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KnightStar ® 330

Bi-Level® Ventilator

Y-102942-00A Rev. D Service Manual


© Copyright 2000, 2001 Puritan-Bennett Corporation, 2200 Faraday Ave., Carlsbad CA 92008-
7208 U.S.A. All rights reserved.

KnightStar®, Bi-Level®, Companion®, and SoftFit® are registered trademarks of Puritan-Bennett


Corporation. Sullivan® is a registered trademark of ResMed, Inc. ADAM™ and Breeze™ are
trademarks of Puritan-Bennett Corporation. For more information, contact your Puritan Ben-
nett representative.

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Table of Contents
Chapter 1: General Information .......................................................................................1
Warnings, Cautions, and Notes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -3
Service Manual Illustrations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -3
Symbols and their Definitions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4
System Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -5
Performance Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
Displayed Patient Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
Circuit Resistance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
Noise- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
Electrical Characteristics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
External Battery Time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
Environmental Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
Physical Characteristics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
Chapter 2: Theory of Operation .......................................................................................8
Safety Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -8
KnightStar 330 Operating Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11
Modes/Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12
System Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
Control Panel Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
Control Panel Buttons- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
Control Panel Indicators- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16
Chapter 3: Modes of Operation ......................................................................................17
Stand-by Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17
Power On - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17
Delay/Ramp - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18
Power Off - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18
Therapy Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18
Breath Detection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19
User Interface Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20
Alarm Control - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20
Breath Detection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 21
Sensitivity Adjustments - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22
Inspiratory Sensitivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22
Expiratory Sensitivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22
Rise Time- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 24
Chapter 4: Service and Repair ........................................................................................25

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KnightStar 330 Connectors and Setup - - - - - - - - - - - - - - - - - - - - - - - - - - 25
Cleaning the KnightStar 330 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 26
Connecting Device Components - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 27
Performance Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 28
Unit Disassembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 28
Re-assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 40
Overlay Replacement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 46
Chapter 5: Final Test ....................................................................................................... 49
Serial Number Transfer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 53
Chapter 6: Troubleshooting ........................................................................................... 54
Chapter 7: KnightStar 330 Service Spare Parts ............................................................ 57
Appendix A: US Control Panel Configuration ............................................................... 59
Appendix B: Alarm Types and Conditions ..................................................................... 61
Appendix C: Working with the RS-232 Sub-D Connector ............................................ 66
Appendix D: Symbols Seen on the KnightStar 330 Display ........................................ 67
Appendix E: KnightStar 330 Setup Checklist ................................................................ 69
Appendix F: KnightStar 330 Settings ............................................................................ 72
Appendix G: Service Information .................................................................................. 74
Appendix H: Limited Warranty ...................................................................................... 75
Index ................................................................................................................................. 77

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Chapter 1: The Puritan Bennett KnightStar 330 is a continuous bi-level ventilator that
General provides noninvasive ventilation for the treatment of respiratory
insufficiency and obstructive sleep apnea that may occur in the home. It is
Information also indicated for the treatment of respiratory failure in institutional
environments. It is intended to assist the ventilation of spontaneously
breathing patients who are over 30 kg (66 pounds) in weight . Read this
manual and the KnightStar 330 Clinician’s Manual thoroughly before
operating the device. They provide service, repair, and technical information
concerning the operation and performance of the Puritan Bennett KnightStar
330 bi-level ventilator.

The KnightStar 330 is a microprocessor-controlled pressure generator


capable of monitoring the air flow and controlling the pressure delivered to
the patient. The following are a few of its operating features:
• Provides three operation modes, including CPAP, I/E PAP, and Assist
Control (A/C).

• Monitors pressure, tidal volume, respiratory rate, air leaks, peak flow,
and the I:E ratio.

• Adjustable inspiratory and expiratory trigger sensitivity provides pre-


cise respiratory support and patient comfort.

• Audible and visual indicators alert users to power failure, system leaks,
device performance.

• Allows a maximum pressure setting of 30 cmH2O, with a pressure lim-


itation 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.

The following components make up the KnightStar 330 system:

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KnightStar 330 bi-level Tubing and proximal
ventilator pressure line

Inlet air filter (with spare)

Power Cord Optional outlet air filter

Puritan
Bennett
KnightStar 330
Bi-level Ventilator

KnightStar 330 Service Manual

Figure 1: KnightStar 330 Components.

It is recommended to use the KnightStar 330 with 6-ft (1.8 m) or 8-ft (2.4 m)
tubing and Puritan Bennett Breeze™, or ADAM™interfaces.

Three modes of operation are available:


• CPAP (continuous positive airway pressure)

• I/E PAP (inspiratory and expiratory positive airway pressure)

• A/C (Assist Control)

In the CPAP mode the system delivers a continuous positive regulated


airway pressure throughout the breath cycle (normal operating range from 3
to 20 cmH2O).

2
In the I/E PAP mode the system tracks patient breathing effort and provides
two levels of pressure—a higher level of pressure for inspiration (normal
operating range of 3 to 30 cmH2O) and a lower pressure for expiration
(normal operating range of 3 to 20 cmH2O).

In the A/C mode, the system delivers the same two levels of pressure as
described for the I/E PAP mode with the addition of a backup breath rate
(normal operating range of 3 to 30 breaths per minute) and an I:E ratio
(normal operatnig range of 1:1.0 to 1:4.0).

When the Lockout mode is active, these settings are available to the patient:
the Delay Time, Ramp Time, and Ramp Starting Pressure.

Warnings, The following words found in this document have special significance.
Cautions, and Warning
Notes Means that there is a possibility of injury or death.

Caution
Means that there is the possibility of damage to the device
or other property.

NOTE:
Indicates information of particular interest for more efficient
and convenient operation.

Service Manual Throughout the manual, illustrations and photographs show the International
Illustrations configuration of the KnightStar 330 (control panel with International
symbols). Refer to Appendix A: US Control Panel Configuration for an
illustration of the control panel found on United States models, and a
description of each of the controls.

3
Symbols and their
Definitions

! Attention, consult accompanying manual

Alternating current (Mains/AC power from wall outlet)

Direct current (battery power)

Type BF equipment, degree of protection against electrical shock

Class 2 equipment, double insulation design

Alarm condition

CE Mark: This device complies with the requirements of Medical Device Directive
93/42/EEC concerning medical devices

Mains/AC power cord connection

Air outlet connector (blower connector)

External Battery/DC power connector

RS-232 communications connector

UL mark, classified by Underwriters Laboratories Inc. with respect to electric shock,


fire, and mechanical hazards only in accordance with standards UL2601-1 and
CAN/CSA C22.2 No. 601.1-M90.
IPX1 Drip proof
SN Serial Number
REF Product model number

Max

Storage temperature range


Min

4
System Setup This section describes how to prepare the KnightStar 330 system for use.
Warning
Be careful when handling the KnightStar 330 during or
immediately after use. Under specified conditions, some
surfaces of the unit may become hot to the touch. This is a
normal occurrence and is typical of this type of device.

The KnightStar 330 system is intended for use in various environments.


Patient parameters and data are entered and displayed on the control panel
on the top of the device.

In the sleep lab, the optional remote control enables control and monitoring
away from the device. Connection between the remote control and the
KnightStar 330 unit is made using a cable that attaches to the rear of the
device.

The KnightStar 330 functions can also be controlled by using an optional


data management software package with an RS-232 port for local or remote
access.

Figure 2: Manometer with KnightStar 330, outlet filter, and


tubing.

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Performance Working Pressure: 3 to 30 cmH2O (1 cmH2O = 0.98 hPa)
Specifications Pressure Limit:40 cmH2O
Static Pressure Regulation: 4 to 30 cmH2O
CPAP ±0.5 cmH2O
Bi-Level ±1.0 cmH2O

Displayed Patient Vt: 20 mL +20% of reading (between 50 mL and 2000 mL)


Parameters Peak Flow: 5LPM + 20% of reading (between 1 and 100 LPM)
Leak: 5LPM + 20% of reading (between 1 and 100 LPM)
Respiratory Rate: 1 BPM (between 1 and 50 BPM)
I:E Ratio: 15% of reading (between 1:1 and 1:9.9)
Pressure: 1 cmH2O +10% of reading (3 to 35 cmH2O)

Circuit Resistance Inspiratory: 0.9 cmH2O at 60 L/min


0.2 cmH2O at 30 L/min
Expiratory: 5.0 cmH2O at 60 L/min
4.1 cmH2O at 30 L/min

Noise 30 dB (A) for IPAP/EPAP = 10 cmH2O


(measured 1 m in front of device)

Electrical Rated Mains/AC Input Voltage: 100–240 V~


Characteristics Rated Input Frequency: 50–60 Hz
Rated Input Power: 140 W

External Battery Direct current power from a 12-volt external battery pack can operate the
Time KnightStar 330. The 32 ampere-hour external battery provides power for at
least 8 hours. The 7 ampere-hour external battery provides power for 3
hours. If needed, cables are available for connecting the KnightStar 330 to a
car or truck cigarette lighter outlet.
Rated Input Voltage: 12 V
Rated Input Current: 6.0 A
Rated Input Power: 140 W

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Environmental Operating Temperature: +41° F to +104° F (+5° C to +40° C)
Requirements Humidity:15 to 95% noncondensing
Altitude: 0 to 8,000 ft (0 to 2,438 m)
Storage Temperature: -40° F to +158° F (-40° C to +70° C)
Humidity: 10 to 100% condensing

Physical Device Size: 3.75 in x 8.25 in x 5.62 in (9.52 cm x 20.95 cm x 14.27 cm)
Characteristics Device Weight: 2.7 lbs (1.21 kg)
Device Airway Volume: 65 mL
Tube Airway Volume: 695 mL (6 ft/1.8 m) or 927 mL (8 ft/2.4 m)

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Chapter 2: The device is a micro-controller-based design employing a 2-pole/3-phase,
Theory of high frequency blower powered by a universal switching power supply. The
device controls can be set via the top panel keyboard and LCD or via the RS-
Operation 232 interface. Internal memory stores waveform, compliance log, and error
log information that can be downloaded to a computer.

