NOxBOXi and NOxMixer Nitric Users Manual and Technical Guide Issue 11 Sw Ver 18.X Issued March 2018

NOxBOX, Ltd. 1080-1081 Galley Drive, Kent Science Park Sittingbourne, Kent, ME9 8GA, England

LAB639_EN (11)

Tel: +44 (0) 1795 859430 Email: [email protected] www.noxboxltd.com

© Copyright 2017-18 NOxBOX Ltd All rights reserved NOxBOX Ltd. reserves the right to change or update this literature without prior notice. This manual was originally written in English. Registered office: England and Wales. Registered No: 09563860

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NOxBOXi & NOxMixer™ User’s Manual and Technical Guide: Issue 11.0, Version 18.X

NOTICES BUSINESS CONFIDENTIAL: This manual contains confidential and proprietary information of NOxBOX Ltd. and is provided in confidence and solely for use in conjunction with the NOxBOX®i system and NOxMixer™ system. The manual may not be reproduced or its contents disclosed to third parties without the prior written consent of NOxBOX Ltd. DISCLAIMERS: All information referred to and/or included in this manual is current as of the issue/revision date of this manual. NOxBOX, Ltd. makes no warranty or representation with respect to the accuracy of the information or with respect to the suitability of the use of such information outside NOxBOX Ltd., nor does NOxBOX Ltd. assume responsibility for any injury or damage which may result, directly or indirectly, from the use of such information. This manual could include technical inaccuracies or typographical errors. Changes are made periodically to the information herein; these changes will be incorporated in subsequent revisions of the manual. NOxBOX Ltd. reserves the right to make improvements and/or changes to the product(s) and/or programs described in this manual at any time and without notice. The installation information in this manual is offered for use by technically qualified personnel at their discretion and risk. All statements, technical information, and recommendations are based on tests and data that NOxBOX Ltd believes to be reliable, but the accuracy or completeness is not guaranteed, and no warranty of any kind is made with respect to this information. NOxBOX, Ltd. provides assistance in commissioning the system and may also provide technical assistance for system installation and testing to determine operating conditions. TRADEMARKS: NOxBOXi, NOxFLOW, NOxBOX, and NOxMixer are trademarks or registered trademarks of NOxBOX Ltd. in the United States and/or other countries. Other trademarks used herein are trademarks or registered trademarks of their respective owners. NOxBOX Ltd. is a wholly owned affiliate of Praxair, Inc.

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Table of Contents

TABLE OF CONTENTS CHAPTER 1 – USER RESPONSIBILITY 1

User Responsibility ... 1-1

CHAPTER 2 – SAFETY 2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.2 2.3 2.4 2.4.1 2.4.2 2.5 2.6 2.7

Basic Safety Recommendations ... 2-1 Basic Hazards ... 2-4 Asphyxiation ... 2-4 Electrocution ... 2-4 Pressure... 2-5 Toxicity ... 2-5 Poisons ... 2-5 Hazard Labels ... 2-6 Cleaning Precautions ... 2-6 Electromagnetic Immunity ... 2-7 RFID Reader System Compatibility ... 2-7 EMC Test Criteria ... 2-7 Network Connections ... 2-9 Applied Parts ... 2-9 Isolation from Mains Power ... 2-9

CHAPTER 3 – EQUIPMENT DESCRIPTION 3.1 3.1.1 3.1.2 3.2 3.2.1 3.3 3.3.1 3.3.2 3.3.3 3.3.3.1 3.3.3.2 3.3.3.3 3.3.3.4 3.3.3.5 3.3.3.6 3.4 3.4.1 3.4.2

Usage Guidelines ... 3-1 Typical Use ... 3-1 Indications for Use ... 3-2 Specification and Environment ... 3-3 Device Specifications ... 3-3 Abbreviations, Definitions, and Icons ... 3-6 Abbreviations ... 3-6 Definitions ... 3-6 Icon Overview ... 3-6 Rear Label Symbols ... 3-7 Front Label Symbols ... 3-8 Power Supply Symbols ... 3-8 Accessory Label Symbols ... 3-9 Manual Override Flow Selector Valve Markings ... 3-10 Packaging Symbols ... 3-10 System Components ... 3-11 Detailed Areas of Dose Delivery Screen... 3-12 NOxBOXi System Features ... 3-15

