Operators Manual
208 Pages
Preview
Page 1
NKV-550 Series
Ventilator System Operator’s 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: Technical Support: Clinical Support:
Ext: 7101 Ext. 7102 Ext. 7103
EC Representative
NIHON KOHDEN EUROPE GmbH Raiffeisenstrasse 10 D-61191 Rosbach Germany Tel +49 (6003) 827-0 Fax +49 (6003) 827-599
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. “Treasure Every Breath” is a registered trademark of Nihon Kohden Corporation. “Protective Control” and “Gentle Lung” are registered trademarks of Nihon Kohden OrangeMed Inc. All other product names and trademarks are property of their respective owners. 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. MAN5502-EN Rev. E 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: Safety Information...11
Safety Symbol Definitions... 11 General Warnings... 11 Warnings Regarding Electrical Safety, Fire Hazards, and Environmental... 14 Warnings Regarding Gas Sources... 15 Warnings: Before and During the Use... 16 Warnings Regarding Accessories... 17 Cautions... 18 Responsibility for Patient Safety... 19 Limitation of Liability... 19
Chapter 3: System Overview...23
System Overview... 23 Graphic User Interface Overview... 24 Touchscreen Overview... 25 Breath Delivery Unit: Front View... 26 Breath Delivery Unit: Rear View... 28 Symbols on Ventilator and Packaging... 30
Chapter 4: Operation of the Ventilator System...37
Example Configurations... 37 Humidifier – Heated Wire Breathing Circuit... 37 HME (Heat Moisture Exchanger) – Non-heated Wire Breathing Circuit... 38 NIV (Non-invasive) – Heated Wire Breathing Circuit... 38 O2 Therapy – Heated Wire Breathing Circuit (single limb)... 39 Preparing the Ventilator for Use... 40 Connect Breathing Circuits, Biofilters, and Humidifier... 40 Connect Mains Power... 41 Connect Gas Supplies... 42 Turn On the Ventilator... 43 Choose Patient Type... 44 Patient Data Entry... 44 Choose Therapy Type... 45 Circuit Check and Device Check... 46 Select Ventilation Mode... 47 Change Ventilation Control Settings... 49 Set Alarm Limits and Alarm Loudness... 50 Start Ventilation... 51 Audio Pause... 51 NKV-550 Series Ventilator System | 3
Reset Inactive Alarm Message... 51 Turn Off the Ventilator... 52 Numeric Monitors... 53 Waveforms and Loops... 54 Status Bar Area... 56 Apps Area... 58 Quick Access Buttons... 59 Patient Transport Within a Hospital... 61 Transporting Patient... 61 Battery Operations... 62 Charge Batteries... 62 Battery Use... 63 Battery Power Alarm Sequence... 64
Chapter 5: Theory of Operations...65
General Theory... 65 Explanation of Pneumatic Diagram Gas Flow... 65 Gas Delivery Module... 65 Inspiratory Module... 65 Safety Control Module... 65 Expiratory Module... 66 Exhalation Control Module... 66 Auxiliary Pressure Module... 66 Ventilator States... 68 Ventilation State... 68 Service State... 68 Charge State... 68 Off State... 68 Device Alert State... 68 Standby State... 69 Ventilation Phases... 70 Initiation of Inspiration... 70 Termination of Inspiration... 70 Therapy Types... 71 Invasive Ventilation... 72 Non-invasive Ventilation (NIV)... 72 O2 Therapy... 73 Ventilation Modes... 74 A/CMV... 74 SIMV... 75 SPONT... 75 Breath Types... 76 VC... 76 PC... 77 PRVC... 78 PS... 79 VS... 80 CPAP... 81 APRV... 82 Additional Breath Types... 83
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Manual Breaths... 83 Tube Compensation... 84 Apnea Ventilation... 85 Additional Breath Controls... 86 Slope %... 86 ET %... 86 TIMax PS ...87 Leak Comp... 87 TI / I:E / Flow Selector... 87
Chapter 6: Applications (Apps)...89
General Rules of the Apps... 89 Standby... 89 Open Airway Suction... 90 Inline Suction... 91 Occlusion Pressure (P0.1) ... 92 Negative Inspiratory Force (NIF/PiMax)... 93 Spontaneous Breathing Trial (SBT)... 94 Camera... 95 Sensors... 95 Auxiliary Pressure (Paux)... 96 Volumetric Capnogram... 97 Transpulmonary Pressure (Ptp) ... 97 Low Flow P/V Maneuver... 98 Custom Settings... 99 Trends...101 Logs...101 Data Retrieval...102 Recruitability Assessment (RA)...102 Recruitment Maneuver (RM)...104 PEEP Titration (PEEP-T)...105 Video...107
