Patient Manual
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GoodKnight® 420G
Patient Manual
Ref. : M-139DFU02-10 Revision C
Revision C
List of Patient Manual revisions
GoodKnight® 420G The pages below are included in the American version of the GoodKnight® 420G patient manual Ref. M-139DFU02-10 revision C.
Current pages
Revision
Cover
C
List of revisions
C
Table of contents
A
Introduction
A
1 – 8 ; 11 – 20
A
9–10 ; 21
B
22
C
Reference or revision
Description
Date
M-139DFU02-10 revision A.
Creation of the manual
February 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.
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Revision C
The Puritain Bennett GoodKnight® 420G device (GK420G) is intended for treating patients with Sleep Disordered Breathing including 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 420G 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 limitations on the use of this device. Therefore, please read this manual carefully before using the GoodKnight 420G. The information contained here is intended to help you use this device under optimum conditions of safety and operation. For any question relating to the equipment and its use, contact your Health Care Provider or your home Medical Equipment Provider. Your doctor has decided on the treatment of your illness. He or she has prescribed the various parameters that the hospital or your home care provider will program. You must not make any adjustment, except under direct supervision of your Home Care Provider.
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.
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Revision A
TABLE OF CONTENTS
BEFORE STARTING...1 SAFETY INSTRUCTIONS...1 INDICATIONS FOR USE ...2 PRECAUTIONS FOR USE...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 ACCESSING INFORMATION ON THE DEVICE ...14 SETTING THE TIME...15 MAINTENANCE AND CLEANING INSTRUCTIONS ...17 GOODKNIGHT 420G ...17 AIR INLET FILTERS ...17 HOSE ...17 NASAL MASK ...18 HUMIDIFIER ...18 OXYGEN ADAPTOR ...18 TROUBLE-SHOOTING...19 TECHNICAL CHARACTERISTICS ...21 DEVICE PERFORMANCE ...21 PHYSICAL CHARACTERISTICS ...21 TRANSPORT AND STORAGE CONDITIONS ...21 CONDITIONS OF USE ...21 DISPOSAL OF THE GOODKNIGHT 420G AT THE END OF ITS LIFE ...21 ELECTRICAL CHARACTERISTICS OF THE POWER SUPPLY MODULE...22 ELECTRICAL CHARACTERISTICS OF THE DEVICE ...22 SYMBOLS ...22
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Revision A
BEFORE STARTING Safety instructions In order to ensure that you use your GoodKnight 420G device safely and efficiently, please read all the information contained in this operating manual. Please pay special attention to the passages preceded by the following terms: WARNING
Means that there is a danger of death or accident to you or others.
CAUTION
Means that there is a possibility of material damage to this or another device.
NOTE
Indicates special points aimed at more efficient and practical operation.
WARNINGS
1.
Before any use, please check your GoodKnight 420G, as specified in the chapter “Checking the components”. (See page 3). 2. In the event of additional oxygen supply, carefully observe the safety instructions for using oxygen given in the chapter “Fitting an oxygen adaptor”. (See page 8). 3. Only use the accessories that have been given to you by your service provider. Check that you have the instructions for using each of the 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 flammable fumes. 6. Follow the device’s installation instructions as specified in this manual in the chapter “Installation”. (See page 5). 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. You may contact the medical team if, when using the GoodKnight 420G, the following symptoms appear: dryness in your airways or nose, 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, whatever it may be. Maintaining this equipment is solely the responsibility of the competent personnel. Do not attempt to open the device. 11. The air flow for breathing produced by this device can be as much as 7°F higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90°F.
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Indications for use The GoodKnight 420G device is indicated for use in the treatment of obstructive respiratory sleep disorders, particularly Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30 kg (66 lb) within a homecare environment.
Precautions for use The GoodKnight 420G device must be used with caution with patients in the following conditions. If you are affected by one of these, contact your doctor at the start of your treatment. •
Pneumothorax or pneumomediastinum
•
Severe bullous emphysema or previously complicated by pneumothorax
•
Massive epistaxis or previous massive epistaxis
•
Decompensated cardiac insufficiency or hypotension, especially in case of depletion in blood volume or in case of cardiac rhythm disorder
•
Pneumoencephalus, traumatism or recent surgery with the after-effect of a cranio-nasopharyngeal fistula
•
Acute sinusitis, otitis media or perforation of the tympanic membrane
•
Severe claustrophobia.
