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GoodKnight® 425
SERVICE MANUAL
GoodKnight® 425ST
P/N: M-145MAT00-20 Revision A
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This document is the property of NELLCOR PURITAN BENNETT, Inc and is distributed on the express condition that
it is neither divulged nor reproduced in part or in full by anyone other than NELLCOR PURITAN BENNETT, Inc without prior written agreement, and no right is granted to divulge or use any information contained in this document.
ã Copyright NELLCOR PURITAN BENNETT, Inc - 2004
ALL RIGHTS RESERVED
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
1
Page 4
PREFACE
This manual provides information necessary to service the GoodKnight 425 and the GoodKnight
425ST Respiratory System. This information is intended for use by technicians or personnel qualified to repair and service medical equipment. The information is not exhaustive and may not be applicable to future models.
DEFINITION OF STATEMENTS
Statements in this manual preceded by the followings words are of special significance.
WARNING
Means there is the possibility of injury or death to yourself or others.
NOTE
Indicates points of particular interest for more efficient and convenient operation.
CAUTION
Means there is the possibility of damage to the GK 425/425ST unit or other property.
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
2
Page 5
REVISION LIST OF
GoodKnight 425 / 425ST Service Manual
This list of effective pages represents manual P/N M-145MAT00-20, revision A.
Revision Description Date
A
05/2004
Effective Pages Revision Effective Pages Revision
All pages A
Initial Release.
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
3
Federal law restricts this device for sale by or on the order of a physician.
Page 6
GoodKnight 425 / 425ST Service Manual
CONTENTS
PREFACE 2
REVISION LIST
3
I - GENERAL INFORMATION I-1
A. SPECIFICATIONS I-2
1) Performances I-2
2) Electrical specifications
I-2
3) Environmental specifications
I-3
4) Physical specifications
I-3
5) Pressure stability
I-3
6) Dynamic resistance
I-4
B. USING A HUMIDIFIER I-4
C. SYMBOLS I-5
D. CLEANING INSTRUCTIONS I-6
1) GoodKnight 425 / 425ST I-6
2) Air filter
I-6
E. DISPOSAL OF THE DEVICE AT THE END OF ITS LIFETIME I-6
II - THEORY OF OPERATION II-1
A. GENERAL DESCRIPTION II-2
1) General design synopsis II-2
2) View of the control panel
II-2
3) Description
II-3
4) Inspiratory/Expiratory sensitivity
II-3
5) Temperature Sensor
II-4
6) Rise Time
II-4
7) Pneumatic Diagram
II-4
P/N: M-145MAT00-20 Rev. A - Page Rev.A
4
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GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
5
B. ELETRICAL DIAGRAM II-5
1) General Block diagram II-5
2) Micro-controller
II-6
3) Pressure measurement chain block diagram
II-7
4) Flow measurement chain block diagram
II-7
5) Temperature measurement
II-8
6) Serial Link
II-8
III - SERVICE AND REPAIR III-1
A. PERFORMANCE VERIFICATION III-3
1) General information III-3
2) Frequency
III-3
3) Equipment required
III-3
4) Preparation for testing
III-4
5) Verification with computer
III-5
5-a) Preparation
III-7
5-b) Pressure verification and calibration III-7
5-c) Verification of the Flow measurement chain
III-8
5-d) Verification of the ramp
III-9
5-e) Verification of the backup frequency (425ST only)
III-9
6) Performance Verification with keypad
III-10
6-a) Verification of the pressure without computer
III-10
6-b) Ramp verification
III-12
6-c) Verification of the backup frequency (425ST only)
III-13
7) Configuration with factory settings
III-14
8) Entering the serial number and hour meter values
III-15
9) “Service” hour meters
III-15
10) Setting the Clock with keypad
III-16
B. CALIBRATION PROCEDURE III-18
1) Equipment required III-18
2) Pressure sensor calibration
III-19
3) Flow sensor calibration
III-20
C. DISASSEMBLY III-22
D. TROUBLESHOOTING GUIDE III-20
Information Messages
III-21
E. ERROR MESSAGES III-26
¨ HISTORY RECORD FORM III-27
IV - SPARE PARTS IV-1
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GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
6
Page 9
I - GENERAL INFORMATION
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev. A
I-1
Page 10
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev. A
I-2
A. SPECIF ICATIONS
1) Performances
GoodKnight 425 and GoodKnight 425ST
Ä Pressure adjustment range
IPAP: 3 to 25 cmH
2
O in 0.5 cmH2O increments
(see note 1)
EPAP: 3 to PIP (maximum 20 cmH
2
O)
Ä Pressure setting accuracy: ± 0.5 cmH
2
O (see note 2)
Ä Flow range 0 to 90 l/min @ 3 to 25 cmH2O
(while maintaining pressure setting accuracy)
Ä Ramp (adjustable) disabled, or 5 to 30 min in 5 min increments
Ä Rise Time (rt) 1 to 5 in 1 increment
Ä Expiratory / Inspiratory sensitiviy 1 to 10 in 1 increment
GoodKnight 425ST only
Ä Backup Frequency Disabled (0) or activated 4 to 25c/min
Ä I/E ratio 1:4.0 to 1:0.5 in 1:0.5 increment
Ä Setting restrictions: The maximum duration of the IPAP pressure is limited to 3 sec-
onds. Consequently certain combinations of frequency, rise time and I/E ratio will be
forbidden, especially for low frequency setting.