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3.4.3 3.5 3.6 3.6.1 3.6.2 3.6.3 3.6.4

Additional Component System Features ... 3-16 Theory of Operation ... 3-18 NOxBOXi Effect on Ventilator Circuit ... 3-21 Oxygen Dilution ... 3-21 Measured Minute Volume ... 3-21 Trigger Sensitivity ... 3-22 Maximum NO Dose Delivery ... 3-22

CHAPTER 4 – INSTALLATION AND PRE-USE SETUP 4.1 4.2 4.3 4.4 4.4.1 4.4.2 4.4.2.1 4.4.2.2 4.5

Unpacking Instructions ... 4-1 Assemble Delivery Unit to Trolley ... 4-1 Setup Instructions ... 4-3 Step-by-Step Guide ... 4-5 NO Gas Cylinder Connection ... 4-7 System Test Setup ... 4-10 NOxFLOW™ Sensor ... 4-11 Assembling the System Test Kit ... 4-12 System Tests ... 4-15

CHAPTER 5 – STANDBY MODE 5

Standby Mode ... 5-1

CHAPTER 6 – PATIENT CIRCUIT SETUP 6.1 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.4.1 6.2.5 6.2.6 6.2.7 6.2.8 6.2.9

Connecting to Patient Ventilator ... 6-1 Ventilator Connection Examples ... 6-2 Standard Ventilator Setup ... 6-2 Acutronic Fabian Setup ... 6-3 Acutronic Fabian HFO Setup... 6-4 Bunnell Life Pulse HFJV Setup ... 6-5 Setup ... 6-6 Dräger VN500/Infinity Setup ... 6-9 High Flow Mask Setup ... 6-10 Nasal Cannula Setup ... 6-11 SensorMedics HFO Setup (3100A/B) ... 6-12 Vapotherm Precision Flow NO DPC Setup ... 6-13

CHAPTER 7 – OPERATION 7.1 7.2 7.3 7.4 7.4.1

Gas Delivery System ... 7-2 Monitoring System ... 7-3 Dose Entry and Alarm Setting ... 7-3 Dose Delivery Screen Display ... 7-6 Tabbed Navigation ... 7-6

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7.4.2 7.4.2.1 7.4.2.2 7.5 7.6 7.7 7.8 7.9

Changing Dose or Alarms during Therapy... 7-6 Change Dose Setting during Therapy ... 7-7 Change Alarm Setting during Therapy ... 7-7 Screen Lock ... 7-8 Alarms ... 7-9 Zero Calibration during Delivery ... 7-10 User Settings Screen ... 7-12 Device Shutdown ... 7-13

CHAPTER 8 – TRANSPORT AND EMERGENCY BACKUP 8.1 8.1.1 8.1.2 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6 8.3 8.3.1 8.3.2 8.3.3 8.3.4

NOxBOXi System Transport Procedure ... 8-1 Ventilator (Synchronous) ... 8-1 Manual Bagging ... 8-3 Manual Bagging and Emergency Backup ... 8-6 Introduction ... 8-6 Manual Bagging Setup ... 8-6 Self-Inflating Manual Bagging Setup ... 8-7 Hyper Inflation Manual Bagging Setup ... 8-8 Neopuff Resuscitator Diagram ... 8-9 Emergency Backup Setup ... 8-10 Delivery in Manual Override Mode ... 8-12 Determine Correct Flow Setting... 8-14 Using the Look-up Tables ... 8-15 Engaging Manual Override Mode (Manual Bagging and Emergency Backup) ... 8-16 Manual Override Flow Control Valve: Approximate NO Flow Values ... 8-17

CHAPTER 9 – MAINTENANCE AND REPAIR 9.1 9.2 9.3 9.4 9.5 9.6 9.7

Periodic Maintenance ... 9-2 System Settings ... 9-3 Cleaning the NOxBOXi System ... 9-3 Calibration ... 9-3 System Replacement Parts ... 9-6 Disposable System Accessories... 9-8 Limited Warranty ... 9-13

