GoodKnight® 420 Evolution
Patient Manual
Ref. : M-139DFU05-70 Revision B
List of patient manual revisions
GoodKnight
The pages below are included in the American version of the patient manual
Ref. M-139DFU05-70 revision B.
Current pages Revision
®
420 Evolution
Revision B
Cover
List of revisions
Table of contents
Introduction
1 – 8 ; 10 – 22
9 ; 23 – 24
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”)
B
B
A
A
A
B
October 2003
© 2002 Puritan Bennett
All rights reserved.
ii GoodKnight 420 Evolution - Patient manual
Revision A
f
r
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 o
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 unde
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 Puritan Bennett.
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
AFETY INSTRUCTIONS..............................................................................................................................................1
S
NDICATIONS FOR USE ...............................................................................................................................................2
I
RECAUTIONS FOR USE .............................................................................................................................................2
P
ODEM TRANSMISSIONS...........................................................................................................................................2
M
HECKING THE COMPONENTS ...................................................................................................................................3
C
DESCRIPTION OF THE DEVICE.................................................................................................................................4
INSTALLATION ..............................................................................................................................................................7
TANDARD INSTALLATION.........................................................................................................................................7
S
ITTING AN OXYGEN ADAPTOR ..................................................................................................................................8
F
NSTALLING A HUMIDIFIER ........................................................................................................................................9
I
NSTALLING AN EXTERNAL BATTERY.......................................................................................................................10
I
USE ...................................................................................................................................................................................11
TARTING TREATMENT............................................................................................................................................11
S
TOPPING TREATMENT ............................................................................................................................................12
S
SING THE RAMP.....................................................................................................................................................12
U
SING THE GOODKNIGHT 420 EVOLUTION TO ACCESS INFORMATION ....................................................................14
U
ETTING THE TIME...................................................................................................................................................16
S
LIST OF AUTHORIZED ACCESSORIES ..................................................................................................................17
NTERFACES ............................................................................................................................................................17
I
UBING ...................................................................................................................................................................17
T
THER ACCESSORIES..............................................................................................................................................17
O
MAINTENANCE AND CLEANING INSTRUCTIONS .............................................................................................19
OODKNIGHT 420 EVOLUTION...............................................................................................................................19
G
IR INLET FILTERS ...................................................................................................................................................19
A
UBING ...................................................................................................................................................................19
T
ASAL INTERFACE ..................................................................................................................................................20
N
UMIDIFIER ............................................................................................................................................................20
H
XYGEN ADAPTOR ..................................................................................................................................................20
O
TROUBLE-SHOOTING ................................................................................................................................................21
TECHNICAL CHARACTERISTICS ...........................................................................................................................23
OODKNIGHT 420 EVOLUTION PERFORMANCE .......................................................................................................23
G
HYSICAL CHARACTERISTICS ..................................................................................................................................23
P
RANSPORT AND STORAGE CONDITIONS..................................................................................................................23
T
ONDITIONS OF USE ................................................................................................................................................23
C
ISPOSAL OF THE GOODKNIGHT 420 EVOLUTION AT THE END OF ITS LIFE ..............................................................23
D
LECTRICAL CHARACTERISTICS OF THE POWER SUPPLY MODULE............................................................................24
E
LECTRICAL CHARACTERISTICS OF THE DEVICE ......................................................................................................24
E
YMBOLS ................................................................................................................................................................24
S
GoodKnight 420 Evolution - Patient manual v
This page is left blank intentionally
vi GoodKnight 420 Evolution - Patient manual
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
CAUTION
NOTE
WARNINGS
Indicates a potential risk of death or accident to you or caregiver.
Information to avoid damaging equipment or losing data.
Tips for ease of use of the GoodKnight 420 Evolution device.
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:
¹
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
The items in the Figures below are described on page 4.
1
2
Revision A
3
Figure 3 – General view
Figure 2 – Top view
4
6
5
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:
¹
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
0
Compliance operation indicator
- 1 : compliance is on
- 0 : compliance is off
Figure 9 – View of the display when the device is running
NOTES
· The pressure unit displayed (hPa or cmH
· The compliance operation indicator is only displayed after the GoodKnight 420 Evolution
O) can be modified by the Practitioner.
2
cmH2O
Device operation indicator
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:
¹
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).
12 GoodKnight 420S - Manuel patient
Revision A
Reduces the starting ramp
pressure
Information access
button
Figure 10 – View of the control buttons
Increases the starting ramp
pressure
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
cmH2O
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
Press
Information
Access button
The screen displays:
APAP
or
CPAP
8.0
cmH2O
P
6.0
cmH2O
P
· 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.
If CPAP is displayed: the machine delivers a constant
pressure.
· The pressure level set by your physician (corresponding to
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.
