Patient Manual
32 Pages
Preview
Page 1
GoodKnight® 420 Evolution
Patient Manual
Ref. : M-139DFU05-70 Revision C
Revision C
List of patient manual revisions GoodKnight® 420 Evolution
The pages below are included in the American version of the patient manual Ref. M-139DFU05-70 revision C.
Current pages
Revision
Cover
C
List of revisions
C
Table of contents
A
Introduction
C
1 – 8 ; 10 – 22
A
9 ; 23
B
24
C
Reference or revision
Description
Date
M-139DFU05-70 revision A.
Creation of the manual
December 2002
Revision B.
Modification of the manual (sections “Installing a humidifier” and “Electrical characteristics of the power supply module”)
October 2003
Revision C.
Modification of the manual (Implementation of the CE-mark in the section “Symbols” and Nellcor Puritan Bennett trademark)
July 2005
© 2002 − 2005 Nellcor Puritan Bennett Inc. All rights reserved.
ii
GoodKnight 420 Evolution - Patient manual
Revision C
The Puritan Bennett GoodKnight 420 Evolution device (GK420 Evolution) 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 caused by contraction of the upper airways, that disturb sleep. The GoodKnight 420 Evolution delivers a Continuous Positive Airway Pressure (CPAP) that prevents the upper airways from becoming obstructed thus eliminating apneas. It is essential for you to understand the use of this device. Therefore, please read this manual carefully before using the GoodKnight 420 Evolution. The information contained here is intended to help you use this device under optimum conditions of safety and operation. For any questions relating to the equipment and its use, contact your medical team or your home care provider. Your doctor has decided on the treatment of your illness. He/she has prescribed the different parameters that the hospital or your home care provider will set. The home care provider will adjust these parameters, as needed.
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 420 Evolution - Patient manual
iii
This page is left blank intentionally
iv
GoodKnight 420 Evolution - 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 DESCRIPTION OF THE DEVICE...4 INSTALLATION ...7 STANDARD INSTALLATION ...7 FITTING AN OXYGEN ADAPTOR ...8 INSTALLING A HUMIDIFIER ...9 INSTALLING AN EXTERNAL BATTERY ...10 USE...11 STARTING TREATMENT ...11 STOPPING TREATMENT ...12 USING THE RAMP ...12 USING THE GOODKNIGHT 420 EVOLUTION TO ACCESS INFORMATION ...14 SETTING THE TIME ...16 LIST OF AUTHORIZED ACCESSORIES...17 INTERFACES ...17 TUBING ...17 OTHER ACCESSORIES ...17 MAINTENANCE AND CLEANING INSTRUCTIONS...19 GOODKNIGHT 420 EVOLUTION...19 AIR INLET FILTERS ...19 TUBING ...19 NASAL INTERFACE ...20 HUMIDIFIER ...20 OXYGEN ADAPTOR ...20 TROUBLE-SHOOTING ...21 TECHNICAL CHARACTERISTICS...23 GOODKNIGHT 420 EVOLUTION PERFORMANCE ...23 PHYSICAL CHARACTERISTICS ...23 TRANSPORT AND STORAGE CONDITIONS ...23 CONDITIONS OF USE ...23 DISPOSAL OF THE GOODKNIGHT 420 EVOLUTION AT THE END OF ITS LIFE ...23 ELECTRICAL CHARACTERISTICS OF THE POWER SUPPLY MODULE ...24 ELECTRICAL CHARACTERISTICS OF THE DEVICE ...24 SYMBOLS ...24
GoodKnight 420 Evolution - Patient manual
v
Revision A
This page is left blank intentionally
GoodKnight 420 Evolution - Patient manual
vi
Revision A
BEFORE STARTING Safety instructions In order to ensure the appropriate use of your GoodKnight 420 Evolution, please read all the information contained in this operator manual. Pay special attention to the passages preceded by the following terms: WARNING
Indicates a potential risk of death or accident to you or caregiver.
CAUTION
Information to avoid damaging equipment or losing data.
NOTE
Tips for ease of use of the GoodKnight 420 Evolution device.