As well, certain combinations of frequency, rise time and I/E ratio which prevent the
IPAP set pressure to be reached will be forbidden, especially for high frequency setting.
NOTE 1
The display can be in “hPa”. The pressure adjustment range is then between 2.9 hPa
and 24.5 hPa. To select the unit, unplug the device, depress the hidden key and recon-
nect the device, keeping the hidden key depressed until the unit is displayed.
NOTE 2
All the stated performances are for a 6 ft (1.80-meter) patient circuit, recommended by
the manufacturer, fitted with a stopper with a 4 mm diameter leak.
Page 11
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev. A
I-3
2) Electrical specifications
Power supply
Ä External Power Supply Class II 100-240 VAC 50/60 Hz—13VCC 4A
Goodknight
Ä Consumption 40 VA max.
Ä Current consumption 1.1A @ 25cmH
2
O with 4 mm leak
3) Environmental specifications
Ä Storage / Transport temperature -20° C to 60° C
Ä Storage / Transport humidity up to 95 % (non-condensing)
Ä Operating temperature +5° C to +40° C
Ä Operating humidity between 15 % and 95 % (non-condensing)
Ä Operating relative pressure 700 hPa to 1060 hPa (approximately up to
altitude of 7874 ft -2.400 m)
4) Physical specifications
Ä Width 5.6” (144 mm)
Ä Height 2.9” (79 mm)
Ä Length 7.7” (198 mm)
Ä Weight (without external power module) 1.58 lbs (780 g)
5) Pressure stability (static mode)
The measured pressures are the pressures measured under a positive airflow continuous of
100 l/min. These measurements were made with a single unit.
Set Pressure
(cmH
2
O)
Measured Pressure
(cmH
2
O)
4 3.8
8 7.8
12 11.7
20 19.9
Page 12
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev. A
I-4
6) Dynamic resistance
The values below were measured from a simulated sinusoidal respiratory signal with a tidal volume
of 500 ml after a warm-up period of 2 hours. These measurements were made with a single unit.
B. USING A HUMIDIFIER
A heating or non-heating humidifier may be used with the GoodKnight 425 / 425ST on the
condition that the following warnings are noted.
WARNING
You are strongly advised to read the manufacturer’s recommendations for the humidi-
fier before use.
WARNING
Using a humidifier can alter the performance of the GoodKnight 425 / 425ST.
WARNING
The GoodKnight 425 / 425ST must always be placed above the humidifier. This position
will minimize the potential for water entering the Cpap device.
Water can damage the device.
Pre ss ure @ Freque ncy Variation in pressure
(CmH2O)
Variation in airflow
(l/s)
Dynamic resistance
(CmH2O/l/s)
7cmH2O @ 10c/min 0,28 0,66 0,42
7cmH2O @ 15c/min 0,37 0,98 0,38
7cmH2O @ 20c/min 0,58 1,28 0,45
14cmH2O @ 10c/min 0,38 0,70 0,54
14cmH2O @ 15c/min 0,43 1,03 0,42
14cmH2O @ 20c/min 0,64 1,33 0,48
20cmH2O @ 10c/min 0,58 0,88 0,58
20cmH2O @ 15c/min 0,50 1,07 0,47
20cmH2O @ 20c/min 0,64 1,26 0,51
Page 13
GoodKnight 425 / 425ST Service Manual
C. SYMBOLS
P/N: M-145MAT00-20 Rev. A - Page Rev. A
I-5
SYMBOLS DEFINITIONS
Alternating current
Direct current
Class 2 Equipment
Type B
Warning ! Consult instructions
before using this unit.
On / Off
Access to settings
Ramp
RS 232
Increase or decrease the adjustment values
Device protected against the vertical falls of water drops.
Federal law restricts this device for
sale by or on the order of a physician. (US Only)
Input DC voltage 13 V
Patient Output
Device complies with the requirements of the Standard CSA C22.2
Nr 601-1. (Canada)
~
Rx ONLY
Page 14
GoodKnight 425 / 425ST Service Manual
D. CLEANING INSTRUCTIONS
1) GoodKnight 425 / 425ST
Frequency
As necessary
How to clean
Wipe with damp cloth moistened with warm, soapy water.
Wipe dry.
2) Air filter
Frequency
Inspect the air filter frequently by removing it from the back panel.
Clean at least once a week or more often, if necessary.
How to clean
Wash in warm, soapy water. Rinse thoroughly to remove all soap.
Pat dry with towel. Allow to air dry completely before reinstalling.
Replace filter if worn or damaged.
E. DISPOSAL OF THE DEVICE AT THE END OF ITS LIFETIME
In order to preserve the environment, the various parts of the device and its accessories must
be disposed of at approved waste sites in accordance with current regulations.
WARNING
Unplug the unit from all electrical power sources before cleaning. Do not allow
water to enter the unit through any opening.
CAUTION
Only the standard air filter can be cleaned. The fine filter supplied as an option and
fitted in addition to the standard air filter, cannot be cleaned. It must be changed.