CHAPTER 10 – TROUBLESHOOTING AND VENTILATOR MANAGEMENT 10.1 10.2 10.3 10.3.1 10.3.2 10.4

Alarm Priorities ... 10-1 Notifications at Switch On ... 10-3 Alarm Priority – Alarms During Therapy ... 10-4 Red Banner Alarms ... 10-4 Amber Banner Alarms ... 10-11 General Troubleshooting ... 10-13

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10.5 10.6 10.6.1

NOxMixer™ System Troubleshooting ... 10-16 Ventilator Management & Compatibility ... 10-16 Ventilator Compatibility List ... 10-17

APPENDICES A A.1 A.2 A.3 A.4 A.5 A.6 A.7 A.8 A.9 A.10 A.11 A.12

NO Dose Look-Up Tables ... A-1 1000PPM Cylinder Concentration ... A-1 900PPM Cylinder Concentration ... A-1 800PPM Cylinder Concentration ... A-2 600PPM Cylinder Concentration ... A-2 500PPM Cylinder Concentration ... A-3 450PPM Cylinder Concentration ... A-3 400PPM Cylinder Concentration ... A-4 300PPM Cylinder Concentration ... A-4 250PPM Cylinder Concentration ... A-5 225PPM Cylinder Concentration ... A-5 200PPM Cylinder Concentration ... A-6 100PPM Cylinder Concentration ... A-6

LIST OF FIGURES 2-1 3-1 3-2 3-3 3-4 4-1 4-2 4-3 8-1 8-2 8-3 8-4 8-5 8-6 8-7 8-8 8-9

Example Hazard Label: No Pushing ... 2-6 NOxBOXi System Device Label... 3-11 NOxMixer™ System Device Label ... 3-11 Theory of Operation Diagram ... 3-20 NOxBOXi System Maximum Dosing Capability (Intelligent Delivery Mode) ... 3-22 System Test Circuit ... 4-10 NOxFLOW™ Sensor ... 4-11 System Test Kit Contents ... 4-12 Adjust Flow Control Valve ... 8-6 Activate Manual Override ... 8-6 Self-inflating Manual Bagging Setup ... 8-7 Hyper Inflation Manual Bagging Setup ... 8-8 Neopuff Resuscitator Diagram ... 8-9 NOxBOXi System Setup for Emergency Backup Use ... 8-10 Adjust Flow Control Valve ... 8-11 Activate Manual Override ... 8-12 Manual Override Delivery Controls ... 8-13

LIST OF TABLES 2-1 3-1 3-2

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions (IEC 60601-1-2) ... 2-7 NOxBOXi System Main Specifications... 3-3 NOxMixer™ System Main Specifications ... 3-5

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3-3 3-4 3-5 3-6 3-7 3-8 3-9 3-10 3-11 3-12 3-13 3-14 3-15 3-16 3-17 4-1 9-1 9-2 9-3 9-4 10-1 10-2 10-3 10-4 10-5 10-6

Abbreviations ... 3-6 Definitions ... 3-6 General Navigation ... 3-6 Main Monitor ... 3-7 User Setting Screen ... 3-7 Rear Label Symbols ... 3-7 Front Label Symbols ... 3-8 Power Supply Symbols ... 3-8 Accessory Label Symbols ... 3-9 Valve Markings... 3-10 Packaging Symbols ... 3-10 Unit Identification Serial Number ... 3-11 Main Screen Display Areas ... 3-12 Different Views ... 3-15 System Features ... 3-16 System Test Circuit ... 4-10 Periodic Maintenance Tasks ... 9-2 Calibration Accessories ... 9-4 System Replacement Parts ... 9-6 Disposable System Accessories... 9-8 Alarm Priority... 10-1 Alarms that May Display at Startup (Before the Home Screen Displays) ... 10-3 Alarm Display When a Critical Problem is Detected During Therapy ... 10-4 Alarm Display When a Problem is Detected During Therapy ... 10-11 General Troubleshooting Issues ... 10.13 NOxMixer™ System Troubleshooting Issues ... 10-16

