AirLife nCPAP System Operators & Routine Maintenance Manual Rev D

Table of Contents Product Description...2 Product Specification ...3 Gas Supply ... 3 Pressure Control / Monitoring ... 3 Oxygen Control / Monitor... 3 Flow Monitoring ... 3 Power Supply ... 3 Weight ... 3 Dimensions... 3 Pressure Relief ... 3 Flow Limit ... 3 Alarm System ... 3 IEC 60601-1 Classification ... 6 Storage and Operation Conditions ... 6 Driver Feature Diagram - Front Panel... 7 Driver Feature Diagram - Back Panel ... 8

Warnings and Cautions Summary ...9 Operating Instructions ...12 Driver Setup... 12 Interface Control Knob Operation ... 16 Standby Mode ... 17 Air or Oxygen Only Mode ... 18 Trending ... 18 System Operaton... 20 Final Checks and Routine Inspection ... 21 Icon Legend... 22

Alarm Details and Actions ...23 Cleaning and Routine Maintenance ...26 Unit Inspection and Cleaning... 26 Disposal... 28

Appendix A: Approved Accessories ...29 Appendix B: Electromagnetic Compatibility...30 Appendix C: Warranty Information ...35 Warranty ... 35 Disclaimer... 35

AirLife® nCPAP Operator’s Manual

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Product Description The AirLife® nCPAP System Driver is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat spontaneously breathing newborns and infants with Respiratory Distress Syndrome (RDS), or are recovering from RDS under the supervision of qualified personnel (e.g., respiratory therapist or nurse). The driver operates on hospital or tank air, and oxygen. The device has an internal battery and can be used for intra-hospital transport, but is not intended for use in ambulances or aircraft. ® The AirLife nCPAP System Driver incorporates an electronic blender using solenoid valves and servo controlled flow to maintain a user-set pressure and FiO2. The system also utilizes a long-life oxygen sensor. The user interface displays oxygen concentration, CPAP level, flow rate, trending, and power and alarm conditions. The oxygen sensor automatically calibrates every time the instrument is powered on. The driver is part of a larger system that includes an nCPAP generator, fixation device, and patient interface (prongs and/or masks).

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AirLife® nCPAP Operator’s Manual

Product Specification Gas Supply 41–66 psig (nominal 50 psig) clean, dry, medical air and oxygen. External pressure regulators should be used if source pressures exceed 66 psig. Pressure Control / Monitoring Control Range: 2–10 cmH2O Monitor Range: 1–11 cmH2O, accuracy ±1 cmH2O. Pressure is displayed as <1 or >11 when outside this range. Oxygen Control / Monitor Control/Display Range: 21%–100% O2, accuracy ±3 percentage points Monitor Range: 17%–104%O2, accuracy ±3 percentage points Sensor Type: Long Life Ultrasonic (5+ years) Flow Monitoring Range: 0–15 LPM, accuracy ±10% Power Supply 15 V DC, 3.3 A from included AC adapter (GlobTek, Inc. Model number GTM21097-5015) or an internal 12 V sealed lead/acid battery. The battery has a life of four (4) hours from a full charge (up to 16 hours required for recharge). Weight Approx. 15 pounds Dimensions 8 ½ x 8 ½ x 6 ½ inches (excluding gas inlets, patient outlets, and mounting brackets) Pressure Relief (2 systems) Automatic electronic valve system preset to vent to ambient air when a High Pressure alarm occurs Mechanical internal relief valve preset to vent at 3 ±0.15 psig (211 ±11 cmH2O) Flow Limit Electronic flow limit to prevent the delivery flow from exceeding 3 LPM over Target Flow or 15 LPM.

Alarm System Alarms are delayed for 120 seconds after entering the main screen in order to allow time for patient setup. If the patient setup takes longer than 120 seconds, the alarms can be muted for an additional 120 seconds by pressing the alarm mute/reset button or the system can be placed into Standby Mode.