The device can be operated using either AC or DC power per the


specifications on page 6.

A gross particulate filter provided at the air inlet filters the incoming air. Use
of a high efficiency bacterial filter at the air outlet is recommended for
optimal device performance. A patient circuit of 6 or 8 feet with proximal
pressure tube provides delivery of air to the patient and pressure feedback to
the device.

Control of delivered pressure is accomplished by measuring the pressure at


the mask via a pressure measurement tube and sensor, and increasing or
decreasing pressure by changing the motor speed with a motor/stator under
direct control of the microprocessor. This methodology provides the ability
to compensate pressure for leaks in the patient circuit and for changes in
altitude. Using an impeller with a low mass allows for rapid speed (pressure)
changes requiring less power than higher mass systems.

The device operates in three distinct modes; CPAP, I/E, and A/C. CPAP
provides continuous positive airway pressure up to 20 cmH2O. I/E PAP and
A/C modes provide two pressure levels; an exhale pressure level of up to 20
cmH2O and an inhale pressure level of up to 30 cmH2O. The A/C mode also
provides a backup breath rate if the patient stops breathing or the patient’s
breath rate drops below the set value. When in I/E PAP and A/C modes, the
device monitors the flow to determine if the patient is inhaling or exhaling.
The detection is performed using a mass flow sensor connected to a pitot
tube at the blower outlet. The sensor output is then connected to an analog
hardware circuit that sends inhale and exhale triggers to the micro-
controller. The sensitivity of the breath detection set by the user is adjusted
by the micro-controller. Five settings each for inspiratory and expiratory
sensitivity are provided for clinician selection. The micro-controller also
monitors the analog flow signal to determine tidal volume and leak. Altitude
compensation of the flow is accomplished by using an internal barometer
that adjusts the flow value in software.

Safety Features Several features have been designed into the device to protect the patient and
user from injury following a single fault condition.

Overcurrent protection - Fuses in the Mains/AC inlet lines protect against


electrical shock.

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Controls protection - A lockout mode allows the clinician to limit patient
access to settings except for comfort features (ramp, delay). There is no
auto-scrolling of setting selections; the selection advances one step with
each button press.

Power off protection - The on/off button must be depressed for three seconds
to power off the device.

Maximum pressure - A software control shuts down the blower if delivered


pressure exceeds 40 cmH2O.

Audible alarms - An alarm sounds for various equipment fault conditions


and device output conditions which exceed thresholds set by the clinician.
Equipment alarms are triggered upon device internal malfunction. Device
output alarms include high pressure, low pressure, and high leak.

See Figure 3 for flow chart of the micro-controller for this bi-level
ventilator.

9
Bi-Level Device Air Inlet/
Filter

AC Power Patient
Power Outlet Patient
Main 85 to Supply
Blower Driver Blower Outlet/
Filter Circuit
Patient
264VAC Flowmeter
Pressure
Current Input
Measurement Tube
DC Power Flow Sensor
External
Battery
12 VDC
Micro-Controller Trigger
Circuit

Blower Control

Currrent Analysis
Cooling
Fan
Flow and Volume
LCD Analysis/Triggering/ Control
Module Patient Compliance/
Altitude Flow Data
Keyboard Compensation Atmospheric
Module Pressure
Switches Pressure Analysis / Sensor
& LEDs Leak Compensation/
Proximal
RS 232, IE Altitude Pressure
Pressure
trig, prog Limitation
Sensor
enable
Program Audible
Data
Memory Alarm
Storage
Real Time
Alarm
Clock &
Battery
Battery

Figure 3: Micro-controller flow chart of the KnightStar 330 bi-


level ventilator.

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KnightStar 330 The KnightStar 330 operates in one of three modes as shown in Table 1.
Operating Modes

Table 1: Operating Modes

Mode Description
A/C I/E PAP with an adjustable respiratory rate and I:E ratio. If the device is unable to track breathing efforts, or the
patient’s spontaneous respiratory rate falls to or below the prescribed backup rate, the device will cycle at the
prescribed levels of pressure and I:E ratio. If the backup rate cycles for five continuous breaths, the f symbol
will appear on the lower left corner of the display, and the yellow LED will illuminate. The symbol f will be
displayed and the yellow LED will remain lit until the patient breathes on his or her own. When the backup rate
is cycling, the patient data for the “f” and “I:E” will be the prescription parameter values.

I/E PAP Inspiratory/Expiratory Positive Airway Pressure with default to EPAP. This occurs when no inspiration is
detected for the average inspiration period plus five seconds. Upon reaching this condition the device will
default to the selected EPAP setting (setting range is 3 -20 cm H2O). When the device is at EPAP pressure for
the average exhalation time plus 5 seconds, the patient data will also default to the given values. When an
inspiration event is detected, the device will resume normal operation. During the default condition the patient
data will be as follows:

f = 0 bpm

P = EPAP setting

Vt = 0 liters

Leak = 0 L/min

V = 0 L/min
I:E = 1:0.0 ratio

CPAP Continuous Positive Airway Pressure: Pressure is continuously delivered at the set level.

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Modes/Settings Each mode enables a different set of system settings. Table 2 lists the modes
and their respective settings. Table 3 shows the KnightStar 330 Initial
Factory Settings.

Table 2: Modes/Settings

CPAP I/E A/C


CPAP IPAP IPAP

Alarm volume EPAP EPAP

Leak alarm IPAP sensitivity Respiratory rate


and Backup
respiratory
setting (f)

Delay before EPAP sensitivity I:E ratio


ramp

Ramp duration Rise time IPAP sensitivity

Start pressure Alarm volume EPAP sensitivity

Leak setting Leak alarm Rise time

Low Pressure Alarm volume


alarm

High Pressure Leak alarm


alarm

Delay before Low Pressure


ramp alarm setting

Ramp duration High Pressure


alarm setting

Start pressure Delay before


ramp

Leak setting Ramp duration

Start pressure

Leak setting

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Table 3: KnightStar 330 Initial Factory Settings

FUNCTION SETTING
MODE A/C

IPAP 5 (Same setting for CPAP)

EPAP 3

Resp rate 10

I:E ratio 1:2.0

I Sensitivity 3

E Sensitivity 3

Rise time 3

Volume 3 (maximum)

Leak alarm 100 LPM

Low pressure alarm 4 cm H2O

High pressure alarm 6 cm H2O

Delay time 0

Ramp time 0

Ramp Start Pressure 3

Mask Leak Hole Setting 2

Over pressure alarm 40 cm H2O (not adjustable)

NOTE:
Refer to Table 4: Top Panel Buttons and Appendix F:
KnightStar 330 Settings for information on changing device
settings.

13
System The following section describes control features of the KnightStar 330.
Description

Control Panel The Liquid Crystal Display (LCD, shown in Figure 4) provides an easy-to-
Display read format for mode, settings, and patient parameters. A backlight
illuminates the display when the Mode or Settings button is pressed. The
display will remain illuminated for approximately 60 seconds after the last
button push.

Control Panel The top panel controls are shown in Figure 4 and their features are listed in
Buttons Table 4.

PURITAN BENNETT
TM

1
2
3

Yellow
Green Red

Control Indicators (LEDs)

Figure 4: KnightStar 330 Control Panel (Int’l model shown).

14
Table 4: Top Panel Buttons

Symbol Name Function


On/Off Turn KnightStar 330 system On with a quick press and release action. The KnightStar
330 retains the prescription settings last entered. To turn the device off, press and
hold the On/Off button for 3 seconds.

Mode Scroll through various modes: CPAP, I/E PAP, A/C (if the Lockout mode is inactive).
1
2
3
Leave Settings Leave Settings mode if adjusting settings.
Mode

On + Autoclear When the KnightStar 330 is in the Stand-by mode (plugged in to AC power but not
button operating), you can press the “On,” “Mode,” and Up arrow buttons and
Mode + combination hold for approximately 20 seconds to clear the updatable “flash” memory, and
restore the default values. Within approximately 20 seconds after simultaneously
releasing the buttons, the user will recognize that this process is occurring by the
“Xs” that appear on the display (in place of the patient ID) during Power On Self
Test (POST).

Mode + Lockout mode If the Lockout mode is active, the patient may only change the delay, start pressure,
and Toggle and ramp duration functions.
To change the Lock or Unlock position, hold the Mode button and the up arrow
together for approximately 2 seconds.

Settings If the Lockout mode is inactive, you may scroll through all of the available
parameters. If the Lockout mode is active, you may only scroll through the patient-
settable parameters (delay, start pressure, ramp duration).

Delay/Ramp Start or stop the Delay/Ramp function.

Down Arrow Decrease a selected setting value when in Settings mode.

Alarm Silence Mute an active alarm for one minute.

Up Arrow Increase a selected setting value when in Settings mode.

Display In AC or I/E mode, when the main display screen is shown, pressing this button
Secondary displays V and I:E ratio if there are no active alarms.
Screen

15
Control Panel The KnightStar 330 control panel has visual indicators (shown in Figure 5)
Indicators that illuminate in response to specific device or tubing circuit problems.

1
2
3

Red
Yellow
Green

Control Indicators
(LEDs)

Figure 5: Control Panel Indicators.

An audible indicator will sound under certain conditions:


• A high priority alarm is indicated by a flashing red LED, along with an
audible alarm that beeps 5 times at intervals of ten seconds.

• A medium priority alarm is indicated by a flashing yellow LED, along


with an audible alarm that beeps 3 times at intervals of 25 seconds.

• A low priority condition is indicated by an illuminated yellow LED


(without an audible alarm).

• An illuminated green LED indicates the presence of power, whether


from Mains/AC or external battery.

Refer to Chapter 6: Troubleshooting for possible causes and corrective


actions for visual and audible indicators.

16
Chapter 3: Device Operation consists of the following modes: Stand-by, Power On,
Modes of Power Off, Delay/Ramp, and Therapy.

