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User's Manual SoKINOX v 1.4 Nitric Oxide Delivery and Monitoring System
| TABLE OF CONTENTS |
TABLE OF CONTENTS
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SoKINOX v 1.4, User's Manual Infologic 1.52
Introduction System overview Operation overview Alarms and alarm handling Cleaning and maintenance Service & Settings Compatibility Technical data Index
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| TABLE OF CONTENTS |
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SoKINOX v 1.4, User's Manual Infologic 1.52
| Introduction | 1 |
1 Introduction Table of contents
1.1 1.2
SoKINOX v 1.4, User's Manual
General description Safety guidelines
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1.1 General description
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Refer to System Flow Chart, SoKINOX, NO delivery and monitoring system, for information concerning accessories and other parts used with the NO delivery and monitoring system. Contact your Air Liquide Healthcare representative. The NO delivery and monitoring system is intended for continuous use together with a compatible ventilator to deliver a set concentration of NO gas to the connected patient.
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Make sure that the NO delivery and monitoring system is compatible with the ventilator you use. A list of compatible ventilators is available in the addendum to this manual: Addendum to User's Manual, SoKINOX Nitric Oxide Delivery and Monitoring System. Refer to table under heading Recommended ventilator settings for compatible ventilators on page 86.
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
3.
a bedside/rail holder
4.
other accessories and disposables (not shown in figure)
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| Introduction | 1 |
Important: • Air Liquide Healthcare has no responsibility for the safe operation of the NO delivery and monitoring system if the information specified in Intended use is not followed. • Air Liquide Healthcare has no responsibility for the safe operation of the NO delivery and monitoring system if the intended use environment requirements specified in this document are not followed. • The operator should always evaluate the particular location in which the NO delivery and monitoring system is used with regard to ventilation and potential exposure to ambient NO and NO2 gas.
1.1.1 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 therapy gas are controlled by the therapy gas labeling. The NO delivery and monitoring system can be used with ventilation devices. Compatible ventilators are listed in the addendum to this manual: Addendum to User's Manual, SoKINOX Nitric Oxide Delivery and Monitoring System. In backup mode, the system can be operated as a stand-alone system.
Refer to chapter Technical data under heading Exposure to gases on page 111.
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1.1.2 Intended user
1.2 Safety guidelines
The NO delivery and monitoring system shall be used only by those who are professional healthcare providers and who have received training in the use of this system and possess experience from ventilation and NO treatment.
Follow these safety guidelines. Additional warnings appear in context throughout this document. Information is highlighted with Warning, Caution, Important or Note, where:
1.1.3 Intended Use Environment The NO delivery and monitoring system shall be used only:
WARNING! Indicates critical information about a potential serious outcome to the patient or the user.
• in hospitals, except MRI environments • during transport of a patient within hospitals 1.1.4 User's Manual This manual summarizes the functions and safety features of the NO delivery and monitoring system. It is not all-inclusive and should not be seen as a substitute for training. Important: The NO delivery and monitoring system may be operated only by authorized personnel and must be operated according to the instructions in this manual.
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CAUTION: Indicates instructions that must be followed in order to ensure the proper operation of the equipment.
Important: Indicates information intended to help you operate the equipment or its connected devices easily and conveniently.
Note: Indicates information requiring special attention.