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Supply Gas Pressure Alarm: An audible and visual Source Pressure alarm will activate if the inlet pressure of one, or both, of the gas sources are outside of the specified gas supply range. There is a 1 second delay for this alarm. The alarm message will indicate the specific gas source that is out of specification. If a single gas source goes out of range during operation, then only the remaining gas source will be available (air or oxygen) and FiO2 blending will become inoperable. The user will be able to select either ‘Air Only’ or ‘Oxygen Only’ to allow the unit to operate in single-gas source mode and mute the FiO2 alarms while the problem is corrected. The system will automatically return to normal operation (blending to the original FiO2 setting) when the problem is corrected and the source pressures are returned to within the specified range. High Pressure Alarm: An audible and visual High Pressure alarm has dual limits. The first limit will activate the alarm when the monitored pressure is greater than or equal to 12 cmH2O for 2 seconds. The second limit will activate the alarm immediately when the monitored pressure is greater than or equal to 18 cmH2O. This alarm automatically activates the electronic pressure relief solenoid and closes the patient delivery solenoid, which instantly reduces the pressure in the patient circuit to zero. Approximately every three (3) seconds, the system will reinstate flow. If the alarm condition has cleared, the unit will operate normally. If the alarm condition still exists, the ‘High Pressure’ alarm will cycle through the 3-second loop. Elevated Pressure Alarm: An audible and visual Elevated Pressure alarm is preset for a CPAP pressure that is 2 cmH2O above the Set CPAP level. There is a 5 second delay for this alarm Low Pressure Alarm: An audible and visual Low Pressure alarm is preset for a CPAP pressure that is 2 cmH2O below the Set CPAP level. There is a 14 second delay for this alarm.

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AirLife® nCPAP Operator’s Manual

Disconnect Alarm: An audible and visual ‘Disconnect’ alarm is preset to detect a pressure line or patient interface that has come loose or that is disconnected. The alarm is set to activate according to the following list: Flow (LPM)

CPAP (cmH2O)

≥0

≤1

≥6

≤2

≥9

≤3

≥ 12

≤4

≥ 14

≤5

While the alarm is active, the patient flow will remain within ±2 LPM of Target Flow. There is a 5 second delay for this alarm. Leak Alarm: An audible and visual Leak alarm is preset for a flow rate that is 3 LPM above the Target Flow rate or for a flow that is greater than 15 LPM. There is a 5 second delay for this alarm Low Flow Alarm: An audible and visual Low Flow alarm is preset for flow rates at or below 3 LPM. There is a 10 second delay for this alarm. Oxygen Concentration Alarms: The oxygen concentration is allowed to operate within a ±3 %O2 range without alarming. A Medium Priority warning will activate whenever the product of the variance outside of the FiO2 range and the duration (in seconds) of the variance exceeds 20. A High Priority alarm will activate whenever the product of the variance outside of the FiO2 range and the duration (in seconds) of the variance exceeds 30. For example: if the Set %O2 is 30% and the reading is 35% for a period of ten (10) seconds, a Medium Priority warning will activate. In this case the reading is 2 percentage points outside of the ±3 percentage point range. If the Set %O2 is 30% and the reading is 35% for a period of 15 seconds, a High Priority alarm will activate. Battery Alarms: An audible and visual Low Battery alarm has dual limits. The first limit will activate the medium priority alarm when the battery falls below 10% remaining (approx. 24 minutes). The second limit will activate the high priority alarm when the battery falls below 5% remaining (approx. 12 minutes). There is a 2 second delay for this alarm. An audible and visual Charge Fault alarm will indicate if the battery is not charging properly. The system verifies proper charging at start up and during the routine oxygen calibration. There is a 5 second delay for this alarm.

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Oxygen Calibration Alarm: An audible and visual Oxygen Calibration alarm will indicate if an oxygen sensor has failed to calibrate. If this alarm occurs, remove patient and cycle the power for re-calibration or remove the driver from service. While the alarm is active, the driver provides CPAP and FiO2, however, the FiO2 may not be accurate. The system calibrates the oxygen sensor during start up and routinely during operation. There is no delay for this alarm Software Fault: An audible and visual Software Fault alarm will indicate any software fault detected. The system will display a fault code which should be recorded. If the fault is non-fatal, the alarm can be cleared and the system will return to normal operation. If the fault is fatal, the driver will need to have the power cycled or be removed from service. There is no delay for this alarm Flow / Pressure Sensor: A visual Sensor Calibration Fault will indicate if a sensor has failed the calibration during the start up routine. A failure screen will appear indicating what sensor has failed and informing the user to remove the device from service.

IEC 60601-1 Classification Internally Powered Equipment, Type BF, IPX 1 This equipment is rated for Continuous Operation. ® Caution: Although the AirLife nCPAP System Driver meets the requirements of current EMC/RFI legislation, this does not guarantee immunity from all sources of radiated energy. Some mobile telephones and other products containing radio transmitting components may cause a malfunction of the ® AirLife nCPAP driver and should not be used in the vicinity of the driver.