Chapter 7: Use of Optional Features...109
Neonatal Flow Sensor...109 Connect Neonatal Flow Sensor...110 Calibrate Neonatal Flow Sensor...110 Enable/Disable Neonatal Flow Sensor...110 Purge Neonatal Flow Sensor...111 Zeroing Neonatal Flow Sensor...111 Aerogen Nebulizer...112 Placement of the Nebulizer in the Breathing Circuit...113 Adult and Pediatric Circuit...113 Alternative Pediatric Circuit...113 Dry Side of the Humidifier...113 Connecting Nebulizer USB Controller To The Ventilator...113 SpO2 ...114
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Signal Quality Bar Display...114 Nihon Kohden SpO2 accessories...115 CO2 Monitor...117 Second Graphic User Interface...120 Protective Control®...120
Chapter 8: Alarms and Troubleshooting...123
General Rules of Alarms...123 Set Alarm Limits...124 Manual Alarm Limits...124 Auto Alarm Limits...125 View On-Screen Help for Alarms...126 Additional Alarm Messages...127 Reset Alarm Messages...127 Silence Alarm Sounds...127 Silenceable Alarms...127 Non-silenceable Alarms...128 Adjust Alarm Volume...129 Alarm Logs...129 Nurse Call...129 Alarm Troubleshooting...130
Chapter 9: Cleaning, Disinfection and Sterilization...145
General Information...145 Frequency of Cleaning, Disinfection and Sterilization...146 Optional Features...147 Exterior Surfaces...148 Fan Filter...149 Removal and Disassembly of Expiratory Module...150 Exhalation Flow Sensor...150 Manually Clean the Exhalation Flow Sensor...152 Manual High-Level Disinfection of the Exhalation Flow Sensor...153 Exhalation Valve Assembly...154 Manually Clean the Exhalation Valve...156 Steam Sterilization of the Exhalation Valve...157 Reassemble and Install the Exhalation Valve Assembly...158 Inspiratory Module...159 Removing the Inspiratory Module...159 Manually Clean the Inspiratory Module...161 Steam Sterilization of the Inspiratory Module...161 Insertion of Umbrella Valve Assembly...162 Replacing the Disc Filter Tubing Assembly...162 Reassemble the Inspiratory Module...162
Chapter 10: Preventive Maintenance...163
Clinician or Service Personnel To Perform...163 Service Personnel to Perform...164
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Replacement of the Oxygen Sensor...165 Replacement of the Fan Filter...166
Chapter 11: Institutional Configuration and Connectivity...167
System Settings...167 Institution Preferences...168 Connectivity...168 Nurse Call Port...168 Second Graphic User Interface Port...170 Ethernet Port...170 RS-232 Port...170
Chapter 12: Specifications...171
Configurations...171 Patient Type...171 Patient Data...171 Ventilation Modes...172 Ventilation Settings...172 Monitors...174 Alarm Audio Pause...176 Adjustable Alarms...176 Quick Access Buttons...177 Applications...177 Gentle Lung® Suite (option)...177 Institutional Settings...177 Connectivity...178 Gases...178 Physical Specifications...178 Communication/Interface...179 Environmental...179 Power...180 Standards...180
Chapter 13: Disclosures...181
Essential Performance ...181 Test Conditions...181 Volume Controlled Breath Type...181 Pressure Controlled Breath Type...182 O2 Concentration Response Time...182 Instrument Measurement Uncertainties...182 Technical Description Disclosures...183 SpO2 Disclosures...185 SpO2 ...185 PR...186 CO2.Disclosures ...186 Electromagnetic Compatibility...188
Chapter 14: Accessories and Service Parts ...195
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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
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Chapter 2: Safety Information
Chapter 2: Safety Information Safety Symbol Definitions This section contains safety information for clinicians, who should always exercise appropriate caution while using the ventilator. WARNING: Warnings provide important information about a potentially hazardous situation which, if not avoided, may cause serious outcomes to the patient, operator, or a third party, including severe injury or death. CAUTION: Cautions alert clinicians to exercise appropriate care for safe and effective use of the product to avoid minor or moderate injury to the patient, operator, or a third party.