Initial pressure
20.0
cmH2O
Maximum pressure
P
4.0
cmH2O
Minimum pressure
P
Press
Information
Access button
14 GoodKnight 420 Evolution - Patient manual
10
· The ramp time prescribed by your physician (period of time
min
over which the pressure gradually increases from the starting
ramp pressure to the pressure level).
Revision A
Press
Information
Access button
Press
Information
Access button
P
5.0
FL: 1
FL: 0
cmH2O
· 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 shows that the parameter is adjustable. You
can increase or lower the value set by using the ON/OFF
(up) key or Ramp key (down). For further details, refer to
the chapter “Using the ramp” (see page 12).
· The validation of pressure increase commands on flow
limitation run, set by your doctor.
NOTE
This function is accessible only if the machine is running
in APAP mode.
The command is enabled.
The command is disabled.
Press
Information
Access button
Press
Information
Access button
Press
Information
Access button
Press
Information
Access button
A 13.0
P
326
178
Id *.*
cmH2O
h
h
· The maximum pressure for the commands on apnoea
NOTE
This function is accessible only if the device is running in
APAP mode.
· The hour meter value (device operating time). The
hourglass symbol stands for “time”.
· The compliance meter value (time during which the
patient has breathed with the device). Hourglass and
human symbols stand for “patient time”.
· The GoodKnight 420 Evolution on-board software
version.
The version number is shown in two digits (*), for
example the screen may display : Id 1.0.
Press the information access button again to exit the parameter setting menu.
GoodKnight 420 Evolution - Patient manual 15
Revision A
The display will again show one of the following two screens indicating the status of your device (the
values are given as a guide only).
¹
10:34
The device is on standby. The device is running.
NOTE
Exit from the parameter setting menu takes place automatically when you do not press any key for 30
seconds.
8.0
1
cmH2O
Setting the time
You can set the time only when the device is on standby. To do so, just press and hold the Ramp
button for one second (see Reference 3 in Figure 2, page 5). Then while continuing to hold the Ramp
button down, press the ON/OFF button (see Reference 4 in Figure 2, page 5). If you release the
pressure on the buttons, the symbol of adjustment appears under the time, as shown on the next
screen:
¹
15:56
NOTE
The time will only be displayed in a 24-hour format. Thus, 15:56 represents 3:56 P.M.
The letter h indicating the hour blinks, you can then set it using the Ramp and ON/OFF keys.
To set the minutes, just press the Information Access button, the symbol of minutes blinks in its turn
and you can set the time by following the same procedure as you did for hours.
Press the Information Access button again to exit the menu.
NOTE
Exit from the parameter setting menu takes place automatically when you do not press any key for 30
seconds.
h
16 GoodKnight 420 Evolution - Patient manual
Revision A
LIST OF AUTHORIZED ACCESSORIES
Below you will find the accessories that can be used with the GoodKnight 420 Evolution equipment.
Interfaces
Adam Pillows (7 sizes):
P/N’s S-616323-00A, S-616324-00C, S-616325-00A, S-616355-00C, S-616356-00C,
S-616357-00C, Y-101969-00.
Adam CPAP systems:
P/N’s Y-100871-00, Y-100872-00, Y-100873-00, Y-100874-00.
SoftFit Interface System:
P/N’s S-133335-00, S-133336-00, S-133337-00, S-133338-00, S-133339-00, S-133340-00.
SoftFit Ultra Interface System:
P/N’s Y-233335-00, Y-233336-00, Y-233337-00, Y-233338-00, Y-233339-00, Y-233340-00.
Nasal interface Breeze:
P/N Y-101400-00.
DreamSeal™ mask:
P/N Y-102616-00, Y-103059-00, Y-103074-00A.
Tubing
6 ft long patient tubing (with internal pressure line):
P/N Y-261000-27.
8 ft long patient tubing (with internal pressure line):
P/N Y-261000-30.
Other Accessories
Oxygen adaptor:
P/N Y-616155-03B.
Heated humidifier:
Fisher & Paykel HC100.
Air inlet filter:
P/N M-413950-02.
GoodKnight 420 Evolution Patient manual · 17
Thin optional filter:
P/N M-413950-04.
Serial connection cable:
P/N M-213930-04.
Battery cable:
P/N M-213930-02.
Battery cable/cigarette lighter plug:
P/N M-213930-03.
Carrying case:
P/N M-213930-01.
Modem kit P/N M-213930-12 includes modem cable and adaptor:
– modem cable P/N M-213530-11
– modem adaptor P/N M-213930-05.
18 · Patient manual GoodKnight 420 Evolution
Revision A
MAINTENANCE AND CLEANING INSTRUCTIONS
In order to ensure that you use your GoodKnight 420 Evolution safely and efficiently, please observe
the maintenance instructions specified below.