P/N: M-145MAT00-20 Rev. A - Page Rev. A
I-6
Page 15
II - THEORY OF OPERATION
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-1
GoodKnight 425 / 425ST Service Manual
Page 16
A. General description
1) General design synopsis
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-2
2) View of the control panel
Ramp activation or
Parameter settings
Hidden Key
LCD Display
On/Off
or
Parameter settings
Information
Access button
GoodKnight 425 / 425ST Service Manual
Current
Alarm Curre nt
Flow direct
Flow filtered
Bus //
Bus I2C
Current filtered
Fl
ow
Pressure filtered
ErrorMotor
BusyI2CMaster
BusyI2CMoto
r
Backlight
Set-up
Battery
Microcontroler
C50 8
Motor driver
Power
Driver
Blower
tection
l
terin
g
lat ion 5V
Current
Measurement
Pressure
Sensor
RTC +
RAM 56 octets
Patien
t
In terf a
c
Air
Input
Power AC
al M odule
C
/DC
le LCD
yp
ad
l Link
Microcontroler
C508
Master
RAM
64 ko
M
ko
Flow
Sensor
Voltage
Reference
Con tro ler of
NVRAM
Watchdog
Reset
Motor Reset
Set Change
Type cycle
Respiratory phase
C
T
N
Temperature Blower
WDI C
E
Slope
External Module
AC/DC
Protection
Filtering
Regulation
5V
Main Power AC
LCD Module
Keypad
Serial Link
ROM
64K
P
i
t
o
t
Patient
Inte rface
Page 17
3) Description
The general architecture of the device is based on the use of a blower (pressurised air generator) and two micro-controllers (one for the general functions of the unit and another one for
the motor control).
Some functions are hardware-controlled, some are software-controlled and others are a mixture of hardware and software.
The GoodKnight 425 BiLevel is a BiLevel positive airway pressure device used in the treatment of obstructive sleep apnea or for the titration in the sleep lab of a patient having obstructive sleep apnea. It is intended to treat OSAS patients who are over 30 kg in weight (66
pounds).
In the BiLevel mode the GoodKnight 425 tracks patient breathing cycles and, in response to
the patient’s inspiratory and expiratory efforts, provides two levels of pressure :
-IPAP : a higher level of pressure for inspiration (a range from EPAP to 25 cmH2O)
-EPAP : a lower pressure for expiration (a range from 3 to IPAP or 20 cmH2O).
-If IPAP is equal EPAP, than the unit operates in CPAP mode.
The GoodKnight 425 BiLevel is a microprocessor-controlled pressure generator capable of
controlling the pressure delivered to the patient. Among its operating features are:
* GK425
ST in CPAP, BiLevel with and without backup frequency
* GK425 in CPAP, BiLevel without backup frequency.
* Monitors pressure, respiratory rate, I/E ratio and compliance.
* Adjusts inspiration and exhalation flow-triggered sensitivity independently to provide
precise patient comfort.
* Provides a maximum pressure setting of 25 cmH2O
* Compensates automatically for altitude and for leaks up to a total flow rate of 120 liters
per minute, on top of the usual 4mm non re-breathing leak at 20 cmH2O.
The GoodKnight 420 Series benefits from a new blower technology that is specifically
designed for this range of Cpap systems. This design provides optimum performances in
terms of size, consumption, noise and stability.
In order to guarantee these optimum performances, some parameters are electronically
tuned during the manufacturing process. These parameters are calculated for each
blower and cannot be duplicated for another one. For this reason it is not possible to
change a blower or an electronic board. In the event of failure, an internal chassis assembly fitted with a factory-set blower and electronic board is available.
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-3
4) Inspiratory and Expiratory sensitivity
The trigger of sensitivity can be set with a scale of 1 to 10.
1= The lower triggering level = The highest sensitiv ity,
10=The highest triggering level = The lower sensitivity.
GoodKnight 425 / 425ST Service Manual
Page 18
7) Pneumatic diagram
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-4
5) Temperature Sensor
The stator of the blower is fitted with a temperature sensor which will protect the system
against the overheating of the blower in the eventuality of a problem.
The GoodKnight BiLevel will stop working if the temperature goes above 95°C +/-5°C during
10 seconds.
6) Rise time (rt)
The rise time between EPAP and IPAP can be set from about 300ms/ 10 cmH
2
O to about
600ms/10 cmH
2
O. This rise time is adjustable on a scale of 1 to 5:
1 ~
300ms / 10cmH2O
2 ~
375ms / 10cmH2O
3 ~
450ms / 10cmH2O
4 ~
525ms / 10cmH2O
5 ~
600ms / 10cmH2O
GoodKnight 425 / 425ST Service Manual
DC Motor
Blower
Impeller
Sensor
Humidifier
(optional)
Nasal mask
or
Flow
Output
connector
nasal pillows
Patient
tube
Inlet filter
Pressure sensor
tube
Pressure Sensor
Pitot Tube
Electrical system
Air
Page 19
B. ELECTRICAL DIAGRAM
1) General block diagram
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-5
GoodKnight 425 / 425ST Service Manual
Case
Main Pow er
AC
13Vcc-4A
Serial Link
1.1.2 Power Supply
1.1.3 AC
External Power Supply
External Module
AC/DC
100 – 264 Vac
1.1.1.1 13Vcc
/ 24W
Interface
Serial Link
Protection
and
Filtrage
Moteur Driver
Blower
Electronic
Regulation
5V
Air
Input
Case GK420
Isol ation
Barrier
4kV
Pressure
Sen sor
Pressure
Sensor
Pitot
tube
PATIENT
Flo w
Sensor
Page 20
2) Micro-controller unit block diagram
a) Micro-Master
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-6
b) Micro-Motor
GoodKnight 425 / 425ST Service Manual
Motor
Bridges
