BMC RESmart User manual

3B Medical, Inc.
1142 N. Scenic Highway
Lake Wales, FL 33844 USA
Email: [email protected]
Tel: [phone] Fax: [phone]
RESmart© Integrated Heated Humidier
User Manual
RESmart
©
Heated Humidifier User Manual V2.6
P13
Warranty
3B Medical, Inc. warrants that this humidifier shall be free from defects of workmanship and materials and will perform in
accordance with the product specifications for a period of two (2) years from the date of sale by 3B Medical, Inc. to the
dealer. If the product fails to perform in accordance with the product specifications, 3B Medical, Inc. will repair or replace,
at its option, the defective material or part. 3B Medical, Inc. will pay customary freight charges from 3B Medical, Inc. to the
dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects
not related to material or workmanship. To exercise your rights under this warranty, contact your local, authorized dealers
or:
3B Medical, Inc.......................................
RESmart® CPAP/Auto CPAP System
User Manual

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The RESmart©Integrated Heated Humidifier is designed only for use with specific BMC
RESmart ® CPAP/Auto CPAP or BPAP devices. Do not use this humidifier with any other
devices.
The humidifier moistens the air delivered by the BMC RESmart®CPAP/BPAP devices.
The Heated Humidifier is only used for single patient and must not be re-used on another
person. This is to avoid the risk of cross-infection.
The Heated Humidifier is not intended for use with a patient whose upper airways have been
bypassed.
Table of Contents
Warnings & Cautions .......................................... 2
Symbols ............................................................... 2
Features ............................................................... 3
Set Up ................................................................... 4
Daily Use .............................................................. 5
Cleaning ............................................................... 6
Service ................................................................. 6
Specifications ...................................................... 7
Disposal ............................................................... 7
Traveling .............................................................. 8
EMC Requirements ............................................. 9
Warranty ............................................................... 12
RESmart ®, InH2 are registered trademarks of BMC Medical Co., Ltd.
©BMC Medical Co., Ltd. 2011
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Guidance and manufacturer's declaration - electromagnetic immunity
The RESmart is intended for use in the electromagnetic environment specified below. The user of the
RESmart should make sure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
the RESmart, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d=1.2√P
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
where Pis the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitter, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applied.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField 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 RESmart is used exceeds the applicable RF compliance level above, the RESmart
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the RESmart.
bOver the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
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The RESmart©Integrated Heated Humidifier is designed only for use with specific BMC
RESmart ® CPAP/Auto CPAP or BPAP devices. Do not use this humidifier with any other
devices.
The humidifier moistens the air delivered by the BMC RESmart®CPAP/BPAP devices.
The Heated Humidifier is only used for single patient and must not be re-used on another
person. This is to avoid the risk of cross-infection.
The Heated Humidifier is not intended for use with a patient whose upper airways have been
bypassed.
Table of Contents
Warnings & Cautions .......................................... 2
Symbols ............................................................... 2
Features ............................................................... 3
Set Up ................................................................... 4
Daily Use .............................................................. 5
Cleaning ............................................................... 6
Service ................................................................. 6
Specifications ...................................................... 7
Disposal ............................................................... 7
Traveling .............................................................. 8
EMC Requirements ............................................. 9
Warranty ............................................................... 12
RESmart ®, InH2 are registered trademarks of BMC Medical Co., Ltd.
©BMC Medical Co., Ltd. 2011

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Warnings & Cautions
IMPORTANT! •Read all instructions before using the humidifier.
•Use only with BMC RESmart devices whose instructions specify the use of this humidifier.
CAUTIONS! •Indicates the possibility of damage to the device.
•US federal law restricts this device to sale by or on the order of a physician.
•If fluids are spilled onto the humidifier platform, unplug the power cord from the AC
wall outlet and allow the humidifier platform to drain and dry before using.
•Take precautions to protect furniture from water damage.
WARNINGS! •Indicates the possibility for injury to the user or the operator.
•Use the humidifier only for its intended use as described in this manual.
•Use only accessories recommended by BMC.
•Never operate the humidifier if any of the parts are damaged, if it is not working
properly, or if the humidifier has been dropped or mishandled. Do not use the humidifier
if the water chamber is leaking or damaged in any way. Have any damaged parts replaced
before continuing use.
•Never touch the heater plate unless the humidifier is unplugged and the plate has cooled
down.
•This equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
•Periodically inspect the power cord for signs of wear or damage. Replace if necessary.
•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.
•When humidifier is used outside the specified ambient temperature range or humidity
range, the performance of humidifier will be compromised.
Symbols
Attention, Consult Type BF Applied part Class II (Double Insulated)
Accompanying Documents
DC Power IPX1 Drip-Proof, Vertical European CE Declaration
of Conformity
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Guidance and manufacturer's declaration - electromagnetic immunity
The RESmart is intended for use in the electromagnetic environment specified below. The user of the
RESmart should make sure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power supply lines
±1 kV for
input/output lines
±2 kV for
power supply lines
±1 kV for
input/output lines
Mains power quality should be that of a
typical home or hospital.
Surge
IEC 61000-4-5
±1 kV
differential mode
±2 kV
common mode
±1 kV
differential mode
±2 kV
common mode
Mains power quality should be that of a
typical home or hospital.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5 % UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
<5% UT
(>95 % dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the RESmart
requires continued operation during power
mains interruptions, it is recommended
that the RESmart be powered from an
uninterruptible power supply or from a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
0.3 A/m
If the pressure deviates more than is
indicated in the device specification, it
may be necessary to position the
RESmart further from sources of power
frequency magnetic fields. The power
frequency magnetic field should be
measured in the intended installation
location to ensure that it is sufficiently low.
NOTE: UTis the AC mains voltage prior to application of the test level.