GoodKnight 420 Evolution
The hard plastic case protecting the internal components of the GoodKnight 420 Evolution does not
require any special maintenance. When necessary, clean the device by using a soft cloth dampened
with warm soapy water. Dry the device thoroughly.
WARNINGS
· Always unplug the
· Do not use a spray cleaner. This is because residues may lodge in the air outlet, the foam
filter, or inside the device. This can cause irritation of the airways.
· Do not submerge the device in water.
· Do not allow water to run onto the
openings.
· Never use the
GoodKnight
GoodKnight
420 Evolution before cleaning it.
GoodKnight
420 Evolution without verifying that the filter has been installed.
420 Evolution, or drip into any of its
Air inlet filters
Change the filters as soon as they are torn or dirty (refer to Reference 9 in Figure 4, page 5).
Clean the outer foam filter at least once a week; or, more often if necessary, in the following way:
1. Remove the filter and wash it with warm mild soapy water.
2. Rinse thoroughly to remove all soap.
3. Pat the filter dry with a towel.
4. Allow the filter to dry completely before re-installing it.
5. Replace the filter at the back of the device.
The high-efficiency white fabric filter (this optional filter is available separately) cannot be washed, it
must be changed at least once a month, or more often if it is visibly dirty.
WARNING
Never use the
GoodKnight
420 Evolution without an air inlet filter.
Tubing
Please refer to the cleaning instructions that were sent to you with the tubing.
GoodKnight 420 Evolution - Patient manual 19
Nasal interface
Please refer to the instructions for use that were given to you with your nasal interface.
Humidifier
Please refer to the instructions for use that were given to you with your humidifier.
Oxygen adaptor
Please refer to the instructions for use that were given to you with the oxygen adaptor.
Revision A
20 GoodKnight 420 Evolution - Patient manual
TROUBLE-SHOOTING
PROBLEM PROBABLE CAUSE SUGGESTION
Revision A
Discomfort due to a
feeling of the
pressure being too
Pressure of the
GoodKnight 420
Evolution.
high.
The GK420 Evolution is
not set in APAP mode.
The device is not
delivering the
correct pressure
(display).
The pressure port tube is
not connected.
Moisture is getting into the
pressure port tube.
The ramp is enabled.
Dry or irritated
The air is too dry. Humidify the air in the room using a humidifier.
nose or throat.
Cold nose. The room temperature is
too low.
Adapting to the nasal pressure takes a while. Try
to use the pressure increase ramp when you go to
sleep (see the chapter “Using the ramp” page 12).
Relax and breathe slowly through your nose.
The pressure may vary during use. If you feel that
the device is not set to the correct pressure,
contact your service provider to have the
equipment checked.
Check that the small pressure port tube is
properly connected to the device.
Dry the small tube. To do this, connect the
patient tubing onto the device, leaving the small
tube disconnected, block up the large tubing with
your hand, turn the device on. Repeat if
necessary.
Check whether the ramp indicator is displayed.
Press the Ramp button to cancel the function (see
Reference 3 in Figure 2, page 5).
Ask the medical-technical team to obtain a
humidifier for your CPAP.
Increase the temperature of the room or place the
tubing under the blankets to reduce heat loss.
Runny nose. Reaction to the air flow
and pressure.
The GoodKnight
420 Evolution is
delivering air that
The air inlet filters may be
dirty. The air inlet is
clogged.
is too hot.
The room temperature is
too high.
Pain in the nose,
sinuses or ears.
Dryness or irritation
of the eyes.
Sinus infection or nasal
congestion.
Air leak around the
interface.
Try high efficiency filter if problem persists.
Contact your physician.
Clean or replace the filters as the case may be
(refer to the chapter on “Maintenance and
cleaning instructions”, page 17). Move any linen,
bedding or clothing away from the GoodKnight
420 Evolution.
Lower the thermostat for the room. Make sure
that the device is away from any heat source.
Remove the hose from under the blankets.
Contact your physician or home care provider
immediately.
Reposition the interface. Ask your physician or
the home care provider to try different sizes of
interfaces.
GoodKnight 420 Evolution - Patient manual 21
PROBLEM PROBABLE CAUSE SUGGESTION
Revision A
Redness of the skin
in contact with the
interface.
Recurrence of the
first symptoms of
sleep apnea
syndrome.
The GoodKnight
420 Evolution does
not come on (no
display).
The GoodKnight
420 Evolution is not
running properly
and seems to be
subject to
interference.
In 01 is displayed.
In 02 is displayed.
In 03 appears on
the display.
Er XX appears on
the display.
(XX = 2 digits).
The headgear is too tight or
too small.
Allergic reaction to the
components of the
interface.
The GoodKnight 420
Evolution is not set to the
correct pressure or is not
operating correctly.
Your physical condition or
your pressure needs have
changed.
Verify that the power
supply module is properly
connected.
