Puritan Bennett KnightStar 330 Service Manual

KnightStar
®
330
Bi-Level® Ventilator
Service Manual
manual 4-070089-00 Rev. B (10/02)
© Copyright 2004 Nellcor Puritan Bennett Inc. All rights reserved.
KnightStar, Bi-Level, SoftFit, ADAM, and Breeze are trademarks of Nellcor Puritan Bennett Inc. For more information, contact your Puritan Bennett representative.
The ventilator should be operated and serviced only by trained professionals. Puritan Bennett’s sole responsibility with respect to the ventilator, and its use, is as stated in the limited warranty provided.
Nothing in this manual shall limit or restrict in any way Puritan Bennett’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Puritan Bennett has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.
Manufacturer: Authorized Representative: Puritan-Bennett Corporation Tyco Healthcare UK Limited 4280 Hacienda Drive 154 Fareham Road Pleasanton, CA 94588 USA Gosport PO13 0AS, U.K. Toll Free: 1.800.635.5267
1
General information
1.1 Safety considerations...................................................................................................1-1
1.2 Electromagnetic susceptibility......................................................................................1-2
1.3 Customer assistance ....................................................................................................1-2
1.4 How to use this manual...............................................................................................1-2
1.5 General product description ........................................................................................1-3
1.6 Configuration information...........................................................................................1-4
1.7 Accessories ..................................................................................................................1-4
1.8 Specifications ..............................................................................................................1-5
1.9 Compliance and approvals ..........................................................................................1-8
1.10 Breathing modes and settings ..................................................................................1-9
1.11 Initial factory settings .............................................................................................1-11
1.12 Controls, indicators, and symbols ............................................................................1-12
1.13 Onscreen symbols and abbreviations.......................................................................1-21
1.14 Ventilator serial numbers and software version ........................................................1-22
1.15 Tools, equipment, and service materials ..................................................................1-22
1.16 Periodic maintenance .............................................................................................1-24
1.17 Spare parts ..............................................................................................................1-24
1.18 Service philosophy ..................................................................................................1-25
SECTION

CONTENTS

1.4.1 Definitions...........................................................................................................1-3
1.4.2 Using the manual to troubleshoot the KnightStar 330..........................................1-3
2
Theory of operation
2.1 Ventilator components ................................................................................................2-1
2.2 Operational overview ..................................................................................................2-2
2.2.1 Operating modes ................................................................................................2-3
2.2.2 Breathing modes .................................................................................................2-4
2.3 Breath delivery ............................................................................................................2-5
2.4 Breath detection..........................................................................................................2-6
2.4.1 Expiratory sensitivity............................................................................................2-6
2.4.2 Inspiratory sensitivity ...........................................................................................2-7
2.4.3 Rise time .............................................................................................................2-7
2.5 External battery operation ...........................................................................................2-8
2.6 Safety features .............................................................................................................2-9
2.6.1 Overcurrent protection........................................................................................2-9
2.6.2 Controls protection .............................................................................................2-9
2.6.3 Power off protection............................................................................................2-9
2.6.4 Maximum pressure..............................................................................................2-9
2.6.5 Audible alarms.....................................................................................................2-9
2.6.5.1 High priority alarm ....................................................................................2-9
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
i
Contents
2.6.5.2 Medium priority alarm ............................................................................ 2-10
2.6.5.3 Low priority alarm................................................................................... 2-10
2.6.5.4 Alarm control .......................................................................................... 2-10
3
Performance verification
3.1 Initial ventilator cleaning and inspection ..................................................................... 3-1
3.2 System set-up ............................................................................................................. 3-1
3.3 Performance verification tests...................................................................................... 3-3
3.3.1 Functional performance tests .............................................................................. 3-3
3.3.1.1 Self tests.................................................................................................... 3-3
3.3.1.2 Blower test................................................................................................ 3-3
3.3.1.3 Leak alarm test.......................................................................................... 3-4
3.3.1.4 Sensitivity test ........................................................................................... 3-4
3.3.1.5 Pressure test.............................................................................................. 3-5
3.3.1.6 Delay sequence test .................................................................................. 3-5
3.3.1.7 Low pressure alarm test............................................................................. 3-5
3.3.1.8 High pressure alarm test............................................................................ 3-6
3.3.1.9 Power failure indicator test........................................................................ 3-6
3.3.1.10 Autoclear procedure.................................................................................. 3-6
3.4 KnightStar 330 performance verification checklist........................................................ 3-7
4
Troubleshooting
4.1 Alarms ........................................................................................................................ 4-1
4.2 Troubleshooting checklist ........................................................................................... 4-3
4.3 Internal malfunction errors.......................................................................................... 4-7
4.4 Logged errors ........................................................................................................... 4-11
5
Repair
5.1 Tools, test equipment, and service materials ............................................................... 5-1
5.2 Ventilator cleaning and inspection .............................................................................. 5-1
5.3 Ventilator assembly drawing ....................................................................................... 5-1
5.4 Initial ventilator disassembly ....................................................................................... 5-2
5.5 Membrane switch replacement................................................................................... 5-4
5.6 LCD panel replacement............................................................................................... 5-5
5.7 Alarm PCBA replacement ............................................................................................ 5-5
5.8 Cooling fan assembly replacement.............................................................................. 5-9
5.9 Ventilator reassembly ................................................................................................ 5-10
5.10 Post-repair testing................................................................................................... 5-10
6
Warranty and service information
6.1 Limited warranty......................................................................................................... 6-1
6.2 Service information ..................................................................................................... 6-1
ii Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
SECTION
SECTION