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Revision A
Checking the components In order to be able to use the GoodKnight 420G with its specific electrical power supply, you must have at least the following items: • A patient tubing. • A nasal mask (often called an “ interface ”) with all its fastening accessories as specified in the instructions for using this mask. In addition to these accessories, your doctor could have prescribed the use of a humidifier. In this case, check that you have all the accessories for this humidifier specified in its operating instructions. In the case of an additional oxygen supply, you must also have an adaptor (only in the case where the oxygen supply is not fitted directly onto the mask). See the chapter “Fitting an oxygen adaptor”. (See page 8). Carefully check the device and each accessory. Check especially that the hoses are not damaged and that the mask does not have any cracks or distortion in the mask housing or seal (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 to the mains using its 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 example):
9:31
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 the motor was running, the screen displays the pressure. The device shows the same adjustments as at the time of the power supply cord disconnection and is set on the pressure used at the time of disconnection. Start the device by pressing the ON/OFF button. (See reference 4 in Figure 2, page 5). The blower should start up and the noise should be regular. Stop the device by pressing 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 service provider.
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DESCRIPTION OF THE DEVICE
The GoodKnight 420G 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 Allows you to visualise different information such as the pressure delivered, the settings of the device or the hour. For further information, refer to the chapter “Accessing information on the device”. (See page 14). 2. Information Access button Used for accessing the different information regarding the device. For further details, refer to the chapter “Accessing information on the device”. (See page 14). 3. Ramp button Used for starting or stopping the pressure increase ramp (for further information, refer to the chapter “Using the ramp”. (See page 12). It is also used to decrease the value of the parameters during the device settings. 4. ON/OFF button Used for turning the device on or off. It is also used to increase the value of the parameters during the device settings. 5. Outlet connector This is the air outlet onto which the hose is connected. For further information, refer to the chapter “Installation”. (See page 7). 6. Supply connector Used for powering the device from the specific power supply module or from an external battery. For further information, refer to the chapter “Installing ”. (See page 10). 7. Air inlet filters These filters prevent dust from entering the device and the air flow. For additional information, refer to the chapter “Maintenance and cleaning instructions” (See page 17).
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Revision A
The items in the Figures below are described on page 4.
1
2 4 3
Figure 2 – Top view
5
Figure 3 – General view
6
7 Figure 4 – Rear view
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INSTALLATION This chapter shows you how to connect the various accessories and cables to your device. Before beginning the installation, please check your device and its accessories, by referring to the chapter on “Checking the components”. (See page 3). CAUTION
In general, place the device on a stable surface. Avoid placing it too near a wall or any other obstacle which could hamper the intake of air into the device.
Standard installation 1.
Connect the patient tubing to the device. To do this, connect the hose onto the outlet connector of the device. (See reference 5 in Figure 3, page 5).
Figure 5 – Connection of the patient tubing to the device
2. 3. 4.
Prepare the mask as described in its instructions for use. Connect the mask to the patient tubing free end. Connect the cable of the power supply module to the supply connector located on the back of the device. (See reference 6 in 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 mains. The type of the device is displayed for a few seconds then the following standby screen indicating the hours and the minutes :
7:14
The two points are blinking.
6.
The device is ready to operate. Please refer now to the chapter “Use”. (See page 11).
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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 nozzle of the patient tubing.
Figure 6 – Connecting the oxygen adaptor to the device
You can then repeat steps 2 to 6 of the standard installation to continue installing the equipment. WARNINGS
• Always follow the instructions of the medical team or 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 device. • Carefully follow the start-of-treatment and end-of-treatment steps described in the chapter on “Use” on page 11. • If supplemental oxygen is being used, the oxygen flow must be turned off when the device is not operating. When the device is not in operation, and the oxygen flow is left on, oxygen delivered into the mask circuit may accumulate within the device enclosure. Oxygen accumulated in the device enclosure will create a risk of fire. This warning applies to most types of CPAP devices.
CAUTION
At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate. This caution applies to most types of CPAP devices.
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Revision B
Installing a humidifier Please refer to the humidifier user instructions for your for further information on its preparation and safety precautions. WARNING
The humidifier must be filled before being connected to the device. CAUTION
In order to avoid water damage, make sure that the humidifier is always placed lower than the GoodKnight 420G unit. Substitute the steps below for step 1 of the standard installation procedure: 1. Connect one end of the short spiral hose onto the outlet connector of the device. (See reference 5 in Figure 3, page 5). 2. Connect the other end of the short humidifier connection tubing onto one of the humidifier’s connectors.
Steps 1 and 2
Steps 3 and 4 Figure 7 – Connecting the humidifier to the device
3.
Connect the end of the patient tubing onto the humidifier’s second connector.
Figure 8 – View of the humidifier connected to the device
You can then resume with steps 2 to 6 of the standard installation to continue installing the equipment.
