Puritan Bennett KnightStar 330 User Manual
KnightStar ® 330
®
Bi-Level
Ventilator
Y-500008-00 Rev. H
Clinician’s Manual
© Copyright 2000, 2003 Puritan-Bennett Corporation, 4280 Hacienda Drive, Pleasanton, CA
94588 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
Bennett representative.
iiii
ii
Contents
Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Patient and Clinician Access Levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Control Panel Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Control Panel Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Control Panel Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Air Outlet Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Inlet Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
System Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Power On Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Modes/Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Display Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Display Preferences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Changing Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Alarm Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Setting Prescription Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Sensitivity Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Inspiratory Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Expiratory Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Rise Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Clinical Application and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Connecting the Device to the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Titrating Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Using the Optional Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Using Supplemental Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Connecting Oxygen to the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
i
Rebreathing of Carbon Dioxide . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Cleaning the Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Cleaning the Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Replacing the Optional Air Outlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Appendix A: KnightStar 330 Setup Checklist. . . . . . . . . . . . . . . . . . .49
Appendix B: KnightStar 330 Specifications . . . . . . . . . . . . . . . . . . . .52
Appendix C: What the Patient and Caregiver Must Know . . . . . . . . .53
Appendix D: Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Appendix E: Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
ii
Introduction The Puritan Bennett KnightStar 330 is a continuous bi-level ventilator
that provides noninvasive ventilation for the treatment of respiratory
insufficiency and obstructive sleep apnea that may occur in the home.
The KnightStar 330 is also indicated for the treatment of respiratory
failure in institutional environments, and is intended to assist the
ventilation of spontaneously breathing patients who are over 30 kg
(66 lbs) in weight.
CAUTION:
Read this manual and the KnightStar
330 User’s Manual thoroughly before
operating the device. The manuals provide clinical as well as 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 KnightStar 330 possesses the following
features:
• Provides three operation modes: CPAP, I/E PAP, and Assist
Control (A/C).
• Monitors pressure, tidal volume, respiratory rate, air leaks, peak
flow, and the I:E ratio.
• Provides adjustable inspiratory and expiratory trigger sensitivity.
• Provides precise respiratory support and patient comfort.
• Provides audible and visual indicators to alert users to power
failure, system leaks, device performance.
• Allows a maximum pressure setting of 30 cmH2O; with a pressure limitation of 40 cmH
O for a single-fault condition.
2
• Compensates for delivered pressure within specification for altitudes from 0 to 8,000 feet (2438 meters), at 4 to 30 cmH
O; and
2
compensates for leaks up to 60 liters per minute.
1
There are certain limitations and instructions that must be understood
by the clinician and patient before using the KnightStar 330. Refer to
Appendix C: What the Patient and Caregiver Must Know.
2
Patient and
The KnightStar 330 features two access levels:
Clinician Access
Levels
• Patient access (Lockout mode “Active”)
• Clinician access
The patient access level enables the patient to turn the device on and
off, and to adjust comfort settings.
The clinician access level enables the caregiver to access all of the
prescription settings and device controls, as well as the patient access
features.
In the sleep lab, the KnightStar 330 can be operated with either the
optional remote control, or the control panel on the device. The
device’s controls enable the user to input the patient’s prescription
settings and review the estimated tidal volume, estimated peak flow,
estimated leak, respiratory rate, I:E ratio, IPAP, and EPAP settings.
For home care applications, the home care provider can set the
patient’s prescribed parameters. All prescription parameters
programmed by the home care provider are stored in the
KnightStar 330’s memory.
If the prescription settings are corrupted, the KnightStar 330 will not
operate. Instead, an alarm symbol and error number appear on the
display, and the audible alarm will sound.
3
Figure 1 shows the components that make up the KnightStar 330
system.
KnightStar 330 bi-level ventilator
Power cord
Tubing and proximal
pressure line
Puritan
Bennett
KnightStar 330
Bi-level Ventilator
Inlet air filter (with spare)
Optional outlet air filter
Clinician’s 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 nasal interfaces, and Breeze™ or
ADAM™ circuits.
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 is from 3 cmH2O to 20 cmH2O).
4
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 from 3 to 30 cmH
pressure for expiration (normal operating range from 3 to 20 cmH
O) and a lower
2
O).