General information 1

This manual provides information needed to service the Puritan Bennett KnightStar 330® Bi-
®
Level personnel with equivalent experience and training in servicing this type of equipment.
This section provides introductory information on the KnightStar 330 ventilator including:

1.1 Safety considerations

Please take the time to familiarize yourself with the following caveats as they cover safety considerations, special handling requirements, and regulations that govern the use of the KnightStar 330 ventilator.
ventilator and is intended for use by certified biomedical engineering technicians or
• General safety information
• Instructions on how to use the manual
• A description of the ventilator, its accessories, and its controls and indicators
• Detailed specifications and required tools and test equipment used for service and repair
• To ensure proper servicing and avoid the possibility of physical injury, only qualified personnel (minimum requirement Certification for Biomedical Equipment Technician or equivalent) should attempt to service or make authorized modifications to the ventilator.
The user of this product shall have sole responsibility for any ventilator malfunction due to operation or maintenance performed by anyone not trained by Puritan Bennett staff.
• To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by turning off the ventilator power switch and disconnecting the power source.
• To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (e.g., flammable anesthetics and/or heaters) away from the KnightStar 330 and oxygen hoses.
Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. (Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen.)
In case of fire or a burning smell, immediately disconnect the ventilator from the oxygen supply, and the power source.
• When handling any part of the KnightStar 330, always follow your hospital infection control guidelines for handling infectious material.
1
Puritan Bennett recognizes that cleaning, sterilization, sanitation, and disinfection practices vary widely among healthcare institutions. It is not possible for Puritan Bennett to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting. Specific cleaning instructions for the KnightStar 330 are given in section 5.2 on page 1.
Puritan Bennett recommends that users of its products that require cleaning and sterilization/disinfection consider the Center for Disease Control (CDC) publication:
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
1-1
1 General information
Guidelines for Prevention of Nosocomial Pneumonia available from the CDC Web site: http://www.cdc.gov/publications.htm. Refer to the table on page 1-23 for a list of approved disinfectants and cleaning agents.
• Patients on ventilation equipment should be appropriately monitored by competent medical personnel and suitable monitoring devices.
• For a thorough understanding of ventilator operations, be sure to thoroughly read this manual and the KnightStar 330 Clinician’s Manual before operating the device. These manuals provide service, repair, and technical information concerning the operation and performance of the ventilator.
• Before patient use, be sure to check the equipment for proper operation.
• Do not use sharp objects to make selections on the keypad.
• Check the ventilator periodically as outlined in this manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated.
• Federal law (U.S.) restricts this device to sale by or on the order of a physician.

