KnightStar 330 Service Manual (English)
KnightStar 330 Service Manual (English)
B i - L e v e l ® Ve n t i l a t o r
10011800 Rev A
June, 2006
manual
KnightStar® 330 Service Manual
B i - L e v e l ® Ve n t i l a t o r
10011800 Rev A
June, 2006
© Copyright 2006 Nellcor Puritan Bennett Inc. All rights reserved.
KnightStar, Bi-Level, SoftFit, ADAM, and Breeze are trademarks of Nellcor Puritan Bennett Inc. For more information, contact
your Puritan Bennett representative.
The ventilator should be operated and serviced only by trained professionals. Puritan Bennett’s sole responsibility with respect
to the ventilator, and its use, is as stated in the limited warranty provided.
Nothing in this manual shall limit or restrict in any way Puritan Bennett’s right to revise or otherwise change or modify the
equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the
contrary, Puritan Bennett has no obligation to furnish any such revisions, changes, or modifications to the owner or user of
the equipment (including its software) described herein.
CONTENTS
Troubleshooting 4-1
4.1 Alarms ........................................................................................................................ 4-1
4.2 Troubleshooting checklist ........................................................................................... 4-3
4.3 Internal malfunction errors........................................................................................ 4-10
4.4 Logged errors ........................................................................................................... 4-14
Repair 5-1
5.1 Tools, test equipment, and service materials ............................................................... 5-1
5.2 Ventilator assembly drawing ....................................................................................... 5-1
5.3 Ventilator cleaning and inspection .............................................................................. 5-1
5.4 Initial ventilator disassembly ....................................................................................... 5-2
5.5 Membrane switch replacement ................................................................................... 5-4
5.6 LCD panel replacement............................................................................................... 5-5
5.7 Alarm PCBA replacement ............................................................................................ 5-6
5.8 Main PCBA, blower, pitot tube replacement ............................................................... 5-9
5.9 Cooling fan assembly, chassis, case foam, suspension muffler replacement ................. 5-9
5.10 Ventilator reassembly .............................................................................................. 5-13
5.11 Post-repair testing ................................................................................................... 5-14
General information 1 1
This manual provides information needed to service the Puritan Bennett KnightStar 330®
Bi-Level® ventilator and is intended for use by certified biomedical engineering technicians
or personnel with equivalent experience and training in servicing this type of equipment.
This section provides introductory information on the KnightStar 330 ventilator including:
• General safety information
• Instructions on how to use the manual
• A description of the ventilator, its accessories, and its controls and indicators
• Detailed specifications and required tools and test equipment used for service and repair
Puritan Bennett recommends that users of its products that require cleaning and
sterilization/disinfection consider the Center for Disease Control (CDC) publication:
Guidelines for Prevention of Nosocomial Pneumonia available from the CDC Web site:
http://www.cdc.gov/publications.htm. Refer to Table 1-17 on page 1-27 for a list of
approved disinfectants and cleaning agents.
• Patients on ventilation equipment should be appropriately monitored by competent
medical personnel and suitable monitoring devices.
• For a thorough understanding of ventilator operations, be sure to thoroughly read this
manual and the KnightStar 330 Clinician’s Manual before operating the device. These
manuals provide service, repair, and technical information concerning the operation and
performance of the ventilator.
• Before patient use, be sure to check the equipment for proper operation.
• Do not use sharp objects to make selections on the keypad.
• Check the ventilator periodically as outlined in this manual; do not use if defective.
Immediately replace parts that are broken, missing, obviously worn, distorted, or
contaminated.
• Federal law (U.S.) restricts this device to sale by or on the order of a physician.
WARNING: The KnightStar 330 should not be used adjacent to or stacked with
other equipment, except the humidifier specified in Section 1.7. If use
adjacent to other equipment is necessary, the KnightStar 330 should
be observed to verify normal operation in the configuration in which
it is used.
1.4.1 Definitions
This manual uses three special indicators to convey information of a specific nature.
They include:
NOTES:
• At a minimum, the repair technician should be a Certified
Biomedical Equipment Technician (CBET) or possess equivalent
experience and training before performing any of the service
instructions described in this manual.
• Due to specific design interactions between the main PCBA, blower,
and pitot tube, these parts must be replaced together using
P/N Y-500020-00 (Kit, Service Calibration, KS330).
1 Refer to Chapter 4 of this manual to diagnose the problem. Using the troubleshooting
guides in this chapter, determine if the problem can be corrected without returning the
device to a factory service center.
2 Use Table 1-19 to identify and order the required parts.
3 Follow the instructions in Chapter 5 to disassemble, repair, and reassemble the
KnightStar 330.
4 Perform the performance verification tests described in Chapter 3 and document the
results using the checklist provided.
• Provides three breathing modes, including Continuous Positive Airway Pressure (CPAP),
Inspiratory/Expiratory Positive Airway Pressure (I/E PAP), and Assist Control (A/C).
• Monitors pressure, tidal volume, respiratory rate, air leaks, peak flow, and I:E ratio.
• Provides precise respiratory support and patient comfort via adjustable inspiratory and
expiratory trigger sensitivity.
• Uses audible and visual indicators to alert users to power failure, system leaks, and other
conditions that could affect device performance.
• Allows a maximum pressure setting of 30 cmH2O, with a pressure limitation of 40 cmH2O
for a single-fault condition.
• Compensates for delivered pressure within specification for altitudes from 0 to 8,000 feet
(2438 meters) at 3 to 30 cmH2O, and compensates for leaks up to 60 liters per minute.
1.7 Accessories
The following accessories are either required or can be used with the KnightStar 330. See
Table 1-1 for ordering information.
Calibration Shell: The calibration shell is required for Performance Verification testing on
the KnightStar 330.
Breathing circuit: Puritan Bennett recommends using the KnightStar 330 with 1.8 m (6 ft) or
2.4 m (8 ft) tubing and approved interfaces.
Oxygen Adapter: An optional O2 adapter may be connected to the KnightStar 330 outlet filter
to enable the use of supplemental oxygen. Refer to the KnightStar 330 Clinician’s Manual for
more information.
