Intended Use ........................................................................................................................................................... 2
Symbol Key .............................................................................................................................................................. 3
System Overview ................................................................................................................................................... 3
Available System One Heated Humidiers ...................................................................................................... 4
System Features and Contents ........................................................................................................................... 4
Connecting the Therapy Device ......................................................................................................................... 5
Connecting the Optional Heated Tubing .......................................................................................................... 6
Disconnecting the Optional Heated Tubing ..................................................................................................... 6
Disconnecting the Therapy Device .................................................................................................................... 7
Home Cleaning Instructions: Water Tank ......................................................................................................10
Home Cleaning Instructions: Humidier Base ..............................................................................................10
Home Cleaning Instructions: Heated Tubing ..................................................................................................11
Hospital and Institution Disinfection: Water Tank and Heated Tubing .....................................................11
Service .................................................................................................................................................................... 12
Traveling with the System ..................................................................................................................................12
CAUTION: U. S. federal law restricts this device to sale by or on the order of a physician.
Intended Use
The System One Heated Humidier is an accessory for the Philips Respironics REMstar and BiPAP therapy devices to provide moisture
to the patient circuit. It is intended for use in spontaneously breathing patients weighing over 30 kg (66 lbs), in the home or hospital/
institutional environment, who use mask-applied positive pressure ventilation therapy.
Warnings
A warning indicates the possibility for injury to the user or the operator.
• Use the humidier only for its intended use as described in this manual. Use only with Philips Respironics full-face masks, nasal
masks and connectors.
• Periodically inspect the humidier for signs of wear or damage. Never operate the humidier if any parts are damaged, if it is not
working properly, or if the humidier has been dropped or mishandled. Do not use the humidier if the water tank is leaking or
damaged in any way. Have any damaged parts replaced before continuing use.
• Periodically inspect the humidier power cord for signs of wear or damage. If it becomes worn or damaged, contact Philips
Respironics or your home care provider for a replacement.
• The humidier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device.
The humidier must be level for proper operation.
• Allow the humidier heater plate and water to cool down for approximately 15 minutes before removing the water tank. A burn
may result from: touching the heater plate, coming in contact with the heated water, or touching the tank pan.
• This equipment is not suitable for use in the presence of a ammable anesthetic mixture with air or with oxygen or nitrous oxide.
• When installing the water tank, do not allow any water to spill into the humidier or therapy device.
• 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 water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord from the
therapy device and discontinue use. Contact your home care provider.
• Before cleaning the humidier, always remove from the therapy device.
• Empty and clean the water tank daily to prevent mold and bacteria growth. Wipe the seal completely.
Note: Please see the “Limited Warranty” section of this manual for information on warranty coverage.
Cautions
A caution indicates the possibility of damage to the device.
• Do not place the humidier directly onto carpet, fabric, or other ammable materials.
• Do not place the device in or on any container that can collect or hold water. Take precautions to protect furniture from water damage.
• Do not ll the water tank above the maximum ll line. Damage to the humidier or therapy device may occur. If the water tank is
overlled, water may leak out of the tank inlet (located on the back of the tank) when installing the tank lid.
• Use only room temperature distilled water in the tank. Do not put any chemicals or additives into the water. Possible airway
irritation or damage to the water tank may result.
• Remove the tank, empty all water, and replace the empty tank before transporting the humidifier base.
• Do not attempt to ll the water tank while it is still inside the humidier.
• To avoid spilling, do not disconnect the humidier from the therapy device with water in the tank. Remove the water tank from
the humidier before disconnecting the therapy device.
• Do not turn the humidier on without the water tank installed. The Humidier setting must remain “off” if there is no water in
the water tank.
• The humidier door must be set in the open position before removing the water tank. Do not remove the water tank without
making sure that the humidier door locks into the open position.
• Do not move the humidier while the water tank has water in it.
• Use a mild liquid dishwashing detergent only for either hand washing or when using a dishwasher.
• Only the hospital and institution cleaning procedures listed in this manual are recommended by Philips Respironics. Use of other
cleaning and disinfecting processes, not specied by Philips Respironics, may affect the performance of the product.
