User Manual
131 Pages
Preview
Page 1
SOKINOX™
User Manual English V1.6 V1.6.I3
YL180178
YL180178 - Revision 3 - 2023-12
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Contents Terms and definitions... 7 Introduction... 9 General description of the main unit...9 Intended use...10 Intended user...10 Intended use environment...11 Possible side-effects... 11 Contraindications...11 Clinical benefits... 11 User Manual...11 Accessories: brief description and intended purpose... 12 General safety guidelines...16 General warnings and precautions... 16 Power supply... 18 Battery...18 Fire hazard...18 Auxiliary equipment... 18 Electromagnetic compatibility (EMC)... 19
System overview...20 Theory of operation...20 NO gas supply...20 Purging...20 Gas administration...21 Emergency dosing... 22 Gas analysis...22 Graphical user interface...23 Power management... 23 Backup NO therapy system... 23 System parts...25 Base unit...25 Mounting the base unit on the mobile cart... 28 Bedside and rail holder...28 Gas flow through the base unit...29 Symbols on base unit...30 Symbols on accessories or packaging...32 Touchscreen display... 34 Transport...41 Before intrahospital transport... 41 During intrahospital transport... 41
Patient application... 42 Attaching NO cylinders and regulators... 42 Mounting cylinder and regulator...42 Dismounting cylinder and regulator...44
Before startup...46 Startup and Pre-Use Check ... 47 General... 47 Start Pre-Use Check... 47 Complete Pre-Use Check... 49 Pre-Use Check expired...50 Purging and flushing procedures...51 Running on battery...52 Connect to patient circuit... 52 Conventional ventilators... 54 Bunnell LifePulse 203... 56 Fisher & Paykel Bubble CPAP...58 Optiflow High Flow Therapy... 59 Optiflow High Flow Therapy - Adult... 60 Sensormedics 3100A...61 Viasys Infant Flow SiPAP... 63 Set treatment parameters... 65 Set alarm limits...66 Autoset alarm limits...67 Default alarm settings...67 Set alarm sound level...68 Start treatment...68 Automatic gas cylinder switch... 69 Replacing an empty cylinder... 69 Aerosol delivery...69 Stop treatment... 71 Other functions... 71 Gas sensor offset adjustment (low calibration)... 71 Calculate remaining gas supply...72 Manual NO cylinder switch...73 Ambient air monitoring... 73 View logs...74 View status information... 74 Using the Backup NO delivery system... 75 Activating the backup system... 76 Turning off...77
Alarms and alarm handling...78 General... 78 Handling alarms...78 Alarm indication...78 Viewing active alarms... 79 Responding to alarms... 80 Silencing alarms until next activation...80 Extended Audio Pause... 81 Pre-silencing alarms...81 Resetting Check Alarms...81 Alarm and information messages...82 High priority alarms... 82 High priority alarms with buzzer sound... 87 Medium priority alarms...88 Low priority alarms... 89
Current messages...89
Cleaning and maintenance... 91 Introduction... 91 General... 91 Reprocessing...91 Single use items... 91 Safety guidelines... 91 Cleaning and disinfection procedure... 92 Preparations before cleaning... 92 Cleaning... 92 Disinfection... 93 Assembling and Pre-Use Check... 93 Preventive maintenance...93 Battery maintenance...94 Gas sensor calibration... 94
Service & Settings...95 Introduction... 95 Biomed... 95 Status... 95 Logs... 96 Configuration...97 Full calibration (high and low)... 99 Software installation... 101 Service...101
Compatibility...102 Validated respiratory devices... 102 Recommended settings for validated respiratory devices...102 Impact of system on validated respiratory devices... 103 Compatible resuscitators... 106
Technical data...107 System - general...107 General technical data... 107 Dimensions, weights and loads... 108 Operating conditions...108 Transport and storage conditions...108 Power supply... 109 Patient system connectors...109 Gas supply... 110 NO gas regulator specifications... 111 Information on NO gas cylinder pressures, symbols and alarms... 112 Parts and accessories...113 Electromagnetic compatibility...115 Electromagnetic environment...115 Cables... 115 Electromagnetic compliance... 116 Emission...116 Immunity... 116 Maintenance...118
Standard condition specification... 118 Primary delivery system for NO gas... 119 Backup delivery system for NO gas... 120 Data on delivered NO concentrations... 120 Monitoring... 121 General monitoring information... 121 Gas analyzer for NO... 121 Gas analyzer for NO2...122 Gas analyzer for O2... 122 Alarms... 123 Alarm limit settings...123 Autoset alarm limits...123 Alarms miscellaneous...124 Gas concentration alarms... 124 Pre-silencing... 125 Silencing until next activation... 125 Extended Audio Pause... 125 Trends and logs... 125 Communication/interface...126 Health and environment... 127 EU regulation 2017/745 (MDR)...127 Exposure to gases...127 Technical description...128
