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Respironics 1116426 User Guide

User manual
DRAFT
DreamStation CPAP
DreamStation CPAP Pro DreamStation Auto CPAP
Table of Contents
DRAFT
Bluetooth® Wireless Technology .........................................................................................................................14
Check Mask Fit .....................................................................................................................................................15
Altitude Compensation ......................................................................................................................................15
Troubleshooting ...................................................................................................................................................20
Limited Warranty ...................................................................................................................................Back Page
© 2015 Koninklijke Philips N.V. All rights reserved.
User Manual
Caution: U. S. federal law restricts this device to sale by or on the order of a physician.
DRAFT
Intended Use
The Philips Respironics DreamStation systems deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (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. Your home care provider will make the correct pressure settings and device configurations including accessories according to your health care professional’s prescription. Several accessories are available to make your OSA treatment with the DreamStation 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. Whe the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask exhalat on 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 4 ° 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.
• Do not use any accessories, detachable parts, and materials not recommended by Philips Respironics. Incompatible parts or accessories can result in degraded performance.
• Use only approved cables and accessories. Misuse may affect EMC performance and should be avoided.
• The Health Industry Manufacturers Association recommends that a minimum separation of six inches be maintained between a wireless phone and a pacemaker to avoid potential interference with the pacemaker. The DreamStation on-board Bluetooth communication should be considered a wireless phone in this regard.
• Use only power cords supplied by Philips Respironics for this device. Use of power cords not supplied by Philips Respironics may cause overheating or damage to the device and may result in increased emissions or decreased immunity of the equipment or system.
• The device should not be used while stacked or in close approximation to other non-approved devices.
• Do not pull or stretch the tubing. This could result in circuit leaks.
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User Manual
• Inspect the tubing for damage or wear. Discard and replace the tubing as necessary.
DRAFT
• 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.
• If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed i line 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 a the mask. 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 o 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/filter acc ss door and the modem access door are both closed 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.
• Make sure the filter area on the side 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.
• 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 Philips Respironics blue pollen 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 a needed for integrity and cleanliness.
• Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filt
• 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 H 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.
O. In the event of certain fault conditions, a maximum pressure of 40 cm H2O is possible. Studies have
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User Manual
Symbol Key
DRAFT
The following symbols may appear on the device, power supply and accessories:
Symbol Definitio Symbol Definitio
Consult accompanying instructions for use.
AC Power
DC Power Bluetooth® symbol
For Airline Use. Complies with RTCA/DO­160G section 21, category M.
Separate collection for electrical and electronic equipment per EC Directive 2012/19/EU.
IP22
Drip Proof Equipment This device contains an RF transmitter.
Caution, consult accompanying documents.
ESD Warning symbol Serial Connection
Class II (Double Insulated) Avoid ultraviolet radiation
Type BF Applied Part
For Indoor Use Only. Do not disassemble.
Oximeter Connection
Caution: U. S. federal law restricts this device to sale by or on the order of a physician.
System Contents
Your DreamStation system may include the following items:
• Device • SD card
• User manual • Flexible tubing
• Carrying case • Reusable blue pollen filte
• Power cord • Disposable light-blue ultra-fine filter (optiona
• Power supply ( 1118499) • Humidifier (optional
Note: If any of these items are missing, contact your home care provider.
How to Contact Philips Respironics
Should you experience trouble with this equipment or require assistance setting up, using, or maintaining the device or accessories, please contact your home care provider. If you need to contact Philips Respironics directly, call the Philips Respironics Customer Service department at 1-800-345-6443 or 1-724-387-4000. You can also use the following address: Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
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User Manual
System Overview
DRAFT
The DreamStation CPAP is a Continuous Positive Airway Pressure therapy device designed for the treatment of Obstructive Sleep Apnea (OSA). The DreamStation CPAP Pro can also deliver CPAP-check therapy, and the DreamStation Auto CPAP can also deliver CPAP-Check and Auto-CPAP therapy. Your home care provider will choose the appropriate pressure settings for you.
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. Also, the Flex comfort feature provides you with pressure relief when you exhale during therapy.
Several accessories are also available for use with your device. Contact your home care provider to purchase any accessories not included with your system.
This gure illustrates some of the device features, described in the following table.
# Device Feature Description
Therapy On/Off Button
1
2 Ambient Light Sensor
Ramp Button
3
4 Door, SD card & Filter Access This door lifts open for access to the SD card and lter area.
5 LCD Display Screen This is the User Interface for the therapy device.
6 Control Dial
7 Door, Accessory Access This door lifts open for access to the (optional) accessories.
8 Humidifi r Connector
9 Air Outlet Port Connect the tubing here.
10 Power Inlet Connect the power cord here.
4
Starts and stops the airow for therapy.
Detects room light levels and adjusts brightness of LCD Display Screen.
Activates the ramp feature during therapy.
Turn the dial to scroll between options on the screen. Press the dial to choose an option.
Humidier connects to the back of the therapy device. The humidier pin connector will attach here.
User Manual
Installing/Replacing the Air Filters
DRAFT
Caution: A properly installed, undamaged Philips Respironics blue pollen filter is required for proper operation
The device uses a blue pollen filter that is washable and reusa le, and a light-blue ultra-fine filter that is disposabl The reusable blue filter screens out normal household dust and ollens, while the light-blue ultra-fine filter provid more complete filtration of very fine particles. The reusable b e filter must be in place at all times when the device i operating. The ultra-fine filter is recommended for people who e sensitive to tobacco smoke or other small particles.
The reusable blue filter is supplied with the device. A disposable light-blue ultra-fine filter may also be included. If yo filter is not already installed when you receive your device, you must at least install the reusable filter before using th device.
This device has an automatic air filter eminder. Every 30 days, the device will display a message reminding you to check your filters and eplace them as directed.
Note: This message is a reminder only. The device does not detect the performance of the filters nor does it recognize when a filter has been cleaned or eplaced.
1. Lift up on the filter access door and swing open. If replacing, pull out the old filter assembl
2. If applicable, place a clean, reusable blue pollen filter (1) on top of a new optional disposable light-blue ultra-fine filter (2) and fir y snap them together.
3. Place the new filter assembly back in the side of the therapy device. Swing the door closed.
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User Manual
Where to Place the Device
DRAFT
Place the device on a firm, flat surface somewhere within easy reach of where you will use it at a level lower tha your sleeping position. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).
Note: When positioning the device, make sure that the power cable is accessible because removing power is the only way to turn off the device.
Caution: Make sure the filter a ea on the side 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
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
Complete the following steps to operate the device using AC power:
1. Plug the socket end of the AC power cord (included) into the power supply (also included).
2. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch.
3. Plug the power supply cord’s connector into the power inlet on the side of the device.
4. Verify that the plug at the side of the device, at the power supply, and at the electrical outlet are fully inserted. This will help to ensure that a secure, reliable electrical connection has been made.
Note: If the following Incorrect Power Supply icon appears on the screen, please repeat step 4.
Important: To remove AC power, disconnect the power supply cord from the electrical outlet. Warning: Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace
if damaged.
Caution: Do not use extension cords with this device.
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User Manual
Connecting the Breathing Circuit
DRAFT
To use the system, you will need the following accessories in order to assemble the recommended breathing 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)
• Philips Respironics flexible tubing 1.83 m (6 ft.)
• Philips Respironics headgear (for the mask)
To connect your breathing circuit to the device, complete the following steps:
1. Connect the flexible tubing to the air outlet on the back of the ther py device. Line up the connector (1) at the top of the heated tube to the top of the air outlet port on the back of the device.
2. Press the tubing into place over the air outlet port until the tabs on the side of the tube click into place in the slots
on the sides of the outlet port.
Note: If you are using a standard tube (not shown) instead of a heated tube, simply slide the tubing over the air
outlet port on the therapy device.
Note: If required, connect a bacteria filter to the device air outlet, and then connect the flexible tubing to th
outlet of the bacteria filter. When using the bacteria filter, the device performance may be affected. However, the device will remain functional and deliver therapy.
3. Connect the tubing to the mask. For proper placement and positioning, refer to the instructions that came with your mask.
Warning: Do not pull or stretch the tubing. This could result in circuit leaks. Warning: Inspect the tubing for damage or wear. Discard and replace the tubing as necessary.
4. Attach the headgear to the mask if necessary. Refer to the instructions that came with your headgear.
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.
Warning: If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filt
should be installed in-line between the device and the circuit tubing to prevent contamination.
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User Manual
Navigating the Device Screens
DRAFT
The User Interface (UI) on this device allows you to adjust the device settings and view information about your therapy. The UI is comprised of the display screen and the control dial. Rotate the control dial in either direction to scroll through the menu options on the display screen. Note: The display is not a touch screen. You must use the control dial to navigate the device menu. To adjust a setting:
1. Rotate the control dial to your desired menu option.
2. Press the control dial to select that setting.
3. Rotate the control dial to change the setting.
4. Press the control dial again to save the change.
Note: The rotate dial icon on any screen indicates to rotate the dial to perform an action. The click dial icon
on any screen indicates to press the dial to perform an action.
Note: Pressing the dial when the down arrow appears on any screen will take you to a sub-menu with more
menu options. Pressing the dial when the up arrow appears on any sub-menu will return you back to the main menu.
Note: The screens shown throughout this manual are examples for reference only. Actual screens may vary based
upon device model and provider settings.
Starting the Device
1. Ensure power is supplied to the device. The first sc een to display will be the Philips Respironics logo, followed by the device model screen, and then the Home screen.
Home Screen
The first time the d vice is powered on, a pop-up will prompt you to set the time on the device. The default setting
is Greenwich Mean Time, but you may adjust the time in 30 minute increments to match your local time zone. If you choose to skip this initial time setting, the time can always be adjusted under the “My Setup” menu. Note: This time setting is not displayed as a clock function on the device. It is only used to align your therapy data for your Provider’s data reports.
2. Put on your mask assembly. Refer to the instructions supplied with the mask.
3. Press the Therapy button ( ) on top of the device to turn on airfl w and begin therapy. The current delivered pressure will display on the screen.
4. Make sure that no air is leaking from your mask. If necessary, adjust the mask and headgear until the air leak stops. See the instructions provided with your mask for more information.
Note: A small amount of mask leak is normal and acceptable. Correct large mask leaks or eye irritation from an air
leak as soon as possible.
5. If you are using the device in a bed with a headboard, try placing the tubing over the headboard. This may reduce tension on the mask.
6. Press the Therapy button again to turn off therapy.
Note: During therapy, it there is a mains interruption (i.e. power loss) the device will return to the Home screen
once power is restored. You may resume therapy as needed.
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