Humidification device: The KnightStar 330 supports the use of an optional Fisher & Paykel
HC100 Humidifier, or equivalent.
External Battery: The KnightStar 330 may be powered by an external battery. A 32 ampere-
hour battery and a 7 ampere-hour battery are available. Separate cables are required to
connect the KnightStar 330 to an external battery or to a vehicle cigarette lighter outlet.
Other accessories: A carrying case and rolling stand are also available for the KnightStar 330.
1.8 Specifications
Table 1-2 lists the technical specifications of the KnightStar 330 ventilator.
Physical characteristics
Device Airway 65 mL
Volume
Environmental specifications
Temperature and Operating: 5 to 40 °C (41 to 104 °F) at 15 to 95% relative humidity, noncondensing
Humidity Storage: -40 to 70 °C (-40 to 158 °F) at 10 to 95% relative humidity, noncondensing
Performance specifications
Electrical specifications
Rated Input 50 – 60 Hz
Frequency
Peak Flow (V) ± 5 LPM +20% of reading (between 1 and 100 LPM)
Circuit Resistance
Communication RS-232 (serial) port (Figure 1-1). A 9-pin female connector provides for RS-232 serial
capabilities communications, I/E PAP digital triggering, and calibration EEPROM programming. The RS-232
function operates at signal levels of at least 3 V into a standard load at a data rate of 9.6 kbps and
19.2 kbps. Pin 9 is used for calibration EEPROM programming at the manufacturing and service
sites, and during normal bi-level operation, supplies a 0 or 5 V signal indicating a respective
exhalation or inhalation trigger. Applying 24 ± 1 V to pin 9 enables the write function of the
calibration EEPROM (U3). Any voltage less than 15 V will not enable the EEPROM write function. The
calibration EEPROM contains calibration constants including those for flow and pressure control.
1 2 3 4 5
6 7 8 9
NOTES:
• The RS-232 connector on devices manufactured prior to the year 2004 is
rotated 180o from the configuration shown above.
• If you would like to use the KnightStar 330 in a special application requiring
serial communications, such as the Service Application Software, contact
Puritan Bennett Technical Support at 1.800.255.6774 or your local Puritan
Bennett representative.
Pin Signal
1 Not connected
2 Transmit data (TxD) to PC
3 Receive data (RxD) from PC
4 Not connected
5 Ground (GND)
6 Not connected
7 Not connected
8 Not connected
9 Dual use I/E PAP trigger-out and program-
enable input
This device complies with the requirements of Medical Device Directive 93/42/EEC
concerning medical devices.
The KnightStar 330 is intended for use in the electromagnetic environment specified below. The customer or user of the
KnightStar 330 should assure that it is used in such an environment.
RF emissions Group 1 The KnightStar 330 uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
The KnightStar 330 is intended for use in the electromagnetic environment specified below. The customer or the user of the
KnightStar 330 should assure that it is used in such an environment.
Electromagnetic environment –
Immunity Test IEC 60601 test level Compliance level
guidance
Electrical fast ± 1 kV for power supply ± 1 kV for power supply Mains power quality should be that of a
transient/burst lines lines typical commercial or hospital
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for input/output environment.
lines lines
Electromagnetic environment –
Immunity Test IEC 60601 test level Compliance level
guidance
Voltage dips, short < 5% UT < 5% UT Mains power quality should be that of a
interruptions and (> 95% dip in UT for (> 95% dip in UT for typical commercial or hospital
voltage variations on 0.5 cycle) 0.5 cycle) environment. If the user of the
power supply input KnightStar 330 requires continued
lines operation during power mains
40% UT 40% UT
IEC 61000-4-11 interruptions, it is recommended that the
(60% dip in UT for (60% dip in UT for KnightStar 330 be powered from an
5 cycles) 5 cycles) uninterruptible power supply or a
battery.
70% UT 70% UT
(30% dip in UT for (30% dip in UT for
25 cycles) 25 cycles)
< 5% UT < 5% UT
(> 95% dip in UT for (> 95% dip in UT for
5 s) 5 s)
The KnightStar 330 is intended for use in the electromagnetic environment specified below. The customer or the user of the
KnightStar 330 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
d = 1.2 P
Conducted RF 3 Vrms 3V
IEC 61000-4-6 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz
NOTES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To asses the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the KnightStar 330 is used exceeds the applicable RF
compliance level above, the KnightStar 330 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the KnightStar 330.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The KnightStar 330 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the KnightStar 330 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the KnightStar 330 as
recommended below, according to the maximum output power of the communications equipment.
100 12 12 23
For transmitters rated at maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTES:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
The listed cables and accessories comply with the following standards:
• RF emissions, CISPR 11 Group 1, Class B
• EN 60601-1-2:2001
WARNING: The use of accessories and cables other than those specified, with the
exception of parts sold by Puritan Bennett as replacements for internal components,
may result in increased emissions or decreased immunity of the KnightStar 330.
Mask leak
CPAP Level of CPAP pressure 3–20 cmH2O (increments of Top panel, RS-232
1 cmH2O)
IPAP Pressure during inspiration 3–30 cmH2O (increments of Top panel, RS-232
1 cmH2O)
EPAP Pressure during expiration 3–20 cmH2O (increments of Top panel, RS-232
1 cmH2O)
I:E ratio Ratio of inhalation time to 1:1.0 to 1:4.0 (increments of Top panel, RS-232
exhalation times for backup 0.5)
breath rate
Inspiratory Sensitivity at which device 1–5 (1 most sensitive; 5 least Top panel, RS-232
sensitivity switches from EPAP to IPAP sensitive)
Expiratory Sensitivity at which device 1–5 (1 most sensitive; 5 least Top panel, RS-232
sensitivity switches from IPAP to EPAP sensitive)
Rise-time Rate of pressure increase 1–5 (1 is the fastest setting; Top panel, RS-232
5 is the slowest)
Alarm volume Sets the loudness of the 0–3 (0=Off, 3=loudest) Top panel, RS-232
alarm.
Japanese configuration only:
NOTE: The alarm 1–3 (1=lowest volume,
volume cannot be 3=highest volume)
turned off on
Japanese versions
of the
KnightStar 330.