No AC power.
The fuse of the device has
blown.
Excessive electromagnetic interference.
A major leak (disconnection) has been detected
in the patient circuit.
Over pressure has been
detected by the device for
more than 10 seconds.
Reduction of the power
supply voltage.
The device has detected an
operating fault.
Adjust the headgear. Contact your physician or
the home care provider to try on interfaces of
different sizes.
Stop using the interface. Contact your physician
or home care provider.
Ask the home care provider to check the
operation of the GoodKnight 420 Evolution.
Contact the ordering physician or home care
provider.
Check the connections between the power supply
module, the device and the electric outlet.
Use another appliance, such as a lamp or radio to
check that the AC power supply is present at the
outlet.
Contact your physician or home care provider.
Move the device away from sources of
interference, such as halogen lamps and cell
phones.
This message disappears as soon as the interface
is connected and you have breathed 3 or 4 times,
or if you press the ON/OFF button twice.
Otherwise, check the patient circuit connection.
Examine the connection of the small pressure port
tube. Verify that it is not obstructed and that it is
properly clean and dry (see the instructions for
using the patient circuit).
Check the connections between the power supply
module, the device and the mains socket. Unplug
the supply module, then connect it again to the
mains. If the problem remains, contact the home
care provider.
Check the 12 volt DC battery and replace it, if
necessary. If the problem remains, contact the
home care provider.
Call your home care provider.
22 GoodKnight 420 Evolution - Patient manual
TECHNICAL CHARACTERISTICS
GoodKnight 420 Evolution performance
Pressure range of the GoodKnight 420 Evolution : 4 cmH2O to 20 cmH2O ± 1 cmH2O
adjustable by increments of 0.5 cmH2O
Maximum achievable pressure at the patient
connection port under single fault condition: 24 cmH2O
Ramp time: 0 to 30 minutes ± 1 minute
device adjustable by increments of 5 minutes
Sound level measured in accordance with: 27.4 dBA
PrEN ISO 17510-1 :2001
Maximum sound level: 31 dBA à 10 cmH2O
Lifetime of the battery soldered onto the board: > 5 ans
Revision B
Physical characteristics
Dimensions (W x H x L ): 5.6 x 2.9 x 7.7 in (without power supply)
Weight: 1.55 lb (without power supply module)
Transport and storage conditions
Temperature: -20°C to +60°C (-4°F to +140°F)
Relative humidity: up to 95 % without condensation
Relative pressure range: 500 hPa to 1060 hPa
(1 hecto-Pascal ~ 1 cmH2O)
Conditions of use
Temperature: +5°C to +40°C (+41°F to +104°F)
Relative humidity: between 10 % and 95 % without condensation
Relative pressure range: 700 hPa to 1060 hPa
(1 hecto-Pascal ~ 1 cmH2O)
Operating Altitude: 0 to approximately 7,800 ft (0-2400 m)
Disposal of the GoodKnight 420 Evolution at the end of its life
In order to protect the environment, various parts of the equipment and its accessories must be
disposed of in conformity with the local regulations.
GoodKnight 420 Evolution - Patient manual 23
Electrical characteristics of the power supply module
Revision B
Class II power supply:
Power supply provided with the device: Egston N2UFMW 24 W 13 V or ANAM TA2412 24 W 12 V.
CAUTION
· Use only one of the above-mentioned specific power supplies provided with the device.
· The above-mentioned power supply modules are not intended to be repaired. In case of
failure, please contact your service provider to have the module replaced.
Input voltage: 100 – 240 VAC (-15%, +10%), 50 / 60 Hz (±1 Hz)
Output voltage: 13 V – 1.85 A (Egston) / 12 V – 2 A (Anam).
Electrical characteristics of the device
Input voltage: 13 V – 1.5 A.
Maximum power consumed: 20 W without humidifier
Current consumed at 20 cmH2O with a 4 mm leak: 0,750 A.
Direct current
13 V power connector
Symbols
ON/OFF
Information access
Ramp
PC connection
Increases setting values
Reduces setting values
Output connector
Device protected against the vertical falls of water drops.
Type B device
Consult the instructions for use before using this device.
For USA only:
Federal law restricts this device for sale by or on the order of a physician.
24 GoodKnight 420 Evolution - Patient manual
Details of your Service Provider
Corporate Headquarters:
Nellcor Puritan Bennett Incorporated
4280 Hacienda Dr.
Pleasanton, CA 94588-8604
Tel. +1 (925) 463-4000
Fax : +1 (925) 463-4420
Made in France by:
Mallinckrodt Développement France
Parc d’activités du bois St-Julien
10, Allée Pelletier-Doisy
F – 54601 VILLERS-LES-NANCY CEDEX
Telephone : (33) 3.83.44.85.00
Fax : (33) 3.83.44.85.01
Loading...