General Warnings WARNING: To ensure proper operation and avoid harm to patients and clinicians, only qualified medical personnel should use this ventilator when applying mechanical ventilation management for patients. Only qualified service personnel should attempt to maintain, service, and repair the ventilator. WARNING: Any use of this ventilator system requires full understanding and strict observation of all sections of this Operator’s Manual. Do not use the ventilator system out of the scope of Intended Use. Strictly follow all Warning and Caution statements in this manual; failure to do so may result in patient severe injury or death. WARNING: Medical devices, such as this ventilator system, may fail to perform per specifications. The ventilator system may be disconnected from the patient accidentally. Therefore, always place the ventilator and the patient in a location and environment where audible alarms can be clearly heard by clinicians all the time, so that any ventilator abnormality can be detected and appropriately handled by clinicians in a timely manner. Never place the ventilator and patient in a location where clinicians cannot clearly hear the audible alarms. The operator should set the alarm loudness at a level that allows the operator to distinguish the audio alarm above background noise levels. Do not silence, disable, or decrease the loudness of the ventilator’s audible alarm if patient safety could be compromised.
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WARNING: In case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in a patient’s severe injury or death. An alternate source of ventilation, such as a self-inflating, manually-powered resuscitator (as specified in ISO 10651-4 with mask) should always be available when using the ventilator. WARNING: The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of conditions. Additional monitors, such as capnography and pulse oximetry with appropriate alarm settings, should be used all the time to assure the appropriate ventilation and oxygenation of the patient. WARNING: To prevent patient injury, do not use the ventilator if it has a known malfunction. Never attempt to override serious malfunctions. Replace the ventilator and have the faulty unit repaired by trained service personnel. To prevent patient injury, do not make unauthorized modifications to the ventilator. WARNING: To prevent injury and avoid interfering with ventilator operation, do not insert tools or any other objects into any of the ventilator’s openings or ports. WARNING: The LCD panel contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances. WARNING: If the Graphic User Interface (GUI) display/LCD panel is blank or experiences interference and cannot be read, check the patient. Because breath delivery is controlled independently from the GUI, problems with the display will not, by themselves, affect ventilation. The ventilator, however, should be replaced as soon as possible and repaired by qualified service personnel. WARNING: The Nihon Kohden NKV-550 Ventilator contains phthalates. When used as indicated, very limited exposure to trace amounts of phthalates may occur. There is no clear clinical evidence that this degree of exposure increases clinical risk. However, in order to minimize risk of phthalate exposure in children and nursing or pregnant women, this product should only be used as directed. WARNING: Replacement of the backup lithium battery must be performed only by qualified trained personnel. WARNING: If long term storage is expected, the backup battery and extended battery pack have to be recharged at least once every 3 months. Failure to do so may result in complete damage of the battery pack. 12 | NKV-550 Series Ventilator System
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WARNING: Follow preventive maintenance requirements and specified intervals described in this manual. WARNING: Even though the NKV-550 Ventilator meets the standards listed in “Chapter 12: Specifications,” the internal Lithium-ion battery of the device is considered to be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. The NKV-550 Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA: International Air Transport Association), International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements may apply. WARNING: Any connected devices or device combinations not complying with the requirements mentioned in this manual may compromise the correct functioning of the ventilator system. Before operating any combination of devices, refer to and strictly comply with the instructions of all connected devices and device combinations. WARNING: Always follow your hospital infection control guidelines for handling infectious materials. Follow the instructions in this manual and your institution’s protocol for cleaning and disinfection of the ventilator and its components. Use all cleaning solutions and products with caution. Follow manufacturer’s instructions for individual cleaning solutions. WARNING: To prevent infection and contamination, always ensure inspiratory and expiratory biofilters are installed before ventilating the patient. If they are not installed, the ventilator components that were exposed to the patient exhaled gas have to be disinfected prior to using the ventilator on the next patient. WARNING: Never attempt to re-use single patient use components or accessories. Doing so increases risk of cross-contamination. Re-processing of single patient use components or accessories may compromise functionality leading to possible loss of ventilation. WARNING: Never attempt to perform service or maintenance on the ventilator while in patient use. Prior to these activities, ensure that a patient is not connected to the device. WARNING: Follow your institutional policy and local regulations when discarding used parts, accessories, and the medical device.