MOSFET
Interfaces
µC
MOTOR
P12/CC0
P13/COUT0
P14/CC1
P15/COUT1
P16/CC2
P17/COUT2
Data
Memory
SRAM
64 ko
CS
WE
OE
µC
MASTER
P51
Reset
WR
RD
Vcc
A15
A8
AD7
AD0
ALE
Software
Memory
ROM
64 ko
CS
G
A0-7
AD0 – 7
D0 – 7
Multiplexer
MAX691
WDI
Reset
Page 21
3) Pressure measurement chain
4) Flow measurement chain
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-7
Pressure
Sensor
Filter RC
Lowpass
Fc = 152 Hz
Follower
µC
MASTER
and
MOTOR
Patient
Tube
Flow
Flow
Sensor
Amplifier
differential
G = 40
Offset
Adjustment
Gain
Adjustment
Linearity
Filter
Hightpass
fc = 7,23 Hz
Filter
Lowpass
fc = 0,17Hz
P42
µC
MASTER
and
MOTOR
P43
P45
Flow filtered
Direct Flow
GoodKnight 425 / 425ST Service Manual
Page 22
P/N: M-145MAT00-20 Rev. A - Page Rev.A
II-8
5) Temperature measurement
6) Serial Link
PC
Tx
Rx
µC
MASTER
P30/RxD
P31/TxD
Interface
RS232
Connector
RS232
Blower
CTN
Linearity Follower
µC Master
GoodKnight 425 / 425ST Service Manual
Page 23
III - SERVICE AND REPAIR
GoodKnight 425 / 425 ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-1
Page 24
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-2
This section describes how to service the individual subassembly of the GoodKnight 425
and 425ST Cpap System. It includes instructions where applicable, for removal, disassembly, calibration, re-assembly and installation.
GoodKnight 425 / 425 ST Service Manual
WARNING
The GK 425 and 425ST Cpap System is electrically powered. To prevent seri-
ous injury or death, follow standard safety procedures. Ensure that power
has been disconnected from the unit before servicing any component.
WARNING
After a component has been serviced, the unit must be calibrated and the overall
system operation checked according to the “Performance Verification” section,
before the unit is returned to service.
CAUTION
Circuit boards contain complementary metal-oxide semiconductor (CMOS) integrated circuits (ICs) which are static sensitive devices. To prevent IC damage, follow
the standard safety procedures :
-handle circuit boards by edges only,
-wear a grounded wrist strap,
-work on a grounded conductive mat
-store circuit board in a conductive plastic bag.
CAUTION
Allow to warm up for half hour before carrying out the performance verification and/
or the calibration procedure.
Page 25
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-3
GoodKnight 425 / 425 ST Service Manual
A. PERFORMANCE VERIFICATION
1) General information
The performance verification should be carried out for any one of the following reasons:
· to determine the cause of operational failure,
· to check the overall operation of the GK 425/425ST system after repair,
· to check that the GK 425/425ST system is operating within specification.
During this verification, the following parameters will be tested :
-Pressure accuracy,
-Flow measurement chain
-Ramp and starting ramp pressure,
-Back-up frequency (425ST only).
2) Frequency
Þ annually,
Þ after repair.
3) Equipment required
· Calibrated pressure meter 0-30 cm H
2
O (local source),
· Patient tube P/N : M-261000-27,
· Test kit P/N : M-212430-02 (consists of a coupling 22/22 mm and a stopper with a
4 mm diameter leak),
· PC computer with Silverlin ing software,
· Serial link cable,
· Calibrated leak M-BH0210 and connecting tube M-213530-05.
Page 26
4) Preparation for testing
a - Verification of the pressure
b - Verification of the flow measurement chain
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-4
Figure 3-2
Calibrated output M-BH0210
Figure 3-1
Pressure meter PTS 2000 P/N: 4-076185-00
Patient tube M-261000-27
Test Kit
with 4 mm leak
P/N: M-212430-02
(i nclud ing coupl ing)
Coupling
Connecting tube
M-213530-05
GoodKnight 425 / 425 ST Service Manual
Page 27
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-5
5) Performance verification with a computer.
5-a) Preparation
- Set the material as shown on figure 3.1 page III-4
- Connect the GoodKnight 425/425ST to your PC,
- Open the Silverlining 3 software,
- The following menu appears,
- The following display appears,
Click on "CPAP or BiLevel connection "
GoodKnight 425 / 425 ST Service Manual
CAUTION
Allow to warm up for half hour before carrying out the performance verification and/
or the calibration procedure.
Page 28
- The following screen appears:
- Enter the password. The password is given to technicians who have been trained by
the manufacturer or a person accredited by the manufacturer.
- After entering the password, press the “Enter” key or click on OK. The following
screen appears :
Alt F9 Control
- Press the three following keys of your computer keyboard simultaneously:
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-6
GoodKnight 425 / 425 ST Service Manual
Note: In some case, depending of the computer, the
combination of key (ctrl, alt, F9) does not operates.
In this case press one time on the key « S » and then
with the left button of the mouse click on the picture
of the computer displayed on the screen.
Page 29
- Click on “Calibrations” and the following screen appears,
Setting cursor
5-b) Pressure Verification and Calibration
-Click on the button "14 cmH
2
O" and verify that the pressure meter is reading:
14 cmH
2
O + 0,5 .
Adjust if necessary the offset of the menu "Pressure/Pression" with the setting cursor
until the pressure meter is reading 14cmH
2
O.
-Click on the button "25 cmH
2
O" and verify that the pressure meter is reading:
25 cmH
2
O + 0,5 .
