Service Manual
148 Pages
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Page 1
NKV-550 Series
Ventilator System Service Manual
Manufacturer Address
Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 United States of America
Website
www.orange-med.com www.nihonkohden.com
Customer Service Department: [email protected] Technical Service and Support: [email protected] Clinical Education and Support: [email protected]
Telephone
(Monday through Friday, 8:00 am to 5:00 pm, Pacific Time) Main Office: +1 (949) 502-6448 Customer Service: Ext: 7101 Technical Support: Ext. 7102 Clinical Support: Ext. 7103
EC Representative
NIHON KOHDEN EUROPE GmbH Raiffeisenstrasse 10 D-61191 Rosbach Germany Tel +49 (6003) 827-0 Fax +49 (6003) 827-599
0344
Copyright Information
© Nihon Kohden OrangeMed, Inc. All rights reserved. Nihon Kohden OrangeMed, Inc.'s NKV-550 Ventilator System is manufactured in accordance with Nihon Kohden OrangeMed, Inc.'s proprietary information. Patent pending. The information in this manual is the sole property of Nihon Kohden OrangeMed, Inc. and may not be duplicated without permission. This manual may be revised or replaced by Nihon Kohden OrangeMed, Inc. at any time and without notice.
SRV5502-EN Rev. C 2 | NKV-550 Series Ventilator System
Table of Contents Chapter 1: Intended Uses... 9
Product Intended Function...9 Intended Patient Population...9 Intended Environment of Use...9 Indication for Use...9 Contraindications...9 User Profile...9
Chapter 2: Theory of Operations...11
General Theory... 11 Explanation of Pneumatic Diagram Gas Flow... 11 Gas Delivery Module... 11 Inspiratory Module... 11 Safety Control Module... 11 Expiratory Module... 12 Exhalation Control Module... 12 Auxiliary Pressure Module... 12
Chapter 3: Cleaning, Disinfection and Sterilization...15
General Information... 15 Frequency of Cleaning, Disinfection and Sterilization... 16
Chapter 4: Preventive Maintenance...17
Clinician or Service Personnel To Perform... 17 Service Personnel to Perform... 18 Replacement of the Oxygen Sensor (SEN5503P)...19 Replacement of the Backup Battery (BAT5502P-1)...20 Replacement of the Extended Battery (BAT5500P-1)...21 Installation of Preventative Maintenance Kit (PMK5501A)...22 Replacement of the Fan Filter (FLT5504M)...22 Replacement of the Water Trap Filter (FLT5511P) and Water Trap O-ring (ORG5523P)...23 Replacement of EXH Flow Sensor (SEN5505P), EXH Drive O-Ring (ORG5512P), P2 EXH Pressure O-ring (ORG5516P), EXH Flow Sensor O-ring (ORG5509P), EXH Valve Screen Module (SCN5505A), EXH Valve Diaphragm (DIA1006M) and EXH Valve Seal
(DIA1004M)...24 Replacement of Safety Valve Diaphragm (DIA5503M), Umbrella Valve (UMV5502M), Umbrella Valve O-ring (ORG5505P), Inspiratory Module Seal O-ring (ORG5519P), Oxygen Sensor O-ring (ORG5501P) and Filter/Tube Assembly (TUB5512A)...27
Chapter 5: Service and Utilities Screens...33
Service-Home Screen ... 33 Service-Utilities Screen... 35
Chapter 6: Calibration...37
Calibration/Checks Guidance... 37 Required Calibration/Test Equipment... 38 Disassembly Guidance Table... 38 NKV-550 Series Ventilator System | 3
1.0 Preparing for Calibrations/Checks... 39 1.1 Removal of Top Cover, Breath Delivery Unit (BDU) ... 39 1.2 Attaching Power Switch Assembly and Detaching Electronic Module... 40 1.3 Attaching Pneumatic Clip Test Assembly... 41 2.0 Air and O2 Inlet Regulator Check... 42 2.1 Air Inlet Regulator Check... 42 2.2 O2 Inlet Regulator Check... 42 Pressure Transducer Calibrations... 43 3.0 Low Pressure Transducers Calibration... 44 3.1 P1 and P2 Transducers Calibrations... 44 3.2 PDrive Transducer Calibration... 44 3.3 Aux Transducer Calibration... 45 3.4 Low Pressure Transducers Calibrations Verification... 45 4.0 High Pressure Transducers Calibration... 46 4.1 Air Inlet Transducer Calibration... 46 4.2 O2 Inlet Transducer Calibration... 46 4.3 High Pressure Transducers Calibration and Verification... 47 5.0 Exhalation & Safety Valve Pressure Regulators Calibration... 47 5.1 Exhalation Pressure Regulator Calibration... 47 5.2 Safety Valve Pressure Regulator Calibration... 48 6.0 Other Calibrations... 49 6.1 Date and Time... 49 6.2 Air Valve Calibration... 49 6.3 O2 Valve Calibration... 50 6.4 Exhalation Valve Calibration... 50 6.5 Exhalation Flow Calibration... 50 6.6 O2 Sensor Calibration... 50 6.7 System Leak Test... 50 7.0 Reassembly... 51 Calibration Test Form... 52
