Life support and monitoring apparatus with malfunction correction guidance

A life support and monitoring apparatus with malfunction correction guidance is provided. The life support and monitoring apparatus of the present disclosure identifies the root cause or potential cause of a fault/failure and then prompts an operator to take appropriate steps to assure the continuance of life support and critical physiologic monitoring. When multiple faults/failures exist, the apparatus automatically prioritizes them based on risk to the patient and prompts the operator to do the most appropriate intervention to assure patient safety.

BACKGROUND

The present disclosure relates generally to medical systems, and more particularly, to a life support and monitoring apparatus with malfunction correction guidance.

2. Description of the Related Art

Achieving adequate ventilation and oxygenation are the primary goals of life support systems. These goals are accomplished through the regular adjustment of parameters which control the number of breaths, the volume or pressure delivered with each breath, the inspired oxygen concentration (FIO2) and the end-expiratory pressure (PEEP). To manage these parameters, a number of controls provide for discrete adjustment of the gas flow, flow timing, air/oxygen (O2) mixing and airway pressure. Physiologic parameters such as oxyhemoglobin saturation (SpO2), end-tidal CO2(ETCO2), heart rate, blood pressure and temperature all play a critical role in the management of life support and are either monitored continuously or intermittently to assure homeostasis. A medical attendant is also responsible for maintaining a number of tubes and hoses (collectively known as the breathing circuit) which conduct gas to and from the patient and the physiologic sensors with their cables that attach to the patient for monitoring. Care providers must also monitor and manage the consumable resources (power, oxygen and compressed air, etc). Active monitoring and management of the patient and life support apparatus is typically guided by continuous noninvasive monitoring of oxygen saturation by pulse oximetry (Sp02), continuous sampling of exhaled carbon dioxide (ETCO2) as well as electrocardiogram (ECG), blood pressure (BP) both invasive and noninvasive, and temperature. Intermittent arterial blood sampling to measure arterial oxygen tension (Pa02), carbon dioxide tension (PaCO2), hydrogen ion concentration (pH) and the measured oxygen saturation (SaO2) is also required.

As a result of the inherent complexity of life support and the associated apparatus, care providers are required to constantly monitor and make adjustments to the apparatus to assure an appropriate level of support. Interruptions in care, even for a few breaths, can significantly affect mortality and/or patient recovery. So, when a fault or failure of the apparatus, breathing circuit, supporting resources (O2supply, power, etc), physiologic sensors or patient occurs, the care provider must immediately diagnose and intervene to assure life support is maintained. Conventional life support systems have used alarm systems that detect the fault or failure and indicate the alarm state by identifying whether a parameter or parameters are above or below the acceptable range along with an audible and visible alarm annunciation. The immediate need to respond requires that the care provider have sufficient clinical knowledge, experience with the apparatus in use and the ability to quickly survey the equipment, connections and patient condition to identify any physical disruptions in the life support system. Based on this rapid assessment, the care provider must prioritize their intervention so that patient care and safety are maintained. This alarm approach places the majority of the burden for a successful intervention and safety of the patient on the care provider and their experience.

Therefore, a need exists for automatic non-human techniques to identify causes of fault/failures in a life support and monitoring apparatus and to provide specific guidance and/or instruction on how to mitigate the fault/failure while safely managing the patient and equipment. Use of such techniques will have a broad impact on patient care as appropriate intervention will be less dependent on care provider memory of procedural training and experience.

SUMMARY

A life support and monitoring apparatus with malfunction correction guidance is provided. The life support and monitoring apparatus of the present disclosure identifies the root cause or potential cause of a fault/failure and then prompts an operator to take appropriate steps to assure the continuance of life support and critical physiologic monitoring. When multiple faults/failures exist, the apparatus automatically prioritizes them based on risk to the patient and prompts the operator to do the most appropriate intervention to assure patient safety.

To facilitate understanding, the images in the drawings are simplified for illustrative purposes and are not depicted to scale.

The appended drawings illustrate exemplary embodiments of the present disclosure and, as such, should not be considered as limiting the scope of the disclosure that may admit to other equally effective embodiments. Correspondingly, it has been contemplated that features or steps of one embodiment may beneficially be incorporated in other embodiments without further recitation.

In some embodiments, particular method steps of the discussed methods are performed in the depicted order. In alternate embodiments, in the respective methods, at least two method steps or portions thereof may be performed contemporaneously, in parallel, or in a different order.

DETAILED DESCRIPTION

The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any configuration or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other configurations or designs. Herein, the phrase “coupled with” is defined to mean directly connected to or indirectly connected with through one or more intermediate components. Such intermediate components may include both hardware and software based components.

Referring toFIG. 1, a life support and monitoring apparatus100having malfunction correction guidance is provided. The apparatus100includes a ventilator and physiologic monitoring module102for life support (e.g., supplying mechanical ventilation, supplemental O2and critical care monitoring) of a patient using an O2concentrator104coupled to the ventilator module102for supplying O2to the ventilator module in the apparatus100. The apparatus100further includes a patient breathing circuit106which includes supply tubes and a hose108for supplying breathing gas (e.g., air or some combination of air and O2) to the patient112and return connections110for sending sensed or measured physiologic data signals from the patient to the life support and monitoring apparatus102.

FIG. 2illustrates a block diagram of the life support and monitoring apparatus102. Generally, the apparatus102includes input connections for a plurality of sensors204, a plurality of analog-to-digital (A/D) converters206reside in the apparatus or are part of the sensor modules contained within the apparatus for converting the inputted sensors into digital form and a controller208controlling an output of the apparatus102based on the sensed parameters of the inputs. In one embodiment, the controller208will include a central processing unit (CPU) and/or a digital signal processor (DSP). The controller208is configured for receiving the digital signals from the A/D converters206to perform the necessary calculations for controlling the overall operations of the apparatus102.

A power supply210is also provided for providing power to components of the apparatus102. In one embodiment, the power supply210is coupled to an external power source, e.g., 120V power source. In another embodiment, the power supply210is coupled to an internal rechargeable battery integrated in the housing212of the apparatus102.