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Chapter 2: Safety Information
Warnings Regarding Electrical Safety, Fire Hazards, and Environmental The electrical safety classification of this device is Class I. WARNING: To avoid the risk of electrical shock: • Use only Nihon Kohden OrangeMed, Inc. authentic batteries, adapters, and cables. • Do not use batteries, adapters or cables with visible signs of damage. • Do not touch internal components. • Always connect mains power to a grounded, electrical outlet. WARNING: Do not use the ventilator in the presence of flammable gases. To avoid a fire hazard, keep all components of the ventilator system away from all sources of ignition (such as matches, lighted cigarettes, flammable medical gases, and/or heaters). An oxygen-rich environment accelerates combustibility. WARNING: For proper ventilator operation, connect the NKV-550 mains power to a grounded, hospital-grade, electrical outlet. WARNING: In case of fire or a burning smell, immediately take the following actions if it is safe to do so: disconnect the patient from the ventilator and disconnect the ventilator from the oxygen supply, facility power, and all batteries. Provide alternate method of ventilatory support to the patient, if required. WARNING: To minimize fire hazard, inspect and clean or replace, as necessary, any damaged ventilator parts that come into contact with oxygen. WARNING: To avoid the risk of ventilator malfunction and patient injury, operate the ventilator in an environment that meets specifications. Do not use the ventilator in a hyperbaric chamber. It has not been validated for use in this environment. Do not use the ventilator in the presence of strong magnetic fields. Do not use the ventilator during magnetic resonance imaging (MRI, NMR, NMI), as it may impair correct functioning of the ventilator and endanger the patient. Do not use the ventilator during radiotherapy (i.e. cancer treatment using ionizing radiation).
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WARNING: Do not position the ventilator next to anything that blocks or restricts the gas inlet or cooling air circulation openings, gas exhaust port, fan intake, or alarm speaker, as this may: • limit the air circulation around the ventilator, potentially causing overheating; • limit the ventilator’s ability to exhaust patient exhaled gas leading to potential harm; • limit the clinician’s ability to hear ventilator alarms. WARNING: The use of accessories and cables other than those specified in this manual may result in increased emissions or decreased immunity of the ventilator. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the NKV-550 as well as all cables specified by Nihon Kohden or Nihon Kohden OrangeMed, Inc. Otherwise degradation of performance of the NKV-550 could result. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided, as this may result in improper operation. If such use is necessary, the ventilator system should be observed to confirm normal operation.
Warnings Regarding Gas Sources WARNING: Do not use nitric oxide, helium, or mixtures containing helium as an input supply gas for the ventilator. It has not been validated for use with these gas mixtures. To avoid the risk of ventilator malfunction, do not use the ventilator with anesthetic gases. WARNING: The ventilator should be connected to a gas pipeline system compliant to ISO 7396-1:2007 because: • Installation of the ventilator on a non-ISO 7396-1:2007 compliant gas pipeline system may exceed the pipeline design flow capacity. • The ventilator is a high-flow device and can interfere with the operation of other equipment using the same gas source if the gas pipeline system is not compliant to ISO 7396-1:2007. WARNING: Use only clean, dry medical grade gases when operating the ventilator. Use of non-medical approved gases could result in damage to the ventilator and invalidate product warranty. WARNING: The maximum flow and/or pressure delivery capability may be limited and the ventilator gas delivery specifications may be compromised, if an air compressor is used, if a restrictive pressure regulator is used in the hospital high pressure pipeline, or if a long and restrictive gas hose is used.