Storage and Operating Conditions • • • • • •

Safe for storage at -20°C–60°C Relative humidity of 15%–95% non-condensing Atmospheric pressure 0.6–1.4 Bar. Operating environment temperature is 5°C–40°C Keep dry and do not expose to direct sunlight This product meets the EMC requirements of IEC60601-1 ®

Warning: The patient accessories for use with the AirLife nCPAP Driver are for single patient use only. Disposable accessories include generators, fixation device, prongs, masks, heated wire breathing circuits, and humidification chambers. DO NOT STERILIZE OR REUSE.

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AirLife® nCPAP Operator’s Manual

Driver Feature Diagrams

3

2

4

5

6

1

12

11 10

9

8

7

Figure 1: Front Panel Features Item

Description

1

Pressure LED Bar Graph (Indicates instantaneous patient pressure)

2

Pressure Display (Indicates average patient pressure)

3

Message Bar

4

FiO2 Display

5

Alarm Priority LEDs and Alarm Mute

6

Alarm Mute/Reset Button (Press & Release for Mute/Reset; Press & Hold for Standby Mode)

7

Power Status

8

Interface Control Knob

9

Trend Selection

10

Flow Display

11

Pressure Line Connection

12

Patient Connection

AirLife® nCPAP Operator’s Manual

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1 2 3

7 8

6

5

4

Figure 2: Back Panel Features Item

8

Description

1

Power Connection

2

Fuse

3

Power Switch (Switch does not disconnect driver from main power supply)

4

Oxygen Inlet

5

Water Trap and Air Filter (behind Air Inlet; not visible in this view)

6

Medical Air Inlet

7

Nationally Recognized Testing Laboratory (NRTL) Classification

8

Serial Number

AirLife® nCPAP Operator’s Manual

Warnings and Cautions Summary The AirLife® nCPAP System Driver is intended to be operated only by qualified personnel under the direction of a physician. The operator is responsible for reading and thoroughly understanding the provided product documentation. Definitions to be considered throughout the document: Warning: Used when the operator or the patient have the possibility of being injured. Caution: Used when the driver or accessories used with the driver have the possibility of being damaged. Note: Used for statements that could allow for more efficient or convenient operation or service of the equipment. The following are warnings, cautions, and notes that will appear within this document. Please become familiar with their content. Warning: The patient accessories for use with the AirLife® nCPAP Driver are for single patient use only. Disposable accessories include generators, fixation device, prongs, masks, heated wire breathing circuits, and humidification chambers. DO NOT STERILIZE OR REUSE. Warning: The driver should only be used after qualified personnel or a technician has authorized it for use. Warning: Oxygen vigorously accelerates combustion. To avoid an explosion hazard, do not use any instrument or piece of equipment that may have been exposed to oil or grease contamination. Warning: To avoid the risk of fire or explosion, use this device in wellventilated areas away from flammable anesthetics. Warning: When driver is connected to power source, keep cords clear of walkways to avoid possible cord entanglement and strangulation. Warning: Use this product only as directed in the product literature to reduce the possibility of nasal and skin irritation, and necrosis.

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Warning: There is always a risk when using oxygen that the O2 level in the arterial plasma will reach an unacceptable level. This driver should always be used in conjunction with a pulse oximeter to monitor patient status. Oxygen toxicity can be a concern with this device for the intended population if it is used for more than a few hours. Risks include:

▪ ▪ ▪

Absorption atelectasisi (collapse of lung tissue) Hypercapnia (increased carbon dioxide) Retrolental hyperplasia (which can cause blindness)

Also, Chemotherapy patients given bleomycin appear to be extremely sensitive to even relatively low levels of oxygen. ® Warning: The use of any power cords with the AirLife nCPAP System Driver other than those supplied with the driver may result in increased ® emissions and/or decreased Immunity of the AirLife nCPAP System Driver.

Caution: Although the AirLife® nCPAP System Driver meets the requirements of current EMC/RFI legislation, this does not guarantee immunity from all sources of radiated energy. Some mobile telephones and other products containing radio transmitting components may cause ® malfunction of the AirLife nCPAP System Driver and should not be used in the vicinity of the driver. Caution: Federal (USA) law restricts sale of this driver to, or on the order of, a physician. Caution: Any liquid introduced into the gas supplies will cause malfunction of this driver and the equipment connected to it. Caution: This driver is designed to mix oxygen and air only. Do not alter the inlets for any other gas sources, such as anesthesia gases. Caution: The power switch does not disconnect the driver from the main power supply. This can only be accomplished by disconnecting the AC adapter from either the driver or the AC outlet. Caution: The correct AC adapter must be used with the driver. Use of an incorrect AC adapter can damage the internal circuits of the driver. Caution: Using the driver without the proper filters can allow dirt or moisture to enter the system. This will damage the electronic blender, leaving the unit non-operational. Caution: Ensure that the driver is unplugged from external power and that the power switch is in the “Off” position before cleaning.