WARNINGS
1. Before you use the GoodKnight 420 Evolution device, examine it as specified in the chapter “Checking the components” (See page 3). 2. If you need an additional supply of oxygen, carefully observe the safety instructions for using oxygen given in the chapter “Starting treatment”. (See page 11). 3. Only use the accessories that have been given to you by your home care provider. Check that you have the instructions for using each of these accessories and read through them. 4. Use only the specific power supply module provided with the device. 5. Do not use the device in the presence of inflammable fumes. 6. Follow the device’s installation instructions as specified in this manual in the chapter “Installation”. (See page 7). In particular, keep the machine away from any sources of 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. If you experience any of the following symptoms when you use the GoodKnight 420 Evolution, discontinue use and contact your home care provider: dryness in your nose and airways; skin sensitivity; runny nose; earache; sinus trouble; daytime drowsiness; mood changes; disorientation; irritability; or, memory loss. 10. Contact your home care provider in the event of any malfunction of the GoodKnight 420 Evolution, whatever it may be. 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 420 Evolution can be as much as 7°F higher than the room temperature. Exercise caution if the room temperature is warmer than 90°F.
GoodKnight 420 Evolution - Patient manual
1
Revision A
Indications for use The GoodKnight 420 Evolution device is indicated for use in the treatment of obstructive respiratory sleep disorders, particularly Obstructive Sleep Apnea (OSA). Patients who have been diagnosed with this condition may use the GoodKnight 420 Evolution if they weigh over 66 lbs (30 kg) and are able to breathe spontaneously. Their treatment may be administered either in a homecare or hospital environment.
Precautions for use Clinical research indicates that CPAP therapy may be contraindicated for patients with any of the following pre-existing conditions: • •
Extremely low blood pressure Pneumothorax or pneumomediastinum (collapsed lung/air trapped in the lung tissue or in the tissue between the lungs) Severe bullous emphysema or previously complicated by pneumothorax Massive epistaxis or previous massive epistaxis (nose bleed) Decompensated cardiac insufficiency or hypotension, especially in case of depletion in blood volume or cardiac rhythm disorder (inadequate blood pressure) Pneumoencephalus (air trapped around the spinal cord), traumatism, or recent surgery with the after-effect of a cranio-nasopharyngeal fistula (abnormal opening between head, nose, and throat) Acute sinusitis (inflammation of the sinus cavity), otitis media (earache), or perforation of the tympanic membrane (eardrum) Severe claustrophobia (fear of being shut up in a confined space).
• • • • • •
Modem transmissions When it is time to review the information stored on your GoodKnight 420 Evolution, your home care provider may set up a modem connection, which is a telephone communication device. The modem translates computer signals into telephone signals that are sent and converted to computer data that will be reviewed with SilverLining 3 special software. NOTE
Your home care provider will set up the modem connection, and instruct you on how to use it.
2
GoodKnight 420 Evolution - Patient manual
Revision A
Checking the components To use the GoodKnight 420 Evolution with its specific electrical power supply, you must be provided with the following items at least: • A spiral tubing enclosing a second small transparent tubing • A nasal-mask (often called an “interface”) and all related accessories as specified in the instructions for using this interface. In addition to these accessories, your doctor may have prescribed the use of a humidifier. In this case, ensure that you have all the accessories required for this humidifier, as specified in its operating instructions. In the event that an additional oxygen supply is needed, you must also have an adaptor (but only in cases where the oxygen supply is not fitted directly onto the interface). Refer to the chapter “Fitting an oxygen adaptor”. (See page 8)
Carefully examine the GoodKnight 420 Evolution and each accessory. Check the tubings for damage. The interface should not have any cracks or distortion in the cup and bellows (part of the mask coming in contact with the face). Verify that the GoodKnight 420 Evolution and the specific power supply module have no external damage, verify that there is no obvious fault. Connect the device to the mains using the power supply module, referring to steps 4 and 5 of the chapter “Standard installation”. (See page 7). The type of the device is displayed for a few seconds then the following standby screen showing the hour (the value displayed is given as a guide only) ; the device’s display should show the time in the 24 hour format:
11:23
Standby Indicator (the two points are blinking).
Figure 1 – View of the display when the device is in standby mode
If the device was disconnected while it was running, the screen displays the pressure. The device shows the same mode as at the time of the power supply cord disconnection and is set on the pressure used at the disconnection time. Start the device by pressing the ON/OFF button (see Figure 2, page 5). The turbine should start up and the noise should be regular. To stop the device, press the ON/OFF button and unplug the power supply lead from the mains. WARNING
In the event of problems or if you discover any anomaly, do not start the treatment and contact your home care provider.