2
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 from 3 to 30 breaths per minute)
and an I:E ratio (normal operating range from 1:1.0 to 1:4.0).
When Lockout mode is active, the settings available to the patient are:
•Delay Time
•Ramp Time
• Ramp Starting Pressure
CAUTION:
Before using the Knightstar 330, read
all warnings and cautions in the next
section.
5
Warnings,
Cautions, and
Information about specific hazards or special significance are
presented in the following formats:
Notes
WARNING: Indicates a condition that can endanger the patient
or the device operator.
CAUTION: Indicates a condition that can damage the device
and/or other property.
NOTE:
Indicates information of particular interest for more efficient
and convenient device operation.
WARNINGS:
Clinical research indicates that CPAP therapy may be
CONTRAINDICATED for patients with the following preexisting conditions:
• Bullous lung disease
• Pneumothorax
• Severe cardiac rhythm disturbances
• Extremely low blood pressure
• Pneumocephalus or pre-existing CSF leaks or head
trauma (Chest 1989; 96: 1425 - 1426)
• Acute sinus or middle ear infection (may be an indication
to suspend CPAP therapy temporarily)
• Unstable airway
• Acute facial trauma
The physician’s prescription should be based upon the
appropriate diagnostic testing. The prescribed nasal pressure should only be adjusted by trained, authorized personnel in accordance with the physician’s prescription.
Use only interfaces and accessories that are approved by
Puritan Bennett.
6
WARNINGS (continued):
The physician’s prescription should be followed in accordance with established medical protocols.
An alternate means of ventilation must be available when
patients are being treated for respiratory failure.
Alarms should never be disabled for patients who could be
injured due to ineffective or interrupted ventilation. The physician should determine secondary or independent alarms.
Alarm volume should be set in accordance with ambient
noise level. Respond immediately to all alarm conditions.
Patients receiving supplemental oxygen should be advised of
the hazards of combustible materials and flames or sparks in
the presence of oxygen. Do not smoke in the presence of
oxygen.
To prevent oxygen from accumulating in the device and tubing, turn on the device before turning on the oxygen supply;
shut off the oxygen before turning off the device.
Patients receiving supplemental oxygen and nasal pressure
therapy should be monitored for arterial blood oxygen saturation.
Configure the KnightStar 330 system as shown in this manual for safe and effective operation.
Always place the KnightStar 330 upright on a firm, flat surface. Setting KnightStar 330 on uneven surfaces or in a position that is not upright may result in damage to the unit.
Do not use the KnightStar 330 with antistatic or electrically
conductive tubing.
The KnightStar 330 should never be operated in the presence
of anaesthetic gases. The equipment is not suitable for use in
the presence of a flammable anaesthetic mixture with air, or
with oxygen or nitrous oxide. Placing the unit in such an area
may result in an explosion.
7
WARNINGS (continued):
The KnightStar 330 device should never be operated where
the air intake might draw in hazardous gases from external
sources such as gas stoves, engine exhaust, or anesthesia
machines. Placing the unit in such an area may result in
asphyxiation of the patient.
Do not set the device on or within 3 feet (1 m) of electric or
electronic appliances, such as space heaters, electric blankets, or televisions. Do not operate cordless phones near the
device. Doing so may result in device malfunction.
The KnightStar 330 should be used with care to avoid overheating the patient when the room temperature exceeds 90 °F
(32.2 °C), since under certain conditions the patient outlet
gas flow can be as much as 6.7 °F (3.7 °C) degrees warmer
than room temperature.
The KnightStar 330 should be used only with interfaces recommended by the device’s manufacturer. An interface
should not be used unless the device is turned on and operating properly. The purge hole(s) associated with the interface should never be blocked. The purge hole(s) allow a
continuous flow of air out of the interface. When the device is
turned on and operating properly, fresh air from the device
flushes most of the expired air out through the interface
purge hole(s). However, when the device is not operating, a
substantial proportion of expired air and carbon dioxide may
be rebreathed. Rebreathing of carbon dioxide can increase
levels of CO
to become somnolent and may even result in death.
, and in some circumstances cause the patient
2
This device must never be operated with an obstructed airway circuit. Prevent foreign matter from entering the airway
circuit. Failure to do so could result in asphyxiation of the
patient.