1.2 Electromagnetic susceptibility

The KnightStar 330 equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2:2001 (or Medical Device Directive 93/42/EEC). This testing shows that the device provides reasonable protection against harmful interference in a typical medical installation. There is, however, no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices or is negatively affected by other devices, the user is encouraged to try to correct the interference by one or more of the following measures:
• Re-orient or relocate the devices
• Increase the separation between the devices
• Connect the equipment to an outlet on a different circuit
• Contact the manufacturer or your local representative for help

1.3 Customer assistance

For further assistance, or for questions regarding the applicability of the information in this manual, contact Puritan Bennett Technical Support at 1.800.255.6774 (within the USA) or your local Puritan Bennett representative (outside the USA).

1.4 How to use this manual

While this manual covers the ventilator configurations currently supported by Puritan Bennett, some product upgrades may be available prior to a corresponding revision of this manual. The current revision of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/PBProductManuals.html.
Puritan Bennett recommends that you become familiar with this manual and the KnightStar 330 Clinician’s Manual before attempting to operate or service the ventilator. These manuals provide service, repair, and technical information concerning the operation and performance of the Puritan Bennett KnightStar 330 bi-level ventilator.
1-2 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
General information 1

1.4.1 Definitions

This manual uses three special indicators to convey information of a specific nature. They include:
Warning
Indicates a condition that can endanger the patient or the ventilator operator.
Caution
Indicates a condition that can damage the equipment or other property.
NOTE:
Indicates points of particular interest that make operation of the ventilator more efficient or convenient.

1.4.2 Using the manual to troubleshoot the KnightStar 330

NOTES:
• At a minimum, the repair technician should be a Certified Biomedical Equipment Technician (CBET) or possess equivalent experience and training before performing any of the service instructions described in this manual
• Due to specific design interactions between the Main PCBA, blower, and pitot tube, individual field replacement of any of these parts is not possible. If required, please return the KnightStar 330 to a Puritan Bennett factory service center for repair.
1 Refer to Section 4 of this manual to diagnose the problem. Using the troubleshooting
guides in this section, determine if the problem can be corrected without returning the device to a factory service center.
2 Use Table 1-14 to identify and order the required service parts.
3 Follow instructions in Section 5 to disassemble, repair, and reassemble the KnightStar
330.
4 Perform and document performance verification tests described in Section 3.

1.5 General product description

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. It is 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 lb) in weight.
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 some of its operating features:
• Provides three breathing modes, including Continuous Positive Airway Pressure (CPAP), Inspiratory/Expiratory Positive Airway Pressure (I/E PAP), and Assist Control (A/C).
• Monitors pressure, tidal volume, respiratory rate, air leaks, peak flow, and I:E ratio.
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-3
1 General information
• Provides precise respiratory support and patient comfort via adjustable inspiratory and expiratory trigger sensitivity.
• Uses audible and visual indicators to alert users to power failure, system leaks, and other conditions that could affect device performance.
• Allows a maximum pressure setting of 30 cmH 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 cmH

1.6 Configuration information

The KnightStar 330 is available in six configurations—North American and five international versions. The major differences between ventilators are listed below:
North American: The North American version has Mode and Settings control panel keys and some displayed information identified in English, and includes English labels, software, and manuals. The power cord provided fits a standard 115 V AC outlet. Alarm volume may be set from 0 (off) to 3 (maximum).
All other versions: All versions of the KnightStar 330 other than North American have control panel keys and displayed information identified using symbols. Labels, software and manuals are provided in various language configurations. A power cord with the appropriate plug end is provided according to the configuration ordered. Alarm volume may be set from 0 (off) to 3 (maximum), except for Japanese. The Japanese KnightStar 330 alarm volume may be set from 1 (minimum) to 3 (maximum) and cannot be set to “off.”
Figure 1-2 on page 1-12 shows the KnightStar 330’s control panel.