Leak alarm Rate of air leaking at which 50–100 liters per minute Top panel, RS-232
alarm sounds (increments of 10 L/min);
0=Off
Low pressure Pressure below the prescribed 1 cmH2O below the IPAP Top panel, RS-232
alarm IPAP setting at which an setting to 1 cmH2O above
alarm will sound EPAP (in increments of
1 cmH2O); 0 = Off.
High pressure Pressure above the prescribed 1 cmH2O above the IPAP Top panel, RS-232
alarm IPAP setting at which an setting to 35 cmH2O (in
alarm will sound increments of 1 cmH2O);
0 = Off.
Delay time Time delay before device 0–30 minutes (in increments Top panel, RS-232
automatically starts of 5 minutes)
Ramp duration Time from device start to 0–30 minutes (increments of Top panel, RS-232
prescribed operating pressure 5 minutes)
Ramp start Pressure at which the device 3–20 cmH2O (increments of Top panel, RS-232
Pressure starts ramp sequence 1 cmH2O)
Interface Patient interface exhalation 1–6 (1 is the lowest leak Top panel, RS-232
(Mask) leak/ port leak rate value, and 6 is the highest)
type
NOTE: For information on using the RS-232 port, contact Puritan Bennett
Technical Support at 1.800.255.6774 or your local Puritan Bennett
representative.
Setting Value
MODE A/C
EPAP 3 cm H2O
Respiratory rate 10
I Sensitivity 3
E Sensitivity 3
Rise time 3
Alarm volume 3
Delay time 0
Ramp duration 0
Mask leak 2
PURITAN BENNETT
TM
Bi-Level âVentilator
1 10
1
2 2
3
4
5
6 9
8
7
PURITAN BENNETT
TM
Bi-Level âVentilator
1 10
2 Mode Set
3 Delay Alarm
Ramp Silence
4
5
6 9
8
7
Figure 1-2. KnightStar 330 Control Panel (International version shown at top,
North American version shown above)
Index
Labeling Function
(Figure 1-2)
NOTE: To change the access mode, press and hold the Mode
and Up Arrow keys simultaneously for approximately
2 seconds.
2 Mode key
1
Pressing the Mode key repeatedly allows you to scroll through CPAP, I/E, and
2
3 A/C modes. Press the Mode key to leave Settings mode when finished
adjusting settings.
International The Mode key does not function when the KnightStar 330 control panel is
locked.
or
Mode
North American
3 Settings key
Press the Settings key repeatedly to scroll through available parameters for
each breathing mode. When the KnightStar 330 control panel is locked, the
Settings key can only be used to change the delay time, ramp duration, and
ramp start pressure.
International version
or
Set
Table 1-12: KnightStar 330 control panel keys and indicators (continued)
Index
Labeling Function
(Figure 1-2)
International version
or
Delay
Ramp
North American version
Alarm
Silence
North American version
6 On/Off key
Turn the KnightStar 330 system on with a quick press and release action. To
turn the device off, press and hold the On/Off key for 3 seconds. The
KnightStar 330 retains in memory the prescription settings last entered.
7 Green LED When illuminated, indicates the presence of power, either from Mains/AC or
battery (DC).
8 Yellow LED When steadily illuminated and accompanied by the f symbol displayed in
the lower left corner of the LCD panel, indicates a LOW PRIORITY alarm
condition.
When flashing, indicates a MEDIUM PRIORITY alarm condition accompanied
by an audible alarm signal (3 beeps at intervals of approximately
25 seconds).
Refer to Chapter 4 Troubleshooting for causes and corrections for alarm
conditions.
Index
Labeling Function
(Figure 1-2)
9 Red LED When flashing, indicates a HIGH PRIORITY alarm condition accompanied by
an audible alarm signal (a series of 3 beeps, then 5 beeps, then 2 beeps at
intervals of approximately 6 seconds). Refer to Chapter 4 Troubleshooting for
causes and corrections for alarm conditions.
10 Liquid Crystal Display The LCD provides an easy-to-read format for mode, settings, and patient
(LCD) data. A backlight illuminates the display when the Mode, Settings, or Up
arrow key is pressed. The display will remain illuminated for approximately
60 seconds after the last key is pressed.
1
back.eps
2
3
1
Index
Labeling Function
(Figure 1-3)
Index
Labeling Function
(Figure 1-3)
NOTE: PCs used with the KnightStar 330 must meet regulatory
standards for Safety of Information Technology Equipment (i.e.
UL 60950 or EN 60950). Available from many sources, these
standards specify requirements intended to reduce risks of fire,
electrical shock, and injury to the operator or service person
who comes into contact with the equipment.
7
3
6
8-00197
4 5
Index
Labeling Function
(Figure 1-4)
See Operator’s
Manual for use with
oxygen
International version
Note
The patient outlet gas flow can be as much as
7˚ F (4˚C) degrees warmer than room temperature.
7 Warning label Warns user that the device can become hot to the touch.
7
8
6
9
5
10
1 2 3 4
1 Class II equipment
(Per IEC 60601-1: Equipment in which protection against electric shock
does not rely on BASIC INSULATION only, but in which additional safety
precautions such as DOUBLE INSULATION or REINFORCED INSULATION
are provided, there being no provision for protective earthing or reliance
upon installation conditions.)
2 Type BF equipment
3 Drip proof
Table 1-15: Symbols found on the KnightStar 330 bottom panel (continued)
8 Authorized to bear the CSA certification mark, signifying the product has
been evaluated to the applicable CSA standards for use in the US and
Canada.
UL2601-1
CAN/CSA C22.2 No. 601.1- M90
Symbol
Symbol (Int’l) Description (North
America)
SN Serial number SN
MODES
CPAP Continuous Positive Airway Pressure mode and pressure setting CPAP
MEASURED PARAMETERS
f Respiratory rate f
P Current pressure P
Vt Tidal Volume Vt
L Leak rate L
SETTINGS
Symbol
Symbol (Int’l) Description (North
America)
ALARMS
Alarm is silenced
Manufacturer/model or
Description Where used
Puritan Bennett part number
Manufacturer/model or
Description Where used
Puritan Bennett part number
The KnightStar 330 and associated test equipment require very little maintenance. Table 1-18
lists the periodic maintenance activities required for the KnightStar 330.
