Tyco GoodKnight 425 User manual

Ref. : M-145DFU00-30 Revision A
GoodKnight®425
GoodKnight®425 ST
Practitioner and
Service Provider manual
Manual de uso del proveedor de
servicios domiciliarios
Manual do Médico
e do Prestador de Serviço

Manufacturer
Fabricante, Fabricante
Mallinckrodt Développement France
Pôle Technologique de Brabois
10, allée Pelletier-Doisy
54601 Villers-lès-Nancy Cedex
France
Tel. [phone]
Technical agencies
U.S.A.
Tyco Healthcare Group LP
Nellcor Puritan Bennett Division
4280 Hacienda Drive
Pleasanton, CA 94588 USA
Technical Support: 1.800.635.5267
Tel. [phone]
Spain
España, Espanha
Tyco Healthcare Spain, S.L.
Fructuós Gelabert, 6
Planta baja
08750 Sant Joan Despí
Barcelona
Tel. [phone]
Portugal
Tyco Healthcare Portugal
Estrada do Outeiro de Polima, lote 10
1º Piso
Abóboda
2785-521 S Domingos de Rana
Tel. [phone]
United Kingdom
Reino-Unido
Tyco Healthcare
Technical Department
Unit 2
Talisman Business Centre
London Road
Bicester
Oxfordshire OX26 6HR
Tel. [phone]

GoodKnight 425 / GoodKnight 425 ST
Practitioner and
Service Provider manual 1
Manual de uso del proveedor de servicios
domiciliarios 15
Manual do Médico
e do Prestador de Serviço 29

GoodKnight 425 / GoodKnight 425 ST EN – 1
GoodKnight®425
GoodKnight®425 ST
Practitioner and
Service Provider manual

EN – ii GoodKnight 425 / GoodKnight 425 ST
List of revisions for the Practitioner
and Service Provider manual
GoodKnight®425 / GoodKnight®425 ST
The pages below are included in the Practitioner and Service Provider manual
Ref. M-145DFU00-30 revision A.
Current pages Revision
Cover A
List of revisions A
Table of contents A
Introduction A
1 – 13
A
Reference or revision Description Date
M-145DFU00-30 Revision A. Creation of the manual July 2004
© 2004 Puritan Bennett
All rights reserved.

GoodKnight 425 / GoodKnight 425 ST EN – iii
The information contained in this manual is a supplement to the GoodKnight 425 /
GoodKnight 425 ST patient manual (GK425/GK425 ST).
This manual is intended for the use of the Practitioner and the Service Provider.
Under no circumstances should it be supplied to the patient.
For all information related to the installation of the device and its accessories, please
refer to the patient manual.
The service provider may enter notes in the space provided in the back of the patient
manual.
All the information contained in this manual is valid for devices GoodKnight 425 and
GoodKnight 425 ST, unless stated otherwise.
The GoodKnight 425 device may be connected to a computer to adjust its settings and
recover data stored in its memory. The Silverlining®software is practical and user-
friendly. It easily displays, analyses and prints the collected data. For more information
about the software use, please refer to its separate user manual.
GoodKnight®is a registered trademark of Tyco Healthcare.

EN – iv GoodKnight 425 / GoodKnight 425 ST
This page is left blank intentionally

GoodKnight 425 / GoodKnight 425 ST EN – v
TABLE OF CONTENTS
BEFORE STARTING ...................................................................................................................................................... 3
SAFETY INSTRUCTIONS ............................................................................................................................................. 3
INDICATIONS FOR USE............................................................................................................................................... 3
PRECAUTIONS OF USE ............................................................................................................................................... 3
ACCESSING THE SETTINGS OF THE DEVICE ....................................................................................................... 4
DEFINITIONS ............................................................................................................................................................. 4
SETTING RANGES ...................................................................................................................................................... 5
SETTINGS.................................................................................................................................................................. 6
LIST OF AUTHORISED ACCESSORIES .................................................................................................................. 11
MASKS ................................................................................................................................................................... 11
HOSES .................................................................................................................................................................... 11
OTHER ACCESSORIES .............................................................................................................................................. 11
TECHNICAL CHARACTERISTICS........................................................................................................................... 13
DISPOSAL OF THE DEVICE AT THE END OF ITS LIFE................................................................................................... 13