1.7 Accessories

The following accessories are either required or can be used with the KnightStar 330. See Tab le 1-1 for ordering information.
O, with a pressure limitation of 40 cmH2O
2
O, and compensates for leaks up to 60 liters per minute.
2
Calibration Shell: The calibration shell is required for Performance Verification testing on the KnightStar 330.
Patient circuit: Puritan Bennett recommends using the KnightStar 330 with 1.8 m (6 ft) or
2.4 m (8 ft) tubing and approved interfaces.
Oxygen Adapter: An optional O or outlet air filter to enable the use of supplemental oxygen. Refer to the KnightStar 330 Clinician’s Manual for more information.
Humidification device: The KnightStar 330 supports the use of an optional Fisher & Paykel HC100 Humidifier, or equivalent.
External Battery: The KnightStar 330 may be powered by an external battery. A 32 ampere- hour or a 7 ampere-hour battery are available. Separate cables are required to connect the KnightStar 330 to an external battery or to a car or truck cigarette lighter outlet.
Other accessories: A carrying case and rolling stand are also available for the KnightStar 330.
adapter may be connected to the KnightStar 330 outlet port
2
1-4 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
General information 1
Table 1-1 lists the ordering information for KnightStar 330 accessories.
Table 1-1: KnightStar 330 accessories
Description Part number
Calibration Shell S-231702-00B
KnightStar 330 Patient tube, 6 ft Y-261000-27
KnightStar 330 Patient tube, 8 ft Y-261000-30
Oxygen Adapter Y-616155-03B
Passover humidifier kit (includes 13 in. hose, base, and reservoir)
Battery Kit, 32 Ampere-hour, Domestic (includes battery, case, 115 VAC charger, charger cable)
Battery Kit, 32 Ampere-hour, European (includes battery, case, 220 VAC charger, charger cable)
Battery Kit, 7 Ampere-hour (includes battery, case, universal charger, charger cable)
Cable, battery adapter Y-102914-00
Cable, cigarette lighter adapter Y-102913-00
Carrying Case, KnightStar 330 Y-213531-01
Rolling Stand, KnightStar 330 902284