Should the patient experience excessive nasal or airway dryness, skin sensitivity, runny nose, ear pain, sinus discomfort,
daytime sleepiness, mood change, disorientation, or memory
lapse when using this device, discontinue use and call the
physician.
8
WARNINGS (continued):
Do not block or restrict airflow around the device. Unimpeded
airflow is necessary to maintain proper pressure and flow to
the patient.
For patient health and comfort, it is important to clean the
patient interface regularly. Follow the cleaning instructions
that came with your patient interface.
Contact the home care company if the equipment malfunctions in any way. Do not attempt to open the device case.
Only qualified personnel may service this equipment.
To reduce the risk of strangulation, ensure that the patient
tubing is routed away from the patient’s head.
The KnightStar 330 equipment has been tested and found to
comply with the limits for medical devices to IEC 601-12:1993 (or EN 60601-1-2:1994 or Medical Device Directive 93/
42/EEC). This testing shows the device provides reasonable
protection against harmful interference in a typical medical
installation. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment
does cause harmful interference to other devices or is negatively impacted by other devices, the user is encouraged to
try to correct the interference by one or more of the following
measures:
• Reorient or relocate the devices
• Increase the separation between the devices
• Connect the equipment to an outlet on a different circuit
• Consult the manufacturer or your local representative
for help
The factory default setting for Lockout mode is inactive. The
clinician is responsible for activating Lockout mode.
Under certain conditions, some alarms may not occur. For
example: (1) The leak alarm may not occur if patient breath
efforts are not detected, as in the case of excessively large
leaks; and (2) The low pressure alarm may not occur under
conditions such as an incorrect alarm threshold setting, or
air pathway resistance. Check all alarms and settings for
correct alarm operation prior to use.
9
WARNINGS (continued):
Be careful when handling the KnightStar 330 during or immediately after use. Under specified operating 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.
CAUTIONS:
Federal (USA) Law restricts this device to sale by or on the
order of a physician.
The KnightStar 330 will discontinue operation upon loss of
A/C power. The optional, external 12 V battery may be used
as an alternate power source, but it is not intended for emergency backup power. Either A/C or external battery power
may be connected to the KnightStar 330, but not both simultaneously. Refer to the battery instruction sheet.
Inspect the inlet air filter often. Remove the foam filter from
the rear panel and clean it at least once per week.
NOTES:
At the end of the KnightStar 330’s useful life, return the
device to the manufacturer for proper disposal.
10
Symbols Table 1 lists descriptions for the various symbols that appear on the
KnightStar 330.
Table 1. Symbols
Symbol Description
!
Attention, consult accompanying manual
Alternating current (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
A/C 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.
11
Table 1. Symbols (continued)
Symbol Description
IPX1 Drip proof
SN Serial Number
REF Product model number
Max
Min
Storage temperature range
12
System Description
Control Panel Display
Control Panel Buttons
The Liquid Crystal Display (LCD) shown in Figure 2 provides an
easy-to-read format for mode, settings, and patient parameters. A
backlight illuminates the display when the Mode or Set button is
pressed. The display remains illuminated for approximately
60 seconds after the last button is pressed.
The control panel buttons are shown in Figure 2 and listed in Table 2.
PURITAN BENNETT
TM
Control panel buttons
Mode
Figure 2. KnightStar 330 Control Panel
Set
13
Delay
Ramp
Alarm
Silence
Table 2. Control Panel Buttons
Symbol Name Function
On/Off Turns the KnightStar 330 on or off.
Turn the KnightStar 330 on with a quick press and release of the
On/Off button. The device retains the prescription settings last
entered.
To turn the device off, press and hold the On/Off button for 3
seconds.
Mode
Scrolls through various device modes.
Mode
On +
Mode +
Mode +
Set
Leave
Settings
Mode
Autoclear
three-button
combination
Lockout
Mode and
Toggle
Set Scrolls through the available parameters. Press Set once to sh ow the
Press the Mode button to scroll through various modes, as follows:
CPAP, I/EPAP, A/C.
Note: If the Lockout function is active, the Mode button will not
operate.
Performs a device Autoclear.
When the KnightStar 330 is in the Stand-by mode (plugged in to AC
power but not operating), perform an Autoclear by pressing and
holding the following three buttons simultaneously for approximately
20 seconds:
On, Mode, and (Up Arrow)
Pressing this three-button combination clears the updatable “flash”
memory and restores the device’s defaul t values.