The life support and monitoring apparatus102of the present disclosure includes a user interface216for interacting with a user and for communicating events, alarms and instructions to the user. The user interface includes a display for providing visual indications to the user and a plurality of inputs or controls disposed on the housing for inputting information to the apparatus102. The display may include a touch screen, a liquid crystal display (LCD), a plurality of LED number segments, individual light bulbs or any combination of these. The display may provide the information to the user in the form of alpha-numeric lines, computer-generated graphics, videos, etc. Visual information provided on the display may include but is not limited to instructional videos, operating manuals associated with the ventilator, a flowchart for troubleshooting, a checklist for troubleshooting, etc. Digital files including the various visual instructions are stored in either memory216or retrieved from a remote event server.

The user interface216will also include an audible output device, e.g., a speaker. The speaker will be coupled to the controller208via a digital-to-analog converter (D/A) for converting digital audio files stored in memory216to analog signals playable by the speaker. The audible output device may simply provide audible instructions to a user when an event is detected or may provide audio with a corresponding video being displayed on the display.

The life support and monitoring apparatus102of the present disclosure will support various file types including but not limited to Microsoft Windows Media Video files (.wmv), Microsoft Photo Story files (.asf), Microsoft Windows Media Audio files (.wma), MP3 audio files (.mp3), JPEG image files (.jpg, .jpeg, .jpe, .jfif), MPEG movie files (.mpeg, .mpg, .mpe, .m1v, .mp2v .mpeg2), Microsoft Recorded TV Show files (.dvr-ms), Microsoft Windows Video files (.avi) and Microsoft Windows Audio files (.wav).

The memory216is configured for storing files executable by the controller, files associated with the visual and/or audible instructions and patient data collected from the life support and monitoring modules. The memory216includes internal storage memory, e.g., random access memory (RAM), or removable memory such as magnetic storage memory; optical storage memory, e.g., the various known types of CD and DVD media; solid-state storage memory, e.g., a CompactFlash card, a Memory Stick, SmartMedia card, MultiMediaCard (MMC), SD (Secure Digital) memory; or any other memory storage that exists currently or will exist in the future. By utilizing removable memory, the apparatus102can be easily upgraded with new instruction files as needed.

In one embodiment, the digital audio files may be programmed directly through the apparatus102. In this embodiment, the apparatus102will include an audio input device, e.g., a microphone, for receiving spoken words in the form of analog signals. The analog signals will then be sent to an analog-to-digital converter (ND) to convert the analog signals into digital signals understandable by the controller208. The controller208will then store the recorded digital audio file in the memory216or use the signals to control the device by hands-free voice control. The user may associate the recorded digital file with a particular alarm through the touch screen display. Alternatively, the user may associate the recorded digital file with an event code.

In a further embodiment, the life support and monitoring apparatus102will include an alarm module218to provide audible and visible alarm messaging separate from the user interface214for indicating alarms to a remote user.

The life support and monitoring apparatus102also includes a bidirectional communication interface219that provides for remote control and monitoring of the device using a wired communication system. In a further embodiment, the bidirectional communication interface219of the apparatus102will provide wireless command and control allowing remote clinicians to monitor and manage care.

The life support and monitoring apparatus102includes an O2inlet220for receiving O2from an O2concentrator or high-pressure O2source104and a fresh gas/emergency air intake222which are all piped to a 3-way mixing valve/ventilator module224. The fresh gas/emergency air intake222allows ambient air into the ventilator module102internal compressor and also functions as an internal antiasphyxia valve which allows the patient to breathe ambient air in the event of a ventilator module failure. The controller208will modulate the mixing valve/ventilator module224to achieve a determined level of FIO2which will be supplied to a patient via gas output226. The controller208will determine the proper level of FIO2based on the input sensors204, e.g., transducer input228, exhalation valve input230and physiologic sensors input232. It is to be appreciated that there can be any number of physiologic sensor inputs, e.g., SpO2, ETCO2input, a heart rate input, blood pressure input, temperature input, etc. An output port234, e.g., a USB port, is provided to communicate to and control the O2concentrator104.

The apparatus100provides a suite of alarms to alert the operator when conditions exceed parameter limits or when operation is affected by a patient, external and/or internal fault or failure. When an alarm occurs, the operator is alerted by audible and visual indicators while context sensitive help messages are displayed on the face of the housing of the apparatus.

FIG. 3Ais a flow diagram of an exemplary method for providing malfunction correction guidance of a life support and monitoring apparatus, e.g., a ventilator, in accordance with an embodiment of the present disclosure. Initially, the apparatus102will start-up and perform a self-test to ensure all subsystems are collectively working properly, step240. At step242, the controller208determines if there are any preexisting alarms. If there are preexisting alarms, the controller208will cause the display of the user interface214to display the alarm(s) and provide instructions on how to resolve the fault/failure, step244. Otherwise, at step246, the ventilator102will begin operation and continuously monitor the inputs to the ventilator102, step250.

At step250, the controller208of the apparatus102will determine if any fault/failure has occurred. If the controller208has determined a fault/failure has occurred, the controller208determines the fault/failure and its associated service code/alarm number, step252. The controller208then retrieves associated data from the memory216based on the determined service code/alarm number, step254. The controller208then causes the display of the user interface214to display the associated data. As will be described in more detail below, the associated data will include at least an alarm name and description, mitigation/resolution instructions, if not resolved instructions and an indication of the priority of the alarm.

In a further embodiment, when multiple faults/failures exist, the apparatus automatically prioritizes them based on risk to the patient and prompts the operator to do the most appropriate intervention to assure patient safety. Referring toFIG. 3B, the apparatus102will process the alarm or event as described above up to step254. If multiple alarms or events are active, the controller208will determine the highest active alarm category, in step258. Next, in step260, the controller208will determine a number of active alarms in the highest alarm category. The controller208will determine if the display needs to be updated based on the determined priorities of the active alarms, step262. If the display needs to be updated, the controller208will reset the current displayed alarm index with the highest alarm first (step264), i.e., the alarm with the highest priority. Otherwise, the controller208will display the current indexed alarm(s) in the active alarm list (step266).

In one embodiment, if multiple alarms or events are indexed and listed on the display, the operator may select the desired alarm to view the context-based mitigation instructions. In another embodiment, the prioritized alarms must be handled in a predetermined order. For example, the controller208will lock out the operator from viewing a lower priority alarm until the highest priority alarm is rectified.