SoKINOX v 1.4, User's Manual
| Introduction | 1 |
1.2.1 General WARNINGS! • When using a ventilator made by a manufacturer other than the manufacturer of the NO delivery and monitoring system, it is important always to check with the respective ventilator manufacturer prior to use to ensure that their ventilator is compatible with NO gas. • Airway pressures outside the range specified (> 70 cmH2O) may cause NO delivery variation or failure to deliver NO. Pay special attention when using ventilators that can deliver airway pressures outside this range. Refer to table under heading Recommended ventilator settings for compatible ventilators on page 86. • Do not use an HME device with the NO delivery and monitoring system. • When connecting a patient to the NO delivery and monitoring system, make sure that tubes and wiring close to the patient are placed in such a way as to prevent risk of patient strangulation. • Make sure that the correct Luer connectors are used to connect the gas sampling line to the gas sampling inlet and the injection line for NO to the gas delivery outlet. Avoid confusion with, and inadvertent connection of, other Luer connectors. • Persons using the NO delivery and monitoring system should be trained and experienced in its use to ensure effective administration of nitric oxide and to avoid
SoKINOX v 1.4, User's Manual
injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide or other reaction products. • 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 Nitric Oxide Delivery and Monitoring System including cables specified by the manufacturer. Otherwise degradation of this equipment could result. • The use of accessories, transducers and cables other than those specified by the manufacturer may result in increased emissions or decreased immunity (EMC) of the system. • The NO delivery and monitoring system may not be used in an MRI environment. • Only accessories, supplies, and auxiliary equipment recommended by Air Liquide Healthcare should be used with the NO delivery and monitoring system. Use of any other accessories, spare parts or auxiliary equipment may cause degraded system performance and safety. Refer to System Flow Chart, SoKINOX, NO delivery and monitoring system, for information concerning accessories and other parts used with the NO delivery and monitoring system. Contact your Air Liquide Healthcare representative. • Do not modify or remove any original parts. • Service, repair and installation may only be performed by Air Liquide Healthcare authorized personnel.
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CAUTIONS: • To avoid malfunction of the rotameters, keep the base unit upright at all times. • During NO therapy, always make sure: - to use two NO cylinders with a volume of at least 5 liters that are open throughout therapy - that the gas pressure of the active cylinder is above the limits specified in the pre-use check and that the inactive cylinder is full by regularly checking the pressure gauge on the cylinder regulator - to replace the NO cylinder directly after an NO cylinder 1 missing (or empty)/NO cylinder 2 missing (or empty) alarm is generated. • It is recommended always to perform a pre-use check before connecting the NO delivery and monitoring system to a patient. If the pre-use check is omitted, the system may not function correctly. • Always use autosense not constant rate when changing ventilator mode from conventional ventilation to High Frequency Oscillation (HFO) Ventilation and vice versa.
• To avoid malfunction of the rotameters and gas sensors, keep the base unit upright at all times. When the bedside/rail holder is attached to a post or rail, make sure the bedside/rail holder is firmly attached to the base unit and that the orientation of the clamp is such that the unit is upright. • The O2 cell and the NO and NO2 gas sensors are to be replaced once a year. • Gas sensor calibration needs to be performed once every three months. This can only be done in STANDBY by tapping SERVICE & SETTINGS/BIOMED/CALIBRATION. Refer to chapter Service & Settings on page 75. • Avoid kinks and small radius bends in the pneumatic tubing, i.e. flow sensor line, gas sampling and injection line for NO. Note that tubing with a small radius bend may work well at room temperature but may become blocked at elevated temperatures. • If drugs required for patient treatment are nebulized, contact the drug manufacturer to ensure that the drugs are compatible with NO delivery.
• In the USA, federal law restricts this device to sale by or on the order of a physician or other licensed medical practitioner.
• When lifting or moving parts of the NO delivery and monitoring system, follow ergonomic guidelines, ask for assistance, and take appropriate safety precautions.
• Do NOT use antistatic or electrically conductive tubing with this system.
• Always place two NO cylinders of the same size on the mobile cart to avoid the risk of overbalancing it. Refer to section Dimensions, weights and loads on page 95.
• Check the NO delivery and monitoring system for damage. If the system is damaged, it should not be used.
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| Introduction | 1 |
• 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
Important: • After unpacking, perform a routine cleaning and a pre-use check. • Make sure that a resuscitator is readily available. • The following should be performed daily: - Check water trap - Check cylinder pressure - Perform sensor offset adjustment • The base unit can be mounted on a mobile cart or bedside/rail holder. When the device is used without the mobile cart, it must be firmly mounted to a post or rail using the bedside/rail holder. Make sure the bedside/rail holder is firmly attached to the base unit and that the clamp is correctly oriented as specified in the Caution above. • Never leave the patient unattended when connected to the NO delivery and monitoring system. • In case of total loss of power, including loss of battery power, the NO delivery and monitoring system will use the default alarm settings when next restarted. Refer to section Default alarm settings on page 54 and section Alarm limit settings on page 104.
