Tyco KnightStar 330 Service Manual
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Tyco KnightStar 330 Service Manual

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KnightStar
330
Service Manual
®
B i - L e v e l
V e n t i l a t o r
Y-102942-00A Rev G
March, 2004
manual
4-070089-00 Rev. B (10/02)

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  • Page 1 ® KnightStar Service Manual ® B i - L e v e l V e n t i l a t o r Y-102942-00A Rev G March, 2004 manual 4-070089-00 Rev. B (10/02)
  • Page 2 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.

  • Page 3: Table Of Contents

    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...
  • Page 4 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 ......................

  • Page 5: General Information

    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.

  • Page 6: Electromagnetic Susceptibility

    • 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.

  • Page 7: Definitions

    • 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.

  • Page 8: Configuration Information

    Oxygen Adapter: An optional O adapter 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.

  • Page 9: Specifications

    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. 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)
  • Page 10 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. Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 11 • The RS-232 connector on devices manufactured prior to the year 2004 is rotated 180 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.

  • Page 12: Compliance And Approvals

    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.

  • Page 13: Breathing Modes And Settings

    General information 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.
  • Page 14 General information Table 1-5: KnightStar 330 settings, ranges, and accessibility (continued) Setting Description Range Accessibility Expiratory Sensitivity at which devices 1–5 (1 most sensitive; 5 least Top panel, RS-232 sensitivity switches from IPAP to EPAP sensitive) Rise-time Rate of pressure increase 1–5 (1 is the fastest setting;...

  • Page 15: Initial Factory Settings

    General information 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 IPAP 5 cm H O (same setting for CPAP) EPAP 3 cm H Respiratory rate I:E ratio 1:2.0...

  • Page 16: 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. URITAN ENNETT â Bi-Level Ventilator Figure 1-2. KnightStar 330 Control Panel (International version shown above, North American version shown below) URITAN ENNETT â Bi-Level Ventilator...
  • Page 17 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 locked. International...
  • Page 18 Silence North American version 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.
  • Page 19 General information Table 1-7: KnightStar 330 control panel keys and indicators (continued) Index (Figure 1-2 Labeling Function on page 1- 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.
  • Page 20 Table 1-8: KnightStar 330 rear view Index (Figure 1-3 Labeling Function on page 1- Mains/AC power electrical input connector. The KnightStar 330 operates on 100V to 240 V AC at 50 or 60 Hz. 1-16 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 21 (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.
  • Page 22 General information 8-00197 cover.eps Figure 1-4. KnightStar 330 front view Table 1-9: KnightStar 330 front view Index (Figure 1-4 on Labeling Function page 1-18) Patient pressure connector. Air outlet connector. Alarm speaker. 1-18 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 23 General information bottomlabel.eps Figure 1-5. KnightStar 330 bottom panel (International version shown) Table 1-10: Symbols found on the KnightStar 330 bottom panel Item Labeling Description 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...
  • Page 24 General information Table 1-10: Symbols found on the KnightStar 330 bottom panel (continued) Item Labeling Description This device complies with the requirements of Medical Device Directive 93/42/EEC concerning medical devices. Alternating current (Mains/AC power from wall outlet). 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.

  • Page 25: Onscreen Symbols And Abbreviations

    General information 1.13 Onscreen symbols and abbreviations Table 1-11 lists the symbols that appear on the KnightStar 330 display during operation. Table 1-11: Display symbols Symbol Symbol (Int’l) Description (North America) START-UP DISPLAY SYMBOLS Total hours of operation ON TIME...

  • Page 26: Ventilator Serial Numbers And Software Version

    Alarm is silenced 1.14 Ventilator serial numbers and software version The KnightStar 330 serial number and software version is displayed during the Power On Self Test (POST) that runs immediately after turning the ventilator on. The model number and serial number are also displayed on the bottom panel of the ventilator.
  • Page 27 • Screwdriver, #2 Phillips ® • Torx T20 driver • Torque driver, #1 Phillips set to 5 ± 0.5 in-lb ® • Torque driver, Torx T20 bit set to 15 ± 0.5 in-lb 1-23 KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)

  • Page 28: Periodic Maintenance

    Table 1-14 for ordering information) 1.17 Spare parts The KnightStar 330 spare parts and their order numbers are listed in Table 1-14. Where applicable, item numbers from the assembly drawing in Figure 5-2 on page 5-3 are shown for reference. Parts may be ordered by calling Puritan Bennett at 1.800.635.5267.