Referring toFIG. 4, an exemplary configuration of a ventilator300in accordance with the teachings of the present disclosure is shown. The ventilator300includes various controls, indicators and connections. Their placement has been chosen to facilitate ease of use and visibility in all operating environments. The connections are labeled to correspond to the connections shown and described inFIG. 2. Control panel302incorporates all controls and a liquid crystal display (LCD) display304. The LCD display304provides continuous display of control settings, operating conditions, power, and alarm status information.

The core concept for operating all major functions of the apparatus300is by pressing a PARAMETER button308associated with the parameter an operator wishes to change. Pressing the PARAMETER button308highlights the primary parameter followed by the secondary parameters moving in a clockwise direction. When the desired parameter is highlighted, the operator turns the ROTARY ENCODER310clockwise or counter clockwise to adjust the parameter to the desired value. The operator then confirms that they want to operate with this new value by pressing the CONFIRM/SELECT button312. Once this is done the highlight goes away and the unit begins operation using the new parameter. At any point, the operator may cancel any operation and return to the primary operating screen by pressing the MUTE/CANCEL button314. When a parameter is selected (highlighted), it stays active for 5 seconds; after this time the unit automatically cancels the operation and returns to the default screen.

Each control will now be described with reference toFIG. 4.

HR (316)—Pressing the HR button316will highlight the current value of the High Heart Rate Alarm Limit and enable its value to be changed. Pressing the HR button a second time will highlight the current value of the Low Heart Rate Alarm Limit and enable its value to be changed. The HR parameters are functional only when the pulse oximeter is connected. Both limits are adjustable in 1 b/min increments. The default value at start up for the high alarm limit is 120 b/min; the low alarm limit is 40 b/min.

Sp02(318)—Pressing the SpO2button318will highlight the current Low SpO2Alarm Limit value. The SpO2display is active only when the pulse oximeter is connected. When no SpO2sensor is connected during start up or the operator turns off the pulse oximeter, “off” is displayed in the parameter window. The default value at start up is 94%.

FI02(320)—pressing the FIO2button320will highlight the current FIO2setting. The default value at start up is 21%.

PIP (PEAK INSPIRATORY PRESSURE) (322)—pressing the PEAK INSPIRATORY PRESSURE button322will highlight the high airway pressure alarm limit. The high alarm limit default value at start up is 35 cm H2O. Alarm values greater than 60 cm H2O require the user to perform a separate confirmation to assure the value is required to manage the particular patient.

Vt (TIDAL VOLUME) (324)—pressing the TIDAL VOLUME button324will highlight the current value and enable its current value to be changed. The default value at start up is 500 ml.

BPM (BREATHING RATE) (326)—pressing the BPM button326highlights the current value. The I:E ratio is also displayed in this window but cannot be changed by the operator. The default BPM value at start up is 12 BPM.

MODE (328)—Pressing the MODE button328allows the operator to select the mode of mechanical ventilation. The current embodiment provides for assist control (AC), synchronized intermittent mandatory ventilation (SIMV) and continuous positive airway pressure (CPAP) modes of ventilation with both volume and pressure breath targeting.

CONFIRM/SELECT (312)—press the CONFIRM/SELECT button312to confirm a new control setting or to select from a menu or setting option. The CONFIRM/SELECT button switch is labeled with a check green “✓”.

POWER OFF/ON (330)—turn the POWER OFF/ON switch330to apply or remove operating power to the EMV.

ROTARY ENCODER (310)—turn the ROTARY ENCODER310clockwise or counter clockwise to change a value or highlight a particular menu option.

ALARM MUTE/CANCEL (314)—press the MUTE/CANCEL pushbutton314to mute most Medium Priority Alarms, to cancel/acknowledge Low Priority Alarm or to cancel an action that is no longer desired (for example a control setting change). The MUTE/CANCEL pushbutton switch is labeled with a red “X”.

MENU (332)—pressing the MENU pushbutton332permits access to user menus and special functions. These may include: (1) Unit Info (Information): lists the serial number for the unit and critical subassemblies, software version, hours of use and last calibration date; (2) Trigger Level: allows the operator to adjust the assisted breath trigger from −6 to −1 cm H2O to optimize patient/ventilator interaction; the default value is −2 cm H2O below baseline; (3) Pulse Oximeter: allows the operator to turn the pulse oximeter on and off; (4) Power Up Settings: allows the operator to select startup settings different from the factory default settings; (5) Storage Mode Menu: allows the operator to configure storage mode to maximize available power or battery life; and (6) Contrast: allows the operator to adjust the contrast of the LCD to optimize visibility in the current lighting environment.

HR window (402) displays the HR and Low/High HR alarm limits. A heart icon is also displayed in this window when the pulse oximeter is in use. The icon flashes at the patient's heart rate. SpO2window (404) displays the SpO2value and the Low SpO2alarm limit. FIO2window (406) displays the set fraction of inspired O2. The peak inspiratory pressure (PIP) window (408) displays the peak airway pressure, positive end-expiratory pressure (PEEP) and High PIP alarm limit. The tidal volume (VT) window (410) displays the set tidal volume. BPM window (412) displays the set breath rate and the inspiratory:expiratory (I:E) ratio. MODE window (414) displays the operating mode.

BATTERY Icon/Indicator (416) indicates (1) the presence of a functional battery, (2) when the battery is charging and (3) the current battery capacity. The BATTERY icon appears in outline form and is filled with vertical rows of lines indicating its current capacity. When the battery is charging, these vertical lines cyclically scroll vertically, one row at a time, from the bottom row to the row that corresponds with the current level of charge. When the battery is fully charged, the icon416is completely filled with lines and scrolling stops. Each line represents approximately 10% of battery capacity. During internal battery operation, a vertical row “disappears” when battery capacity is reduced by a 10% increment. The BATTERY icon416will flash off/on when a Battery Power Low Alarm occurs. The icon416will flash off/on and present with a diagonal line when no battery is connected.

EXTERNAL POWER Icon/Indicator418indicates the presence of external power. When no external power is detected, the icon/indicator presents with a diagonal line. When an External Power Low or External Power Fail/Disconnect Alarm occurs, the icon flashes off/on.

OXYGEN SUPPLY Icon/Indicator420indicates the presence of external O2(55 psig source). The icon420only appears when external oxygen is detected by the pressure transducer. The icon420flashes off/on when the Oxygen Low/Fail Alarm occurs.