Chapter 7: Component Removal and Replacement...57
Disassembly of the NKV-550... 58 1.0 Graphic User Interface (GUI)... 58 2.0 GUI Mount... 59 3.0 Backup and Extended Battery... 60 4.0 Top Cover Assembly... 61 5.0 Extended Battery Receptacle... 63 6.0 Electronic Module... 64 7.0 Power Supply... 67 8.0 Pneumatics Cover... 69 9.0 Safety Regulator... 70 10.0 Sensor Cable... 70 11.0 Neonatal Flow Sensor (NFS) Module... 71 12.0 Heater Assembly... 73 13.0 Thermistor... 74 14.0 Inspiratory Door... 74 15.0 Flow Sensor Door... 75 16.0 Exhalation Valve Door... 75 17.0 I/O Bracket... 76
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18.0 Hydrophobic Filter... 76 19.0 Exhalation Valve Manifold... 76 20.0 Inspiratory Module... 77 21.0 Front Housing Assembly... 78 22.0 O2 Sensor Board... 79 23.0 O2 Sensor... 80 24.0 Base Chassis... 81 25.0 Fan Filter Cover... 83 26.0 Exhalation Valve Manifold Assembly... 83 27.0 Handle... 84 28.0 Ground Wires... 84 29.0 High Inlet O2 Pressure Tube... 84 30.0 High Inlet Air Pressure Tube... 85 31.0 Restrictor... 85 32.0 TSI Sensors... 86 33.0 Gas Delivery Unit and Exhalation Drive Assembly... 86 34.0 SV and P2 Purge Control Module... 90 35.0 P1 and P2 Autozero Control Module... 90 36.0 Bottom Panel Assembly... 91 37.0 Internal Battery Board... 91 38.0 NKV-550 Speaker and Buzzer... 92 39.0 NKV-550 Rubber Feet... 92 Reassembly... 93 CRR Disassembly Table... 94
Chapter 8: Troubleshooting...99
Subcomponent Test Procedures for Troubleshooting ...105
Chapter 9: Operation Verification Procedure...109
Service Screen Tests...109 Ventilator Documentation...109 2.0 System Leak Check...110 Standard Operation Tests...111 3.0 AC Power Indicator & Power On Indicator...111 4.0 Device Check...111 5.0 Start Up Screen Selections and Test Set-up...111 6.0 Circuit Check...112 7.0 Starting Ventilation...112 8.0 Pressure Control ...112 9.0 Trigger...113 10.0 Volume Control ...113 11.0 Flow Waveform...114 12.0 FiO2...115 13.0 User Set Alarms and Alarm Silence...115 14.0 Panel Lock...116 15.0 Manual Breath ...116 16.0 Battery...116 17.0 Crossover Valve ...117 18.0 Standby and Power Down ...118 19.0 USB Ports...118 NKV-550 Series Ventilator System | 5
20.0 Nihon Kohden CO2/SpO2 Connectors...119 OVP Test Form...120
Appendix A: Specifications...131
Configurations...131 Patient Type...131 Patient Data...131 Ventilation Modes...132 Ventilation Settings...132 Monitors...134 Alarm Audio Pause...136 Adjustable Alarms...136 Quick Access Buttons...137 Applications...137 Gentle Lung® Suite (option)...137 Institutional Settings...137 Gases...138 Physical Specifications...138 Environmental...139 Power...139 Standards...140
Appendix B: Service Work Order Form...141 Appendix C: Parts List and Customer Support...145
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The NKV-550 Series Ventilator System Instructions For Use (IFU) contains content not included in this Technical Service manual, including but not limited to: • • • • • • • • • •
Safety Information System Information Operation of the Ventilator System Theory of Operation Applications (Apps) Use of Operational Features Alarms and Troubleshooting Cleaning, Disinfection and Sterilization Institutional Configuration and Connectivity Disclosures
Please refer to the appropriate IFU for your region. p/n MAN5501-US (USA only) p/n MAN5502-EN* (Countries outside the USA) *Various languages available
NKV-550 Series Ventilator System | 7
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Chapter 1: Intended Uses
Chapter 1: Intended Uses Product Intended Function The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. Ventilatory support is intended to be delivered invasively or noninvasively to patients who require Assisted/Control Mandatory Ventilation (A/CMV), Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Ventilation (SPONT).