As Needed Outer surfaces of the ventilator Clean surfaces with cloth dampened with
warm soapy water or disinfectant described
in Table 1-17. Wipe dry. Do not let liquid drip
into any openings in the device.
Weekly Air inlet filter (see Table 1-19 for ordering Inspect filter. Replace if damaged.
information) Use warm, soapy, sterile or distilled water to
wash the filter. Rinse thoroughly with sterile
or distilled water, and let air dry.
When used in the Outlet filter Replace. See Table 1-19 for ordering
KnightStar 330 test setup, information.
Every 2 months.
When used for therapy, as
needed, and after every
patient. Frequency of
replacement can vary,
depending on usage and
environmental conditions.
Every 24 months Blower/motor assembly, main PCBA, pitot Replace using P/N Y-500020-00 (Kit, Service
tube Calibration, KS330). Instructions are included
in kit. See Table 1-19.
Assembly
Drawing Item Description Order No.
No.
9 Dampener Y-102842-00A
11 Chassis Y-101616-00A
Assembly
Drawing Item Description Order No.
No.
16 Baffle Y-102090-00A
Theory of operation 2 2
This section details the operational theory of the KnightStar 330 and contains the following
information:
• Description of ventilator components
• Overview of ventilator operation
• Description of breath delivery functions
• Description of breath detection functions
• Information for battery operation
• Description of safety features
Outlet filter
Power cord
or
NOTE: If you would like to use the KnightStar 330 in a special application that
requires changing the settings via the RS-232 serial communications port
(e.g. Service Application Software), refer to the installation instructions
included in P/N Y-500020-00 (Kit, Service Calibration, KS330), or contact
Puritan Bennett Technical Support at 1.800.255.6774 or your local Puritan
Bennett representative for more information.
Once the settings are entered, the KnightStar 330 can be put into Patient Access mode,
preventing accidental or unauthorized changes to prescribed settings. In Patient Access
mode, the user may only change the delay period, ramp duration, and ramp start pressure.
A gross particulate filter provided at the air inlet filters the incoming air. A high efficiency
bacteria filter at the air outlet is provided to ensure optimal device performance. A breathing
circuit with proximal pressure tube provides air delivery to the patient and pressure feedback
to the device.
NOTE: The KnightStar 330 consumes battery power in Stand-by mode when
connected to an external battery. To conserve battery power, disconnect
the KnightStar 330 from the battery when not in use.
Power on
The device powers on by pressing the On/Off key, then displays the copyright notice,
company name, and firmware version. Each time the device is turned on, the device performs
the following internal tests:
• Valid settings test and critical parameter checksum
• Alarm/battery voltage test
• LED test
After these tests are performed, the KnightStar 330 transitions into Delay/Ramp mode (if
active) or Therapy mode.
Delay/Ramp
Upon completion of the power on sequence, the device begins the delay/ramp function if a
delay and/or ramp are set and the function is active, indicated by the symbol in the
display. The Delay/Ramp mode can be cancelled or restarted by pressing the Delay/Ramp key.
The delay/ramp feature allows the patient to fall asleep during the delay period prior to the
ventilator starting to deliver the prescribed pressures. The delay period can be set from 0 to
30 minutes. When the delay is activated, both inspiratory and expiratory pressures decrease
to the ramp start pressure. After the delay time has elapsed, pressure increases to the
prescription pressures during the set ramp duration period, after which the device starts
Therapy mode. If the delay period is set to zero minutes, the ventilator transitions
immediately to the ramp sequence if a ramp duration is specified, or to Therapy mode if the
ramp duration is set to zero. The ramp duration may be adjusted at any time, even during the
ramp sequence, but the setting will not take effect (unless set to zero) until the ramp sequence
is cancelled and restarted. If the new setting is changed to zero, the ramp sequence cancels
and the device transitions immediately to the prescribed therapy parameters. If you press the
delay/ramp key with both delay period and ramp duration set to zero, there is no effect.
Therapy
In Therapy mode, the KnightStar 330 ventilates patients in one of three breathing modes set
by the clinician:
• CPAP (Continuous Positive Airway Pressure)
• I/E PAP (Inspiratory/Expiratory Positive Airway Pressure)
• A/C (Assist with Control)
CPAP
In the CPAP mode, the system delivers a continuous positive regulated airway pressure
throughout the breath cycle at the prescribed level. The normal operating range is
3 to 20 cmH2O.
The KnightStar 330 continuously monitors and displays pressure (P) and leak rate (L) in CPAP
mode.
I/E PAP
I/E PAP mode provides two pressure levels: an inspiratory pressure level of 3 to 30 cmH2O and
an exhalation pressure level of 3 to 20 cmH2O.
In I/E PAP mode, the KnightStar 330 continuously monitors and displays breath rate (f),
pressure (P), tidal volume (Vt), and leak rate (L). Pressing the Up Arrow key (with no alarm
conditions present) will display, for five seconds, the current peak flow (V) and I:E ratio (I:E)
values.
If no inspiration is detected while at the IPAP level for the average inspiration period plus five
seconds, the device enters a DEFAULT condition. During the DEFAULT condition, the device
cycles to the EPAP level and remains at this level until it detects an inspiration trigger. If an
inspiration is not detected while at the EPAP level, the device remains at the EPAP level until
an inspiration is detected. During the DEFAULT condition the rest of the displayed values
become 0, except for the I:E ratio, which becomes 1:0.0.
Upon detecting an inspiration trigger, the device resumes normal I/E PAP mode operation
supporting all detectable spontaneous breathing at the prescribed pressure levels.
A/C
The A/C mode provides the same inspiratory and expiratory pressure levels as I/E PAP mode
and provides an additional backup breath rate feature (normal operating range of
3 to 30 breaths/min) and a settable I:E ratio (normal operating range of 1:1.0 to 1:4.0).
In A/C mode, the KnightStar 330 continuously monitors and displays breath rate (f), pressure
(P), tidal volume (Vt), and leak rate (L). Pressing the Up Arrow key (with no alarm conditions
present) will display, for five seconds, the current peak flow (V), and I:E ratio (I:E) values.