AIRWAY PRESSURE Graphic422provides a continuous display of airway pressure. Its absolute range is from −0 to 100 cm H2O ATPD with a horizontal resolution of 1 cm H2O/pixel. The scale below the indicator is graduated in 10 cm H2O increments with numerical markers appearing at 0, 50 and 100 cm H2O.

ALARM MESSAGE CENTER (AMC)424is a dedicated area located in the upper left-hand corner of the LCD display304. At the onset of an alarm, the AMC424displays the alarm name and then a series of context-sensitive help messages. These messages serve to guide the operator by presenting suggestions as to the cause and resolution of a particular alarm. When no alarm is present, the AMC displays “No Alarm”.

STATUS INDICATOR LED ARRAY426contains green450, yellow452, red454and infrared (IR)456LED's. During normal operation the STATUS INDICATOR LED ARRAY is enabled. The LED array illuminates green to indicate the presence of operating power and that all ventilator and patient parameters are within normal limits. A yellow indication by the LED array identifies a low priority alarm indicating that there is information about the device or patient that may require operator attention. Furthermore, the LED array illuminates yellow to indicate the presence of a persistent alarm condition, an operator-acknowledged low priority alarm that has not been resolved. The LED array illuminates red to indicate the presence of High and Medium Priority alarm conditions which require immediate intervention by the operator. The infrared LED is disabled during normal operation and enabled only in the “dark” operating mode. It is visible only to those wearing night vision goggles (NVG'S).

The exemplary apparatus300use a comprehensive suite of alarms to alert the operator and guide their actions to resolve alarm conditions and assure patient safety. The primary alarm message is displayed at the top of the AMC424while guidance and operator instructions are displayed below the alarm name. When multiple alarms occur, they are prioritized and displayed based on the risk to the patient. A complete description of each alarm and how the exemplary apparatus300controls alarm conditions will be described below in relation toFIGS. 7 and 8.

At the onset of an alarm, a multi-line message appears in the ALARM MESSAGE CENTER (AMC)424. The AMC424displays the alarm name with a series of messages to help the user resolve the alarm. The number of active alarms is indicated at the bottom of the AMC as a series of ALARM BELL icons with each bell indicating an active alarm. These messages are context-based and suggest what is causing the fault/failure and/or how it can be resolved. The AMC424presents alarm messages using the following format:

Alarm Name/Description428describes the nature and/or cause of the fault or failure. The Alarm Name/Description428appears at the top of the AMC424. When more than one alarm occurs at the same time, the ventilator300prioritizes them based on patient safety. Mitigation/Resolution Instructions430provide instructions for the operator as to how the alarm state may be resolved. The If Not Resolved instruction area432prompts the operator on what to do if they cannot resolve the alarm state. The instruction432is always shown in the following format ** Message . . . **.

When multiple alarms are active, the number of alarm bell icons corresponds to the number of active alarms. The alarm shown on the AMC424is illustrated by a solid bell. An outlined bell instead of a solid bell illustrates that other off-screen alarms. To view each active alarm, the operator turns the rotary encoder310to scroll through all active alarms.

The Service Code436for each alarm is displayed in the lower right hand corner of the AMC424. Each alarm is associated with a 4 digit number which helps the operator communicate with technical assistance or biomedical technician support. The TABLE reproduced at the end of this specification provides a listing of exemplary alarms including the alarm's service code, alarm description and mitigation information. Each service code uses the following format: 1###: high priority alarms; 2###: medium priority alarms; and 3###: low priority alarms.

The Attention Warning Icon438identifies the severity of the alarm, low, medium or high priority. Alarm priorities define the operational state of the device regarding its ability to provide mechanical ventilation. Each of the three priorities is described below.

High Priority: mechanical ventilation under operator control is no longer possible. This alarm category requires immediate intervention by the operator. It also includes system failure alarms where the CPU has failed and a backup has taken over to sound the audible and visual alarms and when the device is turned on and there is no internal or external power source. Pressing the Mute/Cancel pushbutton has no affect on the high priority alarm. The alarm can only be silenced by turning off the apparatus.

Medium Priority: mechanical ventilation is active or is possible (maybe for a finite period of time) but there is a failure/fault with the patient, ventilator circuit, a pneumatic subsystem or pulse oximeter. This alarm category requires immediate intervention by the operator. Pressing the Mute/Cancel pushbutton mutes the medium priority alarm for a fixed period between 30 and 120 seconds.

Low Priority: safe mechanical ventilation is active but, there is a fault that the operator must be aware of to assure safe management of the patient and/or ventilator. Low priority alarms present with both an audible and yellow LED alarm signal alerting the user to the condition. Pressing the Mute/Cancel pushbutton cancels the audible signal. If the alarm is not resolved, the yellow LED remains illuminated to remind the operator of the fault or failure.

Alarms are presented and grouped as categories rather than individual alarms because any given fault/failure may have a different affect on patient safety based on what operating resources are available (e.g., external O2, external power, etc.), environmental conditions and the severity of the fault/failure. In each case, the apparatus300analyzes the fault/failure and attempts to continue supporting the patient while guiding the operator to make an appropriate intervention to resolve the condition. For example, the controller208will determine a fault/failure based on the sensed parameters, e.g., patient airway pressure via transducer input228, pulse oximeter input232, etc. Once the fault/failure is determined, the controller208determines the service code/alarm number, retrieves the associated record from memory216and displays the associated information on display304. For example, referring toFIG. 7, the controller208determines that a patient disconnect has occurred. The controller determines that the service code/alarm number is #2100 and retrieves the associated information from the memory216. The associated information will be the parameters and instructions displayed on the display304. In this example, the alarm name/description428is “Patient Disconnect”. The mitigation/resolution instructions430provide five steps or items for the operator to perform in an attempt to rectify the problem. The If Not Resolved Instruction Area432instructs the operator to manually ventilate the patient if the mitigation instructions do not resolve the problem. In this example, the service code/alarm number436is displayed along with the Attention Warning Icon438which in this case signifies a medium priority alarm.

Although the disclosure herein has been described with reference to particular illustrative embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. Therefore numerous modifications may be made to the illustrative embodiments and other arrangements may be devised without departing from the spirit and scope of the present disclosure, which is defined by the appended claims.