1.8 Specifications

Table 1-2 lists the technical specifications of the KnightStar 330 ventilator.
Physical characteristics
Y-102938-00
Y-C GVPD
Y-C GVPE
Y-CGVP7120
Table 1-2: Ventilator specifications
Weight 1.21 kg (2.7 lb)
Dimensions 9.52 cm x 20.95 cm x 14.27 cm (3.75 in x 8.25 in x 5.62 in)
Air Outlet Port Connector
Device Airway Volume
Patient Circuit Volume
Environmental specifications
Temperature and Humidity
Altitude Operating: 0 to 2438 m (0 to 8,000 ft)
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-5
Standard 22-mm conical male
65 mL
695 mL (1.8 m/6 ft) 927 mL (2.4 m/8 ft)
Operating: 5 to 40 ° C (41 to 104 ° F) at 15 to 95% relative humidity, noncondensing Storage: -40 to 70 ° C (-40 to 158 ° F) at 10 to 95% relative humidity, noncondensing
1 General information
Table 1-2: Ventilator specifications (continued)
Performance specifications
Working Pressure 3 to 30 cmH2O (1 cmH2O = 0.098 kPa)
Pressure Limit 40 cmH
Static Flow Pressure Regulation
For flow rates up to 60 L/min: CPAP ± 0.5 cmH2O for settings from 4 to 20 cmH2O Bi-level ± 1.0 cmH
Noise ≤ 30 dBA for IPAP/EPAP = 10 cmH
O
2
O for settings from 4 to 30 cmH2O
2
O (measured 1 m in front of device)
2
Electrical specifications
Rated Mains/AC
100 – 240 V AC nominal (85 – 264 V AC operating range)
Input Voltage
Rated Input
50 – 60 Hz
Frequency
Rated Input Power 140 W
Displayed Patient Parameter Accuracy
Tidal Volume (Vt) ± 20 mL +20% of reading (between 50 mL and 2000 mL)
Peak Flow (V) ± 5 LPM +20% of reading (between 1 and 100 LPM)
Leak (L) ± 5 LPM +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 cmH
O + 10% of reading (3 to 35 cmH2O)
2
Circuit Resistance
Inspiratory 0.2 cmH2O at 30 L/min
0.9 cmH
Expiratory 4.1 cmH
5.0 cmH
O at 60 L/min
2
O at 30 L/min
2
O at 60 L/min
2
External Battery Specifications
Rated Input Voltage 12 V DC
Rated Input Current 6.0 A
Rated Input Power 140 W
Operating Time 32 Ampere-hour: approximately 8 hours
7 Ampere-hour: approximately 3 hours
NOTE: Actual usage times depend upon patient’s prescription settings.
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General information 1
Table 1-2: Ventilator specifications (continued)
Communication Port Specifications
Communication capabilities
RS-232 (serial) port (Figure 1-1). A 9-pin female connector provides for RS-232 serial communications, I/E PAP digital triggering, and calibration EEPROM programming. The RS-232 function operates at signal levels of at least 3 V into a standard load at a data rate of 9.6 kbps and
19.2 kbps. Pin 9 is used for calibration EEPROM programming at the manufacturing and service sites, and during normal bi-level operation, supplies a 0 or 5-volt signal indicating a respective exhalation or inhalation trigger. Applying 24 ± 1 V to pin 9 enables the write function of the calibration EEPROM (U3). Any voltage less than 15 V will not enable the EEPROM write function. The calibration EEPROM contains calibration constants including those for flow and pressure control.
1 2 3 4 5
8
6
9
7
Figure 1-1. KnightStar 330 RS-232 serial port pinout
NOTES:
• The RS-232 connector on devices manufactured prior to the year 2004 is rotated 180o from the configuration shown above.
• If you would like to use the KnightStar 330 in a special application requiring serial communications, contact Puritan Bennett Technical Support at 1.800.255.6774 or your local Puritan Bennett representative.
Pin Signal
1 Not connected
2 Transmit data (TxD) to PC
3 Receive data (RxD) from PC
4 Not connected
5Ground (GND)
6 Not connected
7 Not connected
8 Not connected
9 Dual use I/E PAP trigger-out and program-
enable input
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-7
1 General information

1.9 Compliance and approvals

The KnightStar 330 was developed in accordance with pertinent FDA guidances and North American and ISO international standards (Table 1-3). The manufacturing facility for this product is ISO 13485 certified.
The ventilator’s IEC 60601-1/EN 60601-1 classification is Protection class II, Type BF, externally powered, IPX1 drip-proof equipment.
Table 1-3: Compliance with standards
Standard Type Standard Number Description
Quality system EN ISO 13485:2000 Quality Systems – Medical Devices –
Particular Requirements for the application of EN ISO 9001:1994
FDA Ventilator Guidance FDA Reviewer Guidance for Ventilators,
Draft (July 1995)
FDA Guidance
FDA Medical Electrical Safety Guidance
FDA Reviewer Guidance for Pre-market Notification Submissions, November 1993 draft, Anesthesiology and Respiratory Devices Branch
Safety, USA UL 2601-1 Medical Electrical Equipment, General
Requirements for Safety, (2
Safety, Canada CAN/CSA C22.2 No.
601.1- M90
EN 60601-1 (compliant with all applicable collateral standards and particular requirements)
EN 60601-1-1 Collateral Standard: Safety Requirements
Safety, Europe & International
EN 60601-1-2 (compliant with all applicable tests)
JIST-1001-1 Safety Requirements for Medical Electrical
CISPR 11 EMC Disturbance Characteristics – Limits
EN 475 Electrically generated alarm signals
Safety of Medical Electrical Equipment, General Requirements (Supplement 1:1994), (A2:1998)
Medical Electrical Equipment, Part 1: General Requirements for Safety, 1 Edition, 1988. (A1:1993), (A2:1995)
for Medical Electrical Systems, 2 2001
Medical Electrical Equipment, Collateral Standard: EMC – Requirements and Test,
nd
Edition, 2001
2
Equipment in Japan
and Methods of Measurement, Industrial Scientific and Medical (ISM) RF Equipment, Edition 3.1, 1999-08
nd
Edition)
st
nd
Edition,
This device complies with the requirements of Medical Device Directive 93/42/EEC concerning medical devices.
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General information 1