Operation

Stand-by Mode Once the AC power cord is connected, the device enters Stand-by Mode.
The device performs a self-test to verify the integrity of the firmware,
hardware, and stored data. Defined in Appendix B: Alarm Types and
Conditions, these tests include the following:

1. Embedded ROM checksum test

2. RAM read/write test

3. Manufacturing EEPROM checksum

4. Real time clock valid date and time

5. “PIC” processor RAM read/write test

6. Stuck Switch test

The device remains in Stand-by mode until the On/Stand-by Switch is


pressed. The device returns to Stand-by mode when turned off (the On/
Stand-by Switch is pressed for three seconds).

During Stand-by mode, the display is blank.

Power On The device powers on by pressing the On/Stand-by Switch, then displays
copyright notice, company name, and firmware version. Each time the
device is turned on, the device performs the following tests:

1. Valid settings test and critical parameter checksum

2. Alarm/battery voltage test

3. LED test

17
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 then commences delivery
of the set therapy mode.

Delay/Ramp Button: This button is used to activate the delay feature.


When the delay is activated, both inspiratory and expiratory pressures will
decrease to the Ramp Start pressure. The time of delay can be set from 0 to
30 minutes. After the delay time has elapsed, pressure will slowly ramp up
to the prescription pressures. The Delay mode can be cancelled by again
pressing the Delay/Ramp button. Once activated, the delay time can be
restarted by again pressing the Delay/Ramp button.

Power Off The device powers off (returns to Stand-by Mode) when the On/Stand-by
Switch is pressed for three seconds. The device retains all settings in
memory during periods when the unit is powered off.

Therapy Modes CPAP Mode: The device will implement CPAP by producing a
continuous pressure at the CPAP level. Pressure will be continuous in the
range of 3 to 20 cm H2O. In this mode, the device will continue to track
respiration rate, tidal volume, leak rate and I/E ratio of the patient.

Bi-level (I/E) Mode : While tracking patient breathing efforts in I/E PAP
mode, the device provides two levels of pressure: a higher level of pressure
for each inhale event (3 to 30 cm H2O) and a lower level of pressure for each
exhale event (3 to 20 cm H2O).

If the device is unable to track patient breathing effort in bilevel mode, the
KS 330 defaults to the modes shown in Table 5 in response to the stated
conditions.

Table 5: I/E Default Operating Modes


CONDITION DEFAULT OPERATING MODE
Inhalation trigger not detected while at Device remains at EPAP level until it
the EPAP level. detects an inhalation trigger.

The time of the average inhalation period Device cycles to the EPAP level and
plus five seconds is exceeded while at the remains at this level until it detects an
IPAP level inhalation trigger.

Upon detecting an inhale trigger the device resumes normal I/E PAP mode
operation supporting all detectable spontaneous breathing at the prescribed
pressure levels.

18
Assist with Control (A/C) Mode : A/C Mode provides the same
ventilatory characteristics as I/E mode as long as the patient’s respiratory
rate (RR) is higher than the set frequency. If the patient’s spontaneous RR
drops below the prescribed RR, the device will cycle at the prescribed IPAP
and EPAP levels, respiratory rate, and I:E ratio (the A/C default condition).
When the patient’s spontaneous RR returns to a rate higher than the
prescribed RR, the device will resume tracking of the patient’s spontaneous
respiratory rate and will continue to provide pressure at the IPAP and EPAP
levels.

Breath Detection When in I/E PAP and A/C modes, the device responds to detected breathing
by adjusting pressure levels. The device detects flow with a pitot tube, mass
flow sensor, and analog trigger circuit to detect inhalation and exhalation.
An inhalation trigger occurs when the flow exceeds a fixed threshold set by
the inhale sensitivity. An exhalation trigger occurs when the difference
between the instantaneous flow and the flow from an earlier time is less than
the threshold set by the exhalation sensitivity. When the device shifts from
inhalation to exhalation or exhalation to inhalation, the device incorporates a
refractory period to prevent auto-cycling due to additional flow triggers.

NOTE:
Autocycling refers to a delivered breath that was not
initiated by the patient.

Inhalation/Exhalation (I/E) Sensitivity: The device is flow triggered


when sensing the patient’s respiration changing from exhalation to
inhalation and from inhalation to exhalation.

Inhalation sensitivity: The device provides 5 inhalation sensitivity


settings across a range. The setting of 1 is the most sensitive inhalation
trigger, 5 is the least sensitive.

The inhalation detection is determined by comparing the high pass and low
pass filtered flow signal to the delayed signal and to a fixed inhalation
threshold. If the delayed signal (from the 0.93Hz filter) is greater than the
fixed threshold, the inhalation detection works as just the reverse of the
exhalation threshold, triggering an inhalation when the filtered flow signal
goes more positive than the delayed signal. If the delayed signal is less than
the fixed threshold, the flow signal is compared to the fixed threshold.

19
Exhalation sensitivity: The device provides 5 exhalation sensitivity
settings across a range. The setting of 1 is the most sensitive exhalation
trigger, 5 is the least sensitive.

The exhalation detection is determined by comparing the high pass and low
pass filtered flow signal with a delayed copy of itself. The signal is more
positive than the delayed signal during the inhalation, but when it crosses to
less than the delayed signal the exhalation is triggered. The 0.93Hz low pass
filter determines the delay. The amplitude of the delayed signal, which is
determined by the gain setting in series with the 0.93Hz filter sets the
threshold.

User Interface Displayed Parameters: The device displays four measured parameters
Display continuously and simultaneously during operation in I/E PAP and A/C
modes:
• The respiration rate (f) in breaths per minute (BPM)

• The measured pressure (P) in centimeters of water (cm H2O)

• The estimated tidal volume (Vt) in milliliters (mL)

• The estimated leak rate (L) in liters per minute (LPM)

In CPAP mode, only pressure and leak rate are displayed.

Pressing the Up Arrow/Alarm Mute switch when the unit is operating in I/E
PAP or A/C modes, and no alarm condition is present, the device displays
the following parameters for 5 seconds:
• Peak flow (V ) in liters per minute (LPM)

• I/E Ratio (I:E) 1: X.X

When a DEFAULT condition occurs in I/E PAP mode, the display of


Respiration Rate, Tidal Volume, Peak Flow and Leak will be “0” and the
display of the I:E ratio will be 1:0.0 until normal operation resumes.

When a DEFAULT condition occurs in A/C mode, the display of


Respiration Rate and I:E ratio will become the set rate and ratio, after four
default breaths.

Alarm Control The device includes an audible alarm capable of an adjustable sound level
and can produce 85 dB(A) sound pressure level at a distance of one meter.

20
The audible alarm function is provided on a separate alarm PCBA, which
connects to the main PCBA via a 10-pin double row header.

The connections for the alarm port appear in Table 6.

Table 6: Alarm Port connections

Pin # Function
1 Ground

2 SDA signal of I2C interface

3 SCL signal of I2C interface

4 Red LED (on membrane switch) anode

5 Resistor and base of PNP transistor on main


board that drives yellow LED

6 Ground

7 Mute key input

8 +27V from main board

9 Ground connection on main board for alarm


board batteries

10 Ground

The alarm processor takes commands from the main PCBA processor via the
I2C interface for the alarm controls (including sound level). The PIC
processor can control its onboard audible alarm and the red and yellow
LED's on the membrane keypad. It is powered at maximum volume on the
alarm PCBA with +13.5V nominal with a 5mA current limit. The alarm is
equipped with a lithium power source. This allows the alarm to function
during power outages or failure of the main PCBA.

Breath Detection When in I/E PAP and A/C modes, the device monitors the breath detection
triggers to determine if the patient is inhaling or exhaling. The actual
detection is done with analog hardware. The sensitivity of the breath
detection is adjusted by the micro-controller. The micro-controller monitors
the analog flow signal and breath trigger signals to determine tidal volume
and leak. An analog signal from the flow sensor is connected to the micro-
controller analog input 0 (Pin 5).

21
Sensitivity An important part of the KnightStar 330 is its adjustable triggering
Adjustments sensitivity for both inspiration and expiration.

Inspiratory A setting of 1 is the most sensitive setting on the KnightStar 330 and a
Sensitivity setting of 5 is the least sensitive setting.

Inspiratory sensitivity should be adjusted for patient comfort to improve


compliance. An inspiratory setting that is too sensitive may cause
autocycling, which may be uncomfortable for the patient.

NOTE:
Autocycling refers to an automatically delivered breath that
was not initiated by the patient.

Expiratory The chart shown in Figure 6 illustrates the effects of changing the expiratory
Sensitivity sensitivity on the KnightStar 330.

A setting of 1 is the most sensitive setting, and it causes the KnightStar 330
to cycle into the expiratory phase quickly. A setting of 5 is the least
sensitive, and inspiratory flow needs to diminish significantly before the
KnightStar 330 cycles into the expiratory phase. The longer it takes for the
device to cycle into the expiratory phase, the greater the potential tidal
volume delivered to the patient.

Expiratory sensitivity can be adjusted by patient assessment. If inspiratory


times appear to exceed the inspiratory efforts of the patient, a lower
expiratory sensitivity can be set and the patient observed for signs of
increasing comfort. If the breath appears to be terminating prematurely, a
higher expiratory sensitivity can be set and patient comfort as well as its
effect on tidal volume re-evaluated.

A high sensitivity, expiratory setting of 1 may be appropriate for patients


who need a longer expiratory period to allow for adequate elimination of
expiratory gases, as in those with chronic obstructive pulmonary disease
(COPD).

22
Figure 6: Effects of changing the expiratory sensitivity on
the KnightStar 330.

23
Rise Time The following graph depicts the “Rise-time” for settings 1, 3, and 5.

Figure 7: Breath waveform pressures for Rise-time settings of 1,


3, and 5.

A setting of 1 causes the pressure to rise more rapidly than a setting of 5.


Patients with aggressive inspiratory demands may be more comfortable on a
setting of 1 or 2. Some patients are more comfortable with a gentler rise to
pressure, for these patients a setting of 4 or 5 may be better suited to their
needs. A setting of 3 represents an intermediate rate of pressure change. The
dotted lines in Figure 7 show the amount of time required for pressures to
reach their peak values at different Rise-time settings.

