Tyco Puritan Bennett GoodKnight 425 User manual

Ref. : M-145DFU00-40 Revision C
GoodKnight®425
GoodKnight®425ST
Patient Manual

Revision C
ii GoodKnight 425 / GoodKnight 425ST Patient Manual
List of Patient Manual Revisions
GoodKnight®425 / GoodKnight®425ST
The pages below are included in the American version of the patient manual
Ref. M-145DFU00-40, Revision C.
Current pages Revision
Cover B
List of revisions B
Table of contents A
Introduction B
1 – 2 ; 4 −5 ; 12 −15 ; 17 −18 ; 21 −22 ; 24 A
8 ; 26 B
3 ; 7 ; 9 −11 ; 16 ; 19 −20 ; 23 ; 25 C
Reference or Revision Description Date
M-145DFU00-40 Revision A. Creation of the manual July 2004
Revision B. Implementation of CE mark symbol (symbols section) June 2005
Revision C. Modification of the manual (“Installing a Humidifier”, “External
Battery Operation”, “List of authorized accessories” sections), for
GoodKnight 425 / GoodKnight 425ST, Nellcor Puritan Bennett
trademark.
July 2005
© 2004 −2005 Nellcor Puritan Bennett Inc.
All rights reserved.

Revision C
GoodKnight 425 / GoodKnight 425ST Patient Manual iii
The Puritan Bennett GoodKnight 425 / GoodKnight 425ST device
(GK425/GK425ST) is intended for the treatment of patients suffering from
Obstructive Sleep Apnea Syndrome (OSAS). The main characteristic of this
pathology is the occurrence of multiple respiratory events during the night, caused
by closure of the upper airways, that disturbs sleep. The GK425/GK425ST delivers
two pressure levels (one inspiratory, one expiratory) that prevent the upper airways
from becoming obstructed and thus eliminate respiratory events. On the
GoodKnight 425ST, a Back-Up rate can be adjusted.
It is essential for you to understand the limitations on the use of this device.
Therefore, please read this manual carefully before using the GoodKnight 425 /
GoodKnight 425ST device.
This manual provides information on the safe and effective operation of this
device. For any questions relative to the equipment and its use, contact your
medical team or your home service provider.
Your doctor has prescribed the GoodKnight 425 / GoodKnight 425ST as a method
of treatment. This method includes specific device parameter values that are set by
the hospital or home service provider. Do not adjust these parameter settings
yourself.
the information contained in this manual is valid for models GoodKnight 425 and
GoodKnight 425ST, unless stated otherwise.
CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
GoodKnight®is a registered trademark of Nellcor Puritan Bennett Inc.

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Revision A
GoodKnight 425 / GoodKnight 425ST Patient Manual v
TABLE OF CONTENTS
BEFORE STARTING............................................................................................................................................................1
SAFETY INSTRUCTIONS .........................................................................................................................................................1
INDICATIONS FOR USE ..........................................................................................................................................................2
PRECAUTIONS FOR USE.........................................................................................................................................................2
MODEM TRANSMISSIONS ......................................................................................................................................................2
CHECKING THE COMPONENTS...............................................................................................................................................3
DEVICE DESCRIPTION......................................................................................................................................................4
INSTALLATION....................................................................................................................................................................7
STANDARD INSTALLATION....................................................................................................................................................7
FITTING AN OXYGEN ADAPTER ............................................................................................................................................8
INSTALLING A HUMIDIFIER ...................................................................................................................................................9
EXTERNAL BATTERY OPERATION .......................................................................................................................................11
USING THE GOODKNIGHT 425 .....................................................................................................................................12
STARTING TREATMENT.......................................................................................................................................................12
STOPPING TREATMENT .......................................................................................................................................................13
USING THE RAMP FEATURE ................................................................................................................................................14
USING THE DEVICE TO ACCESS INFORMATION....................................................................................................................16
SETTING THE TIME..............................................................................................................................................................18
LIST OF AUTHORIZED ACCESSORIES .......................................................................................................................19
INTERFACES........................................................................................................................................................................19
TUBING...............................................................................................................................................................................19
OTHER ACCESSORIES..........................................................................................................................................................19
MAINTENANCE AND CLEANING INSTRUCTIONS ...................................................................................................21
GOODKNIGHT 425 ..............................................................................................................................................................21
AIR INLET FILTERS .............................................................................................................................................................21
BREATHING CIRCUIT ...........................................................................................................................................................21
NASAL INTERFACE..............................................................................................................................................................22
HUMIDIFIER ........................................................................................................................................................................22
OXYGEN ADAPTER .............................................................................................................................................................22
TROUBLESHOOTING.......................................................................................................................................................23
TECHNICAL SPECIFICATIONS .....................................................................................................................................25
DEVICE PERFORMANCE ......................................................................................................................................................25
PHYSICAL CHARACTERISTICS .............................................................................................................................................25
ENVIRONMENTAL CONDITIONS...........................................................................................................................................25
POWER SUPPLY MODULE ELECTRICAL CHARACTERISTICS .................................................................................................25
DEVICE ELECTRICAL CHARACTERISTICS ............................................................................................................................26
SYMBOLS ............................................................................................................................................................................26
DISPOSAL OF THE GOODKNIGHT 425..................................................................................................................................26

