Patient Manual
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GoodKnight® 425 GoodKnight® 425ST
Patient Manual
Ref. : M-145DFU00-40 Revision C
Revision C
List of Patient Manual Revisions GoodKnight® 425 / GoodKnight® 425ST
The pages below are included in the American version of the patient manual Ref. M-145DFU00-40, Revision C.
Current pages
Revision
Cover
B
List of revisions
B
Table of contents
A
Introduction
B
1 – 2 ; 4 − 5 ; 12 − 15 ; 17 − 18 ; 21 − 22 ; 24
A
8 ; 26
B
3 ; 7 ; 9 − 11 ; 16 ; 19 − 20 ; 23 ; 25
C
Reference or Revision
Description
Date
M-145DFU00-40 Revision A.
Creation of the manual
July 2004
Revision B.
Implementation of CE mark symbol (symbols section)
June 2005
Revision C.
Modification of the manual (“Installing a Humidifier”, “External Battery Operation”, “List of authorized accessories” sections), for GoodKnight 425 / GoodKnight 425ST, Nellcor Puritan Bennett trademark.
July 2005
© 2004 − 2005 Nellcor Puritan Bennett Inc. All rights reserved.
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision C
The Puritan Bennett GoodKnight 425 / GoodKnight 425ST device (GK425/GK425ST) is intended for the treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS). The main characteristic of this pathology is the occurrence of multiple respiratory events during the night, caused by closure of the upper airways, that disturbs sleep. The GK425/GK425ST delivers two pressure levels (one inspiratory, one expiratory) that prevent the upper airways from becoming obstructed and thus eliminate respiratory events. On the GoodKnight 425ST, a Back-Up rate can be adjusted.
It is essential for you to understand the limitations on the use of this device. Therefore, please read this manual carefully before using the GoodKnight 425 / GoodKnight 425ST device. This manual provides information on the safe and effective operation of this device. For any questions relative to the equipment and its use, contact your medical team or your home service provider. Your doctor has prescribed the GoodKnight 425 / GoodKnight 425ST as a method of treatment. This method includes specific device parameter values that are set by the hospital or home service provider. Do not adjust these parameter settings yourself. the information contained in this manual is valid for models GoodKnight 425 and GoodKnight 425ST, unless stated otherwise. CAUTION Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
® GoodKnight is a registered trademark of Nellcor Puritan Bennett Inc.
GoodKnight 425 / GoodKnight 425ST Patient Manual
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision A
TABLE OF CONTENTS BEFORE STARTING...1 SAFETY INSTRUCTIONS ...1 INDICATIONS FOR USE ...2 PRECAUTIONS FOR USE ...2 MODEM TRANSMISSIONS ...2 CHECKING THE COMPONENTS ...3 DEVICE DESCRIPTION...4 INSTALLATION...7 STANDARD INSTALLATION...7 FITTING AN OXYGEN ADAPTER ...8 INSTALLING A HUMIDIFIER ...9 EXTERNAL BATTERY OPERATION ...11 USING THE GOODKNIGHT 425 ...12 STARTING TREATMENT ...12 STOPPING TREATMENT ...13 USING THE RAMP FEATURE ...14 USING THE DEVICE TO ACCESS INFORMATION...16 SETTING THE TIME ...18 LIST OF AUTHORIZED ACCESSORIES ...19 INTERFACES ...19 TUBING ...19 OTHER ACCESSORIES ...19 MAINTENANCE AND CLEANING INSTRUCTIONS ...21 GOODKNIGHT 425 ...21 AIR INLET FILTERS ...21 BREATHING CIRCUIT ...21 NASAL INTERFACE ...22 HUMIDIFIER ...22 OXYGEN ADAPTER ...22 TROUBLESHOOTING ...23 TECHNICAL SPECIFICATIONS ...25 DEVICE PERFORMANCE ...25 PHYSICAL CHARACTERISTICS ...25 ENVIRONMENTAL CONDITIONS ...25 POWER SUPPLY MODULE ELECTRICAL CHARACTERISTICS ...25 DEVICE ELECTRICAL CHARACTERISTICS ...26 SYMBOLS ...26 DISPOSAL OF THE GOODKNIGHT 425...26
GoodKnight 425 / GoodKnight 425ST Patient Manual
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision A
BEFORE STARTING Safety Instructions To ensure that you use your device safely and efficiently, please read all the information contained in this user manual. Contact your doctor or your home service provider for further information. Please pay special attention to the passages preceded by the following terms: WARNING
Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user.
CAUTION
Cautions alert the user to exercise care necessary for the safe and effective use of the GoodKnight 425.
NOTE
Notes indicate information of particular interest for more efficient and convenient operation.
WARNINGS
1. Before using your GoodKnight 425 device, refer to the chapter section titled “Checking the Components” on page 3. 2. When using an additional oxygen supply, carefully observe the safety instructions for oxygen in the section titled “Starting Treatment” on page 12. 3. Use only the accessories that have been given to you by your home care provider. Check that you have all the instructions for using these accessories and read them carefully. 4. Use only the specific power supply module provided with the device. 5. Do not use the device in the presence of flammable anaesthetics. 6. Follow the device’s installation instructions as specified in this manual in the chapter entitled “Installation” on page 7. In particular, keep the machine away from water. 7. Do not accidentally or intentionally obstruct the air outlet or any other opening in the device or the respiratory circuit. 8. Do not introduce liquids or objects into the air outlet. 9. Contact the medical team if, when using the GoodKnight 425, the following symptoms appear: dryness in your airways or nose, skin sensitivity, running nose, earache, sinus trouble, daytime drowsiness, mood changes, disorientation, irritability or memory loss. 10. If the GoodKnight 425 malfunctions, contact your home care provider. Maintenance of this equipment should only be performed by trained and authorised personnel. Do not attempt to open the device. 11. The air flow produced by the GoodKnight 425 can be as much as 7 °F higher than the room temperature. Exercise caution if the room temperature is warmer than 90 °F.
GoodKnight 425 / GoodKnight 425ST Patient Manual
1
Revision A
Indications for Use The Puritan Bennett GoodKnight 425 is indicated for use in treating Obstructive Sleep Apnea (OSA) in spontaneous breathing patients weighing over 30 kg (66 lb) within a homecare or hospital environment.
Precautions for Use The GoodKnight 425 device must be used with caution for patients with the following conditions. If you are affected by one of the conditions listed below, contact your doctor at the beginning of your treatment. •
Pneumothorax or pneumomediastinum
•
Severe bullous emphysema or previously complicated by pneumothorax
•
Massive epistaxis or previous massive epistaxis
•
Pneumoencephalus, traumatism or recent surgery with the after-effect of a cranio-nasopharyngeal fistula
•
Acute sinusitis, otitis media or perforation of the tympanic membrane.
Modem Transmissions When it is time to review the information stored in your GoodKnight 425, your home care provider may set up a modem connection. The modem translates computer signals into telephone signals that are then sent over telephone lines and converted to a format suitable for computer input. Finally, the data is fed to a computer that features special software to assist in the analysis and review of the data. NOTE
Your home care provider will set up the modem connection and instruct you in its use.
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision C
Checking the Components In order to use the GoodKnight 425, you must have the following items: •
A breathing circuit
•
A non-invasive patient interface (mask), and all related accessories as specified in the instructions for using it. In addition to these accessories, your doctor may have prescribed the use of a humidifier. If so, check that you have all the accessories required for the humidifier specified in the operating instructions. If supplemental oxygen is required, you will also need an adapter (unless the oxygen supply connects directly onto the interface). See the section titled “Fitting an Oxygen Adapter” on page 8 of this manual. Carefully check the device and each accessory. Check especially the tubings for damage. The interface should not have any cracks or distortion in the mask or pillows (the part of the mask coming in contact with the face). Carefully check the device and the specific power supply module and verify that there is no obvious fault. Plug the device into the power outlet using the power supply module, referring to steps 4 and 5 of the section entitled “Standard Installation” on page 7. The device type is displayed temporarily, then the following standby screen appears that displays the time in the 24-hour format (the value displayed is given as an example only): Flashing Colon
10:34
Standby Indicator Figure 1 – Display in Standby Mode
If the device is disconnected and then power restored, the screen displays the pressure. The device’s pressure settings remain the same as those used when the power supply cord was disconnected. . See item 4 in Figure 2 – Top View on page 5. Start the device by pressing the ON/OFF button You should hear the turbine start and increase speed to deliver the set pressure. Stop the device by pressing the ON/OFF button power outlet.
and unplug the power supply cord from the
WARNING
If you encounter any problems with the device, contact your home service provider and do not start treatment.