Within approximately 20 seconds after simultaneously releasing the
buttons, you 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).
Changes the Lock or Unlock position. If the Lockout mode is active,
the patient may only change the delay, start pressure, and ramp
duration functions.
To change the Lock or Unlock position, hold the Mode button and the
▲ (Up Arrow) button simultaneously for approximately two seconds.
patient-settable parameters (delay, start pressure, ramp duration).
Press Set again to scroll through the remaining parameters.
If the
Lockout mode is inactive, you may scroll through all of the
available parameter settings. If the Lockout mode is active, you may
only scroll through the patient-settable parameters (delay, start
pressure, ramp duration).
14
Table 2. Control Panel Buttons (continued)
Symbol Name Function
Delay/Ramp Starts or stops the Delay/Ramp function. Press the ▼/Delay/Ramp
(Down Arrow/Delay/Ramp) button to start the Delay/Ramp function, if
inactive; press the ▼/Delay/Ramp button to stop this function, if
active.
Delay
Ramp
Down Arrow Decreases a selected setting value when in Settings mode. Press the
▼/Delay/Ramp (Down Arrow/Delay/Ramp) button once to decrease
a setting value by one decrement.
Alarm
Silence
Alarm
Silence
Up Arrow Increases a selected setting value when in Settings mode. Press the
Display
Secondary
Screen
Mutes an active alarm. Press the
Silence) button once to silence an active alarm for one minute.
▲/Alarm Silence (Up Arrow/Alarm Silence) button once to increase a
setting value by one increment.
Displays and I:E ratio.
In AC or I/E mode, when the main display screen is shown, pressing
this button displays and I:E ratio if there are no active alarms.
V
V
▲/Alarm Silence (Up Arrow/Alarm
▼/Delay/Ramp Button. This button is used to activate the Delay
feature. When Delay is activated, both inspiratory and expiratory
pressures will decrease to the Ramp Start pressure. The time of delay
can be set from 0 (no delay) 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, Delay can be restarted by again
pressing the ▼/Delay/Ramp button.
Control Panel Indicators
The KnightStar 330 control panel features visual indicators (shown in
Figure 3) that illuminate in the presence of power and in response to
specific device or tubing circuit problems.
The presence of power, whether from A/C or external battery, is
indicated by an illuminated green LED.
15
A low priority condition is indicated by a steadily illuminated
yellow LED (without an audible alarm).
A medium priority condition is indicated by a flashing yellow LED,
along with an audible alarm that beeps three times at intervals of
25 seconds.
A high priority alarm is indicated by a flashing red LED, along with
an audible alarm that beeps five times at intervals of 10 seconds.
Mode
Green
Figure 3. Control Panel Indicators
Set
Delay
Ramp
Yellow
Control Indicators (LEDs)
Red
Alarm
Silence
NOTE:
An audible alarm will sound under both medium and high
priority alarm conditions.
Refer to the Troubleshooting section on page 45 for possible causes
and corrective actions for visual and audible indicators.
WARNING:
The KnightStar 330 does not have an audible alarm to indicate that the patient has stopped breathing.
16
Air Outlet Assembly
The KnightStar 330’s air outlet assembly consists of the air outlet and
the optional outlet air filter.
Air Outlet. 22-mm conical port where the optional outlet air filter and
tubing circuit are connected.
Optional Outlet Air Filter. This optional, single-patient filter
removes contaminants and microbes as small as 0.2 microns from the
outlet air. It is disposable, and must be replaced between patients. Be
sure to inspect the filter regularly and replace it when noticeably dirty
or discolored. Refer to “Replacing the Optional Air Outlet Filter” on
page 44. Frequency of replacement can vary, depending on usage and
environmental conditions. Contact your home care provider for
replacement filters.
Optional outlet air filter
Figure 4. Optional Outlet Air Filter
Inlet Air Filter The Inlet Air Filter prevents large contaminants (dust and lint) in the
incoming air from entering the device. This filter has an efficiency of
90% or greater at 20 microns. It is reusable, and a spare filter is also
provided. Refer to “Cleaning Instructions” on page 43.
17
Loading...