24
Chapter 4:
Service and
Repair

KnightStar 330 The following table identifies materials and tools needed for service and
Connectors and repair.
Setup

Table 7: KnightStar 330 Service Materials and Tools.


MATERIALS TOOLS
• Isopropyl Alcohol 99% • Calibration Shell, S-231702-00B
• Paper Towels • 6-ft. Patient Tube with Pressure Feedback, P/N Y-
• Reinforced Paper Packaging Tape 261000-27
• Screwdriver, with Phillips bit.
• Torque Driver 5 in-lbs. +/- 0.5
• Torque Driver 15 in-lbs. +/- 0.5
• Static Control Station
• Needle Nose Pliers
• Box Stapler and Staples
• Pressure Gauge (0 to 30 cmH2O range, 1 cmH2O
resolution)
• Outlet air filter, L-6108 (optional)
• KnightStar 330 Service Application Software,
Y-103012-00
• KnightStar 330 Service Communications
Cable, Y-103086-00A
• Personal computer, Pentium w/Windows 95 or
greater
• RS-232 cable, 6-ft cable w/female to 9- pin con-
nectors
• 24-volt power supply

25
Cleaning the Thoroughly clean the exterior of the KnightStar 330 before servicing or
KnightStar 330 repairing the unit with a 10% bleach and water solution or equivalent.

NOTE:
The outlet air filter, L-6108 on the KnightStar 330 test
equipment must be replaced at least once every 2 months.

The connectors on the back of the KnightStar 330 are shown in Figure 8.

RS-232 Battery
Mains/AC power connector
power connector

Figure 8: KnightStar 330 Connectors.

Mains/AC Power Cord Connector: Electrical input connection. The


device operates on 100 to 240V~ at 50 or 60 Hz.

RS-232: This receptacle is used to electrically connect a PC (with


KnightStar 330 Service Application Software installed), or to connect
an optional external modem, or optional remote control to the device.

NOTE:
Personal computers (PCs) used with the KnightStar 330
must be approved according to the requirements of UL
1950 or EN 60950.

26
External Battery Connector: Used for connecting an optional external
12V battery, or for use with a 12 V cigarette lighter adapter when
Mains/AC power is not available.

Connecting Device Upon connecting the KnightStar 330 for the first time, review the device
Components components. (See Figure 9.)

Air outlet

Proximal pressure line

Optional outlet air


filter

Figure 9: Connecting device components.

Test Setup:

1. Ensure that the KnightStar 330 is placed in such a manner that there is
at least 1 inch of clearance at the back of the unit.

2. Connect one end of the Mains/AC power cord into the rear panel of the
KnightStar 330, and the other end into an Mains/AC wall outlet.

27
3. Attach patient circuit, P/N Y-261000-27, and optional air filter, P/N L-
6108, to air outlet.

Figure 10: Manometer with KnightStar 330, outlet filter, and


tubing.

4. Attach proximal pressure line to pressure outlet.

5. Attach calibration shell, P/N S-231702-00B, to the end of patient


circuit, and connect the circuit hose to the pressure gauge.

Performance Power On Self-Test.


Verification
To ensure proper operation of the KnightStar 330, a power on self-test
automatically runs each time you turn on the device. You may notice a 9-
second delay after pressing the On/Off button before you can actually
operate the KnightStar 330. When you turn the KnightStar 330 on, it
displays the copyright notice, manufacturer’s name, and firmware version;
then beeps and flashes the LEDs before beginning its normal operation.

NOTE:
To perform a functional test prior to disassembling the unit,
refer to Chapter 5: Final Test.

Unit Disassembly NOTE:


This process covers the disassembly of P/N Y-KS330-XX.

1. Obtain materials and tools as needed.

28
2. Assure work station is clean.

Caution
Before handling circuit boards with ICs inserted, the
operator must be grounded preventing static discharge to
sensitive components. Place the ground strap from the
static control station around the operator’s wrist before
handling static sensitive components/assemblies.

Components/assemblies which are static sensitive, may be


handled without operator grounding only if they are within a
protective container, i.e. conductive bag, case, or vendor
packaging.

The ESD mat should be used as the working surface.

NOTE:
The following assembly drawings refer to Y-KS330-XX.

Should you need to replace parts during service, see


Chapter 7: KnightStar 330 Service Spare Parts on page
57 for the corresponding replacement part number.

29
Figure 11: KnightStar 330 assembly drawing (page 1).

30
Figure 12: KnightStar 330 assembly drawing (page 2).

Disassembly Steps.

1. Turn base upside down and lay on work surface.

2. Using a #2 Phillips screwdriver, remove the four housing screws,


ITEM #18.

31
Figure 13: Removing the housing screws from KnightStar 330.

3. While holding both housing halves together, turn the unit over and
place the unit onto its bottom.

4. Carefully remove the top housing, ITEM 2, by rotating it towards the


back of the unit, taking care to separate the tongue and groove section
of the base, cover, and pitot tube, as well as the three connectors on the
backside of the unit.

Figure 14: Removal of the top housing.

32
5. Lay the top housing to the back side of the unit and carefully remove
the LCD overlay ribbon cable from the PCBA.

Ribbon cable

Figure 15: Removal of the LCD overlay ribbon cable.

PCBA Replacement.

1. Remove the LCD display, ITEM 16, from the Main PCBA. Using
needle nose pliers, for each of the four plastic snap fit connectors,
pinch the ends together and gently pull the corner of the display over
the connectors.

J4 pins

Snap-fit connectors
Figure 16: Removal of the LCD display.
Caution
Take care not to damage the J4 connector pins.

33
2. Remove the mylar LCD insulator, ITEM 17, and keep for the re-
assembly of the unit.

Mylar LCD
insulator

Figure 17: Removal of the mylar LCD insulator.

3. Disconnect the 10" silicone tube, ITEM 12, from the “P2” flow sensor
tap on the Main PCBA.

Figure 18: Illustration of the flow transducer.

4. Disconnect the 4-1/4" silicone tube, ITEM 13 from the “P1” flow
sensor tap on the Main PCBA.

5. Disconnect the 1-1/4" silicone tube, ITEM 14 from the pressure


transducer on the main PCBA.

34
NOTE:
Verify that all three silicone tubes remain attached to the
outlet connection.

6. Remove the Main PCBA, ITEM 30, from the chassis by removing the
two PCBA screws, ITEM 8.

Figure 19: Removal of the Main PCBA.

35
7. Disconnect the blower wire from the J3 connector on the Main board.

8. Disconnect the fan wire from the J8 connector on the Main board.

36
9. Remove and keep the Lexan shield, ITEM 47, for re-installation.

10. Gently pull up on the Alarm PCBA, ITEM 31, to remove it from the
main PCBA.

NOTE:
If the battery or either of the two PCBAs is being replaced,
dispose of the used items in accordance with local
regulations.

37
11. To reinstall the board, go to Board re-installation section on page 42.

Blower Replacement.

1. Remove the pitot tube, ITEM 19, blower housing bellows, ITEM 15,
and screen, ITEM 20, from the blower. These items will be needed
later for re-assembly.

Figure 20: Removal of the pitot tube.

2. Remove the bottom housing, ITEM 1, from the unit by grasping two
chassis stand-offs, and gently pulling the chassis, ITEM 5, from the
bottom housing.

3. Pull case lower foam section, ITEM 4, from the chassis.


Figure 21: Removal of the base housing.

4. Remove blower assembly, ITEM 9, from the suspension muffler,


ITEM 21.

5. Remove ferrite snap, ITEM 40, from blower wire. Keep ferrite snap for
re-assembly.

38
6. Guide blower wire through chassis hole.

7. To re-install the blower, go to Blower Re-Installation section on


page 40.

39
Fan Replacement.

1. Separate the cooling fan assembly, ITEM 22, and the fan adhesive
foam, ITEM 23 from the chassis.

Figure 22: Removal of the cooling fan.

NOTE:
Ensure that all of the old foam has been removed from the
square recess corner of the chassis before attempting to
install the new fan and adhesive.

2. Apply new fan adhesive foam, ITEM 23, onto the bottom side of the
new cooling fan assembly, ITEM 22, opposite the fan label.

3. Attach cooling fan assembly into the square recess in the corner of the
chassis, with the label side of the fan facing up and wires to the upper
left corner.

4. Attach the fan ferrite, ITEM 40, at the mid-point of the fan wires.

Re-assembly Blower re-installation.

1. Place the suspension muffler, ITEM 21, into the case foam with open
slots in the foam and bottom portion of the muffler lined up.

40
NOTE:
If the blower is being replaced, order P/N
Y-103017-00. Record blower lot code number onto the
Product Experience Report, or equivalent.

2. Place the blower assembly, ITEM 9, on top of the suspension muffler


with the blower air intake into hole in the suspension muffler and the
blower air outlet towards front of base.

Figure 23: Blower assembly and suspension muffler.

3. Put screen, ITEM 20, into the ribbed end of blower housing bellows,
ITEM 15. Install the ribbed end of the blower housing bellows with
screen over air outlet of blower assembly.

41
Figure 24: Screen and ribbed end of the blower housing bellows.

4. Install Chassis, ITEM 5, over case foam and blower assembly, and into
base, routing blower assembly wires through hole in chassis dome.

5. Pull the blower housing bellows through the chassis hole. The long end
of the bellows should be completely visible through blower outlet
opening in chassis.

Chassis hole

Figure 25: Blower housing bellows and chassis hole.


Caution
Ensure the bellows and screen have not separated from the
blower.

6. Place the lower foam, ITEM 4, into bottom of base.

7. Re-install the ferrite snap, ITEM 40, onto the blower wires at
approximately the midpoint of the wire.

Board re-installation.

NOTES:
If the Alarm PCBA has failed, replace it with P/N Y-101931-
00C. Record the new serial number on the Product
Experience Report, or equivalent.

If the KnightStar 330 main PCBA must be replaced, order a


new calibrated Main Board kit, Y-103014-00A. This kit
includes the calibrated PCBA and the internal battery.

42
1. Install the internal battery, ITEM 32, if needed, onto the Main PCBA.
Record the Main board serial number onto the Product Experience
Report, or equivalent.