-Click on the button "3 cmH
2
O" and verify that the pressure meter is reading:
3 cmH
2
O + 0,5 .
Click on the button " Storage/Mémorisation " of the menu "Pressure/Pression"
to store the setting.
{
Menu "Pressure/Pression"
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-7
GoodKnight 425 / 425 ST Service Manual
CAUTION
Allow to warm up for half hour (Cpap mode; P=14cmH2O; plug test with 4mm
leak) before carrying out the performance verification and/or the calibration
procedure.
Page 30
5-c) Verification of the flow measurement chain
Prepare the unit under testing as show in the figure 3.2 page III-4
Setting cursor
-Set the pressure with 14 cmH
2
O,
-BLOCK the calibrated output.
Step #1
-Wait for the “Value” reading on the screen to become stabilized,
-Verify that this “Value” of the menu “Flow/Débit” is reading:
0 l/s (+/- 0.1)
-If not, adjust the Offset with the setting cursor in order to read in the display “Value”
0 l/s +/-0.1, and then store with the button “Storage”.
-If the value read is within specification, go to step #2.
-If the value reading is not within specification, perform the calibration of the
flow sensor described page III-20. Do not go to the step #2
Step #2
-Unblock the calibrated output,
-Wait for the value reading on the screen to become stabilized,
-Check the value reading on the screen in the “Flow/Débit” menu is reading:
1.2 l/s (+/- 0.1)
-If the value reading is within specification, the verification is good.
-If the value reading is not within specification, perform the calibration of the
flow sensor described page III-20.
{
Menu "Flow/Débit"
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-8
GoodKnight 425 / 425 ST Service Manual
Page 31
5-d) Verification of the ramp
Click on the button "Test R" (Test of Ramp). The unit is set with a 5 minutes ramp, start pressure 3 cmH
2
O , end pressure 20 cmH2O.
Verify that the pressure runs from 3 to 20 cmH
2
O in the time of::
5 minutes +/- 20 seconds.
5-e) Verification of the back-up frequency
(425ST only)
Click on the button "Test F" (Test of Frequency). The unit is set with a frequency of 10 cycles /
min.(IPAP=14; EPAP=8; I/E=1:1.0). Verify that the pressure is switching from EPAP to IPAP
in 10 cycles +/- one cycles per minute.
The performance verification of the unit is now ended.
Click on the EXIT button to leave of the technical menu. The unit will retrieve its previous
settings (settings before the technical action).
NOTE
Some verifications can be performed without a computer (section 6 page III-10). In
order to do them you have to select the corresponding settings with the keypad. (refer
to the sections verification of the pressure, the ramp and the back-up frequency in the
following pages).
The verification of the pressure will not be total (maximum pressure in Cpap mode
=20 cmH
2
O).
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-9
GoodKnight 425 / 425 ST Service Manual
Page 32
6) Performance verification with Keypad
6-a) Verification of the pressure without computer
Set the material as shown on figure 3.1 page III-4
Action Keys(s) Display
#1-Connect the device on the main power.
XX.XX is the current time.
#2-Press on the two keys opposite and keep them
depressed for 2 seconds. The menu displayed opposite appears (Set frequency).
#3-Press the opposite key to enter in the setting
of the IPAP pressure.
#4-Select P = 14 cmH2O with the two keys opposite, then press the following key:
#5-Select EPAPA = 14 cmH2O with the two
keys opposite, then press the following key.
#6-Press the opposite key as many times as necessary to return into stand by mode (current time
displayed)
#7-Turn on the unit and leave running for 1/2
hour
Hidden Ke
y
XX: XX
XX
cmHO
c
mH
XX: XX
NOTE
According to the settings limitation it will not be possible to verify the pressure
higher than 20 cmH
2
O. The pressure verification for 25 cmH2O can be done only
with the computer and the software Silverlining.
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-10
GoodKnight 425 / 425 ST Service Manual
Page 33
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-11
Action Key(s) Display
Check the measured value on the pressure meter, the value must be 14 cmH2O ± 0.5.
If yes, go to point #12
If not, go to point #8
#8-Press on the two keys opposite and keep them
depressed for 2 seconds. The menu displayed opposite appears (Set frequency).
#9-Press the key opposite several times until the
display opposite appears (mode calibration).
XXX is a value between 0 and 255.
#10-Adjust the value with the keys opposite until
the pressure meter is reading 14 cmH
2
O.
#11-Record the selected value by pressing the
hidden key, keeping it depressed and pressing
the access key..
#12-Go to points #2 to #5 and select
EPAP=IPAP= 20 cm H
2
O.
Check the measured value on the pressure meter, the value must be 20 cmH2O ± 0.5
#13-Go to points #2 to #5 and select
EPAP=IPAP= 3 cmH
2
O.
#14-Press on the key opposite to switch off the
units (display the current time). The pressure
verification is ended.
Check the measured value on the pressure meter, the value must be 3 cmH2O ± 0.5
If one of these two verifications is not within specification, set IPAP=EPAP=14 cmH
2
O and
go to step #8.
cmH
O
c
mH
Hidden Key
Hidden Key
c
mH
c
mH
XX: XX
XX
XXX
XXX
XXX
GoodKnight 425 / 425 ST Service Manual
Page 34
6-b) Verification of the ramp without computer
Realise the test set up figure 3.1 page III-4
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-12
Action Key(s) Display
#1 to #5-Follow steps #1 to # 5 according to page
III-10 and set pressure P= 20 cmH
2
O and then-
press on the key opposite.