TABLEServiceAlarm NameCodeAlarm description and mitigation information.1001Compressor Failure (Compressor Control Fault - No Backup)Alarm occurs when the compressor fails to operate or fails toprovide the flow required to deliver a breath and high-pressure O2(HP O2) is not available to provide ventilation.Mitigation/Info: Manually Ventilate Patient, Connect HP O2,Restart Ventilator With HP O2**Replace/Service Ventilator**1002Compressor Failure (Compressor Signal Chain Fault - No Backup)Alarm occurs when communication between the compressorcontroller and Smart Pneumatic Module (SPM) is lost and high-pressure O2(HP O2) is not available to provide ventilation.Mitigation/Info: Manually Ventilate Patient, Connect HP O2,Restart Ventilator With HP O2**Replace/Service Ventilator**1003Self Check FailureAlarm occurs when the flow from the first breath is ±20% of theexpected flow for the tidal volume at start up.Mitigation/Info: Manually Ventilate Patient**Replace/Service Ventilator**1010O2 Valve Failure (O2 Valve Failed Open)Alarm occurs when the O2valve fails in the open position whichresults in continuous inspiratory flow. When this occurs the unitautomatically opens the exhalation valve to prevent pressure fromaccumulating in the circuit and ventilation stops.Mitigation/Info: Manually Ventilate Patient**Replace/Service Ventilator**1011O2 Valve Failure (O2 Valve Control Fault - No Back Up)Alarm occurs when the signal to the O2valve is not delivering therequired flow rate and the compressor is not available to provideventilation.Mitigation/Info: Manually Ventilate Patient**Replace/Service Ventilator**1012O2 Valve Failure (O2 Valve Signal Chain Fault - No Backup)Alarm occurs when the communication between the O2valve andthe SPM fails and the compressor is not available to provideventilation.Mitigation/Info: Manually Ventilate Patient**Replace/Service Ventilator**1020O2 Supply Pressure Low (O2 Tank Pressure Low - No Backup)Alarm occurs when the O2supply pressure is ≦35 psig and thecompressor is not able to support ventilation. If the O2source canbe restored the unit should be cycled off then on to reset. By designthe unit will not reestablish O2operation unless the supply pressureis ≧40 psig. If the supply pressure is between 40 and 80 psig theoperator should check all hose connections for leaks. Occasionally,this alarm can be caused by a regulator that provides a staticpressure within range but is not able to provide the flow necessaryto meet the patient demand.Mitigation/Info: Manually Ventilate Patient, Connect 55 psig O2then Restart, Check O2 Supply for Leaks, Replace Regulator**Replace/Service Ventilator **1030Fresh Gas Intake Failure (Compressor Intake Blocked - NoBackup)Alarm occurs when the Fresh Gas/Emergency Air Inlet is blockedso that the compressor is not able to deliver flow sufficient for thecurrent settings and HP O2is not available to support ventilation.The operator should clear the blockage and restart the ventilator.Mitigation/Info: Manually Ventilate Patient, Clear Blocked Intake,Connect 55 psig O2, Restart Ventilator**Replace/Service Ventilator **1041O2 Supply Pressure HighAlarm occurs when the O2supply pressure is >80 psig. Pressuresabove 80 psig could result in a catastrophic failure, harm to thepatient and/or damage to the unit. While the patient is manuallyventilated the operator or assistant should seek to reduce the O2supply pressure. Sometimes this requires changing the regulatorwhich is not functioning as required. If the pressure cannot bereduced and a low flow device like a flow meter is available theoperator can provide supplemental O2via the optional low flow O2reservoir. To clear the alarm the unit should be turned off and thenrestarted with supply pressure in the appropriate range (40 to 79psig) or without HP O2connected.Mitigation/Info: Manually Ventilate Patient, Decrease O2 Supplyto 55 psig, Replace Regulator, Connect Low Flow O2,** Restart Ventilator without O2 Supply**1051Run-Time Calibration FailureAlarm occurs when there is a failure of the calibration system.When this occurs the patient should be manually ventilated, the unitremoved from use and sent for service.Mitigation/Info: Manually Ventilate Patient** Replace/Service Ventilator **1052Airway Pressure Sensing FailureAlarm occurs when communication between the airway pressuresensor and SPM is lost. When this happens the operator shouldmanually ventilate the patient, replace the ventilator and send theunit for service.Mitigation/Info: Manually Ventilate Patient** Replace/Service Ventilator **1060Exhalation System Failure (Exhalation Valve Failure)Alarm occurs when the exhalation control valve fails to operate.When this happens the unit stops ventilating and attempts todischarge the pressure in the breathing circuit to atmosphere. Thisfailure may be caused by a significant blockage of the exhalationvalve or an occlusion/kink in the exhalation valve tube. If possible,the operator should replace the breathing circuit and restart theventilator. If this does not resolve the problem then the operatorshould manually ventilate the patient, replace the ventilator andsend the unit for service.Mitigation/Info: Manually Ventilate Patient, Replace Circuit andRestart** Replace/Service Ventilator **1061Exhalation System Failure (Excessive Airway Pressure)Alarm occurs when the airway pressure (Paw) is above 40 cm H2Oor the PIP limit (when PIP limit is <35 cm H2O) for >5 seconds orwhen the Paw is above 75 cm H2O for >1.5 seconds. When thishappens the unit stops ventilating and attempts to discharge thepressure in the breathing circuit to atmosphere. This failure may becaused by a significant blockage of the exhalation valve or anocclusion/kink in the exhalation valve tube. If possible, the operatorshould replace the breathing circuit and restart the ventilator. If thisdoes not resolve the problem then the operator should manuallyventilate the patient, replace the ventilator and send the unit forservice.Mitigation/Info: Manually Ventilate Patient** Replace/Service Ventilator **11725 Volt Self Check FailureAlarm occurs when the 5 volt power bus fails to provide therequired voltage. If this failure occurs, the operator shouldmanually ventilate the patient, replace the ventilator and send theunit for service.Mitigation/Info: Manually Ventilate Patient, Ventilator NotFunctioning** Replace/Service Ventilator **1173Internal Comm Failure (Host Device Comm Failure)Alarm occurs when communication fails between one of thesubcomponents the host processor. If this failure occurs, theoperator should manually ventilate the patient, replace theventilator and send the unit for service.Mitigation/Info: Manually Ventilate Patient, Backup VentilatorEnabled** Replace/Service Ventilator **1174Off Set Self Check FailureAlarm occurs when the device is not able to calibrate the one ormore