  • Page 29: Service Philosophy

    Drawing Item Description Order No. Shield, alarm Y-102973-00A Outlet air filter L-006197-000 KnightStar 330 Power cord, NEMA 1-15 Y-500012-00 KnightStar 330 Power cord, CEE 7/16 Y-500013-00 KnightStar 330 Power cord, UK Y-500014-00 1.18 Service philosophy Field service of the ventilator is limited to the service activities described in this manual. Any ventilator requiring replacement of the main PCBA, blower, and/or pitot tube should be sent to a Puritan Bennett Factory Service Center for repair.
  • Page 30 General information This page intentionally blank. 1-26 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 31: Theory Of Operation

    • Outlet air/bacteria filter • KnightStar 330 Clinician’s and User’s Manuals Puritan Bennett recommends using the KnightStar 330 with 1.8 m (6 ft) or 2.4 m (8 ft) circuit and any of the following Puritan Bennett interfaces: • Breeze™ Sleepgear with Dreamseal or Nasal Pillows •...

  • Page 32: Operational Overview

    Ventilator breathing modes and settings are selected using the keypad and LCD on the top panel of the ventilator. NOTE: If you would like to use the KnightStar 330 in a special application that requires changing the settings via the RS-232 serial communications port, contact Puritan Bennett Technical Support at 1.800.255.6774 or your local Puritan Bennett...

  • Page 33: Operating Modes

    • Alarm board processor RAM read/write test • Stuck switch test The KnightStar 330 remains in Stand-by mode until the On/Off key is pressed to turn it on. When the device is running, it may be returned to Stand-by mode by pressing and holding the On/Off key for three seconds.

  • Page 34: Breathing Modes

    Theory of operation Therapy In Therapy mode, the KnightStar 330 ventilates patients in one of three breathing modes set by the clinician. The next section describes each mode. 2.2.2 Breathing modes The KnightStar 330 can ventilate a patient with the following breathing modes: •...

  • Page 35: Breath Delivery

    RS-232, IE pressure compensation/ trigger sensor altitude pressure program limitation enable audible alarm data storage program memory real time alarm clock and battery battery Figure 2-2. System and micro-controller block diagram KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)

  • Page 36: Breath Detection

    Theory of operation 2.4 Breath detection When in I/E PAP and A/C modes, the KnightStar 330 monitors the flow to determine if the patient is inhaling or exhaling. Breath 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.

  • Page 37: Inspiratory Sensitivity

    A lower rise time setting will enable the target pressure to be reached sooner than a higher rise time setting. KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)

  • Page 38: External Battery Operation

    Table 1-1 on page 1-5 lists the ordering information for these parts. Caution Connect the KnightStar 330 to only one power source at a time; external battery power or AC power. Damage to the device can result if connected to both power sources simultaneously.

  • Page 39: Safety Features

    To switch the KnightStar 330 from battery power to Mains/AC power: Turn the KnightStar 330 off and disconnect the battery cable from the device. Connect the AC power cord to the rear of the KnightStar 330 and to the Mains/AC outlet. Turn the KnightStar 330 back on.

  • Page 40: Medium Priority Alarm

    PCBA with +13.5 V nominal with a 5 mA current limit. The alarm is equipped with a lithium battery power source. This allows the alarm to function during power outages or failure of the main PCBA. 2-10 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 41: Performance Verification

    ECTION E C T I O N Performance verification This section describes how to set up the KnightStar 330 and verify the performance of the ventilator. 3.1 Initial ventilator cleaning and inspection Prior to verifying the performance of the KnightStar 330 it is important that the ventilator is clean and that the accessories are in good condition.
  • Page 42 Performance verification Test set-up: Set the KnightStar 330 on the test bench, ensuring that it is placed such that there is at least 2.5 cm (1 in) of clearance at the back of the device. Connect one end of the AC power cord into the rear panel of the KnightStar 330, and the other end into an AC wall outlet.

  • Page 43: Performance Verification Tests

    Section 3.4. 3.3.1.1 Self tests A self test is performed when the KnightStar 330 is plugged into an AC wall outlet that verifies the integrity of the firmware, hardware, and stored data. See Section 2.2.1 for information on the specific self tests.