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1

USER RESPONSIBILITY

The NOxBOXi® system will perform in accordance with the description detailed in this manual and accompanying guides and/or labels when assembled, operated, stored, maintained, and repaired in accordance with the instructions provided. This product must be checked and calibrated in-line with the outlined service schedule recommendations. A product found to be faulty should not be used. Any parts or accessories that are broken, damaged, missing, obviously worn, distorted, or contaminated should be replaced immediately. If the product requires repair or replacement, it is recommended that the customer first contacts their distributor or technical support service for the NOxBOXi system. It is essential that only approved components are used to replace or repair any part of the NOxBOXi system, in accordance with the manufacturer’s written instructions. The product must not be altered without prior written approval from the Technical Support department of NOxBOX Ltd. This device has been designed and constructed with high-quality components to ensure accuracy, reliability, and compatibility. If third-party components are installed without prior consent from NOxBOX, Ltd., NOxBOX, Ltd. will not be liable for any incident that may occur as a result of this. This may also invalidate your warranty. The product user bears sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage, or unauthorized alteration by any source not authorised to do so by NOxBOX, Ltd. The information contained herein is provided only for the benefit of licensed physicians and other licensed health care professionals. It does not constitute medical advice. Product information is provided as general information. It is not a substitute for advice from a licensed medical practitioner or other licensed health care professional. Do not use the information contained herein to diagnose or treat a medical condition. Product specifications may change without notice. The products described herein are available for sale and use only in accordance with applicable local laws and regulations, and may not be distributed, sold or used other than in accordance with all required local regulatory approvals and product labelling. Throughout this document, there are highlighted areas that contain information, warnings, or danger notifications: DANGER: This statement contains important information directly related to the safety of the user and/or patient if the manual instructions are not followed.

WARNING: This statement contains important information that may affect the safety of the user and/or patient if the manual instructions are not followed.

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User Responsibility

CAUTION: This statement contains information alerts that could help prevent a problem from occurring.

Information: This statement contains important information that is highlighted for user awareness.

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2

SAFETY WARNING: Do not modify this equipment without authorization from the manufacturer.

WARNING: Read and understand this manual, including any inserts/amendments, before using the NOxBOXi system. Only trained and responsible personnel should work with or around this equipment. Wear appropriate personal protective equipment (PPE) and, if applicable, turn off the power before performing any installation, maintenance, repair, or troubleshooting procedures.

WARNING: To avoid serious injury, pay attention to all precautionary labels that are attached to the equipment, cylinders, containers, and boxes before startup. Do not remove or obscure any label. If a label is missing, becomes worn, or is difficult to read, replace it with a new one. Labels are available from your NOxBOX Ltd. representative.

INFORMATION: This chapter contains information to promote safety in the operation and maintenance of this equipment. It is not intended to supersede, replicate, or replace any safety documentation or procedures provided from or established by official safety sources. Read and understand the Safety Data Sheets (SDS) for the materials used with this equipment. All personnel who work in the vicinity of this equipment should read, understand, and follow all safety information contained in the SDSs and all government and facility safety regulations.

2.1

Basic Safety Recommendations



Prevent formation of unsafe atmospheres-Ensure that properly engineered ventilation and atmospheric monitoring systems are installed and operating properly. Creating a confined space presents the potential for unsafe atmospheres. If dangerous levels of a gas are detected, immediately evacuate the affected area. Do not re-enter the area until safe conditions are restored.



Ventilate working areas-Prevent any leaking gases from accumulating. Vent all gases to the outside, in an area that is safely away from people. Before restarting the equipment, ensure that all parts affected by repairs have been restored to their proper operating condition and that the lines have no leaks.



Prevent injury-Wear safety glasses and other appropriate personal protective equipment (PPE) when the Safety Data Sheet (SDS), task, or code dictates. Ensure that all tools and instruments used

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Safety

are in good condition. Be aware that high-velocity gas may be released at vents and safety relief valves. 

Maintain safety devices-Check all safety devices at least annually or as otherwise required by local codes or manufacturer recommendations. Properly maintain safety valves. Never bypass safety devices, and never operate the equipment outside its specified limits.



Ensure safe maintenance and repair-Only qualified personnel should repair the equipment. Use strict lockout/tagout procedures to protect personnel from hazards related to unexpected energizing, startup, or the release of stored energy during servicing or maintenance.