NOTE:
The battery is designed to last the life of the product.

2. Re-attach Alarm PCBA, ITEM 31, to connector J6 on the Main PCBA,


ITEM 30.

Caution
Ensure Alarm PCBA connector pins are aligned properly
with connector on Main PCBA. Misalignment during
assembly could result in severe damage.

3. Place the Lexan shield, ITEM 47, on the backside of the Alarm PCBA,
ITEM 31, taking care to ensure that it is placed squarely between the
Alarm and Main PCBAs.

4. Attach the fan assembly cable to connector J8 on the main PCBA.

5. Attach the blower assembly cable to connector J3 on the main PCBA.

43
6. Slide pitot tube, ITEM 19, into blower housing bellows, ITEM 15, and
drop into its notch on the side of the base. Double check that all
silicone tube connections have been maintained.

7. Re-attach 10" silicone tube, ITEM 12, to the flow sensor nozzle “P2”
facing towards the back of the main PCBA. Attach 4-1/4" silicone
tube, ITEM 13, to the flow sensor nozzle “P1” facing towards the
curved front of the main PCBA. Ensure tubing is fully seated on taps.

Figure 26: Attaching the tube to the flow sensor nozzle.

44
8. Tuck the blower ferrite to the lower left of the pressure
sensor.

Blower ferrite

Figure 27: Fitting the blower ferrite near the lower left of the
pressure sensor.

9. Attach 1-1/4" silicone tube, ITEM 14, to the pressure transducer on the
main PCBA.

10. Place main PCBA, ITEM 30, onto chassis while carefully routing the
long silicone tubing through tubing guides on chassis dome to front of
unit. Allow a generous loop of tubing towards back of unit. Avoid any
kinks in the tubing. Align main PCBA with the chassis support posts.
Make sure the alarm PCBA drops into notches on the chassis. Align the
blower wire and ferrite to ensure main PCBA seats onto the chassis.

11. Attach ribbon cable from overlay to connector J5 on main PCBA.


Make sure ribbon cable is securely attached. If replacing the overlay,
go to the Overlay Replacement section.

45
NOTE:
For board replacements, the S/N will need to be written to
the main board using the service communications kit. See
section on "Serial Number Transfer."

Overlay 1. Remove old overlay (membrane switch), ITEM 3, from the top
Replacement housing, ITEM 2.

2. Wipe down top housing around overlay slot with isopropyl alcohol.
Remove paper backing from new overlay. Insert the ribbon cable from
the overlay through the cover slot from the front.

3. Carefully apply the overlay into the cover recessed area. Make sure the
overlay completely adheres to the cover.

4. Attach ribbon cable from overlay to connector J5 on the main PCBA.


Make sure ribbon cable is securely attached.

Final Assembly.

NOTE:
During final assembly steps, take extra care not to kink the
silicone tubing or the overlay ribbon cable. Ensure that the
fan wiring and ferrite do not interfere with the seating of the
board.

1. Mount main PCBA to chassis with two (2) screws, ITEM 8. Torque to
5 in. lbs. Make sure all three silicone tubes are not kinked and are
firmly connected.

2. Re-apply the mylar LCD insulator, ITEM 17, onto top of main PCBA
over LCD stand-offs. Mount LCD Assembly, ITEM 16, onto Main
PCBA by lining up with header connector J4 and stand-offs. Snap into

46
place. DO NOT PRESS ON LCD SCREEN WHEN INSTALLING
THE LCD ASSEMBLY.

NOTE:
If the LCD assembly is being replaced with a new LCD
assembly, remove the protective plastic liner from the LCD
screen.

3. Mount the top housing over the main assembly. Tuck overlay ribbon
cable under PCBA. Carefully line up the tongue and groove of the
base, housing, and pitot tube as well as the three (3) connectors on the
backside of the unit coming through the housing. Make sure LCD is
lined up with display window properly.

Figure 28: Back to front view of mounting the housing over the
main assembly.

47
Figure 29: Installing the top housing.

4. Hold unit together and flip upside down. Using screws, ITEM 18, and
Phillips screwdriver, screw the top and bottom of the unit together.
Torque to 15 in. lbs.

5. Remove inlet baffle, ITEM 6, and replace old inlet filter, ITEM 10,
into back of base as shown on print. Re-install inlet baffle over the
filter in the base by snapping it into place.

6. Plug in unit and turn on. Listen for alarm and look for startup display to
verify operation. Turn unit off and unplug.

48
Chapter 5: Final Test: Setup.
Final Test
1. Ensure that the KnightStar 330 is placed in such a manner that there is
at least 1 inch of clearance at the back of the unit.

2. Connect one end of the Mains/AC power cord into the rear panel of the
KnightStar 330, and the other end into an Mains/AC wall outlet.

3. Attach patient circuit, P/N Y-261000-27 and air filter P/N L-6108 to air
outlet.

Figure 30: Attaching the outlet air filter and tubing to the
KnightStar 330 air outlet.

4. Attach proximal pressure line to pressure outlet.

5. Attach calibration shell, P/N S-231702-00B, to the end of patient


circuit, and connect the circuit hose to the manometer.

NOTE:
For each of the following tests, fill out the KnightStar 330
setup checklist found in Appendix E: KnightStar 330 Setup
Checklist.

49
Functional Test.
Warning
Be careful when handling the KnightStar 330 during or
immediately after use. Under specified conditions, some
surfaces of the unit may become hot to the touch. This is a
normal occurrence and is typical of this type of device.

NOTE:
If locked, unlock KnightStar 330, by pressing the Mode
button and the Up arrow at the same time. Hold for
approximately 2 seconds. Verify that the LCD arrow has
moved from the Locked position to the Unlocked position.

1. With the unit turned on, use the Mode button to select the CPAP
mode.

2. Use the Settings button to scroll to an alarm volume (displayed as


VOL ), and set the alarm volume to 0.

3. In the CPAP mode, use the Settings button to scroll to the prescription
pressure. Use the up or down arrow and set the pressure to 3 cmH2O.
Verify that the blower motor speed has decreased.

4. Use the up arrow to increase the pressure to 20 cmH2O. As the


pressure increases, you should be able to hear the motor blower speed
increase.

5. Use the Settings button to scroll to the alarm volume, and set it to 1.

6. Turn the KnightStar 330 off by pressing the ON/OFF button for 3
seconds. Wait for the motor to stop rotating.

7. Remove the calibration shell.

50
8. Turn on the KnightStar 330 and let it run for approximately 3
minutes. Verify that the LEAK alarm indicator L is illuminated,
and that the audible alarm activates. See the lower left corner of the
display.

9. Turn off the KnightStar 330.

Sensitivity and Pressure Test.

1. Turn on the KnightStar 330.

2. Set the following parameters:


• IPAP: 20 cmH2O
• EPAP: 10 cmH2O
• ISENS: 1
• ESENS: 1

3. After a short time, the KnightStar 330 should begin to cycle between
IPAP (20 cmH2O) and EPAP (10 cmH2O).

4. Increase ESENS to 5. The KnightStar 330 should begin to cycle at a


slower rate.

5. Record the IPAP and EPAP pressures listed in Table 8. Decrease IPAP
and EPAP pressure settings in 3 cmH2O intervals until IPAP set
pressure is 14 cmH2O, and EPAP set pressure is at 4 cmH2O. Record
both the IPAP, and EPAP output pressure at each interval.

Table 8: IPAP and EPAP settings.


Mode Setting #1 Setting #2 Setting #3

IPAP 20 17 14

EPAP 10 7 4

51
NOTE:
The output pressure should be within 1 cmH2O in any of the
pressure settings. For accurate readings, ensure that the
manometer has recently been calibrated in accordance with
the manufacturer’s recommendation.

6. Reset IPAP and EPAP pressure back to 20 and 10 cmH2O,


respectively.

7. Increase ISENS to 5. The KnightStar 330 should not cycle to IPAP


and should remain at EPAP pressure (10 cmH2O).

8. Reset ISENS and ESENS to 3.

Delay Test.

1. Use the Mode button and scroll to the I/E PAP mode. Use the Settings
button and scroll to the delay functions. Set delay time for 5 minutes.

2. Use the Settings button to scroll to the START Pressure settings. Set
the START pressure to 4, and press the Mode button.

3. Scroll to the I/E PAP screen, and press the Delay/Ramp button. Use the
manometer to verify that the pressure has dropped to 4 cmH2O.

4. Verify that the delay symbol appears on the KnightStar 330 display.

5. Reset the Delay time to 0.

Low pressure alarm.

1. In the I/E PAP mode, set the low pressure alarm to 1 cmH2O above the
EPAP pressure. Remove the tubing from the patient pressure port. The
low pressure alarm should sound.

52
Power Failure Indicator Verification.

1. While the KnightStar 330 is turned on and running, disconnect the


Mains/AC power cord.

2. Verify that the audible alarm and red LCD activate. To mute the alarm,
press the alarm mute button.

Serial Number 1. For all unit repairs which includes a new KnightStar 330 main board,
Transfer the unit serial number must be downloaded onto the main board. To
accomplish this task, order the KnightStar 330 Service Software, P/
N Y-103012-00 and the KnightStar 330 Service Communication
Cable, P/N Y-103086-00A.

2. Complete, date, and initial all service paperwork.

53
Chapter 6: Any unusual system event results in any or all of the following:
Troubleshooting • Displayed error code

• Illuminated yellow or red LED

• Audible alarm

• Logged error code (contents of error log may be downloaded using ser-
vice software)

To mute an alarm for one minute, press the Alarm Silence button.
• A high priority alarm is indicated by a flashing red LED, along with an
audible alarm that beeps 5 times at intervals of ten seconds.

• A medium priority alarm is indicated by a flashing yellow LED, along


with an audible alarm that beeps 3 times at intervals of 25 seconds.

• A low priority condition is indicated by an illuminated yellow LED


(without an audible alarm).

• An illuminated green LED indicates the presence of power, whether


from Mains/AC or external battery.

The alarm conditions are shown in Appendix B: Alarm Types and


Conditions.

