®
CPAP and Auto-CPAP if the display is erratic.
Contact your home care provider for further instructions.

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RESmart®CPAP and Auto-CPAP User Manual
CAUTION!
Makesurethe RESmart
®
CPAP and Auto-CPAP isaway 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 towork properly.
Indicates the possibility of damage tothe device
• Tobacco smoke may cause tar build-up within the RESmart
®
CPAP and
Auto-CPAP that may result in the device malfunctioning.
IMPORTANT!
Additional warnings and cautions are located throughout
this manual as they apply.
WARNING!
DO NOTconnect any equipment to the RESmart
®
CPAP
and Auto-CPAP unless recommended by BMC oryour
health care provider.
CAUTION ！
Ifthe RESmart
®
CPAP and Auto-CPAP hasbeenexposedto
either very hot or very cold temperatures, allow it to adjust
to room temperature (approximately 2 hours) before
beginning setup.
WARNING!
DO NOTusethe RESmart®CPAP and Auto-CPAP if the display
is erratic. Contact your home care provider for further
instructions.

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RESmart®CPAP and Auto-CPAP User Manual
Specifications
Device Size
Dimensions: 8.66 × 7.6 × 4.4” (220 x 194 x 112mm),
12.3” (313 x 194 x 112mm) (with Integrated Heated Humidifier)
Weight: 3.5 lbs. (1.6 kg), 5.3 lbs. (2.4 kg) (with Integrated Heated
Humidifier)
Product Use, Transport and Storage
Operation Transport and Storage
Temperature: 41˚F to 95˚F (5 to 35˚C) -4˚F to 131˚F (-20 to 55˚C)
Humidity: ≤ 80% Non-condensing ≤ 93% Non-condensing
Atmospheric Pressure: 860 to 1060 cmH2O 500 to 1060 cmH2O
Mode of Operation
Continuous
Work Mode
CPAP, Auto
SD Card Capacity
2G bytes
AC Power Consumption
100 –240V AC, 50/60Hz, 1.0A 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
IPX1 –Drip-Proof, Vertical
Pressure Range
4 to 20 cmH2O (in 0.5 cmH2O increments)
Pressure Stability
4 to 20 cmH2O (±1 cmH2O)
Altitude setting
Auto-CPAP: Manual setting: level 0 - 2
CPAP: Manual setting 0- 10000 ft.
Automatic altitude compensation for therapy pressure

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RESmart®CPAP and Auto-CPAP User Manual
Sound Pressure Level
<30 dB, when the device is working at the pressure of 10 cmH2O
Maximum Flow
Test Pressure (cmH2O)
4
8
12
16
20
Average flow at the
patient connection
port(L/min)
70.1
73.6
75.9
73.0
73.4
Accessories
The RESmart®CPAP and Auto-CPAP are not sold with mask, tubing or
bacterial filters.
Accessories may be purchased separately. The RESmart®product
line is designed to accommodate standard CPAP tubing (22mm) for
easy interconnectibility of masks and air tubing.
WARNINGS AND CAUTION
1. This device is restricted to sale by or on the order of a
physician.
2. Ensure that the SD card is inserted into the device
before you turn on RESmart®CPAP or Auto-CPAP
device.
3. In order to avoid impairing SD card or the data saved
in it, please do not insert or pull out the SD card when
the device is connected to a power source.

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RESmart®CPAP and Auto-CPAP User Manual
Unpacking the System
Includedwithyour RESmart
®
unit:
No. Item Number
1 RESmart®CPAP or Auto-CPAP 1
2 Power Cord 1
3 Carrying Case with shoulder strap 1
4 User Manual 1
5 Provider Instructions 1
6 Extra Filter (M1020) 1
7 Humidifier Plug 1
8 SD Card 1
SN Record Serial Number
IMPORTANT!
Ifanyofthe above partsare missing,contact your homecare
provider.
To order any accessories not included with this system, contact your
home care provider.
Home Care Provider Contact Information

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RESmart®CPAP and Auto-CPAP User Manual
Available Therapies
The RESmart®is available intwo models: CPAP (white) and Auto-CPAP
(black). The two models deliver the following therapies:
Shown with humidifier
CPAP:
DeliversContinuousPositiveAirway Pressure;CPAP maintains a
constant level of pressure throughout the breathing cycle. If your
health care professional prescribed ramp for you, you can press
the Ramp button to reduce the pressure andthen gradually
increase the pressure to the therapeutic pressure setting sothat you
canfall asleep more comfortably.
Shown with humidifier
Auto-CPAP:
Automatically adjustsCPAPtherapy pressurewithinthe pressure
range determined byyour physician or healthcare provider.