#6-Press the key opposite to access to the ram
time set menu. XX is a value between 0 and 30.
#7-Select ramp = 5 min. with the two keys opposite.
#8-Press the key opposite for the display shown
opposite to appear (start ramp pressure set mode.
XX is the pressure value to set).
#9-Select the start pressure to 8 cmH2O with the
two keys opposite.
#10-Press the key opposite several times until
stand by mode (current time displayed).
#11-Switch on the unit and when the pressure
has reached 20 cmH
2
O, press on the key opposite
in order for the pressure to fall down to 3
cmH2O.
#12-Check that the pressure increases from 3 cmH
2
O to 20 cmH2O in 5 minutes +/- 20 seconds.
X
X
min
X
X
cmH
O
cmH
O
min
c
mH
cmH
O
XX
X
XX: XX
GoodKnight 425 / 425 ST Service Manual
Page 35
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-13
6-c) Verification of the back-up frequency without computer
Realise the test set up figure 3.1 page III-4
Action Key(s) Display
#1-Connect the unit on the main power (via the
external power supply), XX.XX is displayed.
(XX.XX is the current time).
#2-Press on the two keys opposite and keep them
depressed for 2 seconds. The menu displayed opposite appears (Set frequency).
#3-Press on one of the two keys opposite to set
F= 10, and press on the following key:
#4-Select P = 14 cmH2O with the two keys opposite, and press on the following key:
#5-Select P = 8 cmH2O with the two keys opposite, and press on the following key several time
to access to the I/E ratio set menu:
#6-Select I/E ratio = 1:1.0 with the two keys opposite
#7-Press the opposite key as many time as necessary to return into stand by mode (current time
displayed)
Switch on the unit and verify the pressure to run from EPAP to IPAP 10 time +/- one time
per minute.
XX: XX
XX
cmHO
c
mH
XX: XX
Hidden Ke
y
GoodKnight 425 / 425 ST Service Manual
Page 36
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-14
7) Configuration with factory settings
a) With the computer
When you select the “Reprogramming device” menu (see page III-6) and you click on
“OK”, the following two operations occur:
-The reconfiguration erases all recorded data,
-The following default factory parameters are set:
· Back up Frequency: Fr=10 (425ST only)
· IPAP=15
· EPAP=5
· Ramp=15 min
· Start ramp pressure = 3cmH
2
O
· I/E Ratio = 1:2.0 (425ST only)
· Inspiratory sensitivity SI=5
· Expiratory sensitivity SE=5
· Rise time: rt=3
· Patient reference: = R + last 7 numerals of the serial number,
· Inventory number = 0000000000.
b) With the Keypad (In case of error message Er 01)
When an Er 01 is displayed the device is not able to communicate with the computer.
-Press on the key:
-The word “Def” is displayed on the device
-Press on the key:
-The default factory parameters will be set:
-The screen remains blank for a few seconds and then returns to normal mode.
GoodKnight 425 / 425 ST Service Manual
Page 37
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-15
8) Entering the serial number and the hour meter values
1- Follow the same steps as those described on pages III-5 to III-6 (Performance Verifi-
cation).
2- After entering the password (page III-6), click on the “Serial number and meters”
menu and follow the screen instructions.
CAUTION
The serial number must match the one printed on the base of the device.
The manufacturer is not responsible for any fraudulent use that might result from modification
of the serial number.
9) Service hour meters
The GoodKnight 425/425ST has two additional “tools” to help you in planning the
maintenance of your device.
These two meters can be customized (choice of the name) and can be reset as necessary.
To use it, follow the steps described on pages III-5 and III-6. After entering the password (page III-6), click on the “Serial number and meters” menu and follow the screen
instructions.
GoodKnight 425 / 425 ST Service Manual
Page 38
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-16
Action
Key(s) Display
#1-The device is in stand-by mode (the clock is
displayed). Press the first key opposite and keep
depressed. Then press the second key opposite
and release the two keys simultaneously.
The display shown opposite appears ( XX:XX is
the clock value to be set). The letter “h” flashes
and the hour value is ready to be adjusted.
#2-Adjust the hours with the two keys opposite
#3-Press the key opposite to adjust the minutes.
The display shown opposite appears. The letters
“min” flash and the minute value is ready to be
adjusted.
#4-Adjust the minutes with the two keys opposite.
#5-Press the key opposite to return to stand-by
mode. (XX:XX is new set time).
10) Setting the clock with the keypad.
NOTE
The setting of date can be done only with the software Silverlining.
and
h
X
X
:
X
X
XX:X
X
min
h
X
X
:
X
X
XX:X
X
min
XX: XX
GoodKnight 425 / 425 ST Service Manual
Page 39
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-17
Personal Notes
GoodKnight 425 / 425 ST Service Manual
Page 40
B. CALIBRATION PROCEDURE
1) Equipment required
* a calibrated pressure meter
* a calibrated leak M-BH210 and a connection tube M-213530-05,
* a patient circuit M-261000-27,
* a test kit M-212430-02
CAUTION
Measure the pressure during calibration at the end of a 6 ft (1.80 m) patient circuit
sealed with a stopper fitted with a 4 mm diameter leak (figure 3.1 page III-4).
NOTE
The calibration pressure mode is accessed via the keypad.
The pressure calibration can be also performed by computer using
Silverlining software. Refer to page III-5 and III-6, click on the “Calibration” menu
and follow the instructions.