transducers and is no longer able to operate safely. If thisfailure occurs, the operator should manually ventilate the patient,replace the ventilator and send the unit for service.Mitigation/Info: Manually Ventilate Patient, Ventilator NotFunctioning** Replace/Service Ventilator **1175Internal Comm FailureAlarm occurs when there is a failure of the internal communicationbus and the host is not able to communicate with thesubassemblies. If this failure occurs, the operator should manuallyventilate the patient, replace the ventilator and send the unit forservice.Mitigation/Info: Manually Ventilate Patient, Ventilator NotFunctioning** Replace/Service Ventilator **1176Off Set Self Check FailureAlarm occurs when the calibration file fails its integrity check. Ifthis failure occurs, the operator should manually ventilate thepatient, replace the ventilator and send the unit for service.Mitigation/Info: Manually Ventilate Patient, Ventilator NotFunctioning** Replace/Service Ventilator **1420Complete Power FailureAlarm occurs when power is lost from both the internal battery andan external source during operation. When this occurs, the LCDblanks (no power for operation); the audible alarm pulses rapidly,and the visual alarm flashes rapidly. This alarm will lastapproximately two minutes.Mitigation/Info: No LCD Display1430Empty BatteryAlarm occurs when the internal battery power drops below theamount required to provide ventilation and external power is notconnected. When this occurs there is enough power to operate theuser interface and provide information to the operator. The patientshould be manually ventilated while an external source of power issought. To cancel the alarm and begin operation with externalpower the unit must be turned off and then back on.Mitigation/Info: Manually Ventilate Patient, Connect to ExternalPower, Restart Ventilator**Replace/Service Ventilator**1471Internal Comm FailureAlarm occurs when the device is no longer able to communicatewith the User Interface Module (UIM) and the interface controls.When this occurs ventilation continues at the current settings or thebackup mode settings and the high priority alarm sounds. Thepatient should be manually ventilated and the ventilator sent forservice.Mitigation/Info: Manually Ventilate Patient, Backup VentilatorEnabled** Replace/Service Ventilator**1472Internal Comm FailureAlarm occurs when the device is no longer able to communicatewith the Smart Pneumatic Module (SPM). When this occursventilation continues at the current settings or the backup modesettings and the high priority alarm sounds. The patient should bemanually ventilated and the ventilator sent for service.Mitigation/Info: Manually Ventilate Patient, Backup VentilatorEnabled** Replace/Service Ventilator**1473Internal Comm FailureAlarm occurs when no valid data is sent from the SPM within 1second. When this occurs ventilation continues at the currentsettings or the backup mode settings and the high priority alarmsounds. The patient should be manually ventilated and theventilator sent for service.Mitigation/Info: Manually Ventilate Patient, Backup VentilatorEnabled** Replace/Service Ventilator**1474Internal Comm FailureAlarm occurs when cyclic redundancy checking between theEMV+ and SPM fails. When this occurs ventilation continues at thecurrent setting or the backup mode settings and the high priorityalarm sounds. The patient should be manually ventilated and theventilator sent for service.Mitigation/Info: Manually Ventilate Patient, Backup VentilatorEnabled** Replace/Service Ventilator**1475LCD Control FailureAlarm occurs when the device has lost communication with thecontrast control and in most instances the content of the LCD is notvisible. When this occurs ventilation continues at the currentsettings or the backup mode setting and the high priority alarmsounds. The patient should be manually ventilated and theventilator sent for service.Mitigation/Info: Manually Ventilate Patient, Backup VentilatorEnabled** Replace/Service Ventilator**1480SPM Compatibility FailureAlarm occurs when the EMV+ and SPM software loads are notcompatible. This alarm is typically associated with an SPM changewhere the technician failed to update the EMV+ and SPM to thecurrent software revision. Ventilation is provided using the backupmode settings. The unit should be removed from use and sent forservice.Mitigation/Info: Manually Ventilate Patient, SoftwareCompatibility Failure** Replace/Service Ventilator **1485Power-On Self-Check FailureAlarm occurs when the Smart Pneumatic Module (SPM) softwarefails and is shut down. Powering the unit off allows the software toreset and may allow operation to continue.Mitigation/Info: Manually Ventilate Patient, Abnormal ResetDetected, Restart Ventilator** Replace/Service Ventilator **2001Compressor FaultAlarm occurs when the communication between the O2valve andthe SPM fails and HP O2is available to provide ventilation. Thealarm will continue to sound as a medium priority alarm until theuser acknowledges that ventilation is being provided using HP O2by setting the FIO2to 100%. At this time the priority changes tolow priority. While operating in this state the operator shouldassure an adequate supply of HP O2. Failure to maintain the HP O2supply will result in a high priority alarm.Mitigation: Operation Switched to O2 valve, Set FIO2 to 100%**Replace/Service Ventilator**2002Compressor FaultAlarm occurs when communication between the compressorcontroller and Smart Pneumatic Module (SPM) is lost and HP O2isavailable to provide ventilation. The alarm will continue to soundas a medium priority alarm until the user acknowledges thatventilation is being provided using HP O2by setting the FIO2to100%. At this time the alarm priority changes to low. Whileoperating in this state the operator should assure an adequatesupply of HP O2. Failure to maintain the HP O2supply will result ina high priority alarm.Mitigation: Operation Switched to O2valve, Set FIO2 to 100%**Replace/Service Ventilator**2003Compressor Fault (Compressor System CompressorCompromised - Backup Available)Alarm occurs when the SPM detects a fault with the compressorflow measuring system and HP O2is available to provideventilation. The alarm will continue to sound as a medium priorityalarm until the user acknowledges that ventilation is being providedusing HP O2by setting the FIO2to 100%. At this time the alarmpriority changes to low. While operating in this state the operatorshould assure an adequate supply of HP O2. Failure to maintain theHP O2supply will result in a high priority alarm.Mitigation: Flow Measurement Problem Detected, OperationSwitched to O2Valve, Ventilate at FIO2= 100%.