  • Page 44: Leak Alarm Test

    Set the Leak alarm ( ) to 100 LPM. Exit the settings mode. Turn the KnightStar 330 off by pressing and holding the On/Off key for 3 seconds. Wait for the motor to stop rotating. Remove the calibration shell. Turn on the KnightStar 330 and let it run for approximately 3 minutes. Verify that the audible alarm activates, the red LED flashes, and the LEAK alarm indicator appears at the lower left corner of the LCD panel.

  • Page 45: Pressure Test

    Performance verification 3.3.1.5 Pressure test The following test ensures that the KnightStar 330 is delivering the correct IPAP and EPAP pressures: NOTE: To ensure accurate readings for the following pressure tests, verify that the manometer has been calibrated in accordance with the manufacturer’s recommendation.

  • Page 46: High Pressure Alarm Test

    Reconnect the Mains/AC power cord. The device should enter Stand-by mode. 3.3.1.10 Autoclear procedure To reset the KnightStar 330 to its factory default settings and to clear patient settings and the compliance log flash memory, perform the autoclear procedure as follows: With the KnightStar 330 in stand-by mode: Simultaneously press and release the On/Off, Mode, and Up Arrow keys.

  • Page 47: Knightstar 330 Performance Verification Checklist

    Performance verification 3.4 KnightStar 330 performance verification checklist Record performance verification test results on the following checklist: Table 3-1: Performance verification checklist KnightStar 330 Serial Number: ____________________________________________________ Technician: ____________________________________________________ Date tested: __________________ Pass Fail Procedure ✓ ✓ Initial Ventilator Cleaning and Inspection ❒...
  • Page 48 Performance verification This page intentionally blank. Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 49: Troubleshooting

    (where required), and that these parts are not damaged, causing a system leak. 4.1 Alarms An equipment malfunction or system error will cause the KnightStar 330 to invoke one or more of the following responses: • Illuminated or flashing yellow or red LED (indicates alarm priority) •...
  • Page 50 5 breaths in A/C rate. mode. * For Japanese versions of the KnightStar 330, alarm volume cannot be turned off. Adjustment range is 1(softest) to 3 (loudest). Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 51: Troubleshooting Checklist

    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. Table 4-2: Troubleshooting checklist...
  • Page 52 Tube detached Re-attach pressure tube (refer to Figure 5-8 on page 5-7 for tubing connections). Yes (excessive Broken Return device noise, scraping) impeller/motor to factory failure service center for repair. Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 53 Bellows failure Return device to factory service center for repair. Pitot tube Return device failure to factory service center for repair. KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 54 Ensure Mains/ power AC power source is adequate or external battery is charged. Device Replace LCD dropped or panel (refer to excessive force Section 5.6 on applied to LCD page 5-5). panel Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 55: Internal Malfunction Errors

    3.3.1.10 on page 3- stored value 6); then cycle power. RAM error Device writes component failure Return device to pattern to RAM factory service during POST and center for repair. read pattern does not match KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 56 POST Persistent SPI write returned Flash failure Return device to SPI write non-ready status factory service failure following a flash center for repair. write operation during POST Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 57 30 seconds. connector not damaged If problem persists, seated properly return device to Device attempts to in J3 connector factory service restart the blower. on main PCBA center for repair. KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 58 0.5 seconds power source for at least 30 seconds; then reconnect. Turn the device on. Device resets if cause of overpressure con- dition is eliminated. Use Puritan Bennett- recommended patient interfaces. 4-10 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 59: Logged Errors

    Support for more calculated for the information. current message sent Overvoltage Motor voltage is Power supply failure Return device to greater than 31 V or blown fuse (F2) factory service center for repair. 4-11 KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 60 Troubleshooting This page intentionally blank. 4-12 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 61: Repair

    To prevent disease transmission, use personal protective equipment when handling contaminated bacterial filters or other patient accessories. Caution Do not soak any portion of the KnightStar 330 in solvent, alcohol, or any other cleaning agent. Soaking ventilator components may damage the ventilator. Clean and inspect the ventilator as follows: Clean ventilator exterior using an approved cleaner/disinfectant.