Table 9: Troubleshooting Checklist

Root Problem Questons Probable Cause Action

No airflow out of Display turns on? Motor turns on? Motor runs on
device another board?

Yes No Yes Blown fuse on main Replace main board


board

No No Board failure Replace main board

Yes No No Motor damaged Replace or reconnect


motor

54
Table 9: Troubleshooting Checklist

Root Problem Questons Probable Cause Action

Low airflow out of Air leaking around Pressure port/line Device deplays high
device pitot and motor? obstructed? pressure

Yes No No Bellows slipped off Replace or reattach


bellows

No Yes Yes Pressure sensor sees Correct obstruction


too much pressure

No No Yes Pressure sensor failure Replace main board

Power loss Cord OK?

No Power cord failure Replace power cord

Yes Power supply failure Replace main board

Overpressure Pressure tubes OK? Error reoccurs after


reset?

Yes Yes Pressure sensor failure Replace main board

High pressure Pressure tubes OK? Alarm set too low?

Yes No Pressure sensor failure Replace main board

Low pressure Pressure tubes OK? Bellows OK? Motor problems?

Yes Yes No Pressure sensor failure Replace main board

No Yes No Tube detached Reattach pressure


tube

Yes Yes Yes (excessive Motor failure Replace blower


sound, scraping, assembly
broken impeller

Circuit leak Bellows OK? Flow sensor tubes


OK?

Yes Yes Flow sensor failure Replace main board

No Yes Bellows faillure Replace or reattach bel-


lows

Yes No Tubes detached Correct flow sensor


tubes

Low breath rate Flow sensor tubes Bellows OK?


(Caused by device OK?
not triggering)
No Yes Flow sensor not con- Connect flow meter
nected tubes

Yes Yes Flow sensor failure Replace main board

Yes No Bellows failure Correct bellows

Memory log full Memory log full Clear memory

55
Table 9: Troubleshooting Checklist

Root Problem Questons Probable Cause Action

Internal malfunc- Error number Error description Check if -


tion

1 ROM chksum Processor incorrect Replace main board

2 Cal chksum EEPROM Replace main board


failure

3 Settings chksum EEPROM Replace main board


failure

4 RAM error Processor failure Replace main board

5 Stack overflow Processor failure Replace main board

7 Spurious interrupt Processor failure Replace main board

8 Stuck key Stuck key Replace overlay

9 Alarm test failure Alarm board failure Replace main board

10, 11 (SPI failure) Alarm test failure Flash failure Replace main board

31 Invalid date/time Clock failure Replace main board

32 Multiple watchdog Processor failure Replace main board

38 PIC error Alarm board failure Replace alarm board

40 Overvoltage Power supply Replace main board

42 Pressure sensor No obstructions? Pressure sensor failure Replace main board

45 Barometric failure Correct RS232 If condition persists Replace main board


cable used without RS232, then
barometer failure

46 Flow sensor Flow sensor failure Replace main board

47 Frequency error Does it reset if Can’t reset? Pressure Replace main board
mask is on? sensor failure

56
Chapter 7: The KnightStar 330 Service repair kits and order numbers are identified in
KnightStar 330 the following table. Where applicable, item numbers from the assembly
drawings in Chapter 4: Service and Repair are provided for reference.
Service Spare
Parts

Table 10: List of Spare Parts

Assy Dwg KnightStar 330 Service Kit Name or


Order No.
Item No. accessories
1 Bottom Housing Y-101618-00A

2 Top Housing with Overlay Y-103027-00A

3 Switch, Membrane (International) Y-101614-00A


Switch, Membrane (North America) Y-103115-00A

4 Foam, lower Y-101924-00A

5 Chassis Y-101616-00A

8 Screws, PCBA S-815371-00A

9 KnightStar 330 Blower Y-103017-00

10 Inlet Filter Y-101922-00A

12 Tubing, Silicone, 10" Y-101992-01A

13 Tubing, Silicone, 4.25" Y-101992-02A

14 Tubing, Silicone, 1.25" Y-101992-03A

15 Bellows, Blower Housing Y-101619-00A

16 LCD Display Assembly Y-102328-00A

17 LCD Insulator Y-102837-00A

18 Housing Screw Y-103095-000

19 Pitot Tube Y-102838-00A

20 Screen Y-102272-00A

21 Muffler, Suspension Y-101784-00A

22 Cooling Fan Y-103026-00

23 Adhesive Foam Base for Fan Y-102499-00A

30 KnightStar 330 Circuit board Y-103014-00A

31 Alarm Board Y-101931-00C

57
Table 10: List of Spare Parts (continued)

Assy Dwg KnightStar 330 Service Kit Name or


Order No.
Item No. accessories
32 Battery, CR2032SLF Y-101788-000

40 Ferrite Y-102951-000

47 Alarm Shield Y-102973-00A

n/a Outlet Air Filter L-6108

n/a KnightStar 330 Calibration Shell S-231702-00B

n/a KnightStar 330 Power cord, NEMA 1-15 Y-500012-00

n/a KnightStar 330 Power cord, CEE 7/16 Y-500013-00

n/a KnightStar 330 Power cord, UK Y-500014-00

n/a KnightStar 330 Patient Tube, 6 FT Y-261000-27

58
Appendix A:
US Control
Panel
Configuration PURITAN BENNETT
TM

Mode Set

Delay Alarm
Ramp Silence

Figure 31: KnightStar 330 US Model Control Panel

59
Table 11: KnightStar 330 US Model Top Panel Buttons

Symbol Name Function


On/Off Turn KnightStar 330 system On with a quick press and release action. The KnightStar
330 retains the prescription settings last entered. To turn the device off, press and
hold the On/Off button for 3 seconds.

Mode Scroll through various modes: CPAP, I/E PAP, A/C (if the Lockout mode is inactive).

Mode
Leave Settings Leave Settings mode if adjusting settings.
Mode

On + Autoclear When the KnightStar 330 is in the Stand-by mode (plugged in to AC power but not
button operating), you can press the “On,” “Mode,” and Up arrow buttons and
Mode + combination hold for approximately 20 seconds to clear the updatable “flash” memory, and
restore the default values. Within approximately 20 seconds after simultaneously
releasing the buttons, the user will recognize that this process is occurring by the
“Xs” that appear on the display (in place of the patient ID) during Power On Self
Test (POST).

Mode + Lockout mode If the Lockout mode is active, the patient may only change the delay, start pressure,
and Toggle and ramp duration functions.
To change the Lock or Unlock position, hold the Mode button and the up arrow
together for approximately 2 seconds.

Settings If the Lockout mode is inactive, you may scroll through all of the available
parameters. If the Lockout mode is active, you may only scroll through the patient-
Set settable parameters (delay, start pressure, ramp duration).

Delay/Ramp Start or stop the Delay/Ramp function.

Down Arrow Decrease a selected setting value when in Settings mode.

Delay
Ramp

Alarm Silence Mute an active alarm for one minute.

Up Arrow Increase a selected setting value when in Settings mode.


Alarm
Silence Display In AC or I/E mode, when the main display screen is shown, pressing this button
Secondary displays V and I:E ratio if there are no active alarms.
Screen

60
Appendix B:
Alarm Types
and Conditions
Table 12: Event Conditions
Type Condition Produces Logging Actions
occurs when: Alarm code

ROM checksum ROM checksum Always 1 Activate internal malfunction alarm. Turn off
does not match all device activity.
internal checksum
during POST.

Calibration Calculated Always 2 Activate internal malfunction alarm. Turn off


checksum checksum of all device activity.
manufacturing
EPROM does not
match stored value.

Settings Calculated Always 3 Activate internal malfunction alarm. Turn off


checksum checksum of all device activity.
manufacturing
EPROM does not
match stored value.

RAM error Device writes Always 4 Activate internal malfunction alarm. Turn off
pattern to RAM all device activity.
during POST and
read pattern does
not match.

Stack overflow Stack is Always 5 Activate internal malfunction alarm. Turn off
overwritten. all device activity.

Spurious More than 2 Always 7 Activate internal malfunction alarm. Turn off
interrupt interrupts detected, all device activity.
which are not
defined.

Key stuck Keypad checked at Always 8 Activate internal malfunction alarm. Turn off
power on. If any all device activity.
key is pressed,
alarm sounds and
unit shuts down.

Alarm test PIC read during Always 9 Activate internal malfunction alarm. Turn off
failure post, and alarm all device activity.
test failure bit is
set.

SPI read failure SPI read returned As defined 10 Condition is logged. If failure occurred during
non-ready status POST at start-up, the internal malfunction
following a flash alarm is activated and all device activity
read operation. ceases.

SPI write failure SPI write returned As defined 11 Condition is logged. If failure occurred during
non-ready status POST at startup, the internal malfunction
following a flash alarm is activated and all device activity
write operation. ceases.

61
Table 12: Event Conditions (continued)
Type Condition Produces Logging Actions
occurs when: Alarm code

Synchronization Device detects an As defined 30 Stop motor. Condition is logged, and an


overcurrent attempt is made to restart the blower.
condition due to Backlight also turn off.
the loss of motor
synchronization.

Invalid date/ Invalid date or time As defined 31 On reset, the device will read the RTC and
time detected during check for a valid date/time. If the device
POST. detects an invalid date/time, it will use the
last date/time associated with the last log
entry or the default date. If no other date is
available, set a flag and do a reset. This will
disable "turnon" if date/time is still invalid
after reset.

Multiple Watchdog reset As defined 32 When a watchdog reset occurs more than 3
watchdog occurs more than 3 times in 10 hours, the error will be logged
times in 10 hours. and treated as an internal malfunction alarm.
In that event, the unit will not restart.

Log full Compliance log fills Never 33 Log and turn on the yellow LED. Turn off the
up yellow LED when log is cleared.

Incipient power Power falls below As defined 34 Stop motor. Condition is logged, and an
loss 24 volts (usually attempt is made to restart the blower.
due to Backlight also turns off.
desynchronization).

RS232 Device receives Never 35 Send appropriate "@E4" response and log
command undefined condition.
command through
its serial port.

