When using oxygen with this system, a Respironics Pressure Valve must be placed in-line with the patient circuit. Failure to use the pressure valve could result in a fire hazard. 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 95 F. If the device is used at room temperatures warmer than 95 F, the temperature of the airflow may exceed 106 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, or if the enclosure is broken, discontinue use and contact your home care provider. Repairs and adjustments must be performed by 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 electric shock, unplug the device before cleaning it. DO NOT immerse the device in any fluids. Using this device at an incorrect altitude setting could result in airflow pressures higher or lower than the prescribed setting. Always verify the altitude setting when traveling or relocating, and adjust the system accordingly. Pins of connectors identified with the ESD warning symbol ( )should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up of electrostatic discharge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing), discharging ones body to the frame of the equipment or system or to earth or a large metal object, and bonding oneself by means of a wrist strap to the equipment or system or to earth. Never operate the device if any of the parts are damaged, or if it is not working properly. Do not use the device 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 unit is unplugged and the plate has cooled down. While the device is in operation, the soft flap on the flapper valve must move freely and close off the opening on top of the water chamber. Replace the flapper valve if the flap is damaged or not intact. When installing the water chamber onto the system, do not allow any water to spill into the CPAP device. When installing the water chamber onto the system, make sure the soft valve is first attached to the water chamber.

1.3.2 Cautions

A Caution indicates the possibility of damage to the device. The device may only be operated at temperatures between 41 F and 95 F. 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 Chapter 8. Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter. Do not place the device in or on any container that can collect or hold water. Make sure that the drain holes on the bottom of the device are not blocked. Condensation may damage the device. Always allow the device to reach room temperature before use. 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. If fluids are spilled onto the heater plate, unplug the power cord from the AC wall outlet and allow the device to drain and dry before using. Take precautions to protect furniture from water damage. Use distilled water only in the chamber. Do not fill water chamber above the fill line indicated on the side of the water chamber. Make sure the protective cover is securely fastened on top of the water chamber before operating the device. Additional warnings, cautions, and notes are located throughout this manual.

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 35 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 physician if you have any questions concerning your therapy. 4 User Manual

1.4System Overview

The SleepEasy device, shown in Figure 12, is a sleep apnea system that delivers Continuous Positive Airway Pressure (CPAP). CPAP maintains a constant level of pressure throughout the breathing cycle. Several accessories are also available for use with your SleepEasy device. Contact your home care provider to purchase any accessories not included with your system.
Figure 12 SleepEasy Device Figure 13 illustrates many of the device features, described in the following table.
Power Inlet (back of unit) Display Screen Flapper (Soft) Valve Heated Humidifier Button Air Inlet Port Protective Cover

Ramp Button

Start/Stop Button Heater Plate Air Outlet Port

Fill Line

Water Chamber
Figure 13 System Overview
Device Feature Display Screen Heated Humidifier Button Ramp Button Start/Stop Button Heater Plate Air Outlet Port Water Chamber Fill Line Protective Cover Flapper Valve Power Inlet Medical Equipment Note (bottom of unit)
Description Shows therapy settings, patient data, and error messages. This button controls the humidifier functions. This button starts or restarts the ramp cycle. This button starts or stops the airflow and the heater plate (if activated). Warms the water in the water chamber. Connect the flexible tubing here. The removable water chamber holds the water for humidification. This indicates the maximum water level for safe operation. Clip on top of the water chamber to prevent debris from entering the water chamber. This valve helps prevent water from splashing into the device. Connect the power cord here. For ease at airport security stations, there is a note on the bottom of the device stating that it is medical equipment. It may help if you also take this manual with you when you travel. A reusable, gray foam filter must be placed in the filter area to screen out normal household dust and pollens. An optional, white ultra-fine filter can also be used for more complete filtration of very fine particles.
Filter Area (back of unit)
1.4.1Breathing Circuit Overview
The patient breathing circuit, shown in Figure 14, consists of the following: Circuit tubing to deliver air from the device to your interface (e.g., mask) A mask or other patient interface device to deliver the prescribed pressure to your nose or nose and mouth, depending on which interface has been prescribed for you An exhalation device to vent exhaled air from the circuit

Patient Interface

Exhalation Device Circuit Tubing

Exhalation Port

Mask's Connector Flexible Tubing Connector
Circuit with Separate Exhalation Device

User Buttons

Heated Humidifier Button

Start/Stop Button
Figure 21 Primary Control Buttons These buttons are described below. Button Description Starts the airflow and places the device into Active state, or stops the airflow, and places the device into Standby state. It is also used to exit any display screen. Controls the humidifier functions. When the airflow is on, this button allows you to activate or restart the ramp function. Ramp lowers the airflow pressure and then gradually increases it, allowing you to fall asleep more easily.
Performs next screen navigation or increases setting. Performs previous screen navigation or decreases setting.

2.2Display

Figure 22 shows the display screen.
Figure 22 Display Screen User Manual 9
The information shown on the display screen is defined as follows: Icon Description
Indicates that the Blower Hours or the User Hours Time Meter is being displayed. Indicates that the Therapy Hours Time Meter is being displayed. When displayed with the Therapy Hours icon, it indicates that the Session Counter is being displayed. Indicates that the Altitude Level is being displayed. Indicates that the humidifier is providing heat. Indicates that the unit is in the Provider Settings Menu. In Active State, indicates that the Ramp function is in progress. In menus, it is used to indicate Ramp Time Setting alone, or in combination with Ramp Start Pressure. Indicates that the Ramp Start Pressure is being displayed. Indicates that a pressure value is being displayed. Indicates that the user may erase the displayed data. Indicates that the unit requires user attention. Indicates that the unit requires user attention. Indicates that the Compliance Checksum for the unit is being displayed.

2.3LED Backlight

The START/STOP, HEAT and RAMP buttons are lit by LED backlights. The START/STOP LED will always be on when power is applied to the device. The HEAT LED is on when the humidifier heater plate is active, and off when it is not. The RAMP LED is on when the ramp function is active and off when it is not.

2.4 Control Panel Inactivity
Some screens have time-out periods. The screens timer starts when the screen is initially displayed and is restarted whenever a button is pressed. Unless otherwise specified, all screens timeout after one minute and will return to the Inactive Display. If in Provider Mode, the unit will additionally exit Provider Mode. 10 User Manual

Chapter 3: Setup

This chapter provides instructions on how to: Install the air filters Position the device Connect the breathing circuit Supply power to the device Setup the integrated humidifier
3.1 Installing the Air Filters
CAUTION: A properly installed, undamaged foam filter is required for proper operation. The device uses a gray foam filter that is washable and reusable, and an optional white ultra-fine filter that is disposable. The reusable filter screens out normal household dust and pollens, while the optional 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. A reusable gray foam filter and a disposable ultra-fine filter are supplied with the device. If your filters are 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, meshside facing in, towards the device. 2. Insert the gray foam filter into the filter area as shown in Figure 31. NOTE: If you are not using the white disposable filter, simply insert the gray foam filter into the filter area.

AC Inlet Filter Area

Disposable White Ultra-fine Filter (optional)
Reusable Gray Foam Filter (required)
Figure 31 Installing the Air Filter NOTE: See Chapter 7, Cleaning and Maintenance, for information on how to clean or replace the air filters. User Manual 11
3.2 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. CAUTION: Make sure that the drain holes on the bottom of the device are not blocked. CAUTION: Take precautions to protect furniture from water damage. CAUTION: Do not turn the device on without the water chamber installed.

3.4Supplying AC Power to the Device
CAUTION: If this device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before beginning the following setup procedures. Do not operate the device outside of the operating temperature range shown in Chapter 8. WARNING: Route the wires to avoid tripping. WARNING: This device is activated when the power cord is connected. Pressing the turns the airflow and humidifier (if activated) on or off. button
Complete the following steps to operate the device using AC power. 1. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch. 2. Plug the power cords connector into the power inlet on the back of the device, as shown in Figure 35.
AC Inlet (back of unit) Power Cord

Filter Area

Figure 35 Connecting the Power Cord to the Device 3. Ensure that all connections are secure. IMPORTANT: To remove AC power, disconnect the power cord from the electrical outlet. WARNING: Inspect the power cord often for any signs of damage. Replace a damaged power cord immediately. WARNING: Do not use extension cords with this device.
3.5Setup the Integrated Humidifier
WARNING: Do not use the SleepEasy device without the water chamber in place.