EN – vi GoodKnight 425 / GoodKnight 425 ST
This page is left blank intentionally

GoodKnight 425 / GoodKnight 425 ST EN – 3
BEFORE STARTING
Safety instructions
In order to ensure safe and efficient device usage, read this operating manual as well as page 1 in
the patient manual. Please pay special attention to the passages preceded by the following terms:
WARNING There may be a danger of death or serious injury to the patient.
CAUTION There is a possibility of material damage to this or any other device.
NOTE Indicates special points aimed at more efficient and practical operation.
WARNINGS
1. Read the general warnings given in the patient manual.
2. Only use accessories authorised by the manufacturer, as listed in this manual.
3. The patient should receive the patient manual, as well as the instructions for using the
accessories.
4. Configure the GoodKnight 425 device according to the instructions given in this manual in
order to be able to use it under optimum conditions of safety and operation.
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 within a homecare and hospital
environment.
Precautions of use
The GoodKnight 425 device must be used with caution in patients presenting with the following
conditions:
·Pneumothorax or pneumomediastinum
·Severe bullous emphysema or previously complicated by pneumothorax
·Massive epistaxis or previous massive epistaxis
·Pneumoencephalus, trauma or recent surgery with the after-effect of a cranio-nasopharyngeal
fistula
·Acute sinusitis, otitis media or perforation of the tympanic membrane.

EN – 4 GoodKnight 425 / GoodKnight 425 ST
ACCESSING THE SETTINGS OF THE DEVICE
The GoodKnight 425 device detects the respiratory cycles of the patient and, in response to its
inspiratory and expiratory efforts, delivers two positive pressure levels, a high level of inspiratory
pressure IPAP and a low level of expiratory pressure EPAP.
If the inspiratory pressure level IPAP is equal to the expiratory pressure level EPAP, then the
device generates a continuous positive pressure during all the respiratory cycle.
The GoodKnight 425 device operates without Back-Up rate, whereas the GoodKnight 425 ST
device can operate with or without Back-Up rate.
The settings parameters are accessible, either directly on the device, or via the computer by using
the SilverLining software.
WARNING
Before setting the device, check that it delivers an airflow when it is in operation mode (see
chapter titled “Use” in the patient manual). In the opposite, stop it immediately and contact
the relevant technical department, listed at the beginning of the manual.
Definitions
Positive Inspiratory Pressure level (IPAP=Inspiratory Positive Airway Pressure) :
High pressure level for the inspiration.
Positive Expiratory Pressure level (EPAP=Expiratory Positive Airway Pressure) :
Low pressure level for the expiration.
Ramp time:
Period of time over which the pressure gradually increases from the starting ramp pressure
to the reference pressure levels with ramp activation.
Starting ramp pressure:
Pressure level at the start of ramp.
Session:
Period during which the data are recorded in the device memory between start-up and
standby. During a session, all the data are collected and displayed in a storage block (the
data cannot be displayed for a session part). A session is recorded if the device is on for 15
minutes without breaking off or after ramp time.
I/E ratio:
Ratio between the inspiratory time and the expiratory time.
Back-Up rate (on the GoodKnight 425 ST device only):
The Back-Up rate corresponds to the respiratory cycle which will be provided when the
device does not detect the patient respiratory cycle or when the patient spontaneous
breathing is lower than the prescribed Back-Up rate.

GoodKnight 425 / GoodKnight 425 ST EN – 5
Setting ranges
For each parameter, the following table shows the minimum, maximum and default values which
can be set:
Parameters Minimum
value
Maximum
value
Default
value
Step
GoodKnight 425
·IPAP level 3 cmH2O 25 cmH2O 15 cmH2O 0,5 cmH2O
·EPAP level 3 cmH2O IPAP or
20 cmH2O
5 cmH2O 0,5 cmH2O
·Ramp time 0 mn 30 mn 15 mn 5 mn
·Starting ramp pressure 3 cmH2OEPAP3cmH
2O 0,5 cmH2O
·Rise time 1
(about 300 ms)
5
(about 600 ms)
3
(about 450 ms)
1
·Inspiratory sensitivity 11051
·Expiratory sensitivity 11051
GoodKnight 425 ST only
·Back-Up rate 0 or 4 bpm 25 bpm 10 bpm 1 bpm
·I/E ratio 1/4 1/0,5 1/2 1/0,5
NOTE
The compensation in altitude (compared to the pressure) is carried out automatically by a pressure
sensor.