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Chapter 2: Safety Information
WARNING: Use of only one gas source could lead to loss of ventilation and/or hypoxemia if that one gas source fails and is not available. To maximize the patient safety, always connect both gas sources to the ventilator to ensure a constant gas supply is available to the patient in case one of the gas sources fails.
Warnings: Before and During the Use WARNING: Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run Circuit Check and Device Check as described in this manual. Do not use this ventilator if it does not pass the Circuit Check or Device Check. Always run Circuit Check and Device Check with the type of breathing circuit that will be used with the patient. If a humidifier is to be used, always pre-fill the humidifier chamber with water prior to running the Circuit Check or Device Check, in order to avoid under or over delivery of gases to the patient. WARNING: Ensure proper connection and engagement of expiratory and inspiratory filters, to avoid accidental disconnection or leak. WARNING: The ventilator accuracies listed in the “Chapter 13: Disclosures” are applicable only under specified operating conditions. If the ventilator is operated outside specified ranges, the ventilator may supply incorrect information and the accuracies listed in the aforementioned tables do not apply. WARNING: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings for use with the patient, based on clinical judgment, the condition and needs of the patient, and the benefits, risks, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not they remain appropriate for the patient’s current needs. WARNING: During non-invasive ventilation, the exhaled volume of the patient can differ from the measured patient volume due to leaks around the mask or other non-invasive interfaces. WARNING: When both neonate and non-invasive ventilation are selected, volume and leak related monitoring and alarms are inactive. Use an external monitor (with alarms) for volume monitoring. WARNING: A ventilator intended for non-invasive ventilation should be equipped with CO2 monitoring for the measurement of expiratory carbon dioxide concentration, e.g., in the expiratory limb or at the patient-connection port, in accordance with ISO 80601-2-55 (ISO 21647replacement). 16 | NKV-550 Series Ventilator System
Chapter 2: Safety Information
WARNING: Avoid nuisance alarms by applying appropriate alarm settings. WARNING: When using the Tube Compensation function, to prevent inappropriate ventilation, select the correct Tube Type (ET or Tracheostomy) and tube inner diameter (ID) for the patient’s ventilatory needs. Inappropriate ventilatory support leading to over-or under-ventilation could result if an ET tube or trach tube setting larger or smaller than the actual value is entered. WARNING: Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not to activate during ventilation, which reduces its efficacy for monitoring the patient and alerting the clinician to situations, such as circuit disconnection or patient under-ventilation, which may require immediate medical intervention. WARNING: Positive-pressure ventilation can lead to negative effects, such as barotrauma or strain on the circulatory system. WARNING: The administration of increased O2 concentrations may cause oxygen toxicity, such as retinopathy of prematurity.
Warnings Regarding Accessories WARNING: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use anti-static or electrically conductive hoses or tubing in or near the ventilator breathing system. WARNING: Use only Nihon Kohden OrangeMed, Inc. authorized accessories. WARNING Adding accessories to the ventilator can change the pressure gradient across the ventilator breathing system (VBS) and affect ventilator performance. Ensure that any changes to the ventilator circuit configurations do not exceed the specified values for circuit compliance and for inspiratory or expiratory limb total resistance. Refer to “Chapter 13: Disclosures.” If adding accessories to the patient circuit, always run Circuit Check to establish circuit compliance and resistance prior to ventilating the patient. Institutions using the ventilator system are responsible for ensuring the compatibility of the ventilator and all of the parts used to connect to the patient before use. WARNING: Use of a nebulizer or humidifier can lead to an increase in the resistance of respiratory filters. Monitor the filters frequently for increased resistance or blockage.
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Chapter 2: Safety Information
WARNING: The added gas from an external pneumatic nebulizer can adversely affect spirometry, delivered O2%, delivered tidal volumes, and breath triggering. Additionally, aerosolized particulates in the ventilator circuit can lead to an increase in expiratory filter resistance. WARNING: Carefully route patient tubing and cabling to reduce the possibility of patient entanglement or strangulation. WARNING: To avoid liquid entering the ventilator, empty the gas condensate vial in the breathing circuits frequently, and always before fluid reaches the maximum fill line. WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to IEC 60601-1. Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input part or signal output part of the ventilator system configures a medical system, and is therefore responsible for ensuring the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult Nihon Kohden Technical Services or your local representative.
Cautions CAUTION: Do not use sharp objects to make selections on the display. CAUTION: To ensure optimal performance, keep the graphic user interface (GUI) touch screen clean and free from foreign substances. Refer to "Chapter 9: Cleaning, Disinfection and Sterilization" on page 145. CAUTION: To avoid damage or tip over of the ventilator and trolley, use the handles whenever moving or positioning the device. Avoid leaning on or using the GUI for positioning the ventilator. CAUTION: To avoid moisture entering the ventilator and possibly causing a malfunction, Nihon Kohden OrangeMed, Inc. recommends using a wall air water trap when using piped medical air from a facility-based air compressor. CAUTION: Use only the cleaning agents specified. For approved cleaning agents refer to "Chapter 9: Cleaning, Disinfection and Sterilization" on page 145.
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CAUTION: When transferring the ventilator from storage conditions, allow its temperature to stabilize at ambient conditions prior to use. CAUTION: Only a USB memory stick and Aerogen nebulizer may be connected to the USB ports. Any other devices are prohibited from connecting to the USB ports.
Responsibility for Patient Safety Caution: Federal law restricts this device to sale by or on the order of a physician. To use this product correctly and safely, carefully read and observe all sections of this manual prior to use. Because the operating manual and labeling of the NKV-550 ventilator assume that its sale and use are restricted to qualified, trained professionals under the direction of a physician who understand the general operating characteristics of ventilators, this manual includes instructions, warnings, and cautions that are specific to the design of this ventilator. This manual does not include all the references to hazards that are obvious to medical professionals, the consequences of product misuse, or potentially adverse effects in patients with abnormal conditions. Product modification or misuse can be dangerous. Nihon Kohden OrangeMed, Inc. disclaim all liability for the consequences of product alterations or modifications, as well as for the consequences that might result from the combination of this ventilator with other products, whether supplied by Nihon Kohden OrangeMed, Inc. or by other manufacturers, if such a combination is not endorsed by Nihon Kohden OrangeMed, Inc. It is the responsibility of the ventilator operator to choose appropriate monitoring of equipment performance and patient condition. Electronic surveillance of equipment performance and patient condition cannot take the place of directly observing clinical signs. The ventilator operator is solely responsible for selecting the optimum level of patient monitoring.
Limitation of Liability The liability of Nihon Kohden and Nihon Kohden OrangeMed, Inc., whether arising out of, or related to manufacture and sale of the goods, their installation, demonstration, sales representation, use, performance, or otherwise, including any liability based upon Nihon Kohden OrangeMed, Inc.’s product warranty, is subject to and limited to the exclusive terms and conditions as set forth, whether based upon breach of warranty or any other cause of action whatsoever, regardless of any fault attributable to Nihon Kohden OrangeMed, Inc. and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise). The stated expressed warranties are in lieu of all other warranties, expressed or implied, including, without limitation, warranties of merchantability, fitness for any purpose, or non-infringement. Nihon Kohden OrangeMed, Inc. shall not be liable for, nor shall the buyer be entitled to recover, any special incidental or consequential damages or any liability incurred by buyer to any third party in any way arising out of or relating to the goods. NKV-550 Series Ventilator System | 19
Chapter 2: Safety Information
For warranty information, contact your local Nihon Kohden representative. Fault tree analysis was used to identify components critical to ventilation. Life data and endurance testing were used to evaluate the critical components for reliability and their ability to meet the service life requirement of 10 years. The analysis concluded that the NKV-550 will meet its intended life of 10 years provided that all preventive maintenance is performed in accordance with the operator’s manual. Endurance testing was performed under extreme conditions and therefore the service life is valid for all ventilation modes when operated in accordance with the operator’s manual.
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