Intended Patient Population The intended patient population includes neonate through adult patients who require invasive or noninvasive respiratory support.
Intended Environment of Use The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device may be used for intra-hospital transport within a hospital or hospital-type facility. The device is not intended for transport between hospitals or hospital-type facilities, therefore is not a transport ventilator as defined by ISO 80601-2-12 Section 201.1.1. The device is not to be used in the presence of flammable anesthetics and MRI applications.
Indication for Use The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Contraindications Do not operate the ventilator in a magnetic resonance imaging (MRI) environment. Not suitable for anesthetic agents.
User Profile For ventilation application, the expected user profiles to operate the Nihon Kohden NKV-550 Series Ventilator System are authorized personnel who possess training, skills, and knowledge regarding the application of mechanical ventilation and are familiar with this ventilator. During normal use, it is expected that clinicians are qualified trained personnel under the direction of a physician. This product is not intended for use by lay people. NKV-550 Series Ventilator System | 9
Chapter 1: Intended Uses
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Chapter 2: Theory of Operations
Chapter 2: Theory of Operations General Theory The NKV-550 Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.
Explanation of Pneumatic Diagram Gas Flow Gas Delivery Module High-pressure air and oxygen enter the breath delivery unit through the high-pressure air and O2 inlets. The air regulator and the O2 regulator respectively reduce inlet gas pressure, providing a more stable input gas pressure to the proportional valves. Regulated gas pressure is monitored by the P4 and P5 transducers. Each gas proportional valve controls the gas flow rate at a response interval of 2 msec. An in-line filter helps protect the proportional valves from contaminant. From the proportional valves, each gas then passes through a hot wire flow sensor, which provides feedback to the microprocessor. This feedback assures the proportional valves deliver the desired flow rate and mix with the other gas in the mixing manifold.
Inspiratory Module The mixed gas is monitored by an oxygen sensor. The mixed gas passes through the umbrella valve (check valve), and exits through the inspiratory port to the inspiratory limb of the breathing circuit for the patient to inspire. The P1 transducer monitors inspiratory port pressure. An in-line filter helps protect the transducer from contaminant.
Safety Control Module The Safety Control Module acts as a “fail safe” for unexpected ventilation situations that could adversely affect patient safety. In normal conditions, the Safety Valve Diaphragm is kept closed by a regulated back pressure of 125 cmH2O. This back pressure is controlled by the Safety Valve Regulator. If circuit pressure unexpectedly increases due to an obstruction, any pressure exceeding 125 cmH2O will be “vented” through the Safety Valve relief port.
NKV-550 Series Ventilator System | 11
Chapter 2: Theory of Operations
If a Device Alert occurs and the ventilator stops delivering breaths, or if the expiratory limb of the breathing circuit is occluded, or if the exhalation valve is stuck closed, the Safety Valve Solenoid activates, interrupting the back pressure holding the Safety Valve Diaphragm closed. With the back pressure now removed, the diaphragm is pushed open by the Safety Valve Spring, allowing circuit pressure to drop to ambient pressure by “venting” through the Safety Valve Relief port.
Expiratory Module When the patient exhales, the exhaled gas travels through the expiratory limb of the breathing circuit and enters the expiratory port of the ventilator where it passes through the exhalation valve and hot-wire expiratory flow sensor, then finally exits through the ventilator’s exhaust port. The Expiratory Module is heated to minimize any “rain out” from the cooling of the exhaled gas. The hot-wire flow sensor continuously measures the exhaled flow rate for the ventilator to compute the volume and flow based parameter data.
Exhalation Control Module The exhalation control module provides the precise control of the exhalation valve for both inspiration and expiration. Driving pressure to the exhalation valve is provided by the high pressure air supply, is controlled by the Exhalation Regulator and Exhalation Proportional Valve, and monitored by the P3 transducer. Exhalation circuit pressure is monitored by the P2 transducer. An in-line filter helps protect the sensor from contamination and a purge solenoid helps to ensure that this pressure tube to the transducer remains free of moisture. If the high pressure air supply fails to the ventilator, a crossover solenoid will activate, and the high pressure oxygen will supply the pressure to the expiratory module.