1.10 Breathing modes and settings

The KnightStar 330 offers three breathing modes: CPAP, I/E PAP, and A/C. Each breathing mode enables a different set of system settings. Table 1-4 lists the modes and the adjustable settings within each mode. Table 1-5 describes each setting, its adjustable range, and how the setting can be accessed.
Table 1-4: Adjustable settings in each breathing mode
CPAP I/E PAP A/C
CPAP IPAP IPAP
Alarm volume EPAP EPAP
Leak alarm Inspiratory sensitivity Respiratory rate and backup
respiratory setting (f)
Delay time
Expiratory sensitivity I:E ratio
Ramp duration Rise time Inspiratory sensitivity
Ramp start pressure Alarm volume Expiratory sensitivity
Mask leak Leak alarm Rise time
Low pressure alarm Alarm volume
High pressure alarm Leak alarm
Delay time Low pressure alarm
Ramp duration High pressure alarm
Ramp start pressure Delay time
Mask leak Ramp duration
Ramp start pressure
Mask leak
Table 1-5: KnightStar 330 settings, ranges, and accessibility
Setting Description Range Accessibility
CPAP Level of CPAP pressure 3–20 cmH
1 cmH
IPAP Pressure during inspiration 3–30 cmH
1 cmH
EPAP Pressure during expiration 3–20 cmH
1 cmH
Backup respiratory rate
I:E ratio Ratio of inhalation time to
Rate of machine-initiated breaths
exhalation times for backup
3–30 bpm (increments of 1 bpm)
1:1.0 to 1:4.0 (increments
0.5)
O (increments of
2
O)
2
O (increments of
2
O)
2
O (increments of
2
O)
2
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
breath rate
Inspiratory sensitivity
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-9
Sensitivity at which devices switches from EPAP to IPAP
1–5 (1 most sensitive; 5 least sensitive)
Top panel, RS-232
1 General information
Table 1-5: KnightStar 330 settings, ranges, and accessibility (continued)
Setting Description Range Accessibility
Expiratory sensitivity
Rise-time Rate of pressure increase 1–5 (1 is the fastest setting; 5
Alarm volume Sets the loudness of the
Leak alarm Rate of air leaking at which
Low pressure alarm
High pressure alarm
Sensitivity at which devices switches from IPAP to EPAP
alarm.
NOTE:
The alarm volume cannot be turned off on Japanese versions of the KnightStar 330.
alarm sounds
Pressure below the prescribed IPAP setting at which an alarm will sound
Pressure above the prescribed IPAP setting at which an alarm will sound
1–5 (1 most sensitive; 5 least sensitive)
is the slowest)
0–3 (0=Off, 3=loudest)
Japanese configuration only: 1–3 (1=lowest volume,
3=highest volume)
50–100 liters per minute (increments of 10 L/min); 0=Off
1 cmH setting to 1 cmH2O above EPAP (in increments of 1 cmH
1 cmH setting to 35 cmH2O (in increments of 1 cmH2O); 0 = Off.
O below the IPAP
2
O); 0 = Off.
2
O above the IPAP
2
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Delay time Time delay before device
automatically starts
Ramp duration Time from device start to
prescribed operating pressure
Ramp start Pressure
Interface (Mask) leak/ type
Patient ID Unique patient identifier 12 digits RS-232
Internal Clock Clock used by device 24-hour clock RS-232
Pressure at which the device starts ramp sequence
Patient interface purge hole leak rate
0–30 minutes (in increments of 5 minutes)
0–30 minutes (increments of 5 minutes)
3–20 cmH 1 cmH
1–6 (1 is the lowest leak value, and 6 is the highest)
O (increments of
2
O)
2
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
Top panel, RS-232
NOTE: For information on using the RS-232 port, contact Puritan Bennett Technical
Support at 1.800.255.6774 or your local Puritan Bennett representative.
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General information 1