  • Page 62: Initial Ventilator Disassembly

    To open the KnightStar 330: Turn the device upside down on work surface with base facing up.
  • Page 63 Repair Table 5-1: KnightStar 330 component descriptions Item Description Base, enclosure Foot, base, enclosure Label, KS 330 Label, serial number Case, foam Suspension/muffler, blower Blower assembly Ferrite, clamp on Dampener Wire patch, dampener Chassis, enclosure Screen, blower housing Bellows, blower housing Tube, pitot Screw, Torx, hilo 2.2 (4pl)

  • Page 64: Membrane Switch Replacement

    Make sure the recessed area is dry before proceeding with the next step. Peel the paper backing away from the new membrane switch and insert the ribbon cable through the slot in the top of the enclosure cover. Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 65: Lcd Panel Replacement

    Remove the protective plastic film covering the LCD screen. Complete the assembly by performing the steps in Section 5.9. 5.7 Alarm PCBA replacement To replace the alarm PCBA: Perform the ventilator disassembly steps in Section 5.4. KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 66 Main PCBA is recommended. LIft the Main PCBA off of the chassis supports and tilt it towards the back of the lower enclosure, following the precautions for the RS-232 PCBA, if applicable (Figure 5-8). Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 67 Alarm PCBA and alarm shield together to remove them from the Main PCBA. Keep the alarm shield for later re-installation or replace if damaged. Figure 5-9. Removing the Alarm PCBA KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 68 3. Torque screws to 5 in-lb. Push the pitot tube back into the bellows and fit the pitot tube into the groove of the lower enclosure. Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...

  • Page 69: Cooling Fan Assembly Replacement

    Perform steps 10-14 of Section 5.7 to complete the assembly. KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)

  • Page 70: Ventilator Reassembly

    T20 driver or #2 Phillips, as required. Torque the screws to 15 in-lb. 5.10 Post-repair testing After the KnightStar 330 has been repaired, run the Performance Verification tests described in Section 3. Record the test results on the checklist found at the end of that section. 5-10 Y-102942-00A Rev.

  • Page 71: Warranty And Service Information

    Warranty and service information 6.1 Limited warranty Puritan Bennett warrants to the owner that the KnightStar 330 ventilator, exclusive of expendable parts and other accessories, shall be free from defects in material and workmanship for twelve months from the original date of sale. Puritan Bennett’s sole obligation, with respect to any such defect, is limited to the repair, replacement of parts, or, at Puritan Bennett’s option, replacement of the ventilator.
  • Page 72 Warranty and service information This page intentionally blank. Y-102942-00A Rev G (03/04) KnightStar 330 Service Manual...
  • Page 73 See cooling fan assembly replacement circuit resistance, patient 1-6 cleaners and disinfectants 1-23 cleaning and inspection. See Repair General information 1-1–1-25 clearing flash memory. See autoclear procedure 3-6 green LED 1-14, 2-3 KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04) Index-1...
  • Page 74 1-14 patient pressure connector 1-18 settings 1-13 peak flow accuracy specification 1-6 up arrow & alarm silence 1-14 Performance verification KnightStar 330 Ventilator System autoclear procedure 3-6 accessories 1-4 checklist 3-7 assembly drawing 5-3 cleaning and inspection 3-1 configuration information 1-4...
  • Page 75 1-6 EPAP 1-9 ventilator air outlet connector 1-5 expiratory sensitivity 1-10 weight 1-5 high pressure alarm 1-10 working pressure 1-6 I:E ratio 1-9 stand-by mode 2-3 inspiratory sensitivity 1-9 Index-3 KnightStar 330 Service Manual Y-102942-00A Rev. G (03/04)
  • Page 76 & alarm silence key 1-14 Ventilator reassembly 5-10 Ventilator serial numbers and software version 1-22 Warranty and service information 6-1 weight, ventilator 1-5 working pressure specification 1-6 yellow LED 1-15, 2-10 Index-4 Y-102942-00A Rev. G (03/04) KnightStar 330 Service Manual...
  • Page 77 © 2004 Nellcor Puritan Bennett Inc. All rights reserved. Y-102942-00A Rev. G...
  • Page 78 Puritan-Bennett Corporation 4280 Hacienda Drive Pleasanton, CA 94588 USA Toll Free: 1.800.635.5267 Authorized Representative Tyco Healthcare UK Limited 154 Fareham Road Gosport PO13 0AS, U.K. Rx ONLY © 2004 Nellcor Puritan Bennett Inc. All rights reserved. Y-102942-00A Rev. G...

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