Auxiliary Pressure Module The Auxiliary Pressure Module provides an external connector to monitor an additional pressure. The P7 transducer monitors this pressure and an in-line filter helps protect the sensor from contamination.
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Chapter 2: Theory of Operations
Figure 2-1: Pneumatic Diagram of the NKV-550
2
1
O2
3 O2 Air
4
6
5
1 Gas delivery module 2 Auxiliary pressure module 3 Inspiratory module
4 Safety control module 5 Expiratory module 6 Exhalation control module
High pressure air High pressure oxygen Expiratory gas Inspiratory mixed gas
Control supply Exhalation drive pressure Regulated control 125 cmH2O Low pressure
Table 2-1: Symbol Legend Pneumatic Diagram Symbol
Description
Symbol
Description
Symbol
Description
Connection port
Regulator, back pressure
Valve, proportional solenoid
Pressure transducer
Regulator, pressure
Valve, safety
Filter, water trap, self draining
Restrictor with silencer
Valve, solenoid
Filter
Sensor, oxygen
Valve, solenoid
Flow sensor
Umbrella valve (check valve)
Valve, solenoid
Valve, exhalation
Check valve NKV-550 Series Ventilator System | 13
Chapter 2: Theory of Operations
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14 | NKV-550 Series Ventilator System
Chapter 3: Cleaning, Disinfection and Sterilization
Chapter 3: Cleaning, Disinfection and Sterilization General Information As cleaning and disinfection practices vary widely among health care institutions, it is not possible for Nihon Kohden OrangeMed, Inc. to specify particular practices that will meet all needs, or to be responsible for the effectiveness of cleaning and disinfection procedures carried out in a specific health care institution. Nihon Kohden OrangeMed, Inc. recommends methods that have been validated by Nihon Kohden OrangeMed, Inc. using the specified equipment and procedures outlined in this manual. If a different method is used in your institution, you should follow your institution’s practice and policy and be responsible for the safety and effectiveness of that method. The following portions of the gas pathways through the ventilator can be contaminated with patient body fluids or expired gases during normal use condition: • Expiratory limb of breathing circuit • Exhalation valve (when exhalation filter is not used) • Exhalation flow sensor (when exhalation filter is not used) In addition, the following portions of the gas pathways can also be contaminated with patient body fluids or expired gases during single fault condition, such as device alert, battery low/imminent shutdown, occlusion alarm, and partial occlusion alarm: • Inspiratory limb of breathing circuit • Inspiratory block (when inspiratory filter is not used) WARNING: • All personnel should be aware of the risk of parts being infected when disassembling and cleaning the ventilator system. Use of personal protection equipment is recommended, when appropriate, per the procedure of the health care institution. •
Do not disinfect the whole ventilator system.
•
To avoid possible injury, follow the disinfectant manufacturers recommendations for use of personal protective equipment, when appropriate.
•
To avoid microbial contamination and potential performance problems, do not clean, disinfect, or reuse single patient use or disposable components. Discard per your institutional policy and local regulations.
•
Risks associated with reuse of single patient use items include but are not limited to microbial cross-contamination, leaks, loss of part integrity, and increased pressure drop. When cleaning reusable components, do not use hard brushes or instruments that could damage the component surfaces.