EN – 6 GoodKnight 425 / GoodKnight 425 ST
Settings
In order to restrict access of certain settings to the medical team, a hidden key has been provided on
the device. It is located under the letters “Go” in the “GoodKnight” name. This is detectable to the
touch as a hollow.
The parameter values may be changed by using the on/off and ramp keys as shown in the figure
“View of the control buttons”below:
View of the control buttons
NOTE
The layout of the buttons is the same on the GoodKnight 425 ST as on the GoodKnight 425, only
the device's name is different.
To access all the settings, press the hidden key for one second and then simultaneously the
information access key .
NOTES
·The symbol reminds you that the parameter value is adjustable.
·All the values displayed in the following screens are given as a guide only.
The screen displays:
F 10
Press the hidden
key for one
second and
key .
Back-up rate of the device.
NOTE
This function is accessible only on the GoodKnight 425
ST device.
Use the on/off or ramp key to increase or decrease the
Back-up rate value. This value is adjustable between 4
and 25 bpm.
If 0 is displayed, it means that there is no Back-up rate.
With each additional press of the information access key, the following settings will be available.
Information Access
button
Decreases parameter
values or enables / disables
some parameters.
Increases parameter
values or enables /
disables some parameters.
Hidden key (allows to move
back through the menu)

GoodKnight 425 / GoodKnight 425 ST EN – 7
15.0 cmH2O
P
Positive Inspiratory Pressure IPAP level set of your
device.
Press
You can increase or decrease the positive inspiratory
pressure level of the device by using the on/off or ramp
key. This value is adjustable between 3 cmH2O and 25
cmH2O.
5.0 cmH2O
P
Press Positive Expiratory Pressure EPAP level set of your
device.
You can increase or decrease the positive expiratory
pressure level of the device by using the on/off or ramp
key. This value is adjustable between 3 cmH2O and the
IPAP value or 20 cmH2O at the maximum.
15 min
Press
Ramp time.
You can decrease or increase the value displayed up to 30
minutes by using the ramp (down) or on/off (up) key.
3.0 cmH2O
P
Press
Starting ramp pressure (pressure level at the start o
f
ramp); this parameter is adjustable and visible only if the
ramp time value is greater than 0.
The value displayed can be decreased or increased,
between 3 cmH2O and the EPAP value, by using the
ramp (down) or on/off (up) key.
For further details, refer to the chapter titled “Using the
ramp” in the patient manual.
Press IE 1:2.0
I/E ratio (ratio between Inspiratory time / Expiratory
time); this parameter can be displayed only if the Back-Up
rate is greater than 0.
NOTE
This function is accessible only on the GoodKnight 425
ST device.
The value displayed can be increased or decreased by
using the on/off (up) or ramp (down) key.
However, certain conditions of Back-Up rate and
pressures can limit the possible extent of this parameter
adjustment.
IS : 5
Press Inspiratory sensitivity.
The value displayed, adjustable between 1 and 10 (1 is the
more sensitive setting), can be increased or decreased by
using the on/off (up) or ramp (down) key.

EN – 8 GoodKnight 425 / GoodKnight 425 ST
ES : 5
Press Expiratory sensitivity.
The value displayed, adjustable between 1 and 10 (1 is the
more sensitive setting), can be increased or decreased by
using the on/off (up) or ramp (down) key.
rt : 3
Press Pressure rise time (period of time over which the
pressure increases from the EPAP level to the IPAP level).
It can be decreased or increased, between 1 (about 300 ms)
and 5 (about 600 ms), by using the ramp (down) or on/of
f
(up) key.
However, certain conditions of Back-Up rate, pressures
and I/E ratio can limit the possible extent of this parameter
adjustment.
325 h
Press
15
Hour meter value (device operating time). The value
displayed on the right below represents the minutes.
NOTE
The hour meter value cannot be changed.
396 h
Press
32
Use meter value (time after the ramp time or 15 minutes
during which the patient has breathed with the mask). The
value displayed on the right below represents the minutes.
NOTE
The use meter value cannot be changed.
234
Press
Offset of the pressure sensor integrated into the
GoodKnight 425 device. You can increase or decrease the
value displayed by using the on/off (up) or ramp (down)
key. This value can be adjustable between 0 and 255. To
set it, refer to the section “Adjustment of the pressure at
the device outlet” on page 9.
Id *.*
xx
Press Software version.
The version number is shown in two digits (*), for
example the screen may display : Id 1.0 and the value
displayed on the right below represents the motor driver
version.
CAUTION
If, when in use, the device stops and displays the message Er 1, this means a problem was detected
in the settings stored. In this case, press the information access button, the device displays the
« dEF » blinking message, then press the on/off button The machine is then automatically reset
to the default values and you must set the desired parameters again.
To exit the parameter setting menu, press again the information access button.