First Use

1. Slide the water chamber out from the side of the unit.
2. Gently remove the base of the chamber with your hands, being careful not to damage the rubber seal. 3. Remove the flapper valve from the air inlet port; unclip the protective cover from the top of the water chamber, as shown in Figure 3-6. Wash these parts by hand only in a solution of warm water and mild liquid dishwashing soap. Rinse the parts with clean water and allow them to air dry.
Protective Cover Flapper Valve

Soft Flap

Figure 36 Flapper Valve and Protective Cover 4. Wash the water chamber and heater plate in the dishwasher (top shelf only) or by hand in a solution of warm water and mild dishwashing soap. 5. Reassemble. Insert the flapper valve into the air inlet port, and clip the protective cover on top of the water chamber, as shown in Figure 3-6. 6. Fill the chamber to the fill line with distilled water. CAUTION: Use only distilled water in the chamber. 7. Slide the chamber into place on the side of the unit. Continue as instructed in Step 5 of Daily Use.

Daily Use

1. Slide the water chamber out from the side of the unit. 2. Before each use, check the flapper valve operation. Visually inspect the soft flap to make sure it is free to open and close when installed in the water chamber. Check to make sure the soft flap is not pushed back into the flapper valve. Replace the valve if the soft flap is damaged or missing. Make sure the protective cover is clipped into place on top of the water chamber. 3. Before each use, rinse the chamber with water. Fill the chamber to the fill line with distilled water using the funnel, as shown in Figure 3-7.

Figure 42 Standby Screen 3. Press the button to turn on the airflow. The altitude setting screen will appear for approximately one second. Put on your mask assembly when the air starts to flow. 4. The Operate screen appears, shown in Figure 43.
Figure 43 Operate Screen The Operate screen shows the current CPAP setting.
5. Make sure that no air is leaking from your mask into your eyes. If it is, 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.
6. If you are using the device in bed, try placing the tubing from the device over your headboard. This may reduce tension on the mask. NOTE: NOTE: If you are having trouble with your mask, refer to the instructions supplied with the mask. You must remove the mask and patient circuit before you get out of bed.
4.2 Using the Ramp Feature
You can press the RAMP this feature. button to activate the Ramp feature, if your provider has enabled

4.2.1Ramp Feature

The device is equipped with an optional ramp feature that your home care provider can enable or disable. This feature reduces the air pressure when you are trying to fall asleep and then gradually increases (ramps) the pressure until your prescription setting is reached, allowing you to fall asleep more comfortably. If ramp is enabled on your device, after you turn on the airflow, press the RAMP button on the top of the device. You can use the RAMP button as often as you wish during the night. NOTE: If the ramp feature is disabled, nothing will happen when you press the RAMP button.

4.2.2Setting Ramp

This screen is entered by pressing and holding the RAMP button for 3 seconds. The Ramp Starting Pressure Screen will appear, Figure 4-4. It can be entered from either the standby or operate screen.
Figure 4-4 Ramp Starting Pressure Screen You can increase or decrease the ramp starting pressure in 0.5 cm H2O increments by pressing the + or buttons. The default setting is 4 cm H2O. You can adjust the setting from 4 cm H2O to the CPAP pressure setting. NOTE: This screen will not display if your provider has not enabled Ramp on your device. button to return to the Standby After you have finished modifying this screen, press the screen. 18
4.3 Using the Heated Humidifier Features
4.3.1Heated Humidifier Feature
The Integrated Heated Humidifier is a feature that may reduce nasal dryness and irritation by adding moisture and heat to the airflow. This feature can be enabled or disabled by your home care provider.
4.3.2Setting Heated Humidifier
If the heated humidifier is enabled on your device, press the HEAT button on the top of the device. The Heat Setting screen will appear, Figure 4-5. You can enter this screen from either the standby or operate screen. NOTE: If the heated humidifier feature is disabled by the home care provider, nothing will happen when you press the HEAT button.