NKV-550 Series Ventilator System | 15
Chapter 3: Cleaning, Disinfection and Sterilization
Frequency of Cleaning, Disinfection and Sterilization Note: Nihon Kohden OrangeMed, Inc. recommends that biofilters are always used at the inspiratory and expiratory ports. The following table summarizes the cleaning, disinfection and sterilization frequency and methods that have been tested by Nihon Kohden OrangeMed, Inc. Table 3-1: Cleaning, Disinfection and Sterilization Frequency and Methods Part
• Fan filter
(p/n FLT5504M)
Frequency
Manual cleaning
Manual Disinfection
SteamAutoclave
Every patient or as needed
Mild detergent (1)
No
No
• Alcohol plus • Exterior surfaces • Graphic user interface
• Cables • Hoses • Support arm • Trolley
Every patient
• Exhalation
valve assembly excluding exhalation flow sensor
• Exhalation
flow sensor (p/n SEN5505P)
Every patient if biofilter not used
Every patient if biofilter not used
quaternary ammonium Super Sani-Cloth® Germicidal Disposable Wipe) -OR• Sodium hypochlorite (PDI Sani-Cloth® Bleach Germicidal Disposable) OR • 70% Isopropyl alcohol Enzymatic detergent (CIDEZYME® or ENZOL® by ASP J&J) Soaking time: minimum of 3 minutes Enzymatic detergent (CIDEZYME® or ENZOL® by ASP J&J) Soaking time: minimum of 3 minutes
• Alcohol plus
quaternary ammonium (Super Sani-Cloth® Germicidal Disposable Wipe) -OR• Sodium hypochlorite (PDI Sani-Cloth® Bleach Germicidal Disposable) OR • 70% Isopropyl alcohol
No
YES No
• 135°C for 3 min
• Dry time: 30 min
Ortho-phthalaldehyde (Cidex® OPA) No Soaking time: minimum of 20 minutes
Every patient if:
• Biofilter is not used • Inspiratory module
AND • Safety valve opened due to device alert, battery low/imminent shutdown, occlusion alarm, and partial occlusion alarm
Enzymatic detergent (CIDEZYME® or ENZOL® by ASP J&J)
YES No
• 135°C for 3 min
• Dry time:
Soaking time: minimum of 3 minutes
30 min
• Neonatal flow
sensor with tubing (p/n NFS5507A)
Single patient use
Discard
No
No
Note 1:Dawn Ultra Dishwashing Liquid, Original. Note 2:The parts for steam-autoclave were wrapped in FDA-cleared Halyard Health H600 wrap during the validation test. 16 | NKV-550 Series Ventilator System
Chapter 4: Preventive Maintenance
Chapter 4: Preventive Maintenance The following chapter gives guidance regarding various maintenance procedures that are required to ensure the proper operation of the NKV-550 ventilator. To operate correctly, the NKV-550 ventilator requires the following preventive maintenance procedures to be conducted.
Clinician or Service Personnel To Perform Table 4-1: Preventive Maintenance Procedures for Clinicians or Service Personnel Display Message
Start up screen displays the following message: Device check not completed
Frequency
Every month
1 Run Device Check 2 Clean and replace fan filter as needed
Every one year
1 Replace the following parts: • O2 sensor 2 Run Device Check 3 Check exhalation valve parts (i.e. diaphragm, o-rings, etc.) for excessive wear, cuts, or pin holes and replace as needed
The status bar displays the Preventive Maintenance (PM) icon
The Alarms message area will display the specific preventive maintenance that is needed
Tasks
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Chapter 4: Preventive Maintenance
Service Personnel to Perform Replacement of parts must be conducted by qualified service personnel. Table 4-2: Preventive Maintenance Procedures for Service Personnel Display Message
Frequency
The status bar displays the Preventive Maintenance (PM) icon Every two years The alarms message area will display the specific preventive maintenance that is needed
Tasks
1 Replace the parts included in the PM kit (p/n PMK5501A) 2 Reset Preventative Maintenance (PM) icon 3 Replace backup battery 4 Replace extended battery 5 Run Device Check
If the ventilator does not appear to be functioning normally, call your qualified service provider for diagnosis and repair. Indications of unusual functioning include failure of the oxygen sensor, backup battery, extended battery, or error messages that display earlier than the regular maintenance intervals listed above. WARNING: Follow your institutional policy and local regulations when discarding used parts, accessories, and the medical device. Dispose of batteries according to local regulations and not with ordinary waste.
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Chapter 4: Preventive Maintenance
Replacement of the Oxygen Sensor (SEN5503P) The Oxygen Sensor scheduled replacement interval is yearly. 1 Remove the access screw on the breath delivery unit and remove the inspiratory access cover. 2 Pull the oxygen sensor outward to remove it from O2 sensor block then disconnect sensor cable. 3 Unscrew the adapter from the end of the oxygen sensor. 4 Thread the adapter onto the new oxygen sensor assembly. Connect the sensor cable, then insert the sensor back into the O2 sensor block. 5 Replace the inspiratory access cover and secure the access screw on the breath delivery unit. Figure 4-1
Figure 4-3
Figure 4-2
Figure 4-4
O2 Sensor Adapter Oxygen Sensor
p/n SEN5503P
NKV-550 Series Ventilator System | 19
Chapter 4: Preventive Maintenance
Replacement of the Backup Battery (BAT5502P-1) The Backup Battery scheduled replacement interval is every two years. 1 Remove the Backup Battery Figure 4-5 Compartment Cover located on the underside of the breath delivery unit by removing the four (4) Philips head screws. Battery cover Philips head screws
2 Disconnect the Backup Battery cable from the Internal Battery Board, then remove and replace the battery. 3 Reinstall the Battery Cover, securing with the four Philips head screws.
Figure 4-6
Backup Battery p/n BAT5502P-1
Backup Battery Cable
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