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Revision A
GoodKnight 425 / GoodKnight 425ST Patient Manual 1
BEFORE STARTING
Safety Instructions
To ensure that you use your device safely and efficiently, please read all the information contained in
this user manual. Contact your doctor or your home service provider for further information. Please
pay special attention to the passages preceded by the following terms:
WARNING Warnings alert the user to potential serious outcomes (death, injury, or
adverse events) to the patient or user.
CAUTION Cautions alert the user to exercise care necessary for the safe and
effective use of the GoodKnight 425.
NOTE Notes indicate information of particular interest for more efficient and
convenient operation.
WARNINGS
1. Before using your GoodKnight 425 device, refer to the chapter section titled “Checking the
Components” on page 3.
2. When using an additional oxygen supply, carefully observe the safety instructions for oxygen
in the section titled “Starting Treatment” on page 12.
3. Use only the accessories that have been given to you by your home care provider. Check that
you have all the instructions for using these accessories and read them carefully.
4. Use only the specific power supply module provided with the device.
5. Do not use the device in the presence of flammable anaesthetics.
6. Follow the device’s installation instructions as specified in this manual in the chapter entitled
“Installation” on page 7. In particular, keep the machine away from water.
7. Do not accidentally or intentionally obstruct the air outlet or any other opening in the device
or the respiratory circuit.
8. Do not introduce liquids or objects into the air outlet.
9. Contact the medical team if, when using the GoodKnight 425, the following symptoms
appear: dryness in your airways or nose, skin sensitivity, running nose, earache, sinus
trouble, daytime drowsiness, mood changes, disorientation, irritability or memory loss.
10. If the GoodKnight 425 malfunctions, contact your home care provider. Maintenance of this
equipment should only be performed by trained and authorised personnel. Do not attempt to
open the device.
11. The air flow produced by the GoodKnight 425 can be as much as 7 °F higher than the room
temperature. Exercise caution if the room temperature is warmer than 90 °F.

Revision A
2 GoodKnight 425 / GoodKnight 425ST Patient Manual
Indications for Use
The Puritan Bennett GoodKnight 425 is indicated for use in treating Obstructive Sleep Apnea (OSA)
in spontaneous breathing patients weighing over 30 kg (66 lb) within a homecare or hospital
environment.
Precautions for Use
The GoodKnight 425 device must be used with caution for patients with the following conditions. If
you are affected by one of the conditions listed below, contact your doctor at the beginning of your
treatment.
•Pneumothorax or pneumomediastinum
•Severe bullous emphysema or previously complicated by pneumothorax
•Massive epistaxis or previous massive epistaxis
•Pneumoencephalus, traumatism or recent surgery with the after-effect of a cranio-nasopharyngeal
fistula
•Acute sinusitis, otitis media or perforation of the tympanic membrane.
Modem Transmissions
When it is time to review the information stored in your GoodKnight 425, your home care provider
may set up a modem connection. The modem translates computer signals into telephone signals that
are then sent over telephone lines and converted to a format suitable for computer input. Finally, the
data is fed to a computer that features special software to assist in the analysis and review of the data.
NOTE
Your home care provider will set up the modem connection and instruct you in its use.