If the device is unable to track breathing efforts, or the patient’s spontaneous respiratory rate
falls to or below the prescribed backup breath rate, the device enters a DEFAULT condition
and will cycle at the prescribed IPAP and EPAP levels, backup respiratory rate, and I:E ratio. If
the backup rate cycles for five (5) continuous breaths, the f symbol will appear at the lower
left corner of the display, and the yellow LED will illuminate (indicating a low priority alarm).
The f symbol and yellow LED will remain active until the patient breathes on his or her
own. When the backup rate is cycling, the patient data for “f” and I:E ratio are displayed as
the prescribed values.
AC Power
Main 85 to
264 V AC
DC Power
External
Battery
12 V DC
Microcontroller
8-00187
NOTE: Autotriggering refers to a delivered breath that was not initiated by the
patient.
The sensitivity of the breath detection set by the user is adjusted by the microcontroller. Five
settings each for expiratory and inspiratory sensitivity are provided for clinician selection.
ESENS 1, 55%
ESENS 2, 44%
ESENS 3, 32%
ESENS 4, 25%
Inspiratory flow
ESENS 5, 18%
Potential delivered
volume increases with
higher ESENS setting.
8-01159
Time
Figure 2-3. Effects of changing expiratory sensitivity
Pressure
8-01159
Time
CAUTION: Connect the KnightStar 330 to only one power source at a time;
external battery power or AC power. Damage to the device can result if
connected to both power sources simultaneously.
When operating on battery power, the KnightStar 330 functions as it does on AC power. The
available 32 ampere-hour battery provides the KnightStar 330 with up to 8 hours of operation,
while the 7 ampere-hour battery powers the device for up to 3 hours.
To switch the KnightStar 330 from Mains/AC power to battery power:
1 Turn the KnightStar 330 off and unplug it from the AC power outlet.
2 Connect the appropriate cable to the battery and to the DC connector at the rear of the
KnightStar 330.
3 Turn the KnightStar 330 back on.
NOTE: The KnightStar 330 consumes battery power in Stand-by mode when
connected to an external battery. To conserve battery power, disconnect
the KnightStar 330 from the battery when not in use.
1 Ground
6 Ground
10 Ground
The alarm processor takes commands from the main PCBA processor via the I2C interface for
the alarm controls (including sound level). The alarm processor can control its onboard
audible alarm and the red and yellow LEDs on the membrane keypad. It is powered at
maximum volume on the alarm PCBA with +13.5 V nominal and a 5 mA current limit. The
alarm is equipped with a lithium battery power source that allows the alarm to function
during power outages or failure of the main PCBA.
Performance verification 3 3
This section describes how to set up the KnightStar 330 and verify the performance of the
ventilator.
3.1 Initial ventilator cleaning and inspection
Prior to verifying the performance of the KnightStar 330 it is important that the ventilator is
clean and that the accessories are in good condition.
CAUTION: Do not soak any portion of the KnightStar 330 in solvent, alcohol, or
any other cleaning agent. Soaking ventilator components may
damage the ventilator.
Inspect the air inlet filter. To remove the air inlet filter, pull the baffle (Item 16), away
from the ventilator and remove the foam filter (Item 17). Clean or replace as required.
(See Table 1-18 on page 1-28 for air inlet filter cleaning instructions.) Re-install the baffle
over the foam filter by snapping the baffle into the base.
3 Visually inspect ventilator exterior for obvious problems such as missing, broken, or
loose parts. Check the power cord for evidence of wear or damage. Repair or replace as
needed.
Test set-up:
1 Set the KnightStar 330 on the test bench, ensuring that it is placed such that there is at
least 2.5 cm (1 in) of clearance at the back of the device.
2 Connect one end of the AC power cord into the rear panel of the KnightStar 330, and the
other end into an AC wall outlet.
3 Attach the breathing circuit and outlet filter to the air outlet.
4 Attach the proximal pressure line to the patient pressure connector on the ventilator.
Refer to Figure 3-1 for connecting the ventilator components.
Air outlet
Patient
pressure
connector
Outlet filter
5 Attach calibration shell to the breathing circuit and connect the pressure tube between
the manometer and calibration shell pressure ports. See Figure 3-2.
Calibrated manometer
Manometer pressure
port Calibration shell
with pressure tube
attached to
manometer’s
pressure port
NOTES:
• Because the KnightStar 330 is double-insulated and has a non-grounded AC power
connector, it is not necessary to perform hi-pot, ground continuity, or leakage
current tests.
• If locked (Patient Access mode), unlock the KnightStar 330 by simultaneously
pressing and holding the Mode and Up Arrow keys for approximately 2 seconds.
Verify that the indicator arrow on the LCD panel has moved from the locked to the
unlocked position.
For the following Performance Verifications tests:
• Perform the functional performance tests in the order that they appear.
• Change the breathing mode by repeatedly pressing the Mode key until the desired
mode is displayed on the LCD panel.
• Change a specific setting by pressing the Settings key to scroll to the desired
setting, then using the Up or Down Arrow keys to adjust its value. Exit the Settings
mode by pressing the Mode key.
• Record the test results on the Performance Verification checklist found in
Section 3.4.
NOTE: To ensure accurate readings for the following pressure tests, verify that
the manometer has been calibrated in accordance with the
manufacturer’s recommendation.
1 With the KnightStar 330 still running at the settings from the sensitivity test, observe the
pressure readings on the manometer. The measured output pressure should be within
1 cmH2O for IPAP and EPAP settings.
2 Change the IPAP and EPAP settings to 17 and 7 cmH2O, respectively, and exit Settings
mode. Observe the measured output pressures and verify that they are within 1 cmH2O
of the IPAP and EPAP settings.
3 Change the IPAP and EPAP settings to 14 and 4 cmH2O, respectively, and exit Settings
mode. Observe the measured output pressures and verify that they are within 1 cmH2O
of the IPAP and EPAP settings.
4 Reset the IPAP and EPAP pressures back to 20 and 10 cmH2O, respectively, and exit
Settings mode.
NOTE: During the ramp period, it may be necessary to block the bleed hole in
the calibration shell with your thumb for approximately 2 seconds to
cause the KnightStar 330 to deliver a breath.