**Replace/Service Ventilator**2011O2 Valve FaultAlarm occurs when the signal to the O2valve is outside of thecalibration range for the required flow rate and the compressor isavailable to provide ventilation. The medium priority alarm willcontinue until the user acknowledges that ventilation is beingprovided using the compressor by setting the FIO2to 21%. At thistime the alarm priority changes to low priority. While operating inthis state the operator should monitor the SpO2to assure thatadequate oxygenation is maintained. If low flow O2is available itcan be entrained through the Fresh Gas/Emergency Air Intake portusing the optional O2reservoir. Maintain an acceptable SpO2byadjusting the O2supply up or down to increase or decrease theamount of O2delivered to the patient.Mitigation: Operation Switched to Compressor, Set FIO2To 21%,Connect Low Flow O2, Monitor SpO2**Replace/Service Ventilator**2012O2 Valve FaultAlarm occurs when the communication between the O2valve andthe SPM fails and the compressor is available to provideventilation. The alarm will continue to sound as a medium priorityalarm until the user acknowledges that ventilation is being providedusing the compressor by setting the FIO2to 21%. At this time thealarm priority changes to low. While operating in this state theoperator should monitor the SpO2to assure that adequate oxy-genation is maintained. If low flow O2is available it can beentrained through the Fresh Gas/Emergency Air Intake port usingthe optional O2reservoir. Maintain an acceptable SpO2by adjustingthe O2supply up or down to increase or decrease the amount of O2delivered to the patient.Mitigation/Info: Operation Switched to Compressor, Set FIO2 To21%, Connect Low Flow O2, Monitor SpO2**Replace/Service Ventilator**2020O2 Supply Pressure LowAlarm occurs when the O2supply pressure is <35 psig and thecompressor is able to support ventilation. When this occurs the unitbegins ventilation using the compressor. The alarm will continue tosound as a medium priority alarm until the user acknowledges thatventilation is being provided using the compressor by setting theFIO2to 21%. Pressing the MUTE/CANCEL button cancels thisalarm completely.NOTE: The device is designed to work with or without external O2.If HP O2is connected the unit will not continue O2operation unlessthe supply pressure is ≧40 psig. This is done to prevent continuouscycling between alarms during the inspiratory phase and no alarmduring the expiratory phases. If low flow O2is available it can beentrained through the Fresh Gas/Emergency Air Intake port usingthe optional O2reservoir. Maintain an acceptable SpO2by adjustingthe O2supply up or down to increase or decrease the amount of O2delivered to the patient.Mitigation/Info: Operation Switched to Compressor, Check O2Supply Pressure, Check/Replace Regulator, Set FIO2 to 21%.Connect Low Flow O2, Monitor SpO2**Replace/Service Ventilator **2030Fresh Gas Intake FaultAlarm occurs when the Fresh Gas/Emergency Air Inlet is blockedso that the compressor is not able to deliver a breath within ±10%of the current settings and HP O2is available to support ventilation.When this occurs the ventilator immediately switches to HP O2powered ventilation. To clear the alarm first set the FIO2to 100% toacknowledge that the patient is being ventilated at 100%, clear theblockage and then set the FIO2back to the original value. If theblockage has been cleared operation with the compressor willrestart. If the blockage cannot be cleared, the alarm will resound,continue ventilation with FIO2set to 100% and assure an adequatesupply of HP O2.Mitigation/Info: Operation Switched to O2 Valve, Clear BlockedIntake, Set FIO2 to 100%, Monitor SpO2**Replace/Service Ventilator **2053Suspicious TriggersAlarm occurs when airway pressure sensor fails to calibrate duringthe expiratory phase of a breath. When this occurs the unitattempts to reestablish a baseline by momentarily setting PEEP to 0cm H20 and suspending triggered breaths. This interruption lasts nolonger than 2 breath cycles. The operator should also check forleaks in the hose and tubes; patient airway and exhalation valve. Ifrecalibration is successful the alarm will automatically cancel. If itcannot, the patient should be manually ventilated; the unit shouldbe replaced and sent for service.Mitigation/Info: Attempting Self Calibration, MomentarilyDisabling Triggers and PEEP, Check Circuit ForLeaks/Disconnects, Check Tube Placement/Cuff**Replace/Service Ventilator**2062Exhalation FaultAlarm occurs when the airway pressure (Paw) measured at the endof expiration is >5 cm H20 above the baseline pressure (PEEPpressure). This is typically caused by a restriction of the exhalationvalve or an occlusion/kink in one or more of the breathing circuittubes or hose. If the breathing circuit tubes appear to be intact thecircuit should be replaced to eliminate the possibility of a badexhalation valve. If the condition does not resolve the operatorshould manually ventilate the patient, replace the ventilator.Mitigation/Info: Check Circuit for Kinked Hose/Tube, Check forBlocked Exhalation Valve, Replace Circuit, Replace/ServiceVentilator** Manually Ventilate Patient**2070Airway Pressure HighAlarm occurs when the Paw is greater than the high airwaypressure limit. When this occurs flow decelerates to maintain Pawat the high airway pressure limit for the duration of the breath(inspiratory time). The operator should check for kinks or blockageof the breathing circuit, exhalation valve or patient airway. In someinstances the cause can be an accumulation of secretions in theairway which will require suctioning to clear. The operator shouldalso assess if the patient is fighting the ventilator (dyssynchrony) orif the high airway pressure limit is set too low.Mitigation/Info: Pressure Exceeds Limit Setting, Check Circuit forKinked Hose/Tube, Check for Airway Obstruction, Suction Airwayif Necessary, PIP Limit Set Too Low?** Manually Ventilate Patient**2071Low Airway PressureAlarm occurs when the Paw is less than the low airway pressurelimit. When this occurs flow increases to maintain the Paw for theduration of the breath (inspiratory time). The operator should checkfor leaks/disconnects in the breathing circuit, patient airway or afailure of the exhalation valve. The operator should also assess ifthe patient is breathing with the ventilator (dissynchrony) or if thelow airway pressure limit is set too high. If a replacement isavailable the operator should replace the breathing circuit. If thesemitigations do not resolve the alarm condition then, the ventilatorshould be replaced and sent for service.Mitigation/Info: Check Patient Connection, Check Circuit ForLoose Hose/Tube, Check Exhalation Valve, Check TubePlacement/Cuff, Is Low Limit Set Correctly?