GoodKnight 425 / GoodKnight 425ST Patient Manual
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Revision A
DEVICE DESCRIPTION The GoodKnight 425 device is powered from an external power supply and equipped with specific accessories. The device consists of the following primary components, as described below. See figures 2, 3 and 4 on page 5. 1.
Display Information such as pressures, device settings, or the time of day is shown on the display. For further information, refer to the section titled “Using the Device to Access Information”, page 16.
2.
Information Access button The information access button allows you to scroll through the device settings. For further details, refer to the section titled “Using the Device to Access Information”, page 16.
3.
Ramp button Used for starting or stopping the pressure increase ramp (for further information, refer to the section titled “Using the Ramp Feature” on page 14). It is also used to decrease the value of the parameters when changing device settings.
4.
ON/OFF button Used for switching the device on or off. It is also used to increase the value of the parameters during the device settings.
5.
Pressure port This is the connector onto which the breathing circuit pressure tube is connected. For further information, refer to the chapter titled “Installation” on page 7.
6.
Outlet connector This is the air outlet onto which the breathing circuit is connected. For further information, refer to the chapter titled “Installation” on page 7.
7.
Serial link connector This connector is intended for use solely by your doctor or your home service provider. Do not connect anything to it.
8.
Supply connector Used for powering the device from the specific power supply module or from an external battery. For further information, refer to the section titled “External Battery Operation” on page 11.
9.
Air inlet filters These filters prevent dust from entering the device and contaminating the air flow. Please refer to the chapter titled “Maintenance and cleaning instructions” on page 21 for further information on maintaining these filters.
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision A
The items in the Figures below are described on page 4.
1
2 Figure 2 – Top View
3
4
6
5 Figure 3 – General View
7 8
9
GoodKnight 425 / GoodKnight 425ST Patient Manual
Figure 4 – Rear View
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision C
INSTALLATION This chapter shows you how to connect the different accessories and cables to your device. Before starting the installation, please check your device and its accessories by referring to the section titled “Checking the Components” on page 3. CAUTION
Place the device on a stable surface. Avoid placing it too near a wall or any other obstacle which could obstruct the intake of air into the machine.
Standard Installation 1.
Connect the breathing circuit to the device. To do this, connect the pressure tube to the pressure port (Figure 3, item 5 on page 5). Connect the breathing circuit to the outlet connector of the device (Figure 3, item 6 on page 5). Breathing circuit
Pressure tube
Figure 5 – Breathing Circuit Connection
WARNING
Take care that the pressure tube is not kinked or blocked. 2. 3. 4.
Prepare the interface as described in its instructions for use. Connect the interface (mask) to the breathing circuit’s free end. Connect the power supply module cable to the supply connector located on the back of the device (Figure 4, item 8 on page 5). CAUTION
5.
Use only the specific power supply module provided with the device. Connect the power supply module plug to the mains. The device type is displayed temporarily, then the following standby screen appears that shows the time: The colon is flashing
6.
10:29
The device is ready to operate. Proceed to the chapter titled “Using the GoodKnight 425” on page 12.
GoodKnight 425 / GoodKnight 425ST Patient Manual
7
Revision B
Fitting an Oxygen Adapter Replace step 1 of the standard installation procedure on page 7 with the following instructions: •
Connect the oxygen adapter onto the device’s outlet connector and connect the other end of the adapter onto the end of the breathing circuit. (see Figure 6). Connect the pressure tube to the pressure port (Figure 3, item 5 on page 5).
Figure 6 – Oxygen Adapter Connection
Perform steps 2 through 6 of the standard installation procedure. WARNINGS
•
When using oxygen, strictly follow the instructions of your physician or home care provider.
•
Never smoke in the presence of oxygen.
•
Never inject oxygen through the air inlet of the device.
•
Carefully follow all instructions contained in the chapter titled “Using the GoodKnight 425” on page 12.
