REMstar Auto A-Flex |
USER MANUAL |
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© 2012 Koninklijke Philips Electronics N.V. All rights reserved.
Table of Contents |
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Intended Use........................................................................................................................................................... |
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Important................................................................................................................................................................. |
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Warnings.................................................................................................................................................................. |
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Cautions................................................................................................................................................................... |
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Contraindications................................................................................................................................................... |
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Symbol Key.............................................................................................................................................................. |
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System Contents.................................................................................................................................................... |
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System Overview................................................................................................................................................... |
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Control Buttons..................................................................................................................................................... |
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Available Therapy Modes...................................................................................................................................... |
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Available Flex Comfort Features........................................................................................................................ |
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Installing the Air Filters......................................................................................................................................... |
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Connecting the Breathing Circuit....................................................................................................................... |
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Where to Place the Device................................................................................................................................. |
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Supplying AC Power to the Device.................................................................................................................... |
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Navigating the Device Screens............................................................................................................................ |
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Starting the Device................................................................................................................................................ |
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Ramp Feature.......................................................................................................................................................... |
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Opti-Start Feature.................................................................................................................................................. |
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Mask Fit Check Feature........................................................................................................................................ |
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Humidifier Preheat............................................................................................................................................... |
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Flex Screen............................................................................................................................................................ |
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Setup Screen.......................................................................................................................................................... |
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Info Screen............................................................................................................................................................. |
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Device Alerts......................................................................................................................................................... |
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Troubleshooting.................................................................................................................................................... |
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Accessories............................................................................................................................................................ |
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Traveling with the System................................................................................................................................... |
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Cleaning the Device............................................................................................................................................. |
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Cleaning or Replacing the Filters...................................................................................................................... |
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Cleaning the Tubing.............................................................................................................................................. |
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Service.................................................................................................................................................................... |
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Specifications......................................................................................................................................................... |
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Disposal.................................................................................................................................................................. |
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How to Contact Philips Respironics................................................................................................................ |
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EMC Information.................................................................................................................................................. |
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Limited Warranty.................................................................................................................................... |
Back Page |
User Manual |
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CAUTION: U. S. federal law restricts this device to sale by or on the order of a physician.
Intended Use
The Philips Respironics REMstar Auto A-Flex system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.
Important
The device is to be used only on the instruction of a licensed physician. The system can deliver CPAP therapy or Auto-CPAP therapy. For enhanced pressure relief in CPAP mode, the device can also deliver C-Flex or C-Flex+. For enhanced pressure relief in Auto mode, the device can deliver C-Flex or A-Flex. Your home care provider will make the correct pressure settings according to your health care professional’s prescription.
When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep and automatically adjust the pressure to meet your needs. When in CPAP therapy, the system will deliver a continuous, set pressure during the night.
Several accessories are available to make your OSA treatment with the REMstar Auto A-Flex system as convenient and comfortable as possible. To ensure that you receive the safe, effective therapy prescribed for you, use only Philips Respironics accessories.
Warnings
A warning indicates the possibility of injury to the user or the operator.
•This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professional’s instructions regarding the use of the device.
•The operator should read and understand this entire manual before using the device.
•This device is not intended for life support.
•The device should be used only with masks and connectors recommended by Philips Respironics or with those recommended by the health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked. Explanation of the Warning: The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask. When
the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask exhalation port. However, when the device is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation.
•If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve.
•When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
•When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen off before turning the device off. This will prevent oxygen accumulation in the device. Explanation of the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
•When using oxygen with this system, a Philips Respironics Pressure Valve must be placed in-line with the patient circuit between the device and the oxygen source. The pressure valve helps prevent the backflow of oxygen from the patient circuit into the device when the unit is off. Failure to use the pressure valve could result in a fire hazard.
•Do not connect the device to an unregulated or high pressure oxygen source.
•Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide.
•Do not use the device near a source of toxic or harmful vapors.
•Do not use this device if the room temperature is warmer than 35° C (95° F). If the device is used at room temperatures warmer than 35° C (95° F), the temperature of the airflow may exceed 43° C (109° F). This could cause irritation or injury to your airway.
•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.
•Contact your health care professional if symptoms of sleep apnea recur.
•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 and discontinue use. Contact your home care provider.
•Repairs and adjustments must be performed by Philips Respironics-authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage.
•Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace if damaged.
•To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. DO NOT immerse the device in any fluids.
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User Manual |
•If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed inline between the device and the circuit tubing to prevent contamination.
•Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture.
•This device is activated when the power cord is connected.
•For safe operation when using a humidifier, the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device. The humidifier must be level for proper operation.
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.
•Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information.
Contact your home care provider regarding EMC installation information.
•Mobile RF communications equipment can affect medical electrical equipment.
•Pins of connectors marked with the ESD warning symbol shall not be touched and connections shall not be made without special precautions. Precautionary procedures include methods to prevent build-up of electrostatic charge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing), discharging one’s body to the frame of the equipment or system or to earth. It is recommended that all individuals that will handle this device understand these precautionary procedures at a minimum as part of their training.