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Features
Power Connector: Plug this connector into the power outlet on the BMC RESmart Device.
Heater Plate: Warms the water in the water chamber.
Indicator Light: When lit, this indicates that the heater plate has been turned on.
Air Inlet with Rubber Connector: Connect to the outlet port on the RESmart device.
Outlet Port: Connect the flexible tubing (coaxial 22 mm) here.
Water Chamber: The removable water chamber holds the water for humidification. It has a silica
gel cover to outflow the water in cleaning.
Fill Line: This indicates the maximum water level for safe operation.
Sensor: Do not block this sensor. The humidifier will not operate unless it can detect that
the RESmart device is connected correctly.
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Traveling With the System
Packing the System When traveling, the optional CPAP carrying case is for carry-on luggage
only. The carrying case will not protect the humidifier if it is put through checked
baggage.
Security Stations For ease at security stations, there is a note on the bottom of the humidifier
stating that it is medical equipment. It may be helpful to bring this manual
along with you for security personnel.
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EMC Requirements
Guidance and manufacturer's declaration - electromagnetic emissions
The RESmart is intended for use in the electromagnetic environment specified below. The user of the
RESmart should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1,
Class B
The RESmart uses RF energy only for its internal function.
Therefore its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Group 1,
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/flicker emissions
IEC 61000-3-3
Class D
The RESmart is suitable for use in all establishments
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.

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Set Up
1. Connect the Humidifier to the RESmart device. Make sure they are connected completely.
2. Place the RESmart device and humidifier on a firm, flat surface at a level lower than your sleeping position.
CAUTION! Do not turn the humidifier on without the water chamber installed.
CAUTION! Take precautions to protect furniture from water damage.
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Specifications
Size Dimensions: 120 ×194 ×112 mm
Weight: < 0.8 kg
Water Capacity >350 ml at recommended water level
Product Use, Transport and Storage
Operation Transport and Storage
Temperature: 5 to 30 -20 to 55
Humidity: ≤80% Non-condensing ≤93% Non-condensing
Atmospheric Pressure: 860 to 1060 hPa 500 to 1060 hPa
Power Requirements
24V DC 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
Heater Settings
1 to 5 (104 to 149° F / 40 to 65 )
Maximum Operating Pressure
30 hPa / cmH20
Pressure Drop w/ Humidifier
<0.5 hPa / cmH20 at 60 LPM flow
Maximum Delivered Gas Temperature
<40
Humidity Range
10 to 45 mg H2O/L
Disposal
When necessary, dispose of the device and accessories in accordance with local regulations.

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Daily Use
1. Fill the chamber to the fill line with water (approx. 350 ml) from the outlet port. Distilled water is recommended. Do not
overfill the water chamber.
CAUTION! Always remove the chamber from the humidifier before filling with water.
2. Press down the spring loaded heater plate with the water chamber and slide the chamber into place. Make sure the rubber
connector on the inlet port fits securely over the RESmart device’s air outlet.
3. Connect the flexible tubing to the outlet port on the water chamber.
CAUTION! Avoid moving or tilting the humidifier when the water chamber has water in it.
4. Press the humidifier button on the RESmart device after CPAP is blowing. The humidifier key will be lighted and the
yellow indicator light on the humidifier will turn on.
5. The ideal humidity setting depends on room temperature and humidity. Initially, a setting of 3 is recommended. You can
adjust this setting at any time. Please adjust the humidifier setting according to the CPAP User Manual.
IMPORTANT! When the air flow is turned off, the humidifier will automatically shut off. If you restart
the air flow within 30 minutes, the humidifier will be reactivated automatically.
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Cleaning
The water chamber should be cleaned daily or after each use.
WARNING! Emptying and cleaning the water chamber daily will help to prevent mold and bacteria
growth.
WARNING! Allow the water in the chamber to cool down to room temperature before removing it from
the humidifier.
WARNING! To avoid electrical shock, disconnect the power cord of RESmart device before cleaning
the humidifier. DO NOT immerse the humidifier into any fluids.
Water Chamber
1. Turn the RESmart device off and allow approximately 15 minutes for the heater plate and water to cool.
2. Disconnect the tubing from the water chamber. Press down on the water chamber and slide it out of the humidifier
platform.
3. Open the silica gel cover of water chamber and discard any remaining water. Fill a solution of warm water and a mild
dishwashing detergent into the chamber, cover the silica gel cover, rock the chamber a few minutes, and then outflow the
solution. Rinse the chamber several times with clean water and allow to air dry.
4. Fill the water chamber and close the silica gel cover. Inspect the water chamber for any leak or damage. Replace the
water chamber if any damage is present.
Humidifier Platform
1. Clean the humidifier platform by wiping with a damp cloth. Allow to air dry.
2. Inspect the humidifier platform for any damage and replace if necessary.
Silicone Tube of Humidifier
1. Clean the Silicone Tube by wiping with an alcohol cotton stick. Allow to air dry.
Service
The humidifier does not require routine servicing.
If the humidifier malfunctions, contact your home care provider immediately. Never attempt to open the
humidifier’s enclosure. If necessary, contact your local authorized dealer or BMC Medical Co., Ltd. for technical
support and documents.