CAUTION
Allow to warm up for 1/2 hour before performing the pressure calibration
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-18
GoodKnight 425 / 425 ST Service Manual
Page 41
2) Pressure sensor calibration
Connect a patient circuit and a pressure meter as shown in figure 3-1 on page III-4
The pressure sensor calibration can be done with a computer and the Technical Menu of the
software Silverlining (procedure described III-7), or with the keypad (procedure described
page III-10).
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-19
NOTE
The pressure calibration with the keypad does not allow to verify the pressure higher than
20 cmH
2
O
The pressure calibration with the keypad does not reboot the unit with the initial settings.
GoodKnight 425 / 425 ST Service Manual
Page 42
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-20
3) Flow sensor calibration
3-a) Set up material
1-Remove the top housing (refer to the disassembly section page III-22),
2-Locate on the MCU board the trimmers TR3 and TR4,
3-Realise the test set up figure 3.1 page III-4
4-Connect the unit to the computer,
5-Follow the steps described page III-5 to III-6 and click on “Calibrations/Performances”,
the following menu will appear.
TR4
TR3
GoodKnight 425 / 425 ST Service Manual
Page 43
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-21
3-b) Calibration
1-Replace the test kit with the calibrated output (figure 3.2 page III-4) and block
the output
2-With the mouse, click on the setting cursor of the menu “Flow/Débit” and adjust
the Offset to 0,
3-Store with the button “Storage”,
4-Place TR4 in a medium position,
5-Adjust TR3 for a Value/Valeur reading of 0 l/s +/-0.05 (Value of Flow in the
“Flow/Débit” menu),
6-Leave the calibrated output free and adjust TR4 for a Value/Valeur reading of:
1.2 l/s +/-0.05,
7-Block again the calibrated output and verify that the value reading is:
0 l/s +/-0.05.
If not, repeat the process from the step #5.
CAUTION
Allow to warm up for 1/2 hour with a set pressure of 14cmH2O, unit in Cpap
mode, before carrying out the pressure calibration.
Setting Cursor
{
Menu "Flow/Débit"
GoodKnight 425 / 425 ST Service Manual
Page 44
C. DISASSEMBLY
Material :
A Torx T10 screwdriver,
A grounded wrist strap,
A grounded conductive mat.
-Remove the four screws located under the device,
-Remove the top housing,
-Remove the chassis assembly.
WARNING
The GK 425/425ST BiLevel System is electrically powered. To prevent serious
injury or death, follow standard safety procedures. Ensure that power has
been disconnected from the unit before servicing any component.
CAUTION
After replacing the chassis assembly, enter the serial number and the hour meter value in the device
memory if necessary
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-22
GoodKnight 425 / 425 ST Service Manual
Page 45
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-23
Top
Housing
Bottom
Housing
Internal Frame assembly
Inlet baffle
foam
GoodKnight 425 / 425 ST Service Manual
Page 46
D. TROUBLESHOOTING GUIDE
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-24
GoodKnight 425 / 425 ST Service Manual
PROBLEM PROBABLE CAUSE SUGGESTIONS
The device does not
produce the correct
pressure.
The ramp is activated.
-Check that the ramp indicator is displayed. Press the ramp button to cancel the
function.
-Call your Technical Support
The air output of the
device is too hot.
The air input filters may be
dirty.
The air input is obstructed.
The room temperature is
too high.
-Clean or replace the filters accordingly.
Move away any bed linen or clothing from
the GK425/425ST.
-Turn the room thermostat down. Make
sure that the GK425/425ST is not near any
source of heat.
-Remove the tube from under the covers.
-Call your Technical Support
The GK425/GK425ST
does not switch on (no
display).
Check that the external
power supply module is correctly connected.
No mains supply.
-Check the connection of the external
power supply module to the mains plug.
-Use another appliance (e.g.: lamp, radio,
etc) to check that there is an AC current
supply at the plug.
-Call your Technical Support
The device does not
work correctly and appears to be suffering
interference
Excessive electromagnetic
disturbance
-Keep device away from all sources of disturbance, such as mobile phones, halogen
lights...
-Call your Technical Support
Er=0XX is displayed
(xx =error code).
The device has detected an
operating fault.
-Refer to the “Error Messages” section on
page III-26.
-Call your Technical Support
Page 47
PROBLEM PROBABLE CAUSE SUGGESTIONS
In 01 is displayed.
The mask and/or the patient
tube is disconnected.
-Check the connection between mask, patient
tube and device. The message disappears
once the connections are correctly established.
-Call your Technical Support.
In 02 is displayed.
Excess pressure (higher
than 28 cmH
2
O) has been
detected by the device for
more than 10 seconds.
-Check the connection of the small pressure
point hose. Check that the tube is not
pinched or blocked.
-Call your Technical Support
In 03 is displayed.
There is a drop in power. -Check the connection between the external
power module, the power cable and the device.
-Check the external battery if used.
-Call your Technical Support
In 04 is displayed. A high frequency (higher
than 30 cycles per minutes)
has been detected for more
than 10 minutes.
-Check the connection of the small pressure
point hose. Check that the tube is not
pinched or blocked or moistly or dusty (refer
to user manual of the circuit patient).
-Call your Technical Support
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-25
GoodKnight 425 / 425 ST Service Manual
Page 48
E. ERROR MESSAGES
CODE DESCRIPTION CORRECTIVE ACTION
Er01 -Settings data checksum error.
or
-The unit is staying set with a
EPAP value > 20cmH
2
O after a
technical action.