Transportation-When transporting the NOxBOXi system trolley, ensure that the correct procedure is followed. Always use the handle located at the front of the trolley. Ensure that the cylinders are securely fastened, and inspect the area for trip hazards (e.g., sample lines).



Strangulation-Minimise the risk of strangulation of the patient by wires or tubing by keeping the NOxBOXi system next to the patient with all the tubing coming from one side. DANGER: Failure to properly isolate the equipment, electrical systems, and piping can cause asphyxiation, fire, and/or explosion. Positively isolate the equipment from the gas supply and the process material before performing any repair work. It is not sufficient to simply close the valves. The lines and tubing must be disconnected.

The NOxBOXi system has not been tested for use in the MRI suite. The NOxBOXi system is MR unsafe and should not be used in the MRI suite.

WARNING: The NOxBOXi system is not intended for use in the vicinity of electrosurgical or diathermy devices.

Information: This device is designed for use with NO gas as approved under applicable law.

Consider the Following when Changing Cylinders: 

Compressed gas cylinders can be extremely hazardous when misused or abused and can present a variety of hazards due to their pressure and/or content.



Careful procedures are necessary for handling the various compressed gases, cylinders, regulators, or valves used to control gas flow.



Compressed gases should be handled only by experienced and properly instructed persons.



Cylinders should be stored in accordance with all local, state, and municipal regulations and in accordance with appropriate standards for example, those from the Compressed Gas Association and the National Fire Protection Association. Always follow the manufacturer’s label.

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

Gas cylinders must be secured at all times to prevent tipping. Use appropriate material, such as chains, plastic-coated wire cable, commercial straps, etc., to secure cylinders. Gas cylinders cannot be stored in public hallways or other unprotected areas.



Cylinders containing compressed gases should not be subjected to a temperature above 51°C / 124°F. Cylinders should not be subjected to artificially created low temperatures without approval of the supplier.



The gas cylinders should be stored where they will not fall over or be damaged by falling objects. Never store a cylinder in an elevated location, because a fall could seriously damage the valve or the cylinder. If a cylinder is dropped or knocked over, check to see that components are not damaged and that the system connection remain secure.



Handle the cylinder in a manner that will avoid jarring or dropping. Never drag, slide, or roll a cylinder; use a cylinder cart.



Do not use the valve cover to lift cylinders; they could be damaged and become unattached.



Never drop cylinders or permit them to strike against each other or against other surfaces violently.



Check the identity of the gas by reading the label or other markings on the cylinder before using. If the cylinder content is not identified by marking, return the cylinder to the supplier without using it. Do not rely on the colour of the cylinder for identification. Color-coding is not reliable because cylinder colours may vary with supplier.



Removable-type valve protective caps should remain in place until you are ready to withdraw the content.



Before using a cylinder, be sure it is properly secured to the trolley.



Do not operate any equipment with leaks.



Do not repair a cylinder leak or safety relief device leak. Do not ship any cylinders with leaks.



Open the valve slowly and only with the NOxBOX Ltd. regulator in place. Stand with the cylinder between yourself and the regulator (cylinder valve outlet facing away) when opening the cylinder valve.



Do not force connections that do not fit. Do not use an adaptor to connect a cylinder to the system.



Always hand-operate the valve and protection cap to loosen it; do not use a hammer to pry or wedge it open.



Avoid contact of oils, greases, flammables, and contaminates with the cylinders and valves.



Close the cylinder valve and release all pressure before removing the regulator from the cylinder.



Consider using the portable environmental monitors as appropriate.



Never attempt to repair or to alter cylinders, valves, or safety relief devices.



Keep the cylinder valve closed at all times, except when the cylinder is in active use.



For valves that are hard to open, or frozen because of corrosion, contact the supplier for instructions.

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2.1.1

Basic Hazards DANGER: Additional hazards may be associated with the gases that are used in your application and with your equipment. Determine which hazards you may encounter, and be prepared to appropriately handle them. Refer to the SDS that was supplied with the gases and all government regulations and industry safety standards (e.g., Compressed Gas Association).

2.1.2

Asphyxiation DANGER: Exposure to gases or vapours may cause asphyxiation. Proceed with caution and in accordance with the SDS.

Practically all gases can act as simple asphyxiates by displacing the natural oxygen in the air. To prevent serious personnel injury and possible death, provide adequate ventilation to the outside environment in areas where any process gas may accumulate. Consider the increased potential for asphyxiation when pressure testing or purging the equipment with nitrogen or other non-air gases.

2.1.3

Electrocution DANGER: Electric shock can kill. Use extreme caution if troubleshooting or servicing this equipment. Do NOT bypass safety interlocks. An electrocution hazard exists even after the equipment has been de-energized. Only qualified personnel working in compliance with all customer requirements and applicable federal/national, state/provincial, and local codes shall perform the electrical wiring.

Adhere to the following guidelines to help guard against possible electrocution: 

Tampering with, or unauthorized substitution of, components may adversely affect the safety of this equipment. Use only factory-approved components for repair.



Turn off the power before opening the equipment or before checking or replacing any component. Use tools designed for work on electrical equipment.



Carefully follow all Hazardous Work Permit (HWP) and lockout/tagout procedures for your facility.



Do not touch live electrical components inside the equipment; electric shock caused by voltage in the control circuits can kill.

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2.1.4

Pressure DANGER: Mishandling of pressurized process equipment or gas cylinders can result in death, serious injury, or property damage. Handle pressurized equipment and cylinders with extreme care and in accordance with the manufacturer’s instructions.

The contents of this equipment are under pressure. Sudden or uncontrolled release of pressurized gas can cause serious injury. The gases themselves or objects propelled by the gases may strike personnel at high speed or possibly cause a spark-induced fire. Avoid high-pressure hazards through careful inspection and proper handling of equipment and cylinders. The pressure-relief devices (for example: safety valves, bursting discs, etc.) supplied with this equipment for over-pressure protection must be maintained at regular intervals to ensure their proper operation. Be aware of the locations at which high-pressure gases exist and the precautions for operating or maintaining equipment that handles these gases.

2.1.5

Toxicity DANGER: Toxic gases can cause personnel injury or death through breathing, absorption through the skin, or swallowing. Provide adequate ventilation, appropriate personal protective equipment (PPE) and gas detection equipment.

This equipment contains toxic gases. Adequate ventilation of enclosed areas serves as the chief precaution against an accumulation of toxic gases. In addition, for highly toxic gases, install automatic devices to constantly monitor gas concentrations and set off alarms if the concentrations approach a danger point. NOxBOX Ltd. offers suitable gas detection alarms as system accessories. Precautions against skin or eye contact with toxic gases include a thorough knowledge of the dangers, training for all personnel handling such gases, the development of procedures and equipment for handling them, and the use of special protective clothing and equipment (such as self-contained breathing apparatus (SCBA), portable gas monitors, protective garments, gloves, and face shields).

2.1.6

Poisons DANGER: Poisonous gases can be fatal if inhaled, even in very small quantities. Provide adequate ventilation and appropriate personal protective equipment (PPE).

This equipment contains poisonous gases. The Threshold Limit Value (TLV) expressed as the Occupational Exposure Limit (OEL) for each gas refers, in general, to airborne concentrations at or below which nearly all workers may be repeatedly exposed without adverse effects. The TLV for the specialty gas used with this equipment are stated on the cylinder body labels and the SDS for the gas. Use this gas only in well-ventilated areas. Precautions against skin or eye contact with poisonous gases include a thorough knowledge of the dangers, training for all personnel handling such gases, the development of procedures and equipment for handling them, and the use of special protective clothing LAB639_EN (11) Issued: Mar 2018

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and equipment (such as self-contained breathing apparatus (SCBA), portable gas monitors, protective garments, gloves, and face shields).

2.2

Hazard Labels

On locations of the NOxBOXi system where hazards may occur, labels such as the one shown in Figure 21: Example Hazard Label: No Pushing, warn you of any potential dangers. Read these labels carefully, and be prepared to handle any hazardous situations that may arise. If the labels become worn or difficult to read, contact your NOxBOX Ltd. representative for replacement labels.

Figure 2-1: Example Hazard Label: No Pushing

2.3

Cleaning Precautions WARNING: Some cleaning agents or solvents can emit toxic fumes. Conduct all cleaning operations in a well-ventilated area. Even though many cleaning agents are not highly toxic, take appropriate precautions.

All new equipment, as well as used equipment that may have become contaminated during service, must be thoroughly cleaned. Any residue could contaminate the process gas and may constitute a safety hazard. Perform cleaning in accordance with applicable cleaning standards to ensure that the equipment has been safely prepared for the application for which it is to be used. Carefully inspect all cleaned parts. If any evidence of contamination is noted, clean the part again. NOxBOX Ltd. offers suitable instrument cleaning wipes as system accessories.

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2.4

Electromagnetic Immunity

The NOxBOXi system complies with the directive IEC60601-1-2 electromagnetic compatibility, but can be affected by cellular phones and by electromagnetic interference exceeding the levels specified in EN55011:2009 + A1:2010 Class B and FCC Part 15, Class A:2010. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the NOxBOXi system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

2.4.1

RFID Reader System Compatibility

The NOxBOXi system has been tested for environmental EMC compatibility with the EMC emissions of typical RFID reader systems. However, RFID systems in the vicinity of the NOxBOXi system should be operated at electric field strengths of no more than 28 V/m and no closer to the NOxBOXi system than 0.4 m.

2.4.2

EMC Test Criteria

During EMC testing, the NOxBOXi system did deliver the user selected NO dose and measured NO, O2, and NO2 concentrations according to the accuracy specifications in Section 3.2. Table 2-1: Guidance and Manufacturer’s Declaration: Electromagnetic Emissions & Immunity (IEC 60601-1-2) The NOxBOXi system is intended for use in the electromagnetic environment specified below. The customer or the user of the NOxBOXi system should ensure that it is used in such an environment.

Emissions Test Radiated Emissions EN55011:2009 + A1:2010 FCC Part 15

Conducted Emissions EN55011:2009 + A1:2010 FCC Part 15

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Compliance Level Class B (EN55011) Class A (FCC)

Class B (EN55011) Class A (FCC)

Electromagnetic Environment Guidance The NOxBOXi system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The NOxBOXi system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

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Table 2-1: Guidance and Manufacturer’s Declaration: Electromagnetic Emissions & Immunity (IEC 60601-1-2) The NOxBOXi system is intended for use in the electromagnetic environment specified below. The customer or the user of the NOxBOXi system should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 8 kV contact ± 15 kV air ± 8 kV indirect

± 8 kV contact ± 15 kV air ± 8 kV indirect

The floor should be wood, concrete, or ceramic tile. If the floors are covered with synthetic material, the relative humidity should be at least 30 percent.

Electrical fast transient/ burst IEC 61000-4-4

± 2 kV for power supply lines

± 2 kV for power supply lines

Mains power quality should be that of a typical hospital environment.

Surge IEC 61000-4-5

± 1 kV line to line ± 2 kV line to earth

± 1 kV line to line ± 2 kV line to earth

Mains power quality should be that of a typical hospital environment.

Voltage dips, short interruptions and voltage variations on power supply. IEC 61000-4-11

< 5 % UT (> 95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30% dip in UT) for 25 cycles < 5 % UT (95 % dip in UT) for 5 seconds

Met or exceeded.

Mains power quality should be that of a typical hospital environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in a hospital environment.

Power frequency (50/60 Hz) Magnetic field IEC 61000-4-8

30 A/m

30 A/m

Conducted RF IEC 61000-4-6

150 kHz – 80 MHz 3Vrms outside ISM bands* 150 kHz – 80 MHz 6Vrms in ISM bands*

Met or exceeded.

Radiated RF IEC 61000-4-3

80 MHz – 2.7 GHz 10 V/m 380 – 390 MHz 27 V/m 430 – 470 MHz 28 V/m 704 – 787 MHz 9 V/m 800 – 960 MHz 28 V/m 1,700 – 1,990 MHz 28 V/m 2,400 – 2,570 MHz 28 V/m 5,100 – 5,800 MHz 9 V/m

80 MHz – 2.7 GHz 10 V/m 380 – 390 MHz 27 V/m 430 – 470 MHz 28 V/m 704 – 787 MHz 9 V/m 800 – 960 MHz 28 V/m 1,700 – 1,990 MHz 28 V/m 2,400 – 2,570 MHz 28 V/m 5,100 – 5,800 MHz 9 V/m

Radiated RF AIM RFID: 2016-08-22

125 kHz 65 A/m RMS 134.2 kHz 65 A/m RMS 13.56 MHz 12 A/m RMS

125 kHz 65 A/m RMS 134.2 kHz 65 A/m RMS 13.56 MHz 12 A/m RMS

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Portable and mobile RF communications equipment should be used no closer to any part of the NOxBOXi system (including cables) than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Interference may occur in the vicinity of equipment marked with the following symbol:

LAB639_EN (11) Issued: Mar 2018

®

NOxBOXi & NOxMixer™ User’s Manual and Technical Guide: Issue 11.0, Version 18.X

Table 2-1: Guidance and Manufacturer’s Declaration: Electromagnetic Emissions & Immunity (IEC 60601-1-2) NOTE 1: UT is the A.C. mains voltage before application of the test level. NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 Is used in calculating the recommended separation distance for transmitters in these frequency ranges. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the NOxBOXi system is used exceeds the applicable RF compliance level above, the NOxBOXi system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NOxBOXi system. Over the frequency ranges 150 kHz to 80 MHz, field strength should be less than 3 V/m.

2.5

Network Connections

The NOxBOXi system is not to be connected to a network. The NOxBOXi system is provided with a USB port. This is solely for the purpose of downloading system logs for record and analysis by a suitably qualified Systems Engineer.

2.6

Applied Parts

The NOxBOXi system has no applied parts. However, the NOxFLOW Sensor and Sample Line are treated as applied parts (apart from labelling requirements) as per BS EN 60601-1:2006 Section 4.5.

2.7

Isolation from Mains Power WARNING: Operators should not contact the patient while simultaneously being in contact with the NOxBOXi® system.

System shutdown is covered in section 6.9, System Shutdown. In order to isolate the system from the mains power, unplug the Mains Power Supply and position the system so that this can be easily accomplished.

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NOxBOXi & NOxMixer™ User’s Manual and Technical Guide: Issue 11.0, Version 18.X

3

EQUIPMENT DESCRIPTION

3.1

Usage Guidelines

3.1.1

Typical Use

The NOxBOX, Ltd. NOxBOXi® Intelligent Nitric Oxide Delivery and Monitoring System controls delivery of nitric oxide (NO) gas into the ventilator inspiratory limb of the patient breathing circuit to provide a consistent NO dose concentration in the inspired breath to the patient, as set by the user, for the purposes of inhaled Nitric Oxide (iNO) therapy. The NOxBOXi system is designed to be compatible with most ventilator models, using the NOxFLOW inline flow detection module to enable precise synchronized proportional NO delivery into the inspiratory limb. To ensure patient safety, the NOxBOXi system provides continuous monitoring of the inhalant sample, analysing NO, oxygen (O2) and nitrogen dioxide (NO2) levels throughout treatment. It is also equipped with a full suite of alarms. The NOxBOXi system has an emergency override failsafe circuit for continuous application of NO. Refer to the NOxMixer system Main Specifications table (see Table 3-2). The NOxBOXi system has a simple delivery calculator and a set of look-up tables to enable best flow selection. The NOxMixer system allows the blending of NO and oxygen, as per the requirements, by making use of the oxygen flowmeter, as well as the needle valve. For transport and transfer conditions, the NOxBOXi system has a rechargeable internal battery that provides over 4 hours1 of use from full charge when no mains power source is available. The scope of patient treatment is defined and controlled by the NO drug labelling. The primary intended clinical setting is the Intensive Care Unit (ICU), with a secondary intended clinical setting for the transport of ICU patients. Information: Always handle and store nitric oxide mixtures in accordance with federal/national, state/provincial, and local codes and regulations.

WARNING: If an alarm triggers on the NOxBOXi system, first take measures to protect the patient before troubleshooting or repairing of the device.

WARNING: The NOxBOXi system is only intended for application of iNO therapy in combination with air and oxygen mixtures.

1

With no alarm conditions.

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