1.11 Initial factory settings

The KnightStar 330’s initial factory settings are listed in Table 1-6.
Table 1-6: Initial factory settings
Setting Value
MODE A/C
IPAP 5 cm H
EPAP 3 cm H
O (same setting for CPAP)
2
O
2
Respiratory rate 10
I:E ratio 1:2.0
I Sensitivity 3
E Sensitivity 3
Rise time 3
Alarm volume 3
Leak alarm 100 L/min
Low pressure alarm 4 cmH
High pressure alarm 6 cmH
O
2
O
2
Delay time 0
Ramp duration 0
Ramp start pressure 3 cm H
O
2
Mask leak 2
Over-pressure alarm 40 cmH
2
O (not adjustable)
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-11
1 General information

1.12 Controls, indicators, and symbols

Refer to Figure 1-2 through Figure 1-4 and Table 1-7 through Table 1-10 for ventilator controls, indicators, and symbols.
P
URITAN BENNETT
TM
Bi-Level âVentilator
1
2
3
4
5
6
1 2 3
8
7
9
10
12
14
13
Figure 1-2. KnightStar 330 Control Panel (International version shown above, North
American version shown below)
P
URITAN BENNETT
TM
Bi-Level âVentilator
Mode
Set
Delay Ramp
Alarm
Silence
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General information 1
Table 1-7: KnightStar 330 control panel keys and indicators
Index (Figure 1-2 on page 1-
12)
1 Lockout Mode Indicator.
Labeling Function
Indicates the KnightStar 330 control panel is locked. In Lockout mode, the patient can change only the delay time, ramp duration, and start pressure settings.
Indicates the KnightStar 330 control panel is unlocked. When Lockout mode is inactive, the clinician may change any ventilator settings.
NOTE:
To change the Lockout state, press and hold the Mode and Up Arrow keys simultaneously for approximately 2 seconds.
2
1 2 3
Mode key. Pressing the Mode key repeatedly allows you to scroll through CPAP, I/E, and
A/C modes. Press the Mode key to leave Settings mode when finished adjusting settings.
The Mode key does not function when the KnightStar 330 control panel is
International
locked.
or
Mode
North American
3
Settings key. Press the Settings key repeatedly to scroll through available parameters for
each breathing mode. When the KnightStar 330 control panel is locked, the Settings key can only be used to change the delay time, ramp duration, and ramp start pressure.
International version
or
Set
North American version
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-13
1 General information
Table 1-7: KnightStar 330 control panel keys and indicators (continued)
Index (Figure 1-2 on page 1-
12)
Labeling Function
4
International version
or
Delay Ramp
North American version
5
Down Arrow & Delay/Ramp key. Use the Down Arrow key to decrease a selected setting value in Settings
mode. If not in Settings mode, use this key to start or stop the Delay/Ramp function.
Up Arrow & Alarm Silence key. Use the Up Arrow key to increase a selected setting value in Settings mode. If
not in Settings mode, use this key to mute an active alarm for one minute.
NOTE:
In A/C or I/E mode, when the main display screen is shown, pressing this key displays V and I:E ratio if there are no active alarms.
International version
or
Alarm
Silence
North American version
6 On/Off key. Turn the KnightStar 330 system on with a quick press and release
action. To turn the device off, press and hold the On/Off key for 3 seconds. The KnightStar 330 retains in memory the prescription settings last entered.
7 Green LED When illuminated, indicates the presence of power, whether from Mains/AC
or external battery (Stand-by mode).
1-14 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
General information 1
Table 1-7: KnightStar 330 control panel keys and indicators (continued)
Index (Figure 1-2 on page 1-
12)
Labeling Function
8 Yellow LED When steadily illuminated and accompanied by the symbol displayed in
the lower left corner of the LCD panel, indicates a LOW PRIORITY alarm condition.