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AirLife® nCPAP Operator’s Manual

Caution: The driver will be damaged if any part of it is immersed in liquid or gas, or steam sterilized. Note: Alarms are delayed for 120 seconds after entering the main screen in order to allow time for patient setup. If the patient setup takes longer than 120 seconds, the alarms can be muted for an additional 120 seconds by pressing the alarm mute/reset button or the system can be placed into Standby Mode. Note: To enhance patient safety and comfort, use only with heated humidifiers and heated wire circuits. The recommended setting is 37 °C, 100% RH. Note: To obtain maximum battery life, it is recommended that the driver remain connected to an external power source even when it is not in use. Note: Class 1 LED product. Note: Hospital personnel should keep records of Performance Verification Tests and identify equipment that is authorized for use. Note: The Driver must have both gases properly connected and within the specified pressure range in order to pass the initial start-up sequence. This will enable the Driver to perform a valid calibration and ensure accurate FiO2 delivery.

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Operating Instructions The AirLife® nCPAP System is designed to provide an airway pressure that ® is practically constant. The AirLife generator utilizes vortice technology to help reduce the patient’s imposed Work of Breathing. The Driver automatically adjusts the gas flow rate to deliver the set CPAP level and compensate for minor leaks in the system. Caution: Federal (USA) law restricts sale of this driver to, or on the order of, a physician. Warning: The driver should only be used after qualified personnel or a technician has authorized it for use. Warning: Oxygen vigorously accelerates combustion. To avoid an explosion hazard, do not use any instrument or piece of equipment that may have been exposed to oil or grease contamination. Warning: To avoid the risk of fire or explosion, use this device in well-ventilated areas away from flammable anesthetics.

Driver Setup 1.

Securely attach the driver to a stand or other mounting system that includes a heater/humidification system. See Figure 3. A mounting plate is included with the Driver and should be attached to the driver using the supplied hardware. Ensure that the stand is rated to safely handle the weight and dimensions of the driver, as detailed in “Product Specification” on page 3.

Figure 3: The Driver Attached to a Stand

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AirLife® nCPAP Operator’s Manual

Note: To enhance patient safety and comfort, use only with heated humidifiers and heated wire circuits. The recommended delivery is 37 °C, 100% RH. 2.

Visually inspect the inlet air filter and water trap, located on the back of the driver. See Figure 4. If the filter is dirty or wet, it must be cleaned or replaced. A tool is included with the driver to assist in removing the water trap.

Air Filter and Water Trap Figure 4: Location of Air Filter and Water Trap Caution: This driver is designed to mix oxygen and air only. Do not alter the inlets for any other gas sources, such as anesthesia gases. Caution: Any liquid introduced into the gas supplies will cause malfunction of this driver and the equipment connected to it. Caution: Using the driver without the proper filters can allow dirt or moisture to enter the system. This will damage the electronic blender, leaving the unit non-operational. 3.

Connect medical air and oxygen hoses to the back of the driver. See Figure 5. Then connect the hoses to their respective high-pressure sources. Note: The Driver must have both gases properly connected and within the specified pressure range in order to pass the initial start-up sequence. This will enable the Driver to perform a valid calibration and ensure accurate FiO2 delivery.

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Medical Air Inlet

Oxygen Inlet

Figure 5: Air and Oxygen Connectors on Driver •

Plug the external power source into the power connector on the back of the driver and an AC outlet. See Figure 6. Power Connector

Figure 6: AC Power Connector on Driver Warning: When driver is connected to power source, keep cords clear of walkways to avoid possible cord entanglement and strangulation. Note: To obtain the maximum battery life, it is recommended that the driver remain connected to the power source even when not in use. 5.

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Power on unit and verify that all of the LEDs illuminate. See Figure 7.

AirLife® nCPAP Operator’s Manual

Figure 7: Illuminated LEDs Note: Class 1 LED product. 6.

Verify that the following default values are indicated on the main screen: • • • •

CPAP Set: 5 cmH2O FiO2 Set: 21% O2 Flow Rate Target: 8 LPM Battery charging (lightning bolt in battery icon)

Note: Alarms are delayed for 120 seconds after entering the main screen in order to allow time for patient setup. If the patient setup takes longer than 120 seconds, the alarms can be muted for an additional 120 seconds by pressing the alarm mute/reset button or the system can be placed into Standby Mode. See Figure 8.

Figure 8: Alarm Mute/Reset Button 7.