•Before operating the device, ensure that the SD card cover is replaced whenever any of the accessories such as the Link Module or Modem are not installed. Refer to the instructions that came with your accessory.
•Condensation may damage the device. If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the operating temperature range shown in the Specifications.
•Do not use extension cords with this device.
•Do not place the device directly onto carpet, fabric, or other flammable materials.
•Do not place the device in or on any container that can collect or hold water.
•A properly installed, undamaged reusable foam inlet filter is required for proper operation.
•Tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning.
•Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly examine the inlet filters as needed for integrity and cleanliness.
•Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter.
•Always ensure that the DC power cord securely fits into your therapy device prior to use. Contact your home care provider or Philips Respironics to determine if you have the appropriate DC cord for your specific therapy device.
•When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s engine is running. Damage to the device may occur.
•Only use a Philips Respironics DC Power Cord and Battery Adapter Cable. Use of any other system may cause damage to the device.
Contraindications
When assessing the relative risks and benefits of using this equipment, the clinician should understand that this device can deliver pressures up to 20 cm H2O. In the event of certain fault conditions, a maximum pressure of 30 cm H2O is possible. 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 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 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.
User Manual |
3 |
Symbol Key
The following symbols may appear on the device and power supply:
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Definition |
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Consult accompanying instructions for use. |
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AC Power |
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DC Power |
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IP22 |
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Drip Proof Equipment |
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Caution, consult accompanying documents. |
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ESD Warning symbol |
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Class II (Double Insulated) |
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Type BF Applied Part |
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For Indoor Use Only. |
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Do not disassemble. |
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For Airline Use. Complies with RTCA/DO-160F section 21, category M. |
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Separate collection for electrical and electronic equipment per EC Directive |
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2002/96/EC. |
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Use only with the standard 60W power supply 1091398. |
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(not for use with Heated Tubing) |
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Use only with the Heated Tubing compatible 80W power supply 1091399. |
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(can also be used when Heated Tubing is not in use) |
4 |
User Manual |
System Contents
Your REMstar Auto A-Flex system may include the following items:
• Device |
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• SD card |
• User manual |
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• Side cover panel (optional) |
• Carrying case |
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• Reusable gray foam filter |
• Flexible tubing |
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• Disposable ultra-fine filter (optional) |
• Power cord |
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• Humidifier (optional) |
• Power supply (60W |
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1091398, or 80W |
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1091399) |
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Note: If any of these items are missing, contact your home care provider.
System Overview
The REMstar Auto A-Flex is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of Obstructive Sleep Apnea (OSA). It can deliver CPAP therapy or Auto-CPAP therapy.
When prescribed for you, the device provides several special features to help make your therapy more comfortable. The ramp function allows you to lower the pressure when you are trying to fall asleep. The air pressure will gradually increase until your prescription pressure is reached. You also have the option of not using the ramp feature at all.
Additionally, the C-Flex, C-Flex+ and A-Flex comfort features provide you with pressure relief when you exhale during therapy.
Several accessories are also available for use with your REMstar Auto A-Flex device. Contact your home care provider to purchase any accessories not included with your system.
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SD Card (Accessory) Slot |
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SD Card Cover |
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Air Outlet Port |
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Power Inlet |
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Tab |
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Filter Area |
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Side Cover |
This figure illustrates some of the device features, described in the following table. |
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Device Feature |
Description |
Air Outlet Port |
Connect the 15 or 22 mm Philips Respironics flexible tubing here. |
(conical, 22 mm) |
Note: Heated Tubing should only be connected to the Air Outlet Port of the compatible |
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System One Heated Humidifier and not to the Air Outlet Port of the therapy device. |
SD Card (Accessory) Slot |
If applicable, insert the optional accessory SD card here. |
SD Card Cover |
If applicable, the optional accessories such as a Link Module or Modem can be installed here. |
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Refer to the instructions supplied with the accessory. When not using an accessory, this |
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cover must be in place on the device. |
Power Inlet |
Connect the power cord here. |
Filter Area |
A reusable, gray foam filter must be placed in the filter area to screen out normal household |
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dust and pollens. A white ultra-fine filter can also be used for more complete filtration of very |
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fine particles. |
Side Cover (optional) |
If using a humidifier with the device, this side cover can be easily removed with the release |
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tab before attaching the humidifier. Refer to the humidifier manual. |
User Manual |
5 |
Control Buttons
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LCD Display Screen |
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Humidifier Icon & |
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Number Settings |
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Control Wheel/Push Button |
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Ramp Button |
This figure shows the primary control buttons on the device, described in the following table. |
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Feature |
Description |
Display Screen |
Shows therapy settings, patient data, and other messages. The startup screen is shown temporarily |
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when the unit is first powered. |
Humidifier Icon |
This Icon lights up (different colors) when the optional humidifier and/or heated tube is attached |
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and heat is being applied.White means classic humidification is selected. Blue means System One |
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humidification is selected. Orange means the heated tube is attached.Please refer to the humidifier |
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user manual for more information. |
Humidifier Numbers |
The humidifier number settings are only visible when the humidifier is attached and therapy is active. |
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You can use the control wheel to change the number settings for the humidifier.When the heated |
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tube is being used with the humidifier, these numbers will control the heated tube setting. |
Control Wheel/Push |
Turn the wheel to toggle between options on the screen. Press the wheel to choose an option. |
Button |
Primary function is to turn airflow on/off. |
Ramp Button |
When the airflow is on, this button allows you to activate or restart the ramp function. When |
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the airflow is off, this button allows you to activate the Mask Fit Check.This button lights up when |
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therapy is active or during specific alerts. |
Available Therapy Modes
The REMstar Auto A-Flex device offers the following therapy modes:
•CPAP – This mode delivers Continuous Positive Airway Pressure; CPAP maintains a constant level of pressure throughout the breathing cycle.
•Auto-CPAP – This mode delivers CPAP therapy while automatically adjusting the pressure level to meet your needs.
•Auto-Trial – If available on your device, this mode delivers CPAP therapy while automatically adjusting the pressure level to meet your needs. Auto-Trial mode is limited to a specific number of days which is set by your physician. Once the set number of days has elapsed, your device will automatically transition to CPAP-Check mode.
•CPAP-Check – If available on your device, this mode delivers CPAP therapy while automatically adjusting the pressure level to meet your needs. Pressure adjustments while in CPAP-Check mode are more gradual than those that occur in Auto-Trial mode and the amount of adjustment that can be made over time is limited.
Available Flex Comfort Features
The REMstar Auto A-Flex device offers the following optional Flex comfort features:
•C-Flex – Provides pressure relief upon exhalation to improve comfort based on your needs.
•A-Flex/C-Flex+ – Provides pressure relief taking place at the end of inhalation and at the start of exhalation to improve comfort based on your needs. When providing Auto-CPAP or Auto-Trial therapy, this comfort feature is called A-Flex. When providing CPAP or CPAP-Check therapy, this comfort feature is called C-Flex+.
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User Manual |
Installing the Air Filters
CAUTION: A properly installed, undamaged gray foam filter is required for proper operation.
The device uses a gray foam filter that is washable and reusable, and a white ultra-fine filter that is disposable. The reusable filter screens out normal household dust and pollens, while the ultra-fine filter provides more complete filtration of very fine particles. The gray reusable filter must be in place at all times when the device is operating. The ultra-fine filter is recommended for people who are sensitive to tobacco smoke or other small particles.
The reusable gray foam filter is supplied with the device.A disposable ultra-fine filter may also be included. If your filter is not already installed when you receive your device, you must at least install the reusable gray foam filter before using the device.To install the filter(s):
1.If you are using the white disposable ultra-fine filter, insert it into the filter area first, mesh-side facing in, towards the device.
2.Insert the required gray foam filter into the filter area after the ultra-fine filter.
Note: If you are not using the white disposable filter, simply insert the gray foam filter into the filter area.
Connecting the Breathing Circuit
To use the system, you will need the following accessories in order to assemble the recommended circuit:
•Philips Respironics interface (nasal mask or full face mask) with integrated exhalation port,or Philips Respironics interface with a separate exhalation device (such as the Whisper Swivel II)
WARNING: If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve.
• Philips Respironics 22 mm (or 15 mm) flexible tubing, 1.83 m (6 ft.)
•Philips Respironics headgear (for the mask)
WARNING: If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed in-line between the device and the circuit tubing to prevent contamination.
To connect your breathing circuit to the device, complete the following steps:
1.Connect the flexible tubing to the air outlet on the side of the device.
Note: Make sure the Tubing type setting (15 or 22) matches the tubing you are using (Philips Respironics 15 or 22 mm tubing).
Note: Heated Tubing should only be connected to the Air Outlet Port of the compatible System One Heated
Humidifier and not to the Air Outlet Port of the therapy device.
Note: If required, connect a bacteria filter to the device air outlet, and then connect the flexible tubing to the outlet of the bacteria filter.
Note: When using the bacteria filter, the device performance may be affected. However, the device will remain functional and deliver therapy.
2.Connect the tubing to the mask. Refer to the instructions that came with your mask.
3.Attach the headgear to the mask if necessary. Refer to the instructions that came with your headgear.
Where to Place the Device
Place the device on a firm, flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position. Make sure the filter area on the back of the device is not blocked by bedding, curtains, or other items. Air must flow freely around the device for the system to work properly. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).
CAUTION: Do not place the device directly onto carpet, fabric, or other flammable materials.
CAUTION: Do not place the device in or on any container that can collect or hold water.
Supplying AC Power to the Device
CAUTION: Condensation may damage the device. If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the operating temperature range shown in the Specifications.
WARNING: Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture.
WARNING: This device is activated when the power cord is connected.
IMPORTANT: If you are using your device with a humidifier, refer to the instructions included with your humidifier for details on how to power the device and humidifier.
User Manual |
7 |
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