SoKINOX v 1.4, User's Manual
• All technical documentation is available for use by Air Liquide Healthcare authorized personnel. • During operation any water traps must be checked regularly and if necessary emptied. Refer to section Emptying/replacing the water trap on page 18. • Do not cover the NO delivery and monitoring system in any way, since the functioning of the equipment may be adversely affected. • Do NOT use lower bias flow than 0.4 l/min for low flow sensor and 2 l/min for high flow sensor, otherwise NO dosing might result in NO or NO2 concentrations that are too high. • When providing high-frequency oscillation (HFO) therapy, pay attention to the maximum flow and select the flow sensor accordingly. •
Important: When using the SoKINOX NO delivery and monitoring system with Servo-n HFOV with an I:E ratio of 1:3, a frequency of up to 8 Hz may be used. Above this limit, there may be overdelivery of NO.
• While the NO delivery and monitoring 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, etc, to minimize the risk of unintentional disconnection.
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Notes: • Do not simultaneously touch the patient and any accessible connector contacts. • Extra care should be taken when handling tubes, connectors and other components of the patient circuit. • Contact an Air Liquide Healthcare representative regarding decommissioning of the equipment.
1.2.2 Power supply WARNINGS! • 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.
Important: • Make sure that both the mains power outlet and the power supply connector are accessible. • Avoid contact with external electrical connector pins.
Notes: • When the NO delivery and monitoring system switches to the battery backup supply instead of mains power, it continues to operate as usual and performance is not affected. • When the NO delivery and monitoring system is connected to mains power, the internal battery is being recharged. This does not affect system behavior.
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SoKINOX v 1.4, User's Manual
| Introduction | 1 |
Battery
1.2.3 Fire hazard
Important: • If a battery status message is displayed on the screen, tap STATUS/Battery for detailed information.
Important: • Close the oxygen cylinder, if used, or disconnect the O2 supply when the NO delivery and monitoring system is turned off.
• Always contact a service technician to replace the battery when the NO delivery and monitoring 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.
• Keep all sources of ignition away from the NO delivery and monitoring system and the oxygen hoses. • Do not use an NO delivery and monitoring 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 is extremely flammable: if a burning odor is detected, disconnect the oxygen supply and mains power and contact a service technician to remove the battery.
1.2.4 Auxiliary equipment Important: • Only a USB memory stick may be connected to the USB port. • Use only a PDMS cable of the length recommended by Air Liquide Healthcare. Refer to chapter Technical data under heading Serial ports on page 109.
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| 1 | Introduction |
1.2.5 Electromagnetic Compatibility The NO delivery and monitoring system must be installed and put into service according to Electromagnetic Compatibility, SoKINOX Nitric Oxide Delivery and Monitoring System.
No degradation or failure of the essential performance has been observed during these tests. No other effects on the NO delivery and monitoring system have been observed during the electromagnetic immunity tests.
In order to ensure that the SoKINOX Nitric Oxide Delivery and Monitoring System, during electromagnetic disturbances, will fulfil its Essential Performance (IEC 60601-1), as listed here: • 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 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
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SoKINOX v 1.4, User's Manual
| System overview | 2 |
2 System overview Table of contents
2.1 2.2 2.3 2.4
SoKINOX v 1.4, User's Manual
System parts Touch screen display Displaying data Transport
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16 25 30 34
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2.1 System parts The NO delivery and monitoring system and its parts, as well as an outline of how to set it up, are presented in the form of text and images. The NO delivery and monitoring system is not made with natural rubber latex or the phthalate DEHP. CAUTION: Do not obstruct the ambient air inlet.
Important: • Only an external battery may be connected to the external 12 V DC inlet. Refer to section Power supply on page 96.
Notes: • NO is supplied by gas cylinders. O2 is supplied by a medical pipeline system or, alternatively, by a gas cylinder. • The purge outlet and the gas sampling outlet may be connected to a hospital gas evacuation system via the evacuation hose. Make sure that the gas evacuation system does not create a negative pressure in the NO delivery and monitoring system. Refer to section Connecting the evacuation hose on page 19. • The upper RS-232 connector is used for connection of a PDMS cable.
• When the AC mains power LED is on, the internal battery is being charged.
