Tyco Knightstar 330 User manual

Bi-Level®Ventilator

KnightStar®330 Service Manual

manual 4-070089-00 Rev. B (10/02)

Y-102942-00A Rev G

March, 2004

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

SECTION

CONTENTS

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

1.4.1 Definitions...........................................................................................................1-3

1.4.2 Using the manual to troubleshoot the KnightStar 330..........................................1-3

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

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)

Contents

ii Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual

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

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

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

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

Warranty and service information

6.1 Limited warranty......................................................................................................... 6-1

6.2 Service information ..................................................................................................... 6-1

SECTION

1-1

General information 1

This manual provides information needed to service the Puritan Bennett KnightStar 330®Bi-

Level®ventilator and is intended for use by certified biomedical engineering technicians or

personnel with equivalent experience and training in servicing this type of equipment.

This section provides introductory information on the KnightStar 330 ventilator including:

• General safety information

• Instructions on how to use the manual

• A description of the ventilator, its accessories, and its controls and indicators

• Detailed specifications and required tools and test equipment used for service and repair

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.

• 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.

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)

1General information

1-2 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual

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.

General information 1

KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-3

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.

1Refer 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.

2Use Table 1-14 to identify and order the required service parts.

3Follow instructions in Section 5 to disassemble, repair, and reassemble the KnightStar

330.

4Perform 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.

1General information

1-4 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual

• Provides precise respiratory support and patient comfort via adjustable inspiratory and

expiratory trigger sensitivity.

• Uses audible and visual indicators to alert users to power failure, system leaks, and other

conditions that could affect device performance.

• Allows a maximum pressure setting of 30 cmH2O, with a pressure limitation of 40 cmH2O

for a single-fault condition.

• Compensates for delivered pressure within specification for altitudes from 0 to 8,000 feet

(2438 meters) at 3 to 30 cmH2O, and compensates for leaks up to 60 liters per minute.

1.6 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

Table 1-1 for ordering information.

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 O2adapter may be connected to the KnightStar 330 outlet port

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.

General information 1

KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) 1-5

Table 1-1 lists the ordering information for KnightStar 330 accessories.

1.8 Specifications

Table 1-2 lists the technical specifications of the KnightStar 330 ventilator.

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)

Y-102938-00

Battery Kit, 32 Ampere-hour, Domestic (includes

battery, case, 115 VAC charger, charger cable)

Y-CGVPD

Battery Kit, 32 Ampere-hour, European (includes

battery, case, 220 VAC charger, charger cable)

Y-CGVPE

Battery Kit, 7 Ampere-hour (includes battery, case,

universal charger, charger cable)

Y-CGVP7120

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

Table 1-2: Ventilator specifications

Physical characteristics

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

Standard 22-mm conical male

Device Airway

Volume

65 mL

Patient Circuit

Volume

695 mL (1.8 m/6 ft)

927 mL (2.4 m/8 ft)

Environmental specifications

Temperature and

Humidity

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

Altitude Operating: 0 to 2438 m (0 to 8,000 ft)

1General information

1-6 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual

Performance specifications

Working Pressure 3 to 30 cmH2O (1 cmH2O = 0.098 kPa)

Pressure Limit 40 cmH2O

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 cmH2O for settings from 4 to 30 cmH2O

Noise ≤30 dBA for IPAP/EPAP = 10 cmH2O (measured 1 m in front of device)

Electrical specifications

Rated Mains/AC

Input Voltage

100 – 240 V AC nominal (85 – 264 V AC operating range)

Rated Input

Frequency

50 – 60 Hz

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 cmH2O + 10% of reading (3 to 35 cmH2O)

Circuit Resistance

Inspiratory 0.2 cmH2O at 30 L/min

0.9 cmH2O at 60 L/min

Expiratory 4.1 cmH2O at 30 L/min

5.0 cmH2O at 60 L/min

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.

Table 1-2: Ventilator specifications (continued)

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