Unplug external power, verify a single audible alarm burst sounds and the interface indicates the driver is operating on battery power. Plug external power source back in. Caution: The power switch does not disconnect the driver from the main power supply. This can only be accomplished by disconnecting the AC adapter from either the driver or the AC outlet.

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Interaction with Display Settings Control of the various AirLife® nCPAP Driver features is accomplished through the use of the Interface Control Knob.

Figure 9: Interface Control Knob Interface Control Knob Operation To adjust the %O2, CPAP, or Flow Target values, follow these steps. 1.

Rotate the knob to move the highlight cursor to the different sections of the screen. See Figure 10. The default location for the highlight cursor is the Set %O2.

Figure 10: Main Display Screen

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2.

Select the parameter by pressing the knob when the section you wish to change is highlighted.

3.

A prompt will appear in the Message Bar at the top of the display showing the current settings for that feature. Rotate the knob clockwise to increase the value, counter-clockwise to decrease the value.

AirLife® nCPAP Operator’s Manual

Figure 11: Parameter Change Screen When the desired value is displayed in the Message Bar, press the knob and release to activate the new set value. The value will set only on the release, not the press, of the knob. The change will automatically be canceled after ten (10) seconds of inactivity and the previous setting will remain unchanged. 4.

The flow rate displayed on the LCD screen indicates the flow rate exiting the patient outlet port. The “Target” flow is pre-set based on the CPAP setting. The flow is automatically adjusted to maintain the CPAP setting and it may normally vary from the Target flow.

5.

The Driver will automatically increase flow up to 3 lpm above the Target flow to compensate for normal leaks (i.e. leaks around prongs, masks, or through the patient’s mouth). • If a large leak exists at the patient, and cannot be corrected by adjusting the patient interfaces, then the Target flow may be set higher (up to 13 lpm) to provide more flow to compensate for leaks. If the leak is resolved, the Driver will automatically reduce the flow to maintain the set CPAP level. • The flow rate should not be less than 3 lpm. A “low flow” alarm will activate if the measured flow rate is less than 3 lpm and would indicate a possible occlusion of the expiratory limb or a defective circuit / generator. If this alarm occurs, check for pinched or kinked tubing, or replace the circuit and / or generator.

Standby Mode ® The AirLife nCPAP System Driver has a Standby Mode to allow the operator to mute the alarms for up to 20 minutes while at the bedside attending to the patient. The mode is selected by pressing and holding the Alarm Mute/Reset button until there is a single audible burst (approximately 3 seconds). The operator can exit the mode by pressing the Alarm

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Mute/Reset button or the system will automatically exit the mode and resume normal operation after 20 minutes. While in Standby Mode the system will operate normally with all audible alarms muted, with the exception of High Pressure and Low Flow. To indicate that the system is in Standby Mode, the Message Bar will display “Standby Mode” and the Alarm Mute Leeds will flash. There will also be a single audible burst every two (2) minutes while in Standby Mode. The driver will exit Standby Mode automatically if a High Pressure or Low Flow alarm occurs. Air or Oxygen Only Mode While switching Air and Oxygen supply hoses from one source to another (e.g. switching from tanks to wall sources), change one source at a time. This will help prevent interruptions in fresh gas flow to the patient. The ® AirLife nCPAP System Driver may be used with a single gas source if one gas source goes outside of the specified range (e.g. running out of gas) during normal operation. During such an event, the Driver will alarm and display the source fault in the Message Bar. In the absence of one gas source, the patient can only receive air (FiO2 ~ 21%) or Oxygen (FiO2 = 100%). If the fault cannot be corrected immediately, then the user may select “Air Only” or “Oxygen Only” operation in order to mute the alarm while the faulty gas source is corrected. When the faulty source pressure is corrected, the system will automatically return to normal operation (alarms will be delayed for 20 seconds) and blend gases to the previous set FiO2 value. Trending ® The AirLife nCPAP System Driver has a trend screen. This screen will display data for the previous 4, 8, 12, or 24 hours. Traces are displayed simultaneously on the screen, see Figure 12. The trending screen will allow the operator to know if there have been any fluctuations in the displayed parameters. Information stored for the previous patient is automatically removed when the unit is powered up.

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AirLife® nCPAP Operator’s Manual

Figure 12: Trending Display on Screen To access the Trend screen: 1.

Rotate the interface control knob until the ‘Trend’ feature is highlighted.

2.

Press and release the knob to activate the Trend screen.

3.

Rotate the knob to select the desired Trending time: 4, 8, 12, or 24 hours. The data that is displayed is not actively updating.

4. Press and release the knob to return to the main display. The system will also exit the Trend screen if an alarm condition occurs or after 120 seconds of inactivity.

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