RS232 Device receives a 36 Send appropriate "@E0" response and log


checksum checksum that does condition.
not match the one
calculated for the
current message
sent.

I2C error (I2 C) The I2C error bit is As defined 37 Retry read or write an additional two times. If
set. (I2 C) therapy isn’t provided, attempt to activate
internal malfunction alarm and turn off all
device activity. If therapy is already provided,
continue to provide therapy, and log error.
The screen will display the base address of
the particular unit that is causing the error.
These are as follows (write and read
respectively):
A0, A1 – Settings portion of settings
EEPROM
A2, A3 – Error Log portion of settings
EEPROM
A4, A5 – MFG EEPROM
D0.. D1 – RTC
D2 .. D3 – PIC Alarm Board
D6 – Failure bit on PIC set
D7 – Settings bit on PIC set

62
Table 12: Event Conditions (continued)
Type Condition Produces Logging Actions
occurs when: Alarm code

PIC system error Hardware error bit As defined 38 Try rereading PIC status register two more
set when reading times. If status bit continues to be set, then
the PIC status activate internal malfunction alarm. Turn off
register. all device activity.

Apnea (assist Patient’s Never 39 Screen displays backup respiratory symbol


active) spontaneous RR f , and yellow LED turns on, until
remains below the condition is cleared (that is, a breath is
prescribed RR for 5 cleared).
breaths in A/C
mode.

Overvoltage Motor voltage is Always 40 Motor shuts down and internal malfunction
over 31 volts. alarm sounds.

Call-Out error I2C (I2 C) read Never 41 Logs and returns.


error during Call-
Out sequence.

No pressure No pressure Always 42 Everything shuts down, and an internal alarm


sensor sounds.

MAX_DESYNCS More than 3 Always 44 When condition is logged, you get a high
desyncs in 30 priority malfunction alarm at full volume.
seconds. Attempts are still made to restart blower.
When the alarm is muted, the alarm is
cleared and the 44 error message goes away.

Barometer bad Barometer rails Always 45 Everything shuts down, and an internal alarm
high or rails low sounds.
when it is read.

Flow sensor bad Flow sensor rails Always 46 Everything shuts down, and an internal alarm
high with minimum sounds.
pressure or low for
60 seconds.

Frequency rail Frequency rails to As defined 47 In CPAP mode error indication appears on
high or low limit, screen. In I/E or A/C mode, high priority
while detecting alarm sounds, which will be reset if the
breaths for one condition goes away.
minute.

Note: All conditions that induce injury or prevent detection of injury have nonadjustable alarms. All other alarms are
suppressible or adjustable.

High pressure Pressure at mask Display shows 50 Reset if the pressure decreases to less than
rises above setting; P the alarm level and frequency is less than the
(0 causes alarm to Alarm maximum frequency limit.
be disabled.) Alarm audible? Yes.
is activated when LED? Yes.
high pressure Volume
condition persists adjust? Yes.
for at least 10
seconds.

63
Table 12: Event Conditions (continued)
Type Condition Produces Logging Actions
occurs when: Alarm code

Low pressure Pressure at mask Display shows 51 Reset if the pressure rises above the alarm
falls below setting: P limit, and/or frequency is above the lower
(0 causes alarm to Alarm frequency limit.
be disabled.) Alarm audible? Yes.
is activated when LED? Yes.
low pressure Volume
condition persists adjust? Yes.
for at least 10
seconds.

Leak Estimated leak rate Display shows 52 Reset if flow decreases to less than the alarm
rises above setting L setting.
(50–100 lpm). Alarm
Condition must audible? Yes.
persist for 60 LED? Yes.
seconds. Volume
adjust? Yes.

Overpressure Pressure greater Display shows 55 Reset if device powered down and then
than 40 cmH2O for ## powered up, provided device then operates
1/2 sec., power Alarm normally. (Motor will be immediately turned
fails, and an audible? Yes. off.)
internal LED? Yes.
malfunction occurs Volume
as defined in the adjust? No.
event table. Highest
volume
setting.

64
Table 13: Alarm Conditions

Alarm Reset
Type Priority Description Display
Volume Conditions
High pressure Medium Pressure at interface rises above P Adjustable Pressure decreases to
setting for 10 seconds; flashing 0–3: less than the alarm
yellow LED. 0=Off; limit.
3=Loudest

Low pressure High Pressure at interface falls below P Adjustable Pressure rises above
setting for 10 seconds; flashing 0–3: the alarm limit.
red LED. 0=Off;
3=Loudest

Leak High Estimated leak rate rises above L Adjustable Leak flow rate
setting for 60 seconds; flashing 0–3: decreases to less than
red LED. 0=Off; alarm limit.
3=Loudest

Internal High Internally detected failure; ## Always Plug in and unplug.


malfunction flashing red LED. enabled; Reset if device
Loudness=3 functions normally.

Apnea Low Patient’s spontaneous respiratory Not Breath detected.


rate remains at or below the f applicable
prescribed respiratory rate for 5
breaths in A/C mode. Yellow
LED is on.

Log full Low Compliance log fills up. Yellow No alarm; Not Clear compliance log
LED is on. only an LED. applicable using PC.

Power Loss High Loss of Mains and external Display is Always Restore Mains or
battery power. Flashing red LED. blank enabled; external battery
Loudness=3 power.

Overpressure High Pressure > 40 cmH2O. Flashing 55 Always Plug in and unplug.
red LED. enabled; Reset if device
Loudness=3 functions normally.

In the event of a system malfunction, use Table 9 on page 54, to identify


possible causes and solutions.

65
Appendix C: A 9-pin sub-D connector located on the rear panel provides for RS-232 serial
Working with communications, modem control, remote control, I/E PAP digital triggering,
and control for programming and calibration. The RS-232 function will
the RS-232 operate at signal levels of at least 3 volts into a standard load at a data rate of
Sub-D 9,600 and 19,200 Baud. Applying 24 volts ±1 volt to pin 9 will enable
calibration EEPROM programming. This pin is used during calibration to
Connector enable the write function of the calibration data EEPROM (U3). Any voltage
less than 15VDC will not enable the EEPROM write function. The
calibration EEPROM contains calibration constants for pressure sensor,
barometric pressure, motor speed, and motor drive voltage, and flow Display
Back Light. During normal Bi-Level operation, pin 9 supplies a 0 or 5-volt
signal indicating inhalation trigger. All pins of the RS-232 connector can be
shorted together indefinitely without damaging the unit.

Table 14: 9-Pin Sub-D port connections.


Pin Function

1 NC
2 TXD
3 RXD
4 NC
5 Ground
6 NC
7 NC
8 NC
9 Dual use I/E PAP trigger-out and program- enable
input.

66
Appendix D: The symbols shown in Table 15 appear on the KnightStar 330 display during
Symbols Seen operation of the device.

on the
KnightStar 330
Table 15: Display Symbols
Display
Symbol Symbol
Description
(USA) (Int’l)
Start-up Display Symbols

ON TIME Total hours of operation

USAGE Total compliance time (usage in hours)

SN Serial number SN

ID Patient identification number (12 digits)

Modes

A/C Assist Control mode A/C


Continuous Positive Airway Pressure mode and
CPAP CPAP
pressure setting
I/E Inspiratory/Expiratory PAP mode I/E

Measured Parameters

f Respiratory rate f

P Current Pressure P

Vt Tidal volume Vt

L Leak Rate L

V Peak inhalation flow V


Ratio of inspiration to expiration time (also a
I:E I:E
setting in A/C mode)
Settings

IPAP Inspiratory pressure IPAP

EPAP Expiratory pressure EPAP

BACKUP f Backup respiration rate (in A/C mode) f

67
Table 15: Display Symbols (continued)
Symbol Symbol
Description
(USA) (Int’l)
ISENS Inspiratory sensitivity ISENS

ESENS Expiratory sensitivity ESENS

RISE Rise time setting

VOL Alarm Volume Level

LEAK Leak alarm setting L

LO P Low pressure alarm setting P

HI P High pressure alarm setting P

DELAY Delay time prior to start of ramp

RAMP Ramp duration

STRT P Ramp Start Pressure P

MASK L Interface (Mask) leak/type (1–6) L

Alarms

P High pressure alarm condition P

P Low pressure alarm condition P

L Leak alarm condition L

f Backup respiratory rate active (apnea) f

## Malfunction (one or two digit error code, ##, ##


denotes alarm type)
Status

Ramp delay active

Lockout mode active

Lockout mode inactive

Alarm is muted

68
Appendix E:
KnightStar 330
Setup
Checklist

Table 16: KnightStar 330 Setup Checklist

Pass Fail
Procedure
✔ ✔
General Exterior Appearance

Any dents, scratches, or loose parts that may indicate dropping or other abuse? ❑ ❑

Inlet baffle missing? ❑ ❑

Check the condition of Mains/AC power cord. ❑ ❑

Check for fluid residue in and around KnightStar 330 openings and housing joints. ❑ ❑

Ensure that the inlet filter is clean and in place. ❑ ❑

Ensure that a new optional outlet air filter is used. ❑ ❑

KnightStar 330 Setup

Ensure that the KnightStar 330 is placed in such a manner that there is at least 1 inch of clearance
at the back.

Connect one end of the Mains/AC power cord into the rear panel of the KnightStar 330, and the
other end into an Mains/AC wall outlet.

Turn the power button on. Both yellow and red indicators should flash for approximately 1 second; ❑ ❑
green stays lit

CAUTION: If an error code appears on the display, or an alarm stays activated following
system power-up, turn the power button off. Then turn the power button on; if the sys-
tem fails again, refer to the Troubleshooting section of this manual.

Functional Test

With the unit turned on, select the CPAP mode and an alarm volume of 0.

Set the CPAP prescription pressure to 3 cmH2O, then increase the pressure to 20 cmH2O. As the ❑ ❑
pressure increases, you should be able to hear the motor blower speed increase.

Set the alarm volume to 1.

Turn the KnightStar 330 off and wait for the motor to stop rotating.

69
Table 16: KnightStar 330 Setup Checklist (continued)

Pass Fail
Procedure
✔ ✔
Turn the KnightStar 330 on and let it run for approximately 3 minutes. Verify that the LEAK alarm ❑ ❑
indicator L is illuminated, and that the audible alarm activates. See the lower left corner of
the display.

Turn off the KnightStar 330.

Sensitivity and Pressure Test ❑ ❑

1. Attach patient circuit and bacteria filter to air outlet.

2. Attach proximal pressure line to pressure outlet.

3. Attach calibration shell to end of patient circuit, and connect circuit to manometer.

4. Turn on the KnightStar 330.


Set the Following Parameters: ❑ ❑
Mode: I/E PAP; IPAP:20 cmH2O; EPAP:10 cmH2O; ISENS:1; ESENS:1

After a short time, the KnightStar 330 should begin to cycle between IPAP (20 cmH2O) and EPAP ❑ ❑
(10 cmH2O).

Increase ESENS to 5. The KnightStar 330 should begin to cycle at a slower rate. ❑ ❑

Make a note of the IPAP and EPAP pressure at these settings.

Decrease IPAP and EPAP pressure settings in 3 cmH2O intervals until IPAP set pressure is 14
cmH2O, and EPAP set pressure is at 4 cmH2O. Make a note of both IPAP and EPAP output pressure
at each interval.

Output pressure should be within 1 cmH2O in any of the pressure settings. ❑ ❑

NOTE: Accuracy of measured output pressure is dependent on the specified/actual accuracy of the manometer. For proper
readings, ensure that the manometer has recently been calibrated in accordance with the manufacturer’s recommendation.

Reset IPAP and EPAP pressure back to 20 and 10 cmH2O, respectively.

Increase ISENS to 5. The KnightStar 330 should not cycle to IPAP and should remain at EPAP ❑ ❑
pressure (10 cmH2O).

Delay Test

Set delay time for 5 minutes. Set the START pressure to 4; and press the Mode button.

70
Table 16: KnightStar 330 Setup Checklist (continued)

Pass Fail
Procedure
✔ ✔
Press the Delay/Ramp button and, using the manometer, verify that the pressure has dropped to 4 ❑ ❑
cmH2O.

Verify that the delay symbol appears on the KnightStar 330 display. ❑ ❑

Low Pressure Alarm

In the I/E PAP mode, set the low pressure alarm to 1 cmH2O above the EPAP pressure. Remove ❑ ❑
tubes from the patient pressure port. Verify the low pressure alarm sounds.

Power Failure Indicator Verification

While the KnightStar 330 is turned on and running, disconnect the Mains/AC power cord.

Verify that the audible alarm activates. To mute the alarm, press the alarm mute button. ❑ ❑

Reset to factory default values ❑ ❑

71
Appendix F:
KnightStar 330
Settings

Setting Description Value Accessibility Mode


CPAP Level of CPAP pressure 3–20 cmH2O (increments of 1 Top panel, remote Only
cmH2O) control, PC, modem CPAP

IPAP Pressure during inspiration 3–30 cmH2O (increments of 1 Top panel, remote Only I/E
cmH2O) control, PC, modem or
A/C

EPAP Pressure during expiration 3–20 cmH2O (increments of 1 Top panel, remote Only I/E
cmH2O) control, PC, modem or A/C

Backup respiratory Rate of machine-initiated 3–30 bpm (increments of 1 Top panel, remote Only A/C
rate breaths bpm) control, PC, modem

I:E ratio Ratio of inhalation time to 1:1.0 to 1:4.0 (increments Top panel, remote Only A/C
exhalation times for backup 0.5) control, PC, modem
breath rate

Inspiration sensitivity Sensitivity at which devices 1–5 (1 most sensitive; 5 least Top panel, remote Only I/E
switches from EPAP to IPAP sensitive) control, PC, modem or A/C

Expiration sensitivity Sensitivity at which devices 1–5 (1 most sensitive; 5 least Top panel, remote Only I/E
switches from IPAP to EPAP sensitive) control, PC, modem or A/C

Rise-time Rate of pressure increase 1–5 (1 is the fastest setting; 5 Top panel, remote Only I/E
is the slowest) control, PC, modem or A/C

Alarm volume Loudness 0–3 (0=Off, 3=loudest) Top panel, remote All
control, PC, modem

Leak alarm Rate of air leaking before 50–100 liters per minute Top panel, remote All
alarm sounds (increments of 1 L/min); 0=Off control, PC, modem

Low pressure alarm Pressure below the prescribed 1 cmH2O below the IPAP Top panel, remote Only I/E
IPAP setting at which an setting to 1 cmH2O above control, PC, modem or A/C
alarm will sound EPAP (in increments of 1
cmH2O); 0 = Off.

High pressure alarm Pressure above the prescribed 1 cmH2O above the IPAP Top panel, remote Only I/E
IPAP setting at which an setting to 35 (in increments of control, PC, modem or A/C
alarm will sound 1 cmH2O); 0 = Off.

Delay time Time delay before automatic 0–30 minutes (in increments Top panel, remote All
device start of 5 minutes) control, PC, modem

Ramp duration Time from device start to 0–30 minutes (increments of Top panel, remote All
prescribed operating pressure 5 minutes) control, PC, modem

72
Setting Description Value Accessibility Mode
Start Pressure Pressure at which the unit 3–20 cmH2O (increments of 1 Top panel, remote All
starts delay ramp sequence cmH2O) control, PC, modem

Interface (Mask) leak/ Patient interface purge hole 1–6 (1 is the lowest leak Top panel, remote All
type leak rate (intended) value, and 6 is the highest) control, PC, modem

Patient ID Unique patient identifier 12 digits PC, modem All

Time for dial-out Clock day/time device phones 7 days/week, 24 hours/day PC, modem All
home health care dealer

Device dial-out Phone number for device to Not applicable PC, modem All
telephone number call home health care dealer

Internal Clock Clock used by device 24-hour clock PC, modem All

73
Appendix G: KnightStar 330 ventilators are warranted against defects in workmanship
Service and materials. The full text of the warranty provides the details. Do not make
any service repairs on this equipment during the stated warranty period. Any
Information unauthorized work immediately voids the warranty. If you need information
or assistance, or if the information in this manual is insufficient, contact
Puritan Bennett at: 800.255.6774 (for North America). Outside the US,
contact your local representative.

Nellcor Puritan Bennett Incorporated does not recognize the owner of a


ventilator as an authorized trained service representative. Puritan Bennett
will not be liable for any repairs attempted by the owner. Any such
attempted repairs other than specified non-warranty repairs void the
warranty. Parts and labor costs incurred by the owner will not be reimbursed
by Puritan Bennett. Puritan Bennett will make available on request:
diagrams, component parts lists, descriptions, calibration procedures and
instructions to assist in the repair of parts classified by Puritan Bennett as
repairable.

Returns should be processed through your local representative.

74
Appendix H: Puritan Bennett warrants to the owner that the KnightStar 330 ventilator,
Limited exclusive of expendable parts and other accessories, shall be free from
defects in material and workmanship for twelve months from the original
Warranty date of sale. Puritan Bennett’s sole obligation, with respect to any such
defect, is limited to the repair or, at Puritan Bennett’s option, replacement of
the ventilator. Purchaser pays return freight charges.

This warranty is made on the condition that prompt notification of a defect is


given to Puritan Bennett within the warranty period, and that Puritan Bennett
has the sole right to determine whether a defect exists.

The warranty does not apply to ventilators that have been partially or
completely disassembled; altered; subjected to misuse, negligence, or
accident; or operated other than in accordance with the instructions provided
by Puritan Bennett. This includes repair by unauthorized personnel.

This warranty represents the exclusive obligation of Puritan Bennett and the
exclusive remedy of the purchaser regarding defects in the ventilator.

THIS WARRANTY IS GIVEN IN LIEU OF ANY EXPRESS OR


IMPLIED WARRANTIES, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

No person is authorized to modify, in any manner, Puritan Bennett’s


obligation as described above.

75
76
Index M
A Mode 15, 60
A/C mode 3 Modem 26
Adjustment 22 Modes
Alarm 61 A/C 3, 11
CPAP 2, 11
Alarms
I/E PAP 11
High Priority 16, 54
Settings 12
Low Priority 16, 54
Medium Priority 16, 54 O
Altitude 7 Operating 7
Autoclear 15, 60 P
B Patient ID 73
Battery Connector 27 PC 26
C Power Cord 26
Clock 73 R
Connectors 25 Ramp 72
AC Power 26 Remote Control 5, 26
RS-232 26 Repair 25
Control Panel 14 Requirements 7
Buttons 14 Respiratory Rate 67
Alarm Silence 15, 60 RS-232 26
Delay/Ramp 15, 18, 60 S
Down Arrow 15, 60 Sensitivity 22, 72
On/Off 15, 60 Service 25
Settings 15, 60 Setup
Up Arrow 15, 60 Checklist 69
Display 14 Start Pressure 18
Indicators 16 Storage 7
CPAP mode 2 T
D Temperature 7
Delay 70, 72 Troubleshooting 54
Dial Out 73 V
Display 14, 67 Volume 68
E W
Electrical 6 Warranty 75
Environmental 7
H
High Pressure 72
Humidity 7
L
Leak 72
Lockout 15, 60
Low Pressure 72

77
78
Note:
Digits of the device serial number refer to the date of manufacture. For example, May 21, 2001 would be represented as
010521 (Y-50201052122).

This device complies with the requirements of Medical Device Directive 93/42/EEC.

Y-102942-00A Rev.D
Model Y-102942-00
Note:
Digits of the device serial number refer to the date of manufacture. For example, May 21, 2001 would be represented as
010521 (Y-50201052122).

This device complies with the requirements of Medical Device Directive 93/42/EEC.

Y-102942-00A Rev.D
Model Y-102942-00

Nellcor Puritan Bennett Incorporated Authorized Representative:


4280 Hacienda Drive
Pleasanton, CA 94588 USA Tyco Healthcare UK Limited
154 Fareham Road
Phone: 1.800.NELLCOR Gosport
PO13 0AS

Phone: +44.1329.224000

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