Revision C
GoodKnight 425 / GoodKnight 425ST Patient Manual 3
Checking the Components
In order to use the GoodKnight 425, you must have the following items:
•A breathing circuit
•A non-invasive patient interface (mask), and all related accessories as specified in the instructions
for using it.
In addition to these accessories, your doctor may have prescribed the use of a humidifier. If so, check
that you have all the accessories required for the humidifier specified in the operating instructions.
If supplemental oxygen is required, you will also need an adapter (unless the oxygen supply connects
directly onto the interface). See the section titled “Fitting an Oxygen Adapter” on page 8 of this
manual.
Carefully check the device and each accessory. Check especially the tubings for damage. The interface
should not have any cracks or distortion in the mask or pillows (the part of the mask coming in contact
with the face).
Carefully check the device and the specific power supply module and verify that there is no obvious
fault. Plug the device into the power outlet using the power supply module, referring to steps 4 and 5
of the section entitled “Standard Installation” on page 7.
The device type is displayed temporarily, then the following standby screen appears that displays the
time in the 24-hour format (the value displayed is given as an example only):
10:34 
Figure 1 – Display in Standby Mode
If the device is disconnected and then power restored, the screen displays the pressure. The device’s
pressure settings remain the same as those used when the power supply cord was disconnected.
Start the device by pressing the ON/OFF button . See item 4 in Figure 2 – Top View on page 5.
You should hear the turbine start and increase speed to deliver the set pressure.
Stop the device by pressing the ON/OFF button and unplug the power supply cord from the
power outlet.
WARNING
If you encounter any problems with the device, contact your home service provider and do not
start treatment.
Standby Indicator
Flashin
g
Colon

Revision A
4 GoodKnight 425 / GoodKnight 425ST Patient Manual
DEVICE DESCRIPTION
The GoodKnight 425 device is powered from an external power supply and equipped with specific
accessories. The device consists of the following primary components, as described below.
See figures 2, 3 and 4 on page 5.
1. Display
Information such as pressures, device settings, or the time of day is shown on the display. Fo
r
further information, refer to the section titled “Using the Device to Access Information”, page
16.
2. Information Access button
The information access button allows you to scroll through the device settings. For furthe
r
details, refer to the section titled “Using the Device to Access Information”, page 16.
3. Ramp button
Used for starting or stopping the pressure increase ramp (for further information, refer to the
section titled “Using the Ramp Feature” on page 14). It is also used to decrease the value o
f
the parameters when changing device settings.
4.
ON/OFF button
Used for switching the device on or off. It is also used to increase the value of the parameters
during the device settings.
5. Pressure port
This is the connector onto which the breathing circuit pressure tube is connected. For furthe
r
information, refer to the chapter titled “Installation” on page 7.
6. Outlet connector
This is the air outlet onto which the breathing circuit is connected. For further information,
refer to the chapter titled “Installation” on page 7.
7. Serial link connector
This connector is intended for use solely by your doctor or your home service provider. Do
not connect anything to it.
8. Supply connector
Used for powering the device from the specific power supply module or from an external
battery. For further information, refer to the section titled “External Battery Operation” o
n
page 11.
9. Air inlet filters
These filters prevent dust from entering the device and contaminating the air flow. Please
refer to the chapter titled “Maintenance and cleaning instructions” on page 21 for furthe
r
information on maintaining these filters.

Revision A
GoodKnight 425 / GoodKnight 425ST Patient Manual 5
The items in the Figures below are described on page 4.
Figure 2 – Top View
Figure 3 – General View
Figure 4 – Rear View
1
2
34
6
5
8
9
7

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Revision C
GoodKnight 425 / GoodKnight 425ST Patient Manual 7
INSTALLATION
This chapter shows you how to connect the different accessories and cables to your device. Before
starting the installation, please check your device and its accessories by referring to the section titled
“Checking the Components” on page 3.
CAUTION
Place the device on a stable surface. Avoid placing it too near a wall or any other obstacle which
could obstruct the intake of air into the machine.
Standard Installation
1. Connect the breathing circuit to the device. To do this, connect the pressure tube to the pressure
port (Figure 3, item 5 on page 5). Connect the breathing circuit to the outlet connector of the
device (Figure 3, item 6 on page 5).
Figure 5 – Breathing Circuit Connection
WARNING
Take care that the pressure tube is not kinked or blocked.
2. Prepare the interface as described in its instructions for use.
3. Connect the interface (mask) to the breathing circuit’s free end.
4. Connect the power supply module cable to the supply connector located on the back of the device
(Figure 4, item 8 on page 5).
CAUTION
Use only the specific power supply module provided with the device.
5. Connect the power supply module plug to the mains. The device type is displayed temporarily,
then the following standby screen appears that shows the time:
10:29 
6. The device is ready to operate. Proceed to the chapter titled “Using the GoodKnight 425” on page
12.
Breathing
circuit
Pressure tube
The colon is flashin
g