3 Verify that the low pressure alarm sounds, the red LED flashes, and the low pressure
alarm indicator ( P ) appears on the LCD panel.
4 Press the Alarm Silence key (Up Arrow) to mute the alarm.
5 Reconnect the calibration shell to the breathing circuit. Verify that the alarm indicators
(flashing red LED and LCD panel indicator) disappear, and the device returns to normal
operation.
NOTE: It may be necessary to block the bleed hole in the calibration shell with
your thumb for approximately 2 seconds to cause the KnightStar 330 to
deliver a breath.
Pass Fail
Procedure
Troubleshooting 4 4
This section describes the actions necessary to diagnose and troubleshoot the KnightStar 330.
It includes a list of alarm conditions, a table for solving problems based upon the most
probable causes, and a table for interpreting individual internal malfunction error codes.
Prior to diagnosing the problem, verify the following:
• Power is securely connected to the KnightStar 330.
• Outlet filter, breathing circuit and proximal pressure tube are properly connected,
calibration shell is properly attached (where required), and that these parts are not
damaged, causing a system leak.
4.1 Alarms
An equipment malfunction or system error will cause the KnightStar 330 to invoke one or
more of the following responses:
• Illuminated or flashing yellow or red LED (indicates alarm priority)
• Audible alarm
• Displayed error code or alarm symbol
Alarms are classified by priority:
• HIGH priority—Indicated by a flashing RED LED accompanied by an audible alarm signal
(a series of 3 beeps, then 5 beeps, then 2 beeps at intervals of approximately 6 seconds).
• MEDIUM priority—Indicated by a flashing YELLOW LED accompanied by an audible
alarm signal (3 beeps at intervals of approximately 25 seconds).
• LOW priority—Indicated by a steadily illuminated YELLOW LED on the control panel and
no audible alarm.
In many cases, the alarm condition can be remedied by patient or caregiver intervention.
Table 4-1 describes the alarm conditions.
NOTE: The Alarm Silence key (Up Arrow) may be pressed to mute the alarm for
one minute.
Display Panel
Alarm Type Alarm Reset
Priority Description Symbol and
(error code) Volume* Condition
LED
Leak HIGH Estimated leak rate rises L Adjustable Leak flow rate
(52) above leak alarm setting from 0 – 3: decreases to
for 60 seconds. Flashing red 0 = Off less than leak
LED alarm setting.
3 = Loudest
Eliminate leaks
in ventilator
system, patient
mask or
breathing
circuit.
* For Japanese versions of the KnightStar 330, alarm volume cannot be turned off. Adjustment range is
1(lowest volume) to 3 (highest volume).
NOTE: Due to specific design interactions between the main PCBA, blower, and
pitot tube, these parts must be replaced together using P/N Y-500020-00
(Kit, Service Calibration, KS330).
Probable
Observed Problem Diagnostic Questions Action
Cause
Probable
Observed Problem Diagnostic Questions Action
Cause
Probable
Observed Problem Diagnostic Questions Action
Cause
Probable
Observed Problem Diagnostic Questions Action
Cause
Probable
Observed Problem Diagnostic Questions Action
Cause
Probable
Observed Problem Diagnostic Questions Action
Cause
Low breath rate Flow sensor tubes Bellows OK? Pitot tube
(device not OK? damaged?
triggering)
No Yes No Tubes Re-attach flow
detached sensor tubes
(refer to
Figure 5-8 on
page 5-7 for
tubing
connections
and
Figure 5-10 on
page 5-9 for
routing).
Inspiratory or Adjust
expiratory inspiratory
sensitivity and/or
settings too expiratory
high sensitivity to
lower settings.
Probable
Observed Problem Diagnostic Questions Action
Cause
Internal
Condition occurs
Malfunction Error Type Check for Probable Cause Action
when:
Error Code
CAUTION: Do
not press any keys
while 24 V is
applied.
Internal
Condition occurs
Malfunction Error Type Check for Probable Cause Action
when:
Error Code
Internal
Condition occurs
Malfunction Error Type Check for Probable Cause Action
when:
Error Code
30 Synchroniza- Device detects the Blower wiring Damaged motor Backlight turns off.
tion loss loss of motor harness or motor Device attempts to
synchronization. connector not connection restart the blower.
seated properly Re-seat blower
in J3 connector harness connector.
on main PCBA If problem persists,
repair device using
P/N Y-500020-00
(Kit, Service
Calibration, KS330)
or return device to
factory service
center for repair.
37 I2C error I2C error bit is set component failure Repair device using
P/N Y-500020-00
(Kit, Service
Calibration, KS330)
or return device to
factory service
center for repair.
Internal
Condition occurs
Malfunction Error Type Check for Probable Cause Action
when:
Error Code
44 Max More than three Blower wiring Motor or motor Device shuts down.
synchroniza- restarts from harness connection is Re-seat blower
tion loss synchronization connector not damaged harness connector.
loss errors seated properly If problem persists,
(error 30) within in J3 connector repair device using
60 seconds of each on main PCBA P/N Y-500020-00
other. (Kit, Service
Calibration, KS330)
or return device to
factory service
center for repair.
46 Flow sensor Flow sensor stuck Flow sensor failure Repair device using
error high or low for P/N Y-500020-00
60 seconds (Kit, Service
Calibration, KS330)
or return device to
factory service
center for repair.
Internal
Condition occurs
Malfunction Error Type Check for Probable Cause Action
when:
Error Code
55 Over- Pressure greater Full face mask Patient cough into Disconnect the
pressure than 40 cmH2O being used full face mask device from the
for at least power source for at
0.5 seconds least 30 seconds;
then reconnect.
Turn the device on.
Device resets if
cause of
overpressure con-
dition is eliminated.
Use Puritan
Bennett-
recommended
patient interfaces.
Repair 5 5
This section provides repair information for the KnightStar 330. After diagnosing the problem
using the Troubleshooting section, perform the suggested repair using the instructions in this
section.
CAUTION: Do not soak any portion of the KnightStar 330 in solvent, alcohol, or
any other cleaning agent. Soaking ventilator components may
damage the ventilator.
