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.

iv GoodKnight 425 / GoodKnight 425ST Patient Manual
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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

vi GoodKnight 425 / GoodKnight 425ST Patient Manual
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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.