GoodKnight 420 Evolution - Patient manual
3
Revision A
DESCRIPTION OF THE DEVICE The GoodKnight 420 Evolution device is powered from an external power supply and equipped with specific accessories. The device is described below. See figures 2, 3 and 4 on page 5. 1.
Display Shows various kinds of information such as the pressure delivered, the settings of the device or the time. For additional information, refer to the chapter “Using the GoodKnight 420 Evolution to access information”. (See page 14).
2.
Information access button Allows you to access various kinds of information regarding the device. For further details, refer to the chapter “Using the GoodKnight 420 Evolution to access information”. (See page 14).
3.
Ramp button Used for starting or stopping the pressure increase ramp (for additional information, refer to the chapter “Using the ramp” on page 12). It is also used to decrease the value of the parameters during the 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 small tubing is connected. For additional information, refer to the chapter “Installation”. (See page 7).
6.
Outlet connector This is the air outlet onto which the large tubing is connected. For further information, refer to the chapter “Installation”. (See page 7).
7.
Serial communication port This connector is intended to be used solely by your physician or your home care provider. Do not connect it to anything.
8.
Supply connector Used for powering the device from the specific power supply module or from an external battery. For additional information, refer to the chapter “Installing an external battery”. (See page 10).
9.
Air inlet filters These filters prevent dust from entering the device and the air flow. Please refer to the chapter on “Maintenance and cleaning instructions” for additional information on the maintenance instructions for these filters. (See page 17).
4
GoodKnight 420 Evolution - Patient manual
Revision A
The items in the Figures below are described on page 4.
1
2 3
Figure 2 – Top view
4
6
5 Figure 3 – General view
7 8
9 Figure 4 – Rear view
GoodKnight 420 Evolution - Patient manual
5
This page is left blank intentionally
6
GoodKnight 420 Evolution - Patient manual
Revision A
INSTALLATION This chapter shows you how to connect the various accessories and cables to your GoodKnight 420 Evolution. Before starting the installation, examine your device and its accessories. Refer to the chapter “Checking the components” (See page 3). CAUTION
When you are ready to use the GoodKnight 420 Evolution, place it on a stable surface. Avoid placing it too near a wall or any other obstacle that could hamper the intake of air into the device.
Standard installation 1. Connect the spiral tubing to the device. To do this, connect the small tubing that emerges through one of the large ends of the spiral tubing, to the pressure port (See Figure 3, page 5). Connect the large end of the spiral tubing onto the outlet connector of the machine (See Figure 3 page 5 and Figure 5 page 7).
Figure 5 – Connection of the spiral tubing to the device
WARNING
Take care that the small tubing is not twisted or bent. 2. Prepare the interface as described in its instructions for use. 3. Connect the interface to the spiral tubing’s free end. 4. Connect the cable of the power supply module to the supply connector located on the back of the device (see Figure 4, page 5). CAUTION
Use only the specific power supply module provided with the device. 5. Connect the plug of the power supply module to the electrical outlet. The type of the device is displayed for a few seconds then the following standby screen showing the hours and the minutes in 24 hour format:
9:37
The two points are blinking.
6. The device is ready to operate. Please refer now to the chapter “Use” (see page 11).
GoodKnight 420 Evolution - Patient manual
7
Revision A
Fitting an oxygen adaptor Substitute the following step for step 1 of the standard installation procedure: • Connect the oxygen adaptor onto the device’s outlet connector and connect the other end of the adaptor onto the large end of the patient tubing. (see Figure 6). Connect the small tube that emerges through one of the patient tubing large ends to the pressure port (see Figure 3, page 5).
Figure 6 – Connecting the oxygen adaptor to the device
To continue installing the equipment, proceed to steps 2 to 6 of the standard installation. WARNINGS •
Always follow the instructions of your physician and home care provider in the event of using oxygen. Do not smoke in the presence of oxygen. Do not inject oxygen through the air inlet of the GoodKnight 420 Evolution. Carefully follow the start-of-treatment and end-of-treatment steps as described in the chapter on “Use” (see page 11). If supplemental oxygen is used, the oxygen flow must be turned off when the GoodKnight 420 Evolution 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 420 Evolution. 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.