GoodKnight 425 / GoodKnight 425 ST EN – 9
In this case, one of the following two screens indicates the status of your equipment (the values
displayed are given as a guide only).
9:34 ¹9.0 cmH2O
1
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.
Adjustment of the pressure at the device outlet
Connect the spiral hose to the device and the small hose that emerges through the spiral hose to the
pressure point. Connect the hose’s free nozzle to a plug equipped with a 4 mm leak and a pressure
point. Turn the device blower on, then connect the pressure point to a manometer and adjust the
pressure order to 14 cmH2O. Access to the pressure sensor offset setting as described in the section
titled « Settings » of this manual. Adjust the value by using the on/off (up) or ramp (down)
key in order to read a pressure equal to 14,0 cmH2O on the manometer. Then, while
maintaining the pressure on the hidden key, press the information access key. The pressure
sensor offset setting is automatically memorized.
Change of unit of pressures displayed
The unit of the pressures displayed may be changed between cmH2O and hPa, and conversely.
To change it, press and hold the hidden key while you connect the device to the electrical outlet (by
the power supply module). The machine displays the new unit selected until you release the
pressure on the hidden key. To change again the unit displayed, repeat the process.
Compliance operation indicator
- 1 : compliance on
- 0 : compliance off
Indication of the:
Positive Inspiratory Pressure IPAP
Positive Expiratoire Pressure EPAP
Indicator of patient respiratory cycle
detection (on the GK425ST only)
The two points are blinking.

EN – 10 GoodKnight 425 / GoodKnight 425 ST
Setting the time
You can set the time only when the device is on standby. To do so, press the ramp button for
one second, and then the on/off button at the same time. If you release the pressure on the
buttons, the symbol of adjustment appears under the hour, as shown on the screen hereafter:
11:12 h
¹
The letter h indicating the hour blinks, you can then increase and decrease it using the ramp and
on/off keys.
To set the minutes, press the information access button, the minutes symbol blinks and you can set
them by following the same procedure as for the hour.
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.
To set the date, please refer to the SilverLining with GoodKnight 425 user manual.

GoodKnight 425 / GoodKnight 425 ST EN – 11
LIST OF AUTHORISED ACCESSORIES
You will find below the accessories which can be used with the GoodKnight 425 device.
Masks
Nasal+confort mask with 4 mm calibrated vent (6 sizes):
Ref. M-2680x0-05 where x varies from 2 to 7.
Nasal+confort mask without 4 mm calibrated vent (6 sizes):
Ref. M-2680x0-06 where x varies from 2 to 7.
Nasal+ mask with 4 mm calibrated vent (6 sizes):
Ref. M-2680x0-02 where x varies from 2 to 7.
Nasal+ mask without 4 mm calibrated vent (6 sizes):
Ref. M-2680x0-04 where x varies from 2 to 7.
WARNING
The Nasal+ and Nasal+confort masks without vent must be used with the Pirouette Port.
Nasal interface Breeze:
Ref. Y-101400-00.
DreamSeal™ mask:
Ref. Y-103074-00A ; Y-102616-00 ; Y-103059-00A.
Hoses
Adam hose:
Ref. S-133293-00 ; S-133294-00.
22mm Æhose:
Ref. M-261000-27 (1,80 m); M-261000-30 (2,70 m).
Other accessories
Oxygen adaptor:
Ref. Y-616155-03.
Pirouette port:
Ref. M-368010-00 (x1), M-368011-00 (x5).

EN – 12 GoodKnight 425 / GoodKnight 425 ST
Heated humidifier:
Fisher & Paykel HC100 and HC150.
Heated humidifier GoodKnight H2O:
Ref. M-114600-UK.
Adam Pillows (7 sizes):
Ref. S-616323-00A, S-616324-00C, S-616325-00A, S-616355-00C, S-616356-00C,
S-616357-00C, Y-101969-00.
Air inlet filter:
Ref. M-413950-02.
Thin filter:
Ref. M-413950-04.
Serial connection cable:
Ref. M-213930-04.
Battery cable:
Ref. M-214530-00
Battery cable/cigarette lighter plug:
Ref. M-214530-01
Carrying case:
Ref. M-213930-01
Kit modem Ref. M-213930-12 including:
GK418 modem cable Ref. M-213530-11
GK420 modem adapter Ref. M-213930-05