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Contraindications
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 uid (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 contraindicated if you exhibit signs of a sinus or middle ear
infection. Not for use with patients whose upper airways are bypassed. Contact your health care professional if you have any
questions concerning your therapy.
Refer to the instructions for use that accompanied your therapy device for any additional contraindications that may be specic to
the use of that device.
Symbol Key
The following symbols may appear on the device:
SymbolDefinitionSymbolDefinition
Maximum Fill Line
Hot Water, Hot SurfaceType BF Applied Part
Follow Instructions for Use
IP22
Drip Proof Equipment
System Overview
The System One Heated Humidier attaches to the therapy device and provides an air outlet port to connect a breathing circuit.
The breathing circuit is comprised of patient tubing, a mask, and in some instances a separate exhalation device. The patient tubing
can be Respironics heated tubing, 22 mm (non-heated) performance tubing or 15 mm (non-heated) performance tubing. For
information related to the mask to be used, including any need for a separate exhalation device, consult the instructions for use that
accompany both the mask and therapy device.
The System One Heated Humidier with Heated Tubing is designed to deliver humidication to provide added comfort during
therapy. This humidication level is controlled through the output of the heated humidier as well as the temperature of the
optional heated tubing. Use of these two accessories allows for a comfortable level of humidity to be maintained at the mask.
The System One Heated Humidier is comprised of the following components:
• HeatedHumidier - The heated humidier is the primary source of humidication. Humidication is controlled by adjusting
the temperature of the heater plate. The heater plate is then used to heat water found in the water tank. This manual includes
instructions that explain how to set up and take of the heated humidier. For instructions on how to adjust the output of the
heated humidier, refer to the instructions for use that accompanied the therapy device.
• WaterTank - The water tank stores the water that will be used by the heated humidier. This manual includes instructions that
cover how to ll up and take care of the water tank.
• HeatedTubing - The heated tubing is an optional accessory that is used, along with the heated humidier, to control the
provided humidication. This is accomplished by controlling the temperature of the air in order to ensure that it does not cool
down prior to reaching the mask. This manual includes instructions that cover how to connect and take care of the heated tubing.
For instructions on how to adjust the temperature of the heated tubing, refer to the instructions for use that accompanied the
therapy device.
3
AvailableSystemOneHeatedHumidiers
Humidifier Connector End
Air Inlet
Air Outlet Port
The System One Heated Humidier is available in the following congurations:
HeatedHumidier - This humidier provides moisture to the patient circuit. It has a standard air outlet port for
use with Philips Respironics 15 and 22mm tubing.
HeatedHumidierwithHeatedTubing - This humidier provides moisture to the patient circuit but also
allows for the option of heated tubing. In order to function with the heated tubing, it has a modied air outlet port
that includes both a 3-pin connector and a heated tubing locking mechanism. The heated tubing compatible System
One Heated Humidier can be seen in the “Connecting the Optional Heated Tubing” section of this manual.
System Features and Contents
IMPORTANT: Read and understand the entire manual for your therapy device before attempting to use this humidier.
Air Inlet PortConnects to the outlet port on the therapy device.
Air Outlet Port (conical, 22 mm)
(Standard Port shown here)
Heater PlateWarms the water in the water tank.
Humidier DoorOpen the door to access the water tank.
Humidier Door LeverLift up on the lever to open the humidier door.
Water TankThe removable water tank holds the water for humidication.
Maximum Fill LinesThe ll lines indicates the maximum water level for safe operation. (Found on front and both
Flexible Heated Tubing
(optional)
Humidier Connector EndConnect this end of the tubing to the humidier.
Note: This humidier is specied for use with Philips Respironics REMstar and BiPAP therapy devices only.
Connect the patient circuit here. (If you are using the optional heated tubing, this outlet port
will look slightly different. Refer to “Connecting the Optional Heated Tubing” section of this
manual.)
sides of tank.)
The optional heated tube connects from the humidier to the patient’s mask.
Heater Plate
Maximum Fill Lines
Flexible Heated Tubing
(optional accessory)
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