1 Terms and definitions
1 Terms and definitions Term
Definition
EMC
Electromagnetic compatibility
ESD
Electrostatic discharge
FiO2
Fraction of inspired oxygen
GUI
Graphical user interface
HFOV
High Frequency Oscillatory Ventilation
HME
Heat and moisture exchanger
HNO3
Nitric acid
iNO
Inhaled nitric oxide
LpA
A-weighted sound pressure level
LwA
A-weighted sound power level
ME
Medical electrical
MRI
Magnetic resonance imaging
NCPAP
Nasal Continuous Positive Airway Pressure
NO
Nitric oxide
NO2
Nitrogen dioxide
N2
Nitrogen
N2O
Nitrous oxide
O2
Oxygen
PDMS
Patient data management system
PUC
Pre-use check
REACH
Registration, evaluation, authorisation and restriction of chemicals. Europe‐ an Union regulation EC/2006/1907. 7
SoKINOX NO Delivery and Monitoring System - User Manual
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Term
Definition
Responsible organiza‐ tion
Entity accountable for the use and maintenance of a medical equipment or system.
SpO2
Peripheral oxygen saturation
SVHC
Substance of very high concern
2 Introduction
2 Introduction
2.1 General description of the main unit
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The SoKINOX™ NO Delivery and Monitoring System consists of: 1. a base unit (this includes both the primary NO delivery system and the backup NO delivery system) 2. a mobile cart or/and 3. a bedside/rail holder 4. other accessories and disposables (not shown in figure) Refer to Parts and accessories on page 113 for information concerning accessories and other parts used with the SoKINOX NO Delivery and Monitoring System. A brief description of each accessory and its intended purpose is available in section Accessories: brief description and intended purpose on page 12. Make sure that the SoKINOX NO Delivery and Monitoring System is compatible with the ventilator you use. A list of compatible respiratory devices is available in the addendum to this manual: Addendum to the User Manual, SoKINOX NO Delivery and Monitoring System.
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SoKINOX NO Delivery and Monitoring System - User Manual The SoKINOX NO Delivery and Monitoring System operates within its specifications for the following respiratory settings: Minute volume
Up to 40 l/min
Respiratory rate
6 to 80 breaths/min
Airway peak pressure
5 to 70 cmH2O
PEEP
0 to 20 cmH2O
Bias flow
0.5 to 40 l/min
Maximum inspiratory peak flow
120 l/min
Tidal volume
10 to 800 ml
The table is only applicable for conventional ventilation. Note: •
•
iNOsystems has no responsibility for the safe operation of the SoKINOX NO Delivery and Monitoring System if the information specified in Intended use on page 10 is not followed. The operator should always evaluate the particular location in which the SoKINOX NO Delivery and Monitoring System is used with regard to ventilation and potential exposure to ambient NO and NO2 gas. Refer to section Exposure to gases on page 127.
2.1.1 Intended use The SoKINOX NO Delivery and Monitoring System delivers physician-prescribed NO therapy gas to patients ranging from neonates to adults and monitors inspired NO, NO2 and O2 gas. The target patient population and use of the SoKINOX NO Delivery and Monitoring System are control‐ led by the therapy gas labeling. The SoKINOX NO Delivery and Monitoring System can be used with ventilation devices. Compatible ventilators are listed in the addendum to this manual: Addendum to the User Manual, SoKINOX NO Delivery and Monitoring System. In backup mode, the system can be operated as a stand-alone system.
2.1.2 Intended user The SoKINOX NO Delivery and Monitoring System must be used only by trained professional health‐ care providers who have ventilation and iNO therapy knowledge. Warning: Persons using the SoKINOX NO Delivery and Monitoring System should be trained and experienced in its use to ensure effective administration of nitric oxide and to avoid injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide or other reaction products.
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2 Introduction
2.1.3 Intended use environment Warning: The SoKINOX NO Delivery and Monitoring System must not be used in an MRI environment. The SoKINOX NO Delivery and Monitoring System must be used only: • •
in hospitals, except MRI environments, during transport of a patient within hospitals.