•
If supplemental oxygen is used, the oxygen flow must be turned off when the GoodKnight 425 is not operating. If the oxygen flow is left on when the device is not operating, oxygen delivered to the interface circuit may accumulate within the GoodKnight 425. Oxygen accumulated in the device could create a fire hazard. CAUTION
If the supplemental oxygen flow rate is fixed, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, interface selection and the leak rate.
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GoodKnight 425 / GoodKnight 425ST Patient Manual
Revision C
Installing a Humidifier Please refer to the instructions for using your humidifier for installation instructions and safety precautions. WARNING
The humidifier must be filled before being connected to the device. CAUTION
To avoid water damage, always ensure that the humidifier is placed lower than the GoodKnight 425 device. Replace step 1 of the standard installation procedure on page 7 with the steps below: WARNING
The following instructions are general instructions for connecting the GoodKnight H2O humidifier. Always follow specific instructions supplied with your humidifier for correct and safe operation. 1. Remove the water chamber. 2. Carefully fill the water chamber with water through the outlet connector opening (refer to the “Installation” section of the GoodKnight H2O user’s manual). Do not fill past the maximum water level mark. 3. Place the GoodKnight H2O heated humidifier onto a flat, even surface. 4. Equip the GoodKnight 425 device with the connection adapter provided with the GoodKnight H2O heated humidifier. 5. Position the GoodKnight 425 device onto the GoodKnight H2O heated humidifier, as shown in Figure 7. • The front of the GoodKnight 425 device must be turned towards the connections of the GoodKnight H2O heated humidifier. • The base of the GoodKnight 425 device must be inserted into the recessed area of the humidifier. CAUTION
• •
Install the humidifier and bi-level device onto a flat, stable surface and keep them out of contact with flammable materials. Never place the GoodKnight H2O on top of the bi-level device. Doing so could allow water into the device, potentially causing damage.
GoodKnight 425 / GoodKnight 425ST Patient Manual
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Revision C
Patient circuit
Pressure tube
Figure 7 – Connection of the GoodKnight 425 to the GoodKnight H2O heated humidifier
6. Replace the water chamber, being careful to avoid spillage, and ensure that the inlet connector of the humidifier reaches the thrust on the connection adapter. 7. Connect the pressure tube from the breathing circuit to the GoodKnight 425 pressure port. 8. Connect the breathing circuit to the outlet connector of the humidifier located on the water chamber. Perform steps 2 to 6 of the standard installation described on page 7 to continue installing the equipment. CAUTION
Disconnect the GoodKnight 425 from the humidifier and empty the water chamber before moving the assembly. Failure to do so risks introducing water into the device, which could cause irreversible damage.
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GoodKnight 425 / GoodKnigh 425 ST - Patient manual
Revision C
External Battery Operation The GoodKnight 425 can be powered by a 12-V car battery using the special cable provided. CAUTION
•
Do not use any battery power cable other than the optional cable supplied with the GoodKnight 425. Doing so risks damaging the device and the battery.
•
Only use 12-Volt DC sources and ensure that the polarity connections (+ and -) are correct.
The device can be used for a minimum of eight hours with a fully charged car battery in normal operation conditions. To connect the battery cable, replace steps 4 and 5 of the standard installation by the following steps: 1. Connect the battery power cable onto the supply connector located at the back of the device (see Figure 4, page 5). 2. Connect the other end of the battery power cable directly to the battery.
Figure 8 − Connection of the GoodKnight 425 to the battery cable
NOTE
Because of its high power consumption, fully charge the GoodKnight 425's battery before using the device. The GoodKnight 425 can be powered through a vehicle cigarette lighter using the cable provided. To do so, replace steps 4 and 5 of the standard installation by the following steps: 1. Connect the battery power cable to the supply connector located at the back of the device (see Figure 4 on page 5). 2. Connect the other end of the battery power cable directly to the cigarette lighter plug.
GoodKnight 425 / GoodKnight 425ST Patient Manual
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Revision A
USING THE GOODKNIGHT 425 This chapter shows you how to use the GoodKnight 425 after installing it as described in the previous chapter. It also shows you how to use the pressure increase (ramp) function and how to access information on device settings. NOTE
You will not be able to alter the device’s settings; you can only view them. WARNING
In the sections “Starting Treatment” and “Stopping Treatment” below, carefully follow the order given. Failure to do so could increase the potential for fire in cases where oxygen is used. Refer to the general warning on using oxygen on page 1.