Revision B
8 GoodKnight 425 / GoodKnight 425ST Patient Manual
Fitting an Oxygen Adapter
Replace step 1 of the standard installation procedure on page 7 with the following instructions:
•Connect the oxygen adapter onto the device’s outlet connector and connect the other end of the
adapter onto the end of the breathing circuit. (see Figure 6). Connect the pressure tube to the
pressure port (Figure 3, item 5 on page 5).
Figure 6 – Oxygen Adapter Connection
Perform steps 2 through 6 of the standard installation procedure.
WARNINGS
•When using oxygen, strictly follow the instructions of your physician or home care provider.
•Never smoke in the presence of oxygen.
•Never inject oxygen through the air inlet of the device.
•Carefully follow all instructions contained in the chapter titled “Using the GoodKnight 425”
on page 12.
•If supplemental oxygen is used, the oxygen flow must be turned off when the GoodKnight
425 is not operating. If the oxygen flow is left on when the device is not operating, oxygen
delivered to the interface circuit may accumulate within the GoodKnight 425. Oxygen
accumulated in the device could create a fire hazard.
CAUTION
If the supplemental oxygen flow rate is fixed, the inhaled oxygen concentration will vary,
depending on the pressure settings, patient breathing pattern, interface selection and the leak
rate.

Revision C
GoodKnight 425 / GoodKnight 425ST Patient Manual 9
Installing a Humidifier
Please refer to the instructions for using your humidifier for installation instructions and safety
precautions.
WARNING
The humidifier must be filled before being connected to the device.
CAUTION
To avoid water damage, always ensure that the humidifier is placed lower than the
GoodKnight 425 device.
Replace step 1 of the standard installation procedure on page 7 with the steps below:
WARNING
The following instructions are general instructions for connecting the GoodKnight H2O
humidifier. Always follow specific instructions supplied with your humidifier for correct and
safe operation.
1. Remove the water chamber.
2. Carefully fill the water chamber with water through the outlet connector opening (refer to the
“Installation” section of the GoodKnight H2Ouser’s manual). Do not fill past the maximum water
level mark.
3. Place the GoodKnight H2Oheated humidifier onto a flat, even surface.
4. Equip the GoodKnight 425 device with the connection adapter provided with the GoodKnight H2O
heated humidifier.
5. Position the GoodKnight 425 device onto the GoodKnight H2Oheated humidifier, as shown in
Figure 7.
•The front of the GoodKnight 425 device must be turned towards the connections of the
GoodKnight H2Oheated humidifier.
•The base of the GoodKnight 425 device must be inserted into the recessed area of the
humidifier.
CAUTION
•Install the humidifier and bi-level device onto a flat, stable surface and keep them out of
contact with flammable materials.
•Never place the GoodKnight H2O on top of the bi-level device. Doing so could allow water
into the device, potentially causing damage.

Revision C
10 GoodKnight 425 / GoodKnigh 425 ST - Patient manual
Figure 7 – Connection of the GoodKnight 425 to the GoodKnight H2Oheated humidifier
6. Replace the water chamber, being careful to avoid spillage, and ensure that the inlet connector of
the humidifier reaches the thrust on the connection adapter.
7. Connect the pressure tube from the breathing circuit to the GoodKnight 425 pressure port.
8. Connect the breathing circuit to the outlet connector of the humidifier located on the water
chamber.
Perform steps 2 to 6 of the standard installation described on page 7 to continue installing the
equipment.
CAUTION
Disconnect the GoodKnight 425 from the humidifier and empty the water chamber before
moving the assembly. Failure to do so risks introducing water into the device, which could cause
irreversible damage.
Patient circuit
Pressure tube

Revision C
GoodKnight 425 / GoodKnight 425ST Patient Manual 11
External Battery Operation
The GoodKnight 425 can be powered by a 12-V car battery using the special cable provided.
CAUTION
•Do not use any battery power cable other than the optional cable supplied with the
GoodKnight 425. Doing so risks damaging the device and the battery.
•Only use 12-Volt DC sources and ensure that the polarity connections (+ and -) are correct.
The device can be used for a minimum of eight hours with a fully charged car battery in normal
operation conditions.
To connect the battery cable, replace steps 4 and 5 of the standard installation by the following steps:
1. Connect the battery power cable onto the supply connector located at the back of the device (see
Figure 4, page 5).
2. Connect the other end of the battery power cable directly to the battery.
Figure 8 −Connection of the GoodKnight 425 to the battery cable
NOTE
Because of its high power consumption, fully charge the GoodKnight 425's battery before using the
device.
The GoodKnight 425 can be powered through a vehicle cigarette lighter using the cable provided.
To do so, replace steps 4 and 5 of the standard installation by the following steps:
1. Connect the battery power cable to the supply connector located at the back of the device
(see Figure 4 on page 5).
2. Connect the other end of the battery power cable directly to the cigarette lighter plug.