2.1.4 Possible side-effects The following side-effect can occur from inhaled NO gas delivery: •
Withdrawal (rebound pulmonary hypertension)
Possible side-effects of the inhaled NO gas therapy are further described in the NO gas labeling and patient leaflet.
2.1.5 Contraindications No contraindications are identified for the use of SoKINOX NO Delivery and Monitoring System. Contraindications are identified for the use of nitric oxide, which is described in the NO gas labeling and patient leaflet.
2.1.6 Clinical benefits The following clinical benefit is identified: •
SoKINOX NO Delivery and Monitoring System enables iNO-treatment.
2.1.7 User Manual This manual summarizes the functions and safety features of the SoKINOX NO Delivery and Monitor‐ ing System. It is not all-inclusive and should not be seen as a substitute for training. The SoKINOX NO Delivery and Monitoring System is referred to as "the system" in this manual.
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SoKINOX NO Delivery and Monitoring System - User Manual
2.2 Accessories: brief description and intended purpose Accessory
Brief product descrip‐ tion
Intended use
Intended user
Intended use environ‐ ment
Low Flow Sensor
These accessories are used together with the medical device “NO de‐ livery and monitoring system”. Their role is to collect ventilation flow data and allow NO injection. They are made out of plastic.
These accessories are intended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. These accesso‐ ries are for single use only.
These accessories must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
These accessories are only used together with the medical de‐ vice “NO delivery and monitoring system”.
These accessories are used together with the medical device “NO de‐ livery and monitoring system”. They adapt to the circuit and are lo‐ cated between the Tconnector and Y-piece to carry the NO gas pa‐ tient tube (inspiratory). They are made out of plastic.
These accessories are intended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. These accesso‐ ries are for single use only.
These accessories must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
These accessories are only used together with the medical de‐ vice “NO delivery and monitoring system”.
These accessories are used together with the medical device “NO de‐ livery and monitoring system”. Their role is to adapt to the circuit. They are located on both sides of the flow sensor to adapt to the tube size. They are made out of plastic.
These accessories are intended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. These accesso‐ ries are for single use only.
These accessories must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
These accessories are only used together with the medical de‐ vice “NO delivery and monitoring system”.
ETT connector
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. It is located between the adapter from main device and the flow sensor adapt‐ er. It is used with the iNO patient kit Bunnell. It is made out of plas‐ tic.
This accessory is in‐ tended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
One-way valve
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. It is located between the ventilator and the flow sensor. It is used with the iNO patient kit Bunnell. Its role is to prevent water from backing up into the flow sensor. It is made out of plastic.
This accessory is in‐ tended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
High Flow Sensor
Additional NO patient tube, 10 mm (Hytrel) Additional NO patient tube, 15 mm (Hytrel) Additional NO patient tube, 22 mm (Hytrel)
Adapter, 15F/15F Adapter, 22F/22F
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2 Introduction Accessory
Brief product descrip‐ tion
Intended use
Intended user
Intended use environ‐ ment
Sampling T-connector, 15 mm
These accessories are used together with the medical device “NO de‐ livery and monitoring system”. Their role is to permit connection facing upwards with the sampling line, to avoid moisture accu‐ mulation in the sam‐ pling line. They are made out of plastic.
These accessories are intended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. These accesso‐ ries are for single use only.
These accessories must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
These accessories are only used together with the medical de‐ vice “NO delivery and monitoring system”.
Luer elbow
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. It is used with the iNO Patient kit Sen‐ sormedics. Its role is to allow the connec‐ tion between inspirato‐ ry branch and water trap (sampling line). It is made out of plastic.
This accessory is in‐ tended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
Bunnell sampling Tconnector
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. It is used with the iNO patient kit Bunnell. Its role is to allow the connec‐ tion between inspirato‐ ry branch and water trap (sampling line). It is made out of plastic.
This accessory is in‐ tended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
NO gas hose
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. The NO gas hose is used for con‐ nection to the gas reg‐ ulator on the NO gas cylinder. The hose is made out of plastic and its connection fit‐ tings are in metal.
This accessory is in‐ tended for the deliv‐ ery of gases during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
Sampling line
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. The sampling line collects gas in‐ haled by the patient and is connected via a sampling T-connec‐ tor / Luer elbow to the breathing circuit. It is made out of plastic.