Starting Treatment Once the device has been installed, follow the instructions below to start treatment: 1. Start the device by pressing the ON/OFF button
.
The display shows the pressure measured as well as the operation and compliance indicators (see Figure 9).
9.0 cmH O 2
Compliance operation indicator 0 - 1 : compliance is on - 0 : compliance is off Device operation indicator
Indication of a: - Positive Inspiratory Pressure - Positive Expiratory Pressure
Indicator of patient respiratory cycle detection (on the GK425ST only) Figure 9 - Display When Device is Running
NOTES •
The units of measure displayed for pressure (hPa or cmH2O) can be modified by the Practitioner. • The compliance operation indicator is not displayed until the device has been operating for at least 15 minutes. 2. Put the patient interface (nasal mask) in place according to its instructions for use. If an interface with an exhalation vent is used, it includes a hole by which the exhaled gases will be flushed out, preventing them from being rebreathed. If an interface without an exhalation vent is used, your ™ doctor must provide you with a Pirouette silent leak or equivalent adapter, allowing gases to be flushed out as close as possible to the nose. NOTE
When using this device, always remember to breathe normally for best results. WARNING
The vent hole associated with the interface should never be blocked. This CPAP device is intended for use with interfaces (or connectors) that have vent holes to allow a continuous flow of air out of the interface. When the CPAP device is turned on and is operating properly, fresh air from the CPAP device flushes the exhaled air out through the interface vent hole. However, when the CPAP device is not functioning, adequate fresh air will not be provided through the interface, and exhaled air may be rebreathed. Rebreathing exhaled air for longer than several minutes could, in some circumstances, lead to suffocation.
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GoodKnight 425 / GoodKnigh 425 ST - Patient manual
Revision A
3. If you are using a heated humidifier, turn it on according to its instructions for use. 4. Start the oxygen flow (if oxygen is used). WARNINGS •
•
When the device is in operation mode, check that it delivers an air flow. If no air flow exists, stop the device immediately and contact the service provider. At lower CPAP pressures, the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.
Stopping Treatment When the device is in operation, follow the instructions below to stop the treatment: 1. Stop the oxygen flow (if oxygen is used). 2. Remove the interface (nasal mask). 3. If you are using a heated humidifier, turn it off as described in its instructions for use. Always disconnect the humidifier from the unit. CAUTION
Do not leave the humidifier connected to the GoodKnight 425 or to the tubing when the humidifier is not in use, to prevent humidity from entering the device or the sensing line and degrading its performance. 4. Turn the device off by pressing the ON/OFF button. The device returns to standby mode and displays the following standby screen that shows the time:
6:24
CAUTION
Check that no humidity appears in the tubing, particularly in the sensing line. If so, let the tubing dry before you use it again.
GoodKnight 425 / GoodKnight 425ST Patient Manual
13
Revision A
Using the Ramp Feature The ramp function enables a gradual rise in pressure after turning the device on; that is, the pressure levels are low at the start of the night to help you fall asleep. You can also use this function if you have to get up during the night and have difficulty going back to sleep. The pressure “rise time” up to the final pressures is prescribed by your medical team and the setting carried out by your service provider is between 0 (no progressive rise) and 30 minutes in 5-minute increments. The ramp may have been preset to 0 according to the prescription provided by your medical team. In this case, the ramp function is disabled and pressing the Ramp button on the front panel of the machine has no effect (Figure 2, item 3 on page 5). The initial ramp pressure can be set to a value between 3 cmH2O and the Positive Expiratory Pressure level prescribed by your physician. This function allows you to set the starting pressure level that enables you to fall asleep. To access the parameter setting menu, just press for one second the Information Access button (Figure 10). NOTE
This function can be used when the device is in either the standby mode or the operation mode.
Increases the starting ramp pressure
Decreases the starting ramp pressure Information Access button Figure 10 – Control buttons
Repeatedly press the information button until the following screen is displayed:
3.0 cmH O 2
P Ramp indicator
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GoodKnight 425 / GoodKnigh 425 ST - Patient manual