-Perform reconfiguration (refer to page III-14).
-If the message persists, change the internal frame assembly
(see page III-22).
Er02 A too high temperature has been
detected by the temperature sensor. (refer to page II-4 §5).
-Unplug the unit from all electrical sources for a few seconds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er06 Checksum error in the Master
micro-controller firmware.
-Unplug the unit from all electrical sources for a few seconds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er07 The blower does not work. -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er08 Problem with internal 5V voltage -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er10 Power limit reached -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er11 Over consumption -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er15 Error in recorded setting. -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er16 Problem with link between master
micro -contro ller and me mory.
-Unplug the unit from all electrical sources for a few seconds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er 17 Checksum error in the Motor
micro-controller firmware.
-Unplug the unit from all electrical sources for a few seconds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-26
GoodKnight 425 / 425 ST Service Manual
Page 49
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-27
¨ HISTORY RECORD FORM
At the end of this manual, you will find an example of the GoodKnight 425/425ST History Record Form.
This form will help you in all the stages of servicing.
This form can be copied.
We recommend that you send a copy of the completed forms to your local Factory Service.
How to fill out the following items
Return number This is the official Return Goods Authorization (RGA) or your own re-
turn number if RGA does not exist.
Failure description Describe the failure in a few words or state “Routine Service” if this is
the case.
Servicing done Describe in a few words what you have done in the service.
Report number Enter here your report number if not the same as the return number.
CODE DESCRIP TION ACTION CORRECTIVE
Er18 Problem with link between motor
micro -contro ller and me mory
-Unplug the unit from all electrical sources for a few seconds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er19 Problem with the Bi-Level setting
data regarding the motor driver.
-Unplug the unit from all electrical sources for a few seconds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er40 Bus I2C Motor not available -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
Er41 Bus I2C Master not available -Unplug the unit from all electrical sources for a few sec-
onds and try again.
-If the message persists, change the internal frame assembly
(see page III-22).
GoodKnight 425 / 425 ST Service Manual
Page 50
P/N: M-145MAT00-20 Rev. A - Page Rev.A
III-28
Personal Notes
GoodKnight 425 / 425 ST Service Manual
Page 51
IV - SPARE PARTS
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
IV-1
Page 52
Part # Description
M-314530-00 Top Housing equipped 425 International
M-314530-01 Top Housing equipped 425ST International
M-314530-02 Top Housing equipped 425 USA
M-314530-03 Top Housing equipped 425ST USA
M-313940-01 Bottom housing 425 / 425ST
M-314560-00 Internal frame assembly 425 (equipped with blower and electronic board
factory set). Inlet baffle foam not included.
M-314560-01 Internal frame assembly 425ST (equipped with blower and electronic
board factory set). Inlet baffle foam not included.
M-413950-01 Inlet baffle foam 425 / 425ST
M-414510-00 External power module 425 / 425ST.
M-660600-04
Power lead Europe.
M-660600-40
Power lead UK
M-660600-39
Power lead USA
M-660600-41
Power lead Australia
M-711902-01 Torx T10 screw for housing.
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
IV-2
Page 53
Failure
Error messages and information recorded in the memory :
Error Messages Information Messages
1.
1.
2.
2.
3.
3.
4.
4.
5.
5.
Servicing Done
Power supply: Good
Parts changed
Part number Description Lot # Serial
Reconfiguration
(1): Yes — No
Verification of the serial# in the memory
(1): Surround the good answer
F ill with a value Calibrations and tests Ä
145FDS002.0
SERIAL #
CUSTOMER
RETURN #
REPORTING #
DATE
Compliance Meter #
Hour Meter
(Before ser vic in g)
Hour Meter
(After servic ing)
Embedded Ver.
(Before ser vic in g)
Embedded Ver.
(After servic ing)
HISTORY RECORD FORM (1/2)
GoodKnight425 GoodKnight 425ST
Defect
Page 54
145FDS002.0
CALIBRATION
Pressure sensor
1) Adjustment 14 cmH2O: Value displayed (before adjustment)
Measured Pressure (before adjustment)
Value displayed (after adjustment)
2) Verification 25 cmH2O: Pressure measured with controller:
3) Verification 3 cmH
2
O: Pressure measured with controller:
cmH2O
cmH2O
cmH2O
Backup Frequency (425ST)
Setting: F=10 IPAP=14 EPAP=8 I/E=1:1.0
Measured Frequency
Pressure
3 cmH
2
O set c measured
14 cmH2O set c measured
25 cmH2O set c measured
cmH2O
cmH2O
cmH2O
PERFORMANCES VERIFICATION
Ramp
Test succeeded (1) Yes — No
Flow (step #1)
Flow (step #2)
l/s
Observations
(1)= Surround the good answer Operator
F ill with a value
Flow sensor
Adjustment with TR3: Value: (Offset =0, calibrated output blocked)
Adjustment with TR4: Value: (Offset =0, calibrated output free)
l/s
l/s
l/s
HISTORY RECORD FORM (2/2)
c/min
Page 55
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
Page 56
GoodKnight 425 / 425ST Service Manual
P/N: M-145MAT00-20 Rev. A - Page Rev.A
MALLINCKRODT DEVELOPPEMEN FRANCE
Parc d'Activités du Bois St Julien
10 allée Pelletier-Doisy
54601 VILLERS LES NANCY CEDEX
Tél: 33 (0) 3.83.44.85.00
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