This accessory is in‐ tended for sampling the inhaled gas during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
Sampling T-connector, 22 mm
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SoKINOX NO Delivery and Monitoring System - User Manual
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Accessory
Brief product descrip‐ tion
Intended use
Intended user
Intended use environ‐ ment
Sampling flow restric‐ tor
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. The sampling flow restrictor adapts the sampling flow to the accepted range of values. It is mounted between the water trap and the gas sampling line connector. It is made out of plastic.
This accessory is in‐ tended for sampling the inhaled gas during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
Nebulization filter
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. The nebuli‐ zation filter prevents nebulized drugs from clogging in the water trap and device. It is mounted between the water trap and the gas sampling line connec‐ tor. It is made out of plastic.
This accessory is in‐ tended for sampling the inhaled gas during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
Water trap
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. The water trap protects the side stream gas analyzers integrated in the device against water, dust and bacterial contami‐ nation. It is mounted on the device at one end of the sampling line. It is made out of plastic.
This accessory is in‐ tended for sampling the inhaled gas during iNO therapy with So‐ KINOX/Monnal iNO de‐ vice. This accessory is for single use only.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
Bed rail holder
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. It makes it possible to mount the base unit device ei‐ ther to a Post (verti‐ cal) or onto a Rail (horizontal). It consists of a PRC (Post Rail Clamp) mounted on a 100x100mm metal plate.
This accessory is in‐ tended for supporting the SoKINOX/Monnal iNO device during iNO therapy.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
2 Introduction Accessory
Brief product descrip‐ tion
Intended use
Intended user
Intended use environ‐ ment
Mobile cart
This accessory is used together with the med‐ ical device “NO deliv‐ ery and monitoring system”. It holds the device, all needed cyl‐ inders, when used at the bedside of a pa‐ tient. The wheels ena‐ ble mobility, and the NO delivery and moni‐ toring device on a mo‐ bile cart can be used in patient transport within the hospital. It is made out of metal.
This accessory is in‐ tended for supporting the SoKINOX/Monnal iNO device during iNO therapy.
This accessory must be used only by trained professional healthcare providers who have ventilation and iNO therapy knowl‐ edge.
This accessory is only used together with the medical device “NO de‐ livery and monitoring system”.
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SoKINOX NO Delivery and Monitoring System - User Manual
2.3 General safety guidelines Follow these general safety guidelines. Specific warnings are distributed across the various sections in this manual. Information is highlighted with Warning, Caution or Note, where: Warning: Indicates critical information about a potential serious outcome to the patient or the user. Caution: Indicates instructions that must be followed in order to: • •
avoid minor or moderate injury to the user or patient, avoid damage to the equipment or other property.
Note: Indicates information requiring special attention.
2.3.1 General warnings and precautions Warning: • • •
• • • •
•
• • • • •
•
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Check the system for damage. If the system is damaged, it should not be used. Always perform a Pre-Use Check before connecting the system to the patient. Only use the system if the Pre-Use Check is successfully passed. Do not use with closed circle anesthesia systems. The recirculation of expired gases may cause NO2 intoxication, NO overdosing or hypoxia. N2O and other volatile agents may also affect NO monitoring. To avoid the risk of electric shock, only connect this equipment to a supply mains with protective earth. Do not connect a multiple-socket outlet or extension cord to the Medical Electrical (ME) system. Only connect items that have been specified as part of the ME system or that have been specified as being compatible with the ME system. 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. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. No modification of this equipment is allowed. Service, repair and installation may only be performed by authorized personnel. The O2 cell and the NO and NO2 gas sensors are to be replaced once a year by an authorized representative. Do not use a Heat and Moisture Exchanger (HME) device containing cellulose together with iNO therapy. 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 SoKINOX NO Delivery and Monitoring System including cables specified by the manufacturer. Otherwise degradation of this equipment could result. The backup system is ineffective for HFOV patients. Make sure that alternative backup solutions are available for these patients.
2 Introduction •
• •
Only accessories, supplies, and auxiliary equipment recommended by iNOsystems should be used with the system. Use of any other accessories, spare parts or auxiliary equipment may cause degraded system performance and safety issues. Refer to Parts and accessories on page 113 for information concerning accessories and other parts used with the SoKINOX NO Delivery and Monitoring System. Do not modify or remove any original parts. If any of the following occurs, discontinue use and contact a service technician: • • • •
Unresolvable alarms Unfamiliar sounds Any unfamiliar or unexplained event System messages that prompt the user to discontinue use
Caution: • • •
Always keep the device upright during operation, to ensure correct monitoring of gas concentrations. Do not use the system with Heliox as a ventilation gas. Perform a calibration (high calibration) of gas cells every third month. This can be done in Standby by tapping SERVICE & SETTINGS/BIOMED/CALIBRATION.