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Revision B
Installing an external battery The GoodKnight 420G can be powered by a 12-Volt car battery by using a special cable provided for this purpose. The device can be used for 8 hours at least with a fully charged car battery in normal operation conditions. CAUTION
• Do not use any battery power cable other than the optional battery cable specific to the GoodKnight 420G. There is a risk of damaging the device and your battery. • Only use 12-Volt DC sources and make the proper polarity connections (+ and -). To install the battery cable, substitute the following steps for steps 4 and 5 of the standard installation procedure: 1. Connect the battery power cable onto the supply connector at the back of the device. (See reference 6 in 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 420G 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 reference 6 in Figure 4, page 5). 2. Connect the other end of the cable directly onto the cigarette lighter-plug.
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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, but only view them). WARNING
In the sections “Starting treatment” and “Stopping treatment” below, please follow the directions carefully. If these directions are not followed, an accident can occur, especially where the use of oxygen is concerned.
Starting treatment Once the device has been installed in accordance with the instructions given in the previous chapter, please follow the instructions below to start treatment: 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).
9.0 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 • •
2.
The pressure unit displayed (hPa or cmH2O) can be modified by the Practitioner. The compliance operation indicator is displayed only after 15 minutes operation of the device. Put the nasal mask in place according to the instructions for its use. If a mask with exhalation vent is used, it includes a hole by which the exhaled gases will be flushed and could not be rebreathed. If a mask without exhalation vent is used, your doctor must provide you with an adaptor allowing gases flushing as close as possible to the nose. Breathe normally. WARNING
3.
A CPAP mask with hose should not be worn unless the CPAP device is turned on and operating properly. The vent hole(s) associated with the mask should never be blocked. This CPAP machine is intended to be used with masks (or connectors) that have vent holes to allow continuous flow of air out of the mask. When the CPAP device is turned on and functioning properly, new air from the CPAP machine flushes the exhaled air out through the mask vent hole. However, when the CPAP device is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to rebreathing CO2 or possible suffocation. This warning applies to most models of CPAP devices. If you are using a heated humidifier, turn it on according to instructions for use.
4.
If you are using oxygen, open the flow now.
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WARNINGS •
When the device is in operation mode, check that it delivers an airflow. If no airflow is felt, turn off the device 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 hose. Some rebreathing may occur.
•
Stopping treatment When the GoodKnight 420G 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
4.
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 and degrade device performance. 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:
9:38
CAUTION
Check that no humidity appears in the tubing. 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 420G device by observing the following instructions: NOTE
If the ramp time is set to zero, this adjustment is not accessible. The initial ramp pressure can be set to a value between 4 cmH2O and the pressure level prescribed by your doctor. 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 on in operation. (See Figure 10).
Increases the starting ramp pressure
Reduces the starting ramp pressure Information Access button Figure 10 – View of the control buttons
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You have to press this button the number of times required for displaying the screen below:
4.0 cmH O 2
vP The pressure value can then be changed by using the ON/OFF and Ramp keys. The ramp function enables you to make the rise in pressure progressive. Thus, the pressure level is low at the start of the night 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 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 your medical team’s prescription. In this case, the ramp function is disabled and pressing the Ramp button on the front panel of the device has no effect. (Refer to 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 fall to a lower value, as previously described, then increase progressively up to the prescribed pressure level, so as not to wake you. The device will run normally, delivering a treatment pressure throughout the night unless you press the Ramp button again. 2. To end the ramp, press the Ramp button again and the function will be disabled. To reset the ramp, press the ramp function again (the ramp indicator lights up when this is activated). Pressure Pmax Set pressure
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
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Accessing information on the device The display enables you to view the different information on the settings of the GoodKnight 420G. (Refer to reference 1 in Figure 2, page 5). The setting information is accessible whether the device is on standby or in operation. For this, just press the Information Access button for one second. (See reference 2 in Figure 2, page 5). With each additional key press, you access further data. 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 pressure level set by the doctor (equivalent to the prescribed pressure when the device is running).
5
•
The ramp time set by the doctor (period of time over which the pressure gradually increases from the starting ramp pressure to the pressure level).
•
The starting ramp pressure (pressure level at the beginning of ramp); this parameter is adjustable and visible only if the ramp time is other than 0. The symbol used shows that the parameter is adjustable. You can increase or reduce the value displayed by using the ON/OFF or Ramp keys. For further details, refer to the chapter “Using the ramp”. (See page 12).
•
The hour meter value (device operating time).
•
The compliance meter value (time during which the patient has breathed with the device).
•
The GoodKnight 420G on-board software version.
2
P
Press Information Access button
Press Information Access button
10.0 cmH O
min
4.0 cmH O 2
P
Press Information Access button
114 h
Press Information Access button
42
Press Information Access button
Id
*.*
h
Press the Information Access button again to exit the parameter setting menu.
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