Figure 4-5 Heat Setting Screen You can increase or decrease the humidifier heat settings by pressing the + or buttons. The possible settings are from 0 (off) to 5 which is the highest setting. NOTE: This screen will not display if your provider has not enabled the humidifier on your device. button to return to the Standby
After you have finished modifying this screen, press the screen.

4.4Altitude Setting

To access the Altitude Setting screen, you press and hold both the RAMP button and the HEAT button simultaneously for 3 seconds. The Altitude Setting screen will then appear, Figure 4-6. NOTE: You can only enter this screen from the standby screen.
Figure 4-6 Altitude Setting Screen
This screen allows you to modify the altitude adjustment setting. Press the + or buttons to increase or decrease the setting by increments of 1: 1 = less than <2500 ft. 2 = 2500 ft. to 5000 ft. 3 = 5000 ft. to 7500 ft. NOTE: Elevations over 7500 ft. may affect the accuracy of the pressure. WARNING: If you incorrectly set the manual altitude setting, the pressure may be too high or too low, depending on your location.

4.5Display Screens

You can view the set pressure on the Active Display screen (Operate screen), as well as the following information on the Patient Data screens: Therapy usage hours (standby screen) Blower hours Number of sessions greater than 4 hours Compliance checksum Current altitude setting
4.5.1Navigating the Display Screens
Use the + and - buttons to navigate the display screens. NOTE: You can only enter these screens from the standby screen.
4.5.2Viewing Data on the Patient Data Screens
The following describes the Patient Data screens. 1. Therapy Usage Hours (Standby Screen) This screen displays the amount of time that the device provided therapy (with the blower on and the patient connected). The decimal digit is displayed if user hours are less than 10000 so it can be displayed with 0.1 hour resolution. Otherwise, the values between 10000 and 99999 hours can be displayed. Note: This screen is only for reference. Your home care provider may periodically ask you for this information.
2. Blower Hours Screen This screen displays the amount of time that the blower has been active over the life of the device. The decimal digit is displayed if user hours are less than 10000 so it can be displayed with 0.1 hour resolution. Otherwise, the values between 10000 and 99999 hours can be displayed. Note: This screen is only for reference. Your home care provider may periodically ask you for this information.
3. Session Counter Screen This screen displays the number of device therapy sessions that exceeded 4 hours. Note: This screen is only for reference. Your home care provider may periodically ask you for this information.

Problem The device does not operate when you press the button. The airflow does not turn on.
Why It Happened There may be a problem with the blower.
What to Do Make sure the device is powered correctly. If the button backlights turn on when you apply power, but the airflow does not turn on, there may be a problem with your device. Contact your home care provider for assistance. Note: When the device is functioning correctly, after you press the button, the airflow turns on after a slight delay. This brief delay is normal.
The devices display is erratic.
The device has been dropped or mishandled, or the device is in an area with high Electromagnetic Interference (EMI) emissions.
Unplug the device. Reapply power to the device. If the problem continues, relocate the device to an area with lower EMI emissions (e.g., away from electronic equipment such as cellular phones, cordless phones, computers, TVs, electronic games, hair dryers, etc.). If the problem still occurs, contact your home care provider for assistance.
Device Resets/Reboots: The device shuts down and restarts automatically during therapy. (This is unlikely to occur.)
The device comes installed with troubleshooting software that automatically monitors performance.
Such a reset poses no danger to the patient and assures that the patient receives prescribed therapy throughout the night. If there is a possibility of damage to the device, the device will shut down permanently. The product will then display the following system error alert symbol to indicate that the device be returned to the home care provider for service: If Ramp has not been prescribed for you, discuss this feature with your home care provider to see if they will change your prescription. If your provider has enabled Ramp, but the feature still does not work, check the CPAP setting on your Active Display screen. If CPAP is set to the minimum setting (4.0 cm H2O), or the starting pressure is the same as the prescribed pressure, the Ramp feature will not work. Clean or replace the air filters as described in Chapter 7. The temperature of the air may vary somewhat based on your room temperature. Make sure that the device is properly ventilated. Keep the device away from bedding or curtains that could block the flow of air around the device. Make sure the device is away from direct sunlight and heating equipment. If the problem continues, contact your home care provider.
The Ramp feature does not work when you press the Ramp button ( ).

Chapter 7: Cleaning and Maintenance
This chapter describes how to clean the device and its filters and provides tips on traveling with your SleepEasy system.

7.1 Cleaning the Device

WARNING: To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. CAUTION: Do not immerse the device in liquid or allow any liquid to enter the enclosure, inlet filter, or any opening. 1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild detergent. Let the device dry completely before plugging in the power cord. 2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts.
7.2 Cleaning or Replacing the Filters
CAUTION: Operating the device with a dirty filter may keep the system from working properly and may damage the device. Under normal usage, you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months. The white ultra-fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty. DO NOT clean the ultra-fine filter. CAUTION: Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly examine the inlet filters as needed for integrity and cleanliness. 1. If the device is operating, stop the airflow by pressing the button. Disconnect the device from the power source. 2. Remove the filter(s) from the enclosure by gently squeezing the filter in the center and pulling it away from the device. 3. Examine the filter(s) for cleanliness and integrity. 4. Wash the gray foam filter in warm water with a mild detergent. Rinse thoroughly to remove all detergent residue. Allow the filter to air dry completely before reinstalling it. If the foam filter is torn, replace it. (Only Respironics-supplied filters should be used as replacement filters.) 5. If the white ultra-fine filter is dirty or torn, replace it. 6. Reinstall the filters, inserting the white ultra-fine filter first if applicable, refer to chapter 3. CAUTION: Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter.

7.3 Cleaning the Tubing

Clean the tubing daily. Disconnect the flexible tubing from the device. Gently wash the tubing in a solution of warm water and a mild detergent. Rinse thoroughly. Air dry.
7.4 Cleaning the Water Chamber
Refer to Figure 7-1 when cleaning the water chamber.
Flapper (Soft) Valve (Hand wash only!) Protective Cover (Hand wash only!)
Water Chamber with Removable Base Plate
Figure 71 Cleaning the Water Chamber NOTE: The Flapper (Soft) Valve has a one year lifespan. You must replace this valve after one year. NOTE: Hand washing can be performed daily. Dishwashing can be performed once a week. WARNING: Empty and clean the water chamber daily to prevent mold and bacteria growth. WARNING: Allow the water in the chamber to cool to room temperature before removing the chamber from the humidifier. 1. Turn the therapy device off and allow approximately 15 minutes for the heater plate and water to cool. 2. Disconnect the tubing from the water chamber. 3. Slide the water chamber out of the humidifier platform. Empty any remaining water. 4. Gently remove the base of the chamber with your hands, being careful not to damage the rubber seal. 5. Remove the flapper valve from the air inlet port; unclip the protective cover from the top of the water chamber. Wash these two parts by hand only in a solution of warm water and mild dishwashing soap. Rinse with clean water and allow them to air dry.
6. Wash the water chamber and base plate in the dishwasher (top shelf only) or by hand in a solution of warm water and mild dishwashing soap. 7. Inspect all parts for damage prior to reassembly. 8. Reassemble the water chamber. Make sure the base plate is fully seated on the water chamber. Also, make sure you install the flapper valve properly into the air inlet port of the water chamber. See Figure 7-1. NOTE: Be sure to reinstall the protective cover on top of the water chamber to prevent debris from entering the water chamber. 9. Fill the water chamber to the fill line. Inspect the water chamber for any leaks or damage. Replace the water chamber if any damage is present.

7.5Service

The SleepEasy device does not require routine servicing. WARNING: If you notice unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if the enclosure is broken, or if water has entered the device, discontinue use, and contact your home care provider.

Class B Class A Complies

Guidance and Manufacturers Declaration - Electromagnetic Immunity This device is intended for use in the
electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test
Electrostatic Discharge (ESD) IEC 61000-4-2 Electrical fast Transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-kV differential mode 2 kV common mode <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 sec 3 A/m 1 kV differential mode 2 kV for common mode <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 sec 3 A/m Mains power quality should be that of a typical home or hospital environment. Mains power quality should be that of a typical home or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

IEC 60601 Test Level

6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input-output lines

Compliance Level

6 kV contact 8 kV air 2 kV for supply mains 1 kV for input/output lines
Electromagnetic Environment Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical home or hospital environment.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -Guidance

150 kHz to 80 MHz d = 1.2

0.12 0.38 1.2 3.8 12

80 MHz to 800 MHz d = 1.2
800 MHz to 2.5 GHz d = 2.3

0.23 0.73 2.3 7.3 23

0.01 0.10 100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Limited Warranty

Respironics, Inc. warrants that the system 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 Respironics, Inc. to the dealer. If the product fails to perform in accordance with the product specifications, Respironics, Inc. will repair or replace at its option the defective material or part. Respironics, Inc. will pay customary freight charges from Respironics, 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. Respironics, Inc. disclaims all liability for economic loss, loss of profits, overhead, or consequential damages which may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This warranty is given in lieu of all other express warranties. In addition, any implied warranties including any warranty of merchantability or fitness for the particular purpose are limited to two years. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state. To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact Respironics, Inc. at: 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550 1-724-387-4000

Help your insomnia patients sleep easy
Cognitive behavioral therapy for insomnia (CBTI) program
Empower your insomnia patients
to help them optimize their potential for quality sleep.The four-week cognitive this valuable service to patients while reducing your investment of time and behavioral therapy for insomnia (CBTI) program enables your facility to offer Offer your insomnia patients a user-friendly, non-medicinal therapy option frustrated and sleepless to sleeping easily. resources.You can quickly start empowering insomnia patients to go from
Your facility can become a valuable resource for insomnia patients who have exhausted, or dont want, traditional options, such as sleep aids.Through weekly meetings and the tools and techniques you provide, you will help patients learn the fundamentals of sleep, how to obtain quality sleep, and how to manage sleep on their own.
Easy and cost effective It takes time, effort, and resources to develop and implement a CBTI program on your own.The CBTI program does the initial work for you by integrating proven cognitive behavioral therapy techniques with the Actiwatch ambulatory actigraphy system.The Actiwatch supports the CBTI approach by providing reliable, objective data on sleep/wake patterns. Your facility just needs to provide a sleep coach who can facilitate the weekly sessions with patients throughout the program.The sleep coach helps patients recognize and understand their sleep habits and behaviors and the effect these have on their sleep.The sleep coach also educates patients on tools they can use to become their own sleep coach once the program ends. Distinguish your facility By offering the CBTI program and expanding your services beyond sleep-disordered breathing diagnosis and care, you can distinguish your facility from your competitors and create new patient opportunities. Materials from the program can be used to show your referral base and prospects how patient progress is being documented and how objective data is being collected to validate progress findings. While designed as a stand-alone program, the CBTI program is easy to adapt as an adjunct treatment modality.
on sleep/wake patterns throughout the four-week CBTI program.
The noninvasive and easy-to-use Actiwatch 2 device collects data
The CBTI program offers everything you need to help your insomnia patients achieve and maintain optimum sleep, even after the program ends.
Help your patients help themselves
Actiwatch actigraphy system objective and reliable The noninvasive and ambulatory Actiwatch actigraphy system provides the patient and sleep coach with a unique opportunity throughout the program to assess and contrast the patients objective sleep/wake data with the patients subjective experience.The objective measures recorded by the Actiwatch software help the therapist set and track the patients compliance with therapeutic options and helps reduce the time spent calculating sleep statistics for establishing or modifying therapy. Actiwatch integration assistance is included for sleep centers that have not used the technology before. Specific instructions for system and device setup are included to ensure the outputs from the system match those needed for sleep hygiene and compliance reviews and the weekly sleep restriction calculations.
Comprehensive tools and materials The comprehensive CBTI program includes all the materials necessary to deliver an insomnia program to your patients and enable you to share results with referring physicians: Patient workbook. Prior to the beginning of the first session, the patient receives a reference binder with educational information about the basics of sleep and CBTI. Once the sessions begin, the sleep coach provides the patient with a new chapter each week that contains educational information and/or exercises, such as stimulus control and sleep restriction.This information builds upon the previous weeks lessons and enables the patient to better understand and apply the principles of CBTI. If the lessons are applied correctly they should lead to improvement in the patients sleep quality and quantity. Therapist (sleep coach) workbook.This workbook includes chapters that provide instructions for the therapist on how to implement an adaptable, structured program that includes sleep hygiene, sleep restriction, stimulus control, and relaxation techniques in an individual or group setting.

Sleep restriction worksheet
Session 2 Average Sleep Efficiency % (From actigraphy report summary statistics table) If sleep efficiency is greater than 85% If sleep efficiency is less than 85% Bed Time Session 1 Average Total Sleep Time (TST) (From actigraphy report summary statistics table) Get Up Time (Agreed upon with sleep coach) Bed Time (Get up time TST) = = = = Then Then = = = = = = = Then Then = = = = = = = Then Then = Move bed time 20 minutes earlier Do not change bed time Move bed time 20 minutes earlier Do not change bed time Completed by the Patient Completed by the Sleep Coach Move bed time 20 minutes earlier Do not change bed time Completed by the Patient
Completed by the Sleep Coach

Sleep diary

Name ____________________________ Please answer all of the following questions shortly after getting out of bed each morning: Example Mon. Tues. Wed. Thurs. Fri. Sat. Sun. Average* Beginning at Session # _________ 1. How many minutes did you nap yesterday? 2. What time did you try to fall asleep last night (last attempt)? 3. How long do you think it took you to fall asleep? 4. How many times do you recall waking up last night? 5. How much time do you think you spent awake in total during these awakenings? 6. About what time was it when you finished sleeping for the night? 7. What time did you finally get out of bed? 8. How rested did you feel this morning? Not at all 1 to 5 Very 20 minutes 11:30 pm 45 minutes minutes
Session 4 Average Time in Bed (TIB) (Sleep diary: average of line 7 average of line 2) Average Sleep Onset Latency (Sleep diary: average of line 3) Average Wake After Sleep Onset (WASO) (Sleep diary: average of line 5) Average Snooze Time (Sleep diary: average of line 7 line 6) Average Total Sleep Time (TST) (TIB Sleep Onset Latency WASO Snooze Time) Average Sleep Efficiency % (TST/TIB X 100) If sleep efficiency is greater than 85% If sleep efficiency is less than 85% Bed Time
Session 3 Average Time in Bed (TIB) (Sleep diary: average of line 7 average of line 2) Average Sleep Onset Latency (Sleep diary: average of line 3) Average Wake After Sleep Onset (WASO) (Sleep diary: average of line 5) Average Snooze Time (Sleep diary: average of line 7 line 6) Average Total Sleep Time (TST) (TIB Sleep Onset Latency WASO Snooze Time) Average Sleep Efficiency % (TST/TIB X 100) If sleep efficiency is greater than 85% If sleep efficiency is less than 85% Bed Time

5:00 am 5:30 am 2

9. What sleep aids you take last night (including alcohol)? 10. What was the total dosage/ quantity of these sleep aids?
a) Ambien b) beer c) a) 10 mg b) 1 c)

a) b) c) a) b) c)

The above actogram depicts the sleep/wake patterns of an insomniac as collected by the Actiwatch device over 14 days.
. *Average = total of seven days by seven
2009 Koninklijke Philips Electronics N.V. All rights are reserved.
The sleep restriction worksheet and sleep dairy are two of the main tools used by the sleep coach and patient throughout the CBTI program.
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2009 Koninklijke Philips Electronics N.V. All rights are reserved. Philips Healthcare reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. CAUTION: US federal law restricts these devices to sale by or on the order of a physician. PTech SB 08/26/09 MCI 4102723 PN 1066480