•
Refer to chapter Service & Settings on page 95. When lifting or moving parts of the SoKINOX NO Delivery and Monitoring System, follow ergonomic guidelines, ask for assistance, and take appropriate safety precautions.
Note: •
• • • • • •
• • • •
After unpacking, perform cleaning and disinfection according to reprocessing instruc‐ tions. After this, a Pre-Use Check must also be performed. Refer to chapter Cleaning and maintenance on page 91 Technical documentation is available by contacting your iNOsystems representative. Do not cover the system, it can affect the functioning of the equipment. While the system is in stationary use, the wheels of the mobile cart must be locked and the mobile cart must be on a horizontal surface. Securely attach all cables and connectors to minimize the risk of unintentional disconnec‐ tion. Do not simultaneously touch the patient and any accessible connector contacts. The base unit can be mounted on a mobile cart or bedside and rail holder. When the device is used without the mobile cart, it must be firmly mounted to a post or rail using the bedside and rail holder. Make sure that the bedside and rail holder is firmly attached to the base unit and that the base unit is in upright position. Contact an iNOsystems representative regarding decommissioning of the equipment. Do not use the SoKINOX NO Delivery and Monitoring System outside intended use condi‐ tions. Any serious incident that occurs in relation to the SoKINOX NO Delivery and Monitoring System must be reported to the manufacturer and the relevant competent authority. The SoKINOX NO Delivery and Monitoring System can only be reused if it is reconditioned under the responsibility of the manufacturer.
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SoKINOX NO Delivery and Monitoring System - User Manual
2.3.2 Power supply Warning: • •
The power cord must be connected only to an AC mains power outlet with protective earth to avoid the risk of electric shock. The power supply cord must be plugged directly into the mains power outlet without the use of any multiple socket outlets. If a multiple socket outlet is used together with other products, total leakage current might be exceeded in the event of a fault in the protective earth.
Note: • • • • • •
Make sure that both the mains power outlet and the power supply connector are accessi‐ ble. Avoid contact with external electrical connector pins. Only an external battery may be connected to the external 12 V DC inlet. Refer to section Power supply on page 18. When the AC mains power LED is on, the internal battery is being charged. When the system switches to the battery backup supply instead of mains power, it contin‐ ues to operate as usual and performance is not affected. When the system is connected to mains power, the internal battery is being recharged. This does not affect system behavior.
2.3.3 Battery Note: • • •
If a battery status message is displayed on the screen, tap the Battery icon or select STATUS/Battery for detailed information. Always contact an iNOsystems representative to replace the battery when the system provides notification of imminent expiration or of diminished operating capacity. Check the STATUS/Battery window to ensure safe battery operation. Always ensure that the battery is fully charged before use.
2.3.4 Fire hazard Warning: • • • •
Close the oxygen cylinder, if used, or disconnect the O2 supply when the system is turned off. Keep all sources of ignition away from the system and the oxygen hoses. Do not use a system with worn or frayed gas supply hoses or hoses that have been contaminated by combustible materials such as grease or oil. Oxygen-enriched gas enhances the risk of combustion: if a burning odor is detected, dis‐ connect the oxygen supply and mains power and contact a service technician to remove the battery.
2.3.5 Auxiliary equipment Only a memory stick with a minimum of 1 GB should be connected to the USB port. Note: Only use an RS232 cable of the length recommended by iNOsystems. Refer to section Serial ports in Communication/interface on page 126.
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2 Introduction
2.3.6 Electromagnetic compatibility (EMC) The system must be installed and put into service according to Electromagnetic compatibility on page 115. The systems Essential Performance consists of the following functions: • • • •
Delivery of NO therapy gas at the patient connection port within the alarm limits set by the operator or generation of an alarm condition. Monitoring of NO, NO2 and O2 gas, including generation of an alarm condition. Measurement accuracy for NO, NO2 and O2 gas and gas reading alarm condition or generation of a technical alarm condition. Delivery of NO therapy gas at the Back-up gas delivery outlet of at least 40% of set NO concentra‐ tion.