When steadily illuminated, with no symbol displayed on the LCD panel, indicates a full compliance log (see Table 4-4 on page 4-11).
When flashing, indicates a MEDIUM PRIORITY alarm condition accompanied by an audible alarm signal (3 beeps at intervals of approximately 25 seconds).
Refer to Section 4 for causes and corrections for alarm conditions.
9 Red LED When flashing, indicates a HIGH PRIORITY alarm condition accompanied by
an audible alarm signal (a series of 3 beeps, then 5 beeps, then 2 beeps at intervals of approximately 6 seconds). Refer to Table 4 for causes and corrections for alarm conditions.
10 Liquid Crystal Display
(LCD)
The LCD provides an easy-to-read format for mode, settings, and patient data. A backlight illuminates the display when the Mode, Settings, or Up arrow key is pressed. The display will remain illuminated for approximately 60 seconds after the last key is pressed.
f
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-15
1 General information
1
2
3
1
2
back.eps
3
Figure 1-3. KnightStar 330 rear view
Table 1-8: KnightStar 330 rear view
Index (Figure 1-3 on page 1-
16)
1 Mains/AC power electrical input connector. The KnightStar 330 operates on
Labeling Function
100V to 240 V AC at 50 or 60 Hz.
1-16 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
General information 1
Table 1-8: KnightStar 330 rear view (continued)
Index (Figure 1-3 on page 1-
16)
2 RS-232 (serial) port. The KnightStar 330 is capable of serial communications
3 External battery connector. Used for connecting an optional external 12 V
Labeling Function
with other devices such as a personal computer (PC). Contact your Puritan Bennett representative for more information.
NOTE:
PCs used with the KnightStar 330 must meet regulatory standards for Safety of Information Technology Equipment (i.e. UL 60950 or EN 60950). Available from many sources, these standards specify requirements intended to reduce risks of fire, electrical shock, and injury to the operator or service person who comes into contact with the equipment.
DC battery, or for use with a 12 V automobile cigarette lighter adapter when Mains/AC power is not available.
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-17
1 General information
2
1
1
2
7
3
6
3
cover.eps
5
8-00197
Figure 1-4. KnightStar 330 front view
Table 1-9: KnightStar 330 front view
Index
(Figure 1-4 on
page 1-18)
1 N/A Patient pressure connector.
2 Air outlet connector.
3
Labeling Function
N/A Alarm speaker.
1-18 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
General information 1
7
6
5
8
1
2
3
4
Figure 1-5. KnightStar 330 bottom panel (International version shown)
Table 1-10: Symbols found on the KnightStar 330 bottom panel
Item Labeling Description
1 Class II equipment
(Per IEC 60601-1: Equipment in which protection against electric shock does not rely on BASIC INSULATION only, but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being no provision for protective earthing or reliance upon installation conditions.)
2 Type BF equipment.
bottomlabel.eps
3 Drip proof.
4 Attention! Consult accompanying documents.
!
5 Direct current (battery power).
KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-19
1 General information
Table 1-10: Symbols found on the KnightStar 330 bottom panel (continued)
Item Labeling Description
6 This device complies with the requirements of Medical Device Directive
93/42/EEC concerning medical devices.
7 Alternating current (Mains/AC power from wall outlet).
8 Authorized to bear the CSA certification mark, signifying the product has
been evaluated to the applicable CSA standards for use in the US and Canada.
UL2601-1
CAN/CSA C22.2 No. 601.1- M90
1-20 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual
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