Revision A
12 GoodKnight 425 / GoodKnigh 425 ST - Patient manual
USING THE GOODKNIGHT 425
This chapter shows you how to use the GoodKnight 425 after installing it as described in the previous
chapter. It also shows you how to use the pressure increase (ramp) function and how to access
information on device settings.
NOTE
You will not be able to alter the device’s settings; you can only view them.
WARNING
In the sections “Starting Treatment” and “Stopping Treatment” below, carefully follow the order
given. Failure to do so could increase the potential for fire in cases where oxygen is used. Refer to
the general warning on using oxygen on page 1.
Starting Treatment
Once the device has been installed, follow the instructions below to start treatment:
1. Start the device by pressing the ON/OFF button .
The display shows the pressure measured as well as the operation and compliance indicators (see
Figure 9).
9.0 cmH2O
0
Figure 9 - Display When Device is Running
NOTES
•The units of measure displayed for pressure (hPa or cmH2O) can be modified by the
Practitioner.
•The compliance operation indicator is not displayed until the device has been operating for
at least 15 minutes.
2. Put the patient interface (nasal mask) in place according to its instructions for use. If an interface
with an exhalation vent is used, it includes a hole by which the exhaled gases will be flushed out,
preventing them from being rebreathed. If an interface without an exhalation vent is used, your
doctor must provide you with a Pirouette™silent leak or equivalent adapter, allowing gases to be
flushed out as close as possible to the nose.
NOTE
When using this device, always remember to breathe normally for best results.
WARNING
The vent hole associated with the interface should never be blocked. This CPAP device is
intended for use with interfaces (or connectors) that have vent holes to allow a continuous
flow of air out of the interface. When the CPAP device is turned on and is operating properly,
fresh air from the CPAP device flushes the exhaled air out through the interface vent hole.
However, when the CPAP device is not functioning, adequate fresh air will not be provided
through the interface, and exhaled air may be rebreathed. Rebreathing exhaled air for longer
than several minutes could, in some circumstances, lead to suffocation.
Indication of a:
- Positive Inspiratory Pressure
- Positive Expiratory Pressure
Compliance operation indicator
- 1 : compliance is on
- 0 : compliance is off
Device operation indicator
Indicator of patient respiratory
cycle detection (on the GK425ST
only)

Revision A
GoodKnight 425 / GoodKnight 425ST Patient Manual 13
3. If you are using a heated humidifier, turn it on according to its instructions for use.
4. Start the oxygen flow (if oxygen is used).
WARNINGS
•When the device is in operation mode, check that it delivers an air flow. If no air flow exists,
stop the device immediately and contact the service provider.
•At lower CPAP pressures, the flow through the exhalation port may be inadequate to clear all
exhaled gas from the tubing. Some rebreathing may occur.
Stopping Treatment
When the device is in operation, follow the instructions below to stop the treatment:
1. Stop the oxygen flow (if oxygen is used).
2. Remove the interface (nasal mask).
3. If you are using a heated humidifier, turn it off as described in its instructions for use. Always
disconnect the humidifier from the unit.
CAUTION
Do not leave the humidifier connected to the GoodKnight 425 or to the tubing when the
humidifier is not in use, to prevent humidity from entering the device or the sensing line and
degrading its performance.
4. Turn the device off by pressing the ON/OFF button. The device returns to standby mode and
displays the following standby screen that shows the time:
6:24 
CAUTION
Check that no humidity appears in the tubing, particularly in the sensing line. If so, let the
tubing dry before you use it again.

Revision A
14 GoodKnight 425 / GoodKnigh 425 ST - Patient manual
Using the Ramp Feature
The ramp function enables a gradual rise in pressure after turning the device on; that is, the pressure
levels are low at the start of the night to help you fall asleep. You can also use this function if you have
to get up during the night and have difficulty going back to sleep. The pressure “rise time” up to the
final pressures is prescribed by your medical team and the setting carried out by your service provider
is between 0 (no progressive rise) and 30 minutes in 5-minute increments. The ramp may have been
preset to 0 according to the prescription provided by your medical team. In this case, the ramp function
is disabled and pressing the Ramp button on the front panel of the machine has no effect (Figure 2,
item 3 on page 5).
The initial ramp pressure can be set to a value between 3 cmH2O and the Positive Expiratory Pressure
level prescribed by your physician. This function allows you to set the starting pressure level that
enables you to fall asleep.
To access the parameter setting menu, just press for one second the Information Access button
(Figure 10).
NOTE
This function can be used when the device is in either the standby mode or the operation mode.
Figure 10 – Control buttons
Repeatedly press the information button until the following screen is displayed:
3.0 cmH2O
P
Decreases the starting
ramp pressure
Increases the starting
ramp pressure
Information Access
button
Ramp indicator