CAUTION:
• Before handling PCBAs with static-sensitive components inserted, prevent
electrostatic discharge (ESD) damage by using the static-dissipative field service kit
when disassembling the device. Place the strap connected to the static dissipative
mat around your wrist before handling static-sensitive components, and use the
static dissipative mat as the work surface.
• Assemblies that are static sensitive may be handled without the technician being
attached to the static-dissipative workstation only if the assemblies are placed into
a protective container such as a conductive bag or case, or vendor packaging.
3 While holding both housing halves together, turn the device over and place it onto its
base.
4 Carefully remove the enclosure cover (Item 27) by rotating it towards the back of the
device, taking care while separating the tongue and groove section of the base, cover,
and pitot tube (Figure 5-3).
CAUTION: Be careful not to damage the three electrical connectors on the back
side of the device.
Item Description
1 Base, enclosure
3 Label, KS 330
5 Case, foam
6 Suspension/muffler, blower
7 Blower assembly
8 Ferrite, clamp on
9 Dampener
11 Chassis, enclosure
14 Tube, pitot
16 Baffle
24 Spacer (2 pl)
25 Insulator, LCD
27 Cover, Enclosure
28 Switch, Membrane
30 Screw, 4-20 x .375, PH. pan head (2 pl) 33 Assembly, PCB, main board
5 Place the enclosure cover on the work surface at the back of the device and carefully
disconnect the membrane switch ribbon cable connector from the J5 header on the
Main PCBA (Figure 5-4).
Ribbon cable
connector
5 Place the enclosure cover on the work surface at the back of the device and carefully
disconnect the membrane switch ribbon cable connector from the J5 header on the
main PCBA (Figure 5-4).
Ribbon cable
connector
Stand-offs
Connector to J4
on main PCBA
3 Carefully pull the LCD panel away from the J4 connector on the main PCBA.
4 Remove the LCD panel insulator (Item 25) and discard if it is damaged. Install a new
LCD panel insulator, if necessary.
5 Install the new LCD panel by aligning the header pins on the LCD panel with the J4
connector on the main PCBA, and pressing the corners onto the standoffs. Make sure
that the ends of the four standoffs fully engage into the holes on the LCD panel.
CAUTION:
• Be careful to align the header and connector properly.
• Do not press directly on the LCD screen when installing the new LCD panel.
Bellows
Figure 5-6. Removing the pitot tube from the enclosure groove and bellows
3 Remove the two screws (Item 30) using the #1 Phillips screwdriver (Figure 5-7). For
assemblies with an RS-232 PCBA (Item 31), carefully remove the insulator (Item 32) and,
if loose, the two plastic spacers (Item 24) from beneath the RS-232 PCBA mounted on the
main PCBA. Set these parts aside for re-assembly.
NOTE: Non-Sandman devices (P/N Y-KS330-SD) do not have the RS-232 PCBA,
insulator, and spacers.
CAUTION: Be careful when handling the main PCBA with the RS-232 PCBA to
prevent damage to the RS-232 PCBA and its connecting wires. Use of
an anti-static tape to hold the RS-232 PCBA to the main PCBA is
recommended.
4 Lift the main PCBA off of the chassis supports and tilt it towards the back of the lower
enclosure, following the precautions for the RS-232 PCBA, if applicable (Figure 5-8).
NOTE: It is not necessary to remove the chassis from the lower enclosure.
5 Disconnect the blower assembly (Item 7) wiring harness from the blower connector, J3,
on the main PCBA (Figure 5-8).
P3 connection Blower
from pitot tube to connector, J3
pressure sensor,
1 1/4” tube
P1 connection
from pitot tube to
flow sensor,
4 1/4” tube Fan
connector, J8
P2 connection
from pitot tube to
flow sensor,
10” tube
Fan assembly
6 Disconnect the fan assembly (Item 19) wiring harness from the fan connector, J8, on the
main PCBA (Figure 5-8).
7 Locate the Alarm PCBA (Item 20) and the alarm shield (Item 34) (Figure 5-9). Gently pull
up on the Alarm PCBA and alarm shield together to remove them from the main PCBA.
Keep the alarm shield for later re-installation or replace if damaged.
Alarm shield
located behind
alarm PCBA
CAUTION: When installing the new Alarm PCBA, ensure header pins are aligned
properly with the J6 connector on the main PCBA. Misalignment
during assembly could result in severe damage and necessitate
replacement of the Alarm PCBA and the main PCBA.
8 Install the new Alarm PCBA by attaching it to connector J6 on the main PCBA.
9 Re-install the alarm shield, ensuring that it is placed squarely between the Alarm PCBA
and the main PCBA components.
CAUTION: If, during disassembly, the chassis was accidentally removed from the
lower enclosure and the foam pulled away, carefully re-attach the
foam to the chassis so that it is not pinched in any way that occludes
the blower air inlet.
10 Reconnect the fan wire to the J8 connector, and the blower wire to the J3 connector.
11 Place the main PCBA back onto the chassis support posts, ensuring that the Alarm PCBA
fits into the notches on the chassis. Refer to Figure 5-10, and if necessary, slide the ferrite
on the blower wiring harness so that it rests in the space near the pressure transducer
(the pressure transducer is connected to the 1.25” silicone tube). This enables the main
PCBA to sit flush with the chassis support posts. Check that the Mains/AC connector
rests properly in the enclosure base and that the 10” silicone tubing rests in the carriers
of the chassis as shown in Figure 5-10.
CAUTION: Ensure that none of the silicone tubing is pinched or kinked during
re-assembly.
Correct ferrite
position
10” tubing
supported in
chassis carriers
12 Replace the RS-232 PCBA insulator shield and plastic spacers and fasten the main PCBA
onto the chassis using the screws removed in step 3. Torque screws to 5 in-lb.
13 Push the pitot tube back into the bellows and fit the pitot tube into the groove of the
enclosure base.
CAUTION: Ensure that the bellows does not get pushed back through the chassis
at any point and that the pitot tube fits properly in the bellows.
5.9 Cooling fan assembly, chassis, case foam, suspension muffler replacement
1 Perform steps 1-6 of Section 5.7, Alarm board assembly replacement. If you are not
replacing the cooling fan, skip to step 4.