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| System overview | 2 |
2.1.1 Base unit
25
1 9 2
3
5
10
6
11
7
12
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13
4
16 17 18 19 20 14 15
1.
O2 flow meter
11. Purge outlet
2.
Concentration indication for NO Refer to section Data on delivered NO concentrations on page 101.
12. Gas inlet for O2
21 22 23 24
13. AC mains power LED, blue 14. AC mains connection for power cord
3.
Backup switch
4.
Instruction to power on to purge NO2
16. RS-232 connector for PDMS cable
5.
O2 flow scale
17. RS-232 connector (currently inactive)
6.
Flow indicator for NO
18. Gas inlets for NO
7.
Adjustment knob for backup O2 flow and corresponding NO concentration
19. Serial number label
8.
Backup gas delivery outlet to resuscitator
9.
USB port
10. Gas sampling outlet
15. On/Off switch
20. External 12 V DC inlet 21. Water trap 22. Gas sampling inlet 23. Delivery outlet for NO 24. Flow sensor connection 25. Touch screen display/screen
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| 2 | System overview |
Installing the water trap
1
2
• To install the water trap, align it with the receptacle and push gently into place as shown. Make sure that the locking mechanism is fully engaged by pulling the water trap, which should remain firmly in position. • Connect the gas sampling line to the gas sampling inlet.
3
4
Emptying/replacing the water trap CAUTION: Handle the contents of the water trap as you would handle any body fluid. Potential infection hazard!
1.
2. Important: • After water trap replacement, check that the monitored gas concentrations are appropriate.
3. 4.
To remove the water trap, push the release button on the receptacle and pull out the water trap as shown in figure 1. To empty the water trap, twist and pull the container relative to the filter housing. Empty the container. Re-assemble the water trap and follow the installation instructions above to re-install it.
• Replace the complete water trap every month or as required, e.g. to resolve certain alarms.
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| System overview | 2 |
Connecting the evacuation hose Connect the evacuation hose to evacuate NO gas, and to reduce noise.
1.
Pass the hard plastic end of the hose through the ring at the tip of the purge outlet to connect it.
2.
Optionally, connect the remaining hose end to the hospital gas evacuation system.
Disconnecting the evacuation hose To disconnect the evacuation hose, push the ring at the tip of the purge outlet and simultaneously pull the hose to release it. 1
1600004
2
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| 2 | System overview |
2.1.2 Gas flow through the base unit
NO2
NO
O2
1.
Pressure gauge on cylinder regulator
16. Sampling pump
2.
Gas inlets for NO
17. Gas sampling outlet
3.
Purge outlet
4.
Dosing valves for NO gas
18. Flow sensor input via flow sensor connection
5.
Gas delivery outlet to NO injection line
A. High-pressure part of the system
6.
Gas inlet for O2 (from wall or cylinder)
B. Low-pressure part of the system
7.
Backup switch
8.
Adjustment knob for backup O2 flow and corresponding NO concentration
9.
O2 flow meter
10. Flow indicator for NO 11. Backup gas delivery outlet to resuscitator 12. Gas sampling line to gas sampling inlet 13. Gas sensor offset adjustment valve 14. Ambient air inlet 15. O2 cell and gas sensors for NO and NO2 20
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| System overview | 2 |
Symbols on base unit Symbol
Symbol
Consult instructions for use
Description
CE label-indicates compliance with the requirements of the Medical Device Directive 93/42/EEC
Manufacturer Manufacturing date
CSA label-Indicates compliance with Canadian and US standards
Consult accompanying documentation
Type B-indicates classification according to IEC 60601-1 RS-232/Serial port - connector for data communication
Serial number Order number
Ingress protection, IP21 7 kg
- +
External 12V DC input
Description
76 kg
Weight of base unit/weight of base unit on mobile cart
12V Mains power On/Off Mains connected, batteries charging USB connection
MR Unsafe - keep away from magnetic resonance imaging (MRI) equipment.
Notes: • Special waste. This product contains electronic and electrical components. Discard disposable, replaced and left-over parts in accordance with appropriate industrial and environmental standards.
Inlet Outlet Gas cylinder inlets Flow sensor Water trap release button Backup mode
This way up - indicates correct upright position Special waste
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