8
GoodKnight 420 Evolution - Patient manual
Revision B
Installing a humidifier Refer to the humidifier instructions for additional information on assembly and safety precautions. WARNING
The humidifier must be filled with distilled water before being connected to the GoodKnight 420 Evolution. CAUTION
In order to avoid water damage, make sure that the humidifier is always placed lower than the GoodKnight 420 Evolution unit. Substitute the steps below for step 1 of the standard installation procedure: 1. Connect one of the ends of the short humidifier hose onto the outlet connector of the device. (see Figure 3 page 5 and Figure 7). 2. Connect the other end of the short humidifier hose onto one of the humidifier’s connectors.
Steps 1 and 2
Steps 3 and 4
Figure 7 – Connecting the humidifier to the GoodKnight 420 Evolution
3. Connect the small tube that emerges through one of large patient tubing’s ends to the pressure port (see Figure 3 page 5 and Figure 7). 4. Connect this same end of the long patient tubing onto the humidifier’s second connector.
Figure 8 – View of the humidifier connected to the GoodKnight 420 Evolution
You can then resume with steps 2 to 6 of the standard installation for installing the equipment.
GoodKnight 420S - Patient manual
9
Revision A
Installing an external battery The GoodKnight 420 Evolution can be powered by an external 12-Volt car battery by using a optional cable provided for this purpose. CAUTION
• Do not use any battery power cable other than the optional cable supplied with the GoodKnight 420 Evolution. There would be a risk of damaging the device and your battery if you use unapproved accessories. • Use only 12-Volt DC sources and ensure that the polarity connections (+ and -) are correct. The device can be used for 8 hours at least with a fully charged car battery in normal operation conditions. To install the battery power cable, substitute the following steps for steps 4 and 5 of the standard installation procedure: 1. Connect the battery power cable onto the battery supply connector located on the back of the GoodKnight 420 Evolution (see Figure 4, page 5). 2. Connect the other end of the cable directly onto the battery. NOTE
Before using the battery, always be sure it is fully charged. The GoodKnight 420 Evolution can be powered through a vehicle cigarette lighter by using the cable provided for this purpose. To do so, replace steps 4 and 5 of the standard installation by the following steps: 1. Connect the battery power cable onto the supply connector at the back of the device (see Figure 4, page 5). 2. Connect the other end of the cable directly onto the cigarette lighter-plug.
10
GoodKnight 420 Evolution - Manuel patient
Revision A
USE This chapter shows you how to use the device 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 settings (you will not be able to alter these settings, only view them). WARNING
In the sections, “Starting treatment” (page 11) and “Stopping treatment” (page 12), follow the instructions carefully. The instructions must be followed in order, or an accident could occur, especially when oxygen is involved.
Starting treatment Once the GoodKnight 420Evolution has been properly installed, follow these instructions: . 1. Start the device by pressing the ON/OFF button The display shows the pressure available as well as the operation and compliance indicators. (See Figure 9).
8.0 cmH O 2
0
Compliance operation indicator - 1 : compliance is on - 0 : compliance is off
Device operation indicator
Figure 9 – View of the display when the device is running
NOTES • The pressure unit displayed (hPa or cmH2O) can be modified by the Practitioner. • The compliance operation indicator is only displayed after the GoodKnight 420 Evolution
has been operating for 15 minutes. 2. Put the patient interface (nasal mask) in place according to the instructions for use. If an interface with exhalation vent is used, it includes a hole by which the exhaled gases will be flushed and could not be rebreathed. If an interface without exhalation vent is used, your Homecare Provider must provide you with an adaptor allowing gases flushing as close as possible to the nose. Breathe normally with your mouth closed. WARNING
A patient interface with hose should not be worn, unless the CPAP device is turned on and operating properly. The vent hole(s) associated with the interface should never be blocked. This CPAP device is intended to be used 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 functioning properly, fresh air from the CPAP device flushes the exhaled air out through the interface vent hole. However, when the CPAP device is not operating, 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. 3. If you are using a heated humidifier, turn it on according to the instructions for use. 4. If you are using oxygen, open the flow now. GoodKnight 420 Evolution - Patient manual
11
Revision A
WARNINGS •
When the device is in operation mode, check that it delivers an air flow. If the device is not properly operating, stop it immediately and contact the home care 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 operating, follow the instructions below to discontinue the treatment: 1. If you are using oxygen, stop the flow now. 2. Remove the interface (nasal mask). 3. If you are using a heated humidifier, turn it off according to the instructions for use. Disconnect the humidifier from the unit. CAUTION
Do not leave the humidifier connected to the unit or to the tubing when the humidifier is not in use, as humidity could enter the device or the sensing line and degrade device performance. 4. Turn the device off by pressing the ON/OFF button. The device will return to standby mode and display the following standby screen showing the time:
5:32
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.
Using the ramp First of all adjust the starting ramp pressure of your GoodKnight 420 Evolution device by observing the following instructions: NOTE
If the ramp time is set to zero, this adjustment is not possible, since the pressure settings are not accessible. The initial ramp pressure can be set to a value between 4 cmH2O and the pressure level prescribed by your physician. This function allows you to set the appropriate pressure level to enable you to fall asleep. . To access the parameter setting menu, just press for a second the Information Access button, whether the device is on standby or in operation (see Figure 10).
Increases the starting ramp pressure
Reduces the starting ramp pressure
Information access button 12
Figure 10 – View of the control buttons GoodKnight 420S - Manuel patient
Revision A
Then, in order to scroll through the settings, continue to press the Information Access button, the number of times required for displaying the screen below:
4.0 cmH O 2
vP The starting ramp pressure value can then be changed by using the ON/OFF key (up) and Ramp key (down). The ramp function enables gradual increases in the delivered pressure. The pressure level may be decreased at nightfall to help you to 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 pressure is prescribed by your physician and the setting carried out by your home care provider is between 0 (no progressive rise) and 30 minutes, in 5-minute increments. The ramp may have been preset to 0, according to your physician’s prescription. In this case, the ramp function is disabled, and pressing the Ramp button on the front panel of the GoodKnight 420S has no effect. (see Reference 3 in Figure 2, page 5). 1. To start the ramp, just press the Ramp button when the device is on. The pressure will decrease to a low set value, then increase progressively up to the prescribed pressure level, so you won’t be awakened. The device will run normally, delivering a treatment pressure throughout the night, unless you press the Ramp button again, in which case the pressure will drop down again to the ramp level that you have selected. 2. To end the ramp, press the Ramp button again and the function will be disabled. It is possible to reset the ramp time by reactivating the ramp function (the ramp indicator lights up when this is activated). Pressure Pmax Pressure level (CPAP) Initial pressure (APAP)
Starting ramp pressure
Pmin
Pressure rise time
Pressure rise time
Time
Resetting the ramp Start-up and RAMP function active
Figure 11 – Changes in pressure over time when activating the ramp function
GoodKnight 420 Evolution - Patient manual
13
Revision A
Using the GoodKnight 420 Evolution to access information The display enables you to view the information on the settings of the GoodKnight 420 Evolution. (See reference 1 in Figure 2 on page 5). The setting information is accessible whether the device is on standby or in operation. To access this information, just press the Information Access button for one second. (See reference 2 in Figure 2 on page 5). You will access additional data each time you press the key. Only those settings that display the symbol are changeable in this mode of access. NOTE
In the following screens, the device is shown in operation mode and all the values are given as a guide only. Press for one second on Information Access button
The screen displays:
APAP
• The GoodKnight 420 Evolution operating mode:
If APAP is displayed: the device runs in automatic mode, the device’s pressure is best suited to your pathology.
or
CPAP
If CPAP is displayed: the machine delivers a constant pressure. • The pressure level set by your physician (corresponding to
Press Information Access button
8.0 cmH O 2
P
the pressure prescribed when the device is operating). When the device is in CPAP mode, a single value is displayed. When the device is in APAP mode, three setting values may be viewed successively by pressing the information access key each time.
6.0 cmH O 2
P
Initial pressure
20.0 cmH O
Maximum pressure
4.0 cmH O
Minimum pressure
2
P 2
P Press Information Access button
14
10
min
• The ramp time prescribed by your physician (period of
time over which the pressure gradually increases from the starting ramp pressure to the pressure level).
GoodKnight 420 Evolution - Patient manual