2 Pull the cooling fan assembly (Item 19) away from the adhesive foam (Item 18) and then
remove the foam from the chassis (Figure 5-11). If you are also replacing the chassis, you
do not need to remove the adhesive foam.
3 Open the ferrite (Item 8) by sliding your fingernail underneath the latch, and remove it
from the fan wiring harness. Keep the ferrite for re-installation. If you are only replacing
the cooling fan, skip to step 15 in this section.
4 Unsnap the ferrite bead (Item 8) from the blower harness (Figure 5-12). Keep the ferrite
bead for re-installation. Peel back the wire patch on the chassis dome to allow the blower
harness connector to pass through. Lift the chassis assembly out of the enclosure base.
5 Turn the chassis assembly over to expose the case foam, and peel the foam away from the
chassis.
6 Remove the suspension muffler from the blower. If you are not replacing the suspension
muffler, keep it for re-installation.
7 Carefully push the lip of the bellows through the chassis air outlet port and remove the
blower (Item 7), screen (Item 12), and bellows (Item 13) together, guiding the harness
9 Re-use or install a new suspension muffler (Item 6) into the new case foam (Item 5) as
shown in Figure 5-14.
10 Insert the blower harness connector through the hole in the chassis dome and place the
blower assembly into the chassis, aligning the blower outlet with the port in the chassis
(Figure 5-15).
11 Gently push the bellows through the port so that the lip seals around the edge of the
port. Be careful not to pull the bellows and screen off the blower. Route the blower
harness so that the wires lead toward the tubing carriers, then cover the hole in the
chassis dome with the wire patch (Item 10) (Figure 5-16).
Wire patch
covers harness
CAUTION: Make sure the foam is flat across the chassis and will not obstruct the
cooling fan.
13 Turn the chassis assembly over and place it into the enclosure base (Item 1) . Check that
the bellows is still properly sealed around the hole in the chassis.
14 Install the ferrite bead (Item 8) onto the blower harness.
15 Apply new fan adhesive foam (Item 18) to the bottom of the new cooling fan assembly
(Item 19) (side opposite the fan label).
NOTE: If you are NOT replacing the chassis, ensure that all of the old foam has
been removed from the square recessed corner of the chassis before
installing the new fan and foam assembly.
16 Press the cooling fan assembly, adhesive side down, into the square recess in the corner
of the chassis. Make sure that the wires are oriented as shown in Figure 5-11.
17 If the new fan assembly does not have a ferrite included with the assembly, attach the
old ferrite to the mid-point of the fan wiring harness, by aligning the harness in the
ferrite’s channel and snapping it closed.
18 Perform steps 10-14 of Section 5.7 to complete the assembly.
2 Tuck the membrane switch ribbon cable underneath the main PCBA as you place the
enclosure cover onto the ventilator assembly, carefully aligning the tongue and groove
portions of the cover and base and the connectors with the holes at the back of the
cover. Ensure that there are no wires or silicone tubing pinched between the cover and
base enclosures. Ensure that the LCD is properly aligned with the membrane switch
window.
Figure 5-17. Aligning the rear connectors Figure 5-18. Installing the enclosure cover
3 Hold the device together and turn over so that the base is facing upward. Install four
screws (Item 15) using a Torx® T20 driver or #2 Phillips, as required. Torque the screws to
15 in-lb.
INDEX
H test 3-4
high pressure alarm low pressure alarm
setting 1-14 setting 1-14
test 3-6 test 3-5
I M
I/E PAP mode mains/AC input connector 1-20
default condition 2-4 mains/AC input voltage specification 1-6
description 2-4 maintenance and service 1-28
I:E ratio accuracy specification 1-6 mask leak setting 1-14
I:E ratio setting 1-13 membrane switch replacement 5-4
inhalation detection 2-7 mode key 1-17
initial ventilator cleaning and inspection 3-1
initial ventilator disassembly 5-2 N
input frequency specification 1-6 noise specification 1-6
input power specification 1-6
inspiratory circuit resistance specification 1-6 O
inspiratory sensitivity on/off key 1-18
description 2-7 onscreen symbols and abbreviations 1-25
setting 1-13 operating modes
interface leak setting 1-14 delay/ramp 2-3
interfaces, recommended 2-1 power on 2-3
internal clock setting 1-14 standby 2-3
IPAP setting 1-13 therapy 2-4
K P
keypad replacement 5-4 patient circuit volume, specifications 1-5
keys patient ID setting 1-14
down arrow & delay/ramp 1-18 patient pressure connector 1-22
mode 1-17 peak flow accuracy specification 1-6
on/off 1-18 performance verification
settings 1-17 autoclear procedure 3-6
up arrow & alarm silence 1-18 checklist 3-8
KnightStar 330 ventilator system cleaning and inspection 3-1
accessories 1-4 delay sequence test 3-5
assembly drawing 5-3 high pressure alarm test 3-6
configuration information 1-4 leak alarm test 3-4
general description 1-3 low pressure alarm test 3-5
initial factory settings 1-15 power failure indicator test 3-6
intended use 1-3 pressure test 3-5
periodic maintenance 1-28 sensitivity test 3-4
spare parts list 1-28 periodic maintenance 1-28
specifications 1-5–1-7 POST (Power On Self Test) 3-3
power failure indicator test 3-6
L power on mode 2-3
LCD 1-19 power specifications 1-6
LCD panel replacement 5-5 pressure accuracy specification 1-6
leak accuracy specification 1-6 pressure limit specification 1-6
leak alarm pressure test 3-5
setting 1-14 Puritan Bennett Technical Support
U
up arrow & alarm silence key 1-18
V
ventilator reassembly 5-13
ventilator serial numbers and software version 1-26
W
weight, ventilator 1-5
working pressure specification 1-6
Y
yellow LED 1-18, 2-10
Authorized Representative
Tyco Healthcare UK Limited
154 Fareham Road
Gosport PO13 0AS, U.K.
Rx ONLY
© 2006 Nellcor Puritan Bennett Incorporated. All rights reserved. 10011800 Rev. A (6/06)