SleepEasy ® User Manual
Would you like a free travel bag for your SleepEasy? If so, go to http://sleepeasy.respironics.com/register to register your product and receive your SleepEasy travel bag. A nominal charge for shipping and handling will be applied. This SleepEasy device is covered by one or more of the following patents: U.S. Patent No. 6,622,724. Other U.S. and Foreign Patents Pending. © 2007 Respironics, Inc. and its affiliates. All rights reserved.
Table of Contents Chapter 1: Introduction....................................................................................................................... 1 1.1 System Contents............................................................................................................. 1 1.2 Intended Use.................................................................................................................... 2 1.3 Warnings, Cautions, and Contraindications......................................
Chapter 4: Device Operation...........................................................................................................17 4.1 Starting the Device......................................................................................................17 4.2 Using the Ramp Feature.............................................................................................18 4.2.1 Ramp Feature.....................................................................................................18 4.
Chapter 1: Introduction This chapter provides information on: • SleepEasy system contents • Intended Use • Warnings, cautions, and contraindications • System overview • Glossary and symbol key • How to contact Respironics 1.
1.2 Intended Use The Respironics SleepEasy device delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing >66 lbs. It is intended for use in the home or hospital environment. Your home care provider will make the correct pressure settings according to your health care professional’s prescription. Several accessories are available to make your OSA treatment with the SleepEasy system as convenient and comfortable as possible.
• • • • • • • • • • • • • • • • • User Manual 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.
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.
1.4 System Overview The SleepEasy device, shown in Figure 1–2, 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 1–2 SleepEasy Device Figure 1–3 illustrates many of the device features, described in the following table.
Device Feature Display Screen Description Shows therapy settings, patient data, and error messages. Heated Humidifier Button Ramp Button Start/Stop Button 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.
1.4.1 Breathing Circuit Overview The patient breathing circuit, shown in Figure 1–4, consists of the following: • Circuit tubing to deliver air from the device to your interface (e.g.
1.6 Symbol Key The following symbols appear on the device: Symbol Definition Consult accompanying instructions for use. Type BF Applied Part Class II (Double Insulated) IPX1 Drip Proof Equipment Electrostatic Discharge Canadian/US Safety Certification Hot Surface Caution Serial Interface Maximum Fill Line 1.7 How to Contact Respironics To have your device serviced, contact your home care provider.
Chapter 2: Device Controls and Displays This chapter describes the device’s control buttons and displays, patient circuit connections, and rear panel connections. 2.1 Controls Buttons Figure 2–1 shows the five primary control buttons on the SleepEasy device. Display Screen User Buttons Heated Humidifier Button Ramp Button Start/Stop Button Figure 2–1 Primary Control Buttons These buttons are described below.
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.
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.
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).
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: The bacteria filter is recommended to protect the patient, care provider and equipment from the transference of a virus or bacteria through the breathing circuit. 2. a. Connect the tubing to the mask: If you are using a mask with a built-in exhalation port, connect the mask’s connector to the flexible tubing, as shown in Figure 3–3.
3.4 Supplying 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.
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. Flapper Valve Protective Cover Soft Flap Figure 3–6 Flapper Valve and Protective Cover 4.
CAUTION: Use only distilled water in the chamber. CAUTION: Do not overfill the water chamber. Damage to the therapy device may occur. CAUTION: Do not allow the water chamber to sit for any length of time after it has been filled with water. Immediately install the chamber in the device (step 4). Allowing water to sit in the chamber (when the chamber is not installed in the device) may cause the chamber to separate from the bottom plate and may cause water leakage. 4.
Chapter 4: Device Operation This chapter explains how to start the device and change the settings. NOTE: The numbers shown in the screens throughout this manual are examples only. Actual numbers will vary. 4.1 Starting the Device 1. Plug the device in to an AC power source. The HEAT, RAMP and START/STOP buttons light up and the Software Version screen momentarily appears, shown in Figure 4–1. Figure 4–1 Software Version Screen 2. The next screen to appear is the Standby screen, shown in Figure 4–2.
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: 6. 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. 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.
4.3 Using the Heated Humidifier Features 4.3.1 Heated 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. 4.3.2 Setting 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.
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.
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: 3. Session Counter Screen This screen displays the number of device therapy sessions that exceeded 4 hours. Note: 4. This screen is only for reference.
Chapter 5: Alerts and Troubleshooting This chapter describes the device alerts and also provides troubleshooting information for issues you may run into when using the device. 5.1 Device Alerts The device provides two alert levels, high and medium priority. • High Priority – These alerts require immediate operator response.
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: The device’s display is erratic.
Problem The device has fallen off your table or night stand. Why It Happened The device may not have been properly seated on the night stand, or the placement of the tubing may have caused the device to fall. What to Do Always make sure your device is placed on a hard, flat surface so the rubber feet on the bottom of the device can adhere to the surface (make sure there is no fabric under the device). The device must be level for proper operation.
Chapter 6: Accessories Contact your home care provider for additional information on the accessories available for your SleepEasy system. When using optional accessories, always follow the instructions enclosed with the accessories. 6.1 Adding Supplemental Oxygen Oxygen may be added at the mask connection, as shown in Figure 6-1. Please note the warnings listed below when using oxygen with the device.
6.2 Traveling with the System For your convenience at security stations, there is a note on the bottom of the device stating that it is medical equipment. It may be helpful to bring this manual along with you to help security personnel understand the SleepEasy device. A travel bag is available as an accessory for the SleepEasy device. Contact Respironics to find out more information on the travel bag. NOTE: Before traveling, you must completely empty and dry the water chamber.
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.
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 7–1 Cleaning the Water Chamber NOTE: The Flapper (Soft) Valve has a one year lifespan.
6. 7. 8. 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. Inspect all parts for damage prior to reassembly. 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.
Chapter 8: Specifications Environmental Operating Storage Temperature 41° F to 95° F -4° F to 140° F Relative Humidity 15 to 95% (non-condensing) 15 to 95% (non-condensing) Atmospheric Pressure 77 to 101 kPa (0 - 7500 ft) N/A Physical Dimensions: Weight: Water Capacity: 10” L x 7.5” W x 5.5” H (25 x 19 x 14 cm) Approximately 3.
Humidity 10 to 40 mg H2O/L Humidity Range: Pressure Pressure Increments: 4.0 to 20.0 cm H2O (in 0.5 cm H2O increments) Pressure Stability: 4.0 to 20 cm H2O (±1.0 cm H2O) Measured in accordance with EN ISO 17510-1 @ 1/3, 2/3, and Pmax with BPM set to 10, 15, and 20 BPM @ 20° C (±5° C), 50% RH (±5%). Maximum Flow: 35 LPM Measured in accordance with EN ISO 17510-1 @ Pmin, 1/4, 2/4, 3/4 and Pmax with BPM set to 4, 8, 12, 16, and 20 BPM @ 23° C (±2° C), 50% RH (±5%).
Appendix A: EMC Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions – 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. Emissions Test Compliance Electromagnetic Environment - Guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
Guidance and Manufacturer’s 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.
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device: The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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.
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