** Manually Ventilate Patient**2072High Tidal VolumeAlarm occurs when operating with a pressure target and the deliv-ered tidal volume exceeds the operator defined limit. This can becaused by a leak in the patient connection or breathing circuit.When the ventilator is not able to reach the pressure target flowincreases to compensate which leads to the high delivered tidalvolume. The operator should check for leaks/disconnects in thebreathing circuit, patient airway or a failure of the exhalation valve.The operator should also assess if the patient is anxious and breath-ing deeply or if the high tidal volume limit is set too low. If a re-placement is available the operator should replace the breathingcircuit.Mitigation/Info: Check Patient Connection, Check Circuit ForLoose Hose/Tube, Check Exhalation Valve, Check TubePlacement/Cuff, Is High Limit Set Correctly?** Monitor Patient**2073Low Tidal VolumeAlarm occurs when operating with a pressure target and the deliv-ered tidal volume does not reach the operator defined limit. Whenthis occurs flow decelerates to maintain the Paw at airway pressurelimit for the duration of the breath (inspiratory time). If the PIPsetting is set properly the breath should be greater than the lowlimit (provided it is set properly as well). The operator shouldcheck for kinks or blockage of the breathing circuit or patient air-way. In some instances the cause can be an accumulation ofsecretions in the airway which will require suctioning to clear. Theoperator should also assess if the patient is fighting the ventilator(dissynchrony) or if the high airway pressure limit is set too low.Mitigation/Info: Check Circuit For Kinked Hose/Tube, Check ForAirway Obstruction, Suction Airway If Necessary, Volume LimitToo Low?** Manually Ventilate Patient**2074High Breath RateAlarm occurs when the actual breathing rate (set rate plus spontan-eous patient rate) exceeds the high alarm limit. This can be causedby the patient breathing too fast due to anxiety or pending respira-tory failure. It can also be caused by autotriggering due to a leak orthe when the spontaneous/assisted breath trigger is set too close tothe baseline pressure (PEEP). The operator should check forleaks/disconnects in the breathing circuit, patient airway or a failureof the exhalation valve. The operator should also assess if thepatient is anxious and breathing deeply or if the high tidal volumelimit is set too low. If a replacement is available the operator shouldreplace the breathing circuit.Mitigation/Info: Check For Loose Hose/Tube, Is Trigger Level TooSensitive, Is High Alarm Limit Set Correctly?** Consult Physician**2075Low Breath Rate/ApneaAlarm occurs when the actual breathing rate (set rate plus spontan-eous patient rate) is less than the low alarm limit. This can becaused by the patient not breathing or breathing at a rate less thanthe limit. If the spontaneous/assisted breath trigger is not sensitiveenough the patient may not be able to trigger breaths. The operatorshould also determine if the low rate is set too high for the patient.Mitigation/Info: Is Patient Breathing Spontaneously?, Is TriggerLevel Sensitive Enough?, Is Low Alarm Limit Set Correctly?,Increase Ventilation Support** Manually Ventilate Patient**2090PEEP LeakAlarm occurs when Paw drops below the PEEP setting by 2 cmH20 during the expiratory phase of the breath. This can be causedby a leak in the breathing circuit, exhalation valve or patient air-way. The operator should check the breathing circuit and exhala-tion valve to assure that all connections are tight. When the circuitappears damaged or is suspect it should be replaced. The operatorshould also check if there is a leak around the cuff of the patient'sairway. If these mitigations do not resolve the alarm condition then,the ventilator should be replaced and sent for service.Mitigation/Info: Check Patient Connection, Check Circuit ForLoose Hose/Tube, Check Exhalation Valve, Check TubePlacement/Cuff** Replace Circuit**2091Gas TrappedAlarm occurs when the exhaled flow from the patient continuesthroughout the expiratory period causing the expiratory controlvalve to cycle throughout the period to maintain the baselinepressure. When this occurs the operator should increase the expira-tory period by decreasing the inspiratory time, decreasing thebreathing rate or both. The physician should also be consulted.Mitigation/Info: Incomplete Exhalation, Increase Expiratory Time,Decrease Inspiratory Time, Decrease Respiratory Rate** Consult Physician**2095Insufficient FlowAlarm occurs when the pressure target is not reached during theinspiratory period during pressure targeted ventilation. Typicallythis can occur when the ventilator is configured to start withpediatric settings and the max flow has been set below 100liters/min in anticipation of the pediatric patient. The default settingfor adult breathing is 100 liters/min. To adjust the max flow, pressand hold the BPM parameter button (during pressure targetedbreathing) and adjust the max flow up or down based on the patientflow requirement. If the flow cannot be adjusted appropriately thenthe patient should be ventilated using volume targeted ventilation.Mitigation/Info: Pressure Target Not Met, Increase Max Flow,Press/Hold BPM Button** Ventilate With Volume Target**2100Patient DisconnectAlarm occurs when the Paw fails to exceed the PEEP setting by ~7cm H2O. When this occurs the operator should quickly check thepatient connection, breathing circuit connections and the exhalationvalve. At times this alarm can be caused by the patient breathingwith the ventilator during inspiration which prevents the Paw frompassing the minimum pressure. While resolving the alarm conditionthe operator should be sure to manually ventilate the patient.Mitigation/Info: Check Patient Connection, Check Circuit forLoose Hose/Tube, Check Exhalation Valve, Patient Breathing WithVentilator?, Replace Circuit**Manually Ventilate Patient**2300Pulse Ox Module FailedAlarm occurs when the pulse oximeter module fails while in use.There is no operator intervention. When the alarm is active “-- --”will display in the HR and SpO2 windows. Pressing theMute/Cancel button silences the audible alarm for 30 seconds. Toresolve the alarm, remove the probe from the unit and turn off thepulse oximeter function. in the user menu.Mitigation/Info: Internal Failure, SpO2/HR Not Available, TurnOff Pulse Ox**Replace/Service Ventilator**2301Internal Comm FailedAlarm occurs when the communication between the pulse oximetermodule and unit fails. When this occurs the operator is required toturn off the pulse oximeter monitor to end the alarm condition.When this is done “off” appears in the data windows for SpO2andHR as those parameters are no longer available. When appropriatethe operator should replace the ventilator and send it for service.Mitigation/Info: Pulse Ox Module Failure, SpO2/HR NotAvailable, Turn Off Pulse Ox**Replace/Service Ventilator**2314SpO2 Sensor Off PatientAlarm occurs when an operating sensor losses the patient signal.The most common cