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`Technical Guide: Issue 6.0 September 2015
`(Software V.17.1)
`
`saving lives, one breath at a time
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`www.bedfont.com
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`1
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`Ex. 2024-0001
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`CONTENTS
`1 User Responsibility .............................................................................................................................................................. 5
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`2 Safety ................................................................................................................................................................................... 5
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`2.1
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`Basic Safety Recommendations ............................................................................................................................. 6
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`Basic Hazards ................................................................................................................................................................... 7
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`2.1.1 Asphyxiation........................................................................................................................................................... 7
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`2.1.2 Electrocution .......................................................................................................................................................... 7
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`Pressure ........................................................................................................................................................................... 7
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`2.1.3 Toxicity ................................................................................................................................................................... 7
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`2.1.4 Poisons ................................................................................................................................................................... 8
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`2.2
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`2.3
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`2.4
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`2.5
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`2.6
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`2.7
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`Hazard Labels .............................................................................................................................................................. 8
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`Cleaning Precautions .................................................................................................................................................. 8
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`Electromagnetic Immunity ......................................................................................................................................... 9
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`Network Connections ............................................................................................................................................... 10
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`Applied Parts ............................................................................................................................................................ 10
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`Isolation From Mains ................................................................................................................................................ 10
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`3
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`Equipment Description ................................................................................................................................................. 10
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`3.1
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`3.2
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`Intended Use ........................................................................................................................................................ 11
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`Specification And Environment ........................................................................................................................... 12
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`3.3 Abreviations, Definitions And Icons ........................................................................................................................... 14
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`3.3.1 Abreviations ......................................................................................................................................................... 14
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`3.3.2 Definitions ............................................................................................................................................................ 14
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`3.3.3 Icons Overview ..................................................................................................................................................... 14
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`3.3.4 Rear Label Symbols .............................................................................................................................................. 14
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`3.3.5 Front Label Symbols ............................................................................................................................................. 15
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`3.3.6 Power Supply Symbols ......................................................................................................................................... 15
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`3.3.7 Accessory Label Symbols ..................................................................................................................................... 15
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`3.3.8 Manual Override Flow Selector Valve Markings ................................................................................................ 15
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`3.4 System Components ................................................................................................................................................... 15
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`3.4.1 Noxboxi System Features ..................................................................................................................................... 16
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`3.5 Noxboxi Effect On Ventilator Circuit .......................................................................................................................... 17
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`3.5.1 Oxygen Dilution.................................................................................................................................................... 17
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`3.5.2 Measured Minute Volume ................................................................................................................................... 18
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`2
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`Ex. 2024-0002
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`3.5.3 Trigger Sensitivity ............................................................................................................................................... .. 18
`3.5.3 Trigger Sensitivity ................................................................................................................................................. 18
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`3.5.4 Maximum No Dose Delivery ................................................................................................................................ 18
`3.5.4 Maximum No Dose Delivery .............................................................................................................................. .. 18
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`4 Installation ....................................................................................................................................................................... .. 19
`4 Installation ......................................................................................................................................................................... 19
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`4.1 Unpacking Instructions ............................................................................................................................................... 19
`4.1 Unpacking Instructions ............................................................................................................................................. .. 19
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`4.2 Assemble Delivery Unit To Trolley ............................................................................................................................. 19
`4.2 Assemble Delivery Unit To Trolley ........................................................................................................................... .. 19
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`4.3 Setup Instructions ..................................................................................................................................................... .. 21
`4.3 Setup Instructions ....................................................................................................................................................... 21
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`4.4 Connecting No Gas Cylinders ..................................................................................................................................... 23
`4.4 Connecting No Gas Cylinders ................................................................................................................................... .. 23
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`4.5 System Test Setup ..................................................................................................................................................... .. 26
`4.5 System Test Setup ....................................................................................................................................................... 26
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`5 Patient Circuit Setup ........................................................................................................................................................ .. 30
`5 Patient Circuit Setup .......................................................................................................................................................... 30
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`5.1 Noxflow ..................................................................................................................................................................... .. 30
`5.1 Noxflow ....................................................................................................................................................................... 30
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`5.2 System Test Circuit ..................................................................................................................................................... 30
`5.2 System Test Circuit ................................................................................................................................................... .. 30
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`5.3 Vent Circuit (Example 1) ............................................................................................................................................. 31
`5.3 Vent Circuit (Example 1) ........................................................................................................................................... .. 31
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`5.4 Vent Circuit (Example 2) ............................................................................................................................................. 32
`5.4 Vent Circuit (Example 2) ........................................................................................................................................... .. 32
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`5.5 Manual Bagging & Emergency Backup....................................................................................................................... 32
`5.5 Manual Bagging & Emergency Backup ..................................................................................................................... .. 32
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`5.5.1 Setup ................................................................................................................................................................... .. 32
`5.5.1 Setup ..................................................................................................................................................................... 32
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`5.5.2 Emergency Backup ............................................................................................................................................... 33
`5.5.2 Emergency Backup ............................................................................................................................................. .. 33
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`5.5.3 Self-Inflating ......................................................................................................................................................... 34
`5.5.3 Self-lnflating ....................................................................................................................................................... .. 3
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`5.5.4 Hyper Inflation ..................................................................................................................................................... 34
`5.5.4 Hyper Inflation ................................................................................................................................................... .. 3
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`5.5.5 Neopuff Resuscitator ........................................................................................................................................... 35
`5.5.5 Neopuff Resuscitator ......................................................................................................................................... .. 35
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`6 Operation ........................................................................................................................................................................... 35
`6 Operation ......................................................................................................................................................................... .. 35
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`6.1 Gas Delivery System ................................................................................................................................................... 36
`6.1 Gas Delivery System ................................................................................................................................................. .. 36
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`6.2 Monitoring System ................................................................................................................................................... .. 37
`6.2 Monitoring System ..................................................................................................................................................... 37
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`6.3 Touch Screen Interface ............................................................................................................................................. .. 37
`6.3 Touch Screen Interface ............................................................................................................................................... 37
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`6.3.1 Brief Navigation Guide ......................................................................................................................................... 37
`6.3.1 Brief Navigation Guide ....................................................................................................................................... .. 37
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`6.3.2 On-Screen User Guide ........................................................................................................................................ .. 38
`6.3.2 On-Screen User Guide .......................................................................................................................................... 38
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`6.4 System Tests ............................................................................................................................................................. .. 40
`6.4 System Tests ............................................................................................................................................................... 40
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`6.5 Connecting To Patient Ventilator ............................................................................................................................... 41
`6.5 Connecting To Patient Ventilator ............................................................................................................................. .. 41
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`6.6 Dose Entry And Alrm Setting ...................................................................................................................................... 41
`6.6 Dose Entry And Alrm Setting .................................................................................................................................... .. 41
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`6.7 Main Screen Display ................................................................................................................................................... 44
`6.7 Main Screen Display ................................................................................................................................................. ..4
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`6.7.1 Detailed Areas Of Main Screen .......................................................................................................................... .. 4
`6.7.1 Detailed Areas Of Main Screen............................................................................................................................ 44
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`6.7.2 Tabbed Navigation ............................................................................................................................................... 45
`6.7.2 Tabbed Navigation ............................................................................................................................................. .. 45
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`6.7.3 Change Dose And Alarms ..................................................................................................................................... 46
`6.7.3 Change Dose And Alarms ................................................................................................................................... .. 46
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`6.7.4 Standby Mode ...................................................................................................................................................... 47
`6.7.4 Standby Mode .................................................................................................................................................... .. 47
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`3
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`Ex. 2024-0003
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`6.8 Screen Loc
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`6.8 Screen Lock ................................................................................................................................................................. 48
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`6.8.1 Setting The Screen Lock Format .......................................................................................................................... 49
`6.8.1 Setting The Screen Lock Format ........................................................................................................................ .. 49
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`6.9 Alarms ....................................................................................................................................................................... .. 49
`6.9 Alarms ......................................................................................................................................................................... 49
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`6.9.1 Red Banner Alarms ............................................................................................................................................ .. 50
`6.9.1 Red Banner Alarms .............................................................................................................................................. 50
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`6.9.2 Gas Supply Alarms ............................................................................................................................................... 52
`6.9.2 Gas Supply Alarms ............................................................................................................................................. .. 52
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`6.9.3 Calibration Overdue ........................................................................................................................................... .. 52
`6.9.3 Calibration Overdue ............................................................................................................................................. 52
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`6.9.4 Other Alarms And System Alerts ......................................................................................................................... 53
`6.9.4 Other Alarms And System Alerts ....................................................................................................................... .. 53
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`6.10 Zero Calibration During Delivery .............................................................................................................................. 54
`6.10 Zero Calibration During Delivery ............................................................................................................................ .. 5
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`6.11 User Settings Screen ............................................................................................................................................... .. 56
`6.11 User Settings Screen ................................................................................................................................................. 56
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`6.12 Manual Override – Manual Bagging And Emergency Backup ................................................................................. 57
`6.12 Manual Override — Manual Bagging And Emergency Backup ............................................................................... .. 57
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`6.12.1 Determine Correct Flow Setting ........................................................................................................................ 58
`6.12.1 Determine Correct Flow Setting ...................................................................................................................... .. 58
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`6.12.2 Using The Printed Look-Up Tables..................................................................................................................... 59
`6.12.2 Using The Printed Look-Up Tables ................................................................................................................... .. 59
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`6.12.3 Engage Manual Override – Manual Bagging And Emergency Backup ............................................................. 59
`6.12.3 Engage Manual Override — Manual Bagging And Emergency Backup ........................................................... .. 59
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`6.12.4 Manual Override Flow Selector: Approximate No Flow Values ....................................................................... 60
`6.12.4 Manual Override Flow Selector: Approximate No Flow Values ..................................................................... .. 60
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`6.13 Shutdown ................................................................................................................................................................ .. 60
`6.13 Shutdown .................................................................................................................................................................. 60
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`7 Maintenance And Repair .................................................................................................................................................. 62
`7 Maintenance And Repair ................................................................................................................................................ .. 62
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`7.1 Periodic Maintenance ............................................................................................................................................... .. 63
`7.1 Periodic Maintenance ................................................................................................................................................. 63
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`7.2 System Settings ........................................................................................................................................................... 63
`7.2 System Settings ......................................................................................................................................................... .. 63
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`7.3 Cleaning The Noxboxi System .................................................................................................................................... 63
`7.3 Cleaning The Noxboxi System .................................................................................................................................. .. 63
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`7.4 Calibration ................................................................................................................................................................. .. 6
`7.4 Calibration ................................................................................................................................................................... 64
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`7.5 System Replacement Parts ......................................................................................................................................... 65
`7.5 System Replacement Parts ....................................................................................................................................... .. 65
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`7.6 Disposable System Accessories .................................................................................................................................. 66
`7.6 Disposable System Accessories ................................................................................................................................ .. 66
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`7.7 Warranty ................................................................................................................................................................... .. 68
`7.7 Warranty ..................................................................................................................................................................... 68
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`8 Alarms Troubleshooting .................................................................................................................................................... 69
`8 Alarms Troubleshooting .................................................................................................................................................. .. 69
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`8.1 Alarm Priorities ......................................................................................................................................................... .. 69
`8.1 Alarm Priorities ........................................................................................................................................................... 69
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`8.2 Notifications At Switch On ....................................................................................................................................... .. 69
`8.2 Notifications At Switch On ......................................................................................................................................... 69
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`8.3 Alarm Priority – Alarms During Therapy .................................................................................................................... 70
`8.3 Alarm Priority — Alarms During Therapy .................................................................................................................. .. 70
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`8.4 General Troubleshooting ............................................................................................................................................ 74
`8.4 General Troubleshooting .......................................................................................................................................... .. 7
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`8.5 Noxmixer ................................................................................................................................................................... .. 75
`8.5 Noxmixer ..................................................................................................................................................................... 75
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`9 Ventilator Management .................................................................................................................................................... 76
`9 Ventilator Management .................................................................................................................................................. .. 76
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`9.1 Ventilator Compatibility List ...................................................................................................................................... 76
`9.1 Ventilator Compatibility List .................................................................................................................................... .. 76
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`4
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`Ex. 2024-0004
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`1 USER RESPONSIBILITY
`The NOxBOXi product will perform in accordance with the description detailed in this document and accompanying
`guides and/or labels when assembled, operated, stored, maintained and repaired in accordance with the instructions
`provided.
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`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.
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`In the event of the product requiring repair or replacement, it is recommended that the customer first contacts their
`distributor or technical support service for the NOxBOXi. It is essential that only approved components are used to
`replace or repair any part of the NOxBOXi, in accordance with the manufacturer’s written instructions. The product must
`not be altered without prior written approval from the Technical Support department of Bedfont Scientific Ltd.
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`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 Bedfont, Bedfont will not be liable for
`any incident which may occur as a result of this. This may also invalidate your warranty.
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`The product user bears sole responsibility for any malfunction resulting from improper use, faulty maintenance,
`improper repair, damage or unauthorized alteration by any source not authorized to do so by Bedfont Scientific Ltd.
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`Throughout this document, there are highlighted areas containing information, warnings or danger notifications:
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`Information: Statement contains important information highlighted for user awareness.
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`Caution: Statement contains information alerts that could help avert a problem occurring.
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`Warning: Statement contains important information that may affect the safety of user and/or patient if
`manual instructions are not followed.
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`Danger: Statement contains important information that has direct bearing on the safety of user and/or
`patient if manual instructions are not followed.
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`WARNING: Do not modify this equipment without authorisation of the manufacturer.
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`WARNING: Read and understand this manual including any inserts/ amendments prior to using the
`NOxBOXi. 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.
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`5
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`2 SAFETY
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`Ex. 2024-0005
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`WARNING: To avoid serious injury, pay attention to all precautionary labels attached to equipment,
`cylinders, containers, and boxes prior to 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
`Bedfont representative.
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`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 Material Safety Data Sheets (MSDS) 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 MSDSs and all government and facility safety regulations.
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`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, evacuate the affected area immediately. Do not
`re-enter the area until safe conditions are restored.
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` Ventilate working areas- Prevent any leaking gases from accumulating. Vent all gases to the outside to 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.
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` Prevent injury- Wear safety glasses and other appropriate PPE when the MSDS, task, or code dictates. Ensure
`that all tools and instruments used are in good condition. Be aware that high-velocity gas may be released at
`vents and safety relief valves
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` Maintain safety devices- Check all safety devices a