In order to ensure that the system will fulfill its Essential Performance (IEC 60601-1) during elec‐ tromagnetic disturbances, the following performance has been monitored during electromagnetic immunity tests: • •
Delivered NO gas Monitoring of:
•
• NO concentration • NO2 concentration • Oxygen concentration • Internal electrical power source • Mains power status • Gas supply Ability to generate alarms
No degradation or failure of the essential performance has been observed during these tests. 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 system including cables specified by the manufacturer. Otherwise degradation of this equipment could result. The flow sensor functionality may temporarily be disturbed by RFID transmitters (operating at 860-960 MHz) in close proximity (<0.3 m) to the system. If this happens, relocate the RFID transmitter. No other effects on the system have been observed during the electromagnetic immunity tests.
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SoKINOX NO Delivery and Monitoring System - User Manual
3 System overview 3.1 Theory of operation The SoKINOX NO Delivery and Monitoring System consists of the following two independent subsys‐ tems: • •
The primary NO therapy system The backup NO therapy system
3.1.1 NO gas supply NO gas is supplied by external NO gas cylinders connected to the system. The NO gas supply consists of two NO gas cylinders for redundancy. In order to provide seamless NO delivery, the system is able to automatically switch supply cylinders when the active NO cylinder becomes empty. If only one NO cylinder is connected, the Pre-Use Check will be designated as not completely passed. The system will alarm for a missing cylinder, and it will not be possible to switch to a backup cylinder. Warning: • • •
To ensure seamless NO delivery, always have two open NO gas cylinders of the same size connected during operation. Always use medical grade gas. Always use NO gas regulators specified for use with the device.
3.1.2 Purging In order to remove accumulated NO2 from the device and NO gas supply hoses, the high pressure system must be purged before start of treatment and before any switching of NO cylinders. Warning: The system must be purged of NO2 before use. The initial purge is performed in the Pre-Use Check of the system after power on. NO2 will accumulate while the device is in Standby. If the time between purge and treatment start exceeds 12 hours, the Pre-Use Check must be redone. If the Pre-Use Check is bypassed, purging the system from NO2 takes significantly longer time. Prior to a manual or automatic cylinder switch, purging of a previously inactive NO gas cylinder is also automatically performed.
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3 System overview
3.1.3 Gas administration The combined external flow sensor and NO injection module is positioned between the inspiratory outlet of the respiratory device and the inlet of the active humidifier, always on the dry side of the inspiratory limb of the patient circuit. This location, at a significant distance from the sampling point and Y-piece, is important to allow for adequate mixing of gases. The different types of flow sensors are seen in the following table: Flow sensor
Flow range
Low flow sensor
0.25 - 40 l/min
High flow sensor
2 - 120 l/min
The flow sensor instantaneously measures the inspired flow rate and makes the data available to the gas delivery system. A control algorithm uses the flow rate data to titrate proper amount of NO gas using dosing valves, in order to reach the user set desired NO concentration to the patient. The NO gas mixes with the ventilation gas in the humidifier and patient circuit to achieve a homogenous mixture when the gas reaches the Y-piece. Warning: Due to NO being added to the ventilation gas, the resulting FiO2 may be lower than the FiO2 set on the ventilator. Always check the monitored FiO2 and adjust FiO2 settings on the ventilator accordingly. Caution: Using the Constant Rate dosing mode when tidal volumes exceed 150 ml can cause underdelivery of NO, due to limitations in gas mixing. There are 3 different dosing modes available: •
•
•
Auto Sense - Default dosing mode, intended for use with most respiratory devices. In this mode, NO gas is delivered in proportion to the flow sensed by the external flow sensor mounted in the inspiratory limb. Jet Sense – Similarly to the Auto Sense mode, NO gas is delivered in proportion to the flow sensed by the external flow sensor mounted in the gas inlet line of the Bunnell LifePulse patient circuit. This mode is uniquely adapted to the Bunnell LifePulse 203 jet ventilator, to optimize dosing accuracy. Constant Rate – In the Constant Rate dosing mode, the system delivers NO in order to achieve a constant NO concentration at the flow rate entered by the user. The flow rate is independent of the flow sensed by the external flow sensor. Any deviations in the actual flow will consequently result in variations in the delivered NO concentration if the Constant Rate dosing mode is used. The variations can be minimized by titrating the Flow Rate setting to the measured flow. The measured flow is found in STATUS/General. Warning: To avoid rapid changes in the delivered NO concentration, never use the Constant Rate dosing mode when large flow variations are expected. In order to prevent NO2 accumulation in the patient circuit: • •
always stop Constant Rate treatment before the respiratory device is paused or stopped. never perform inspiratory or expiratory hold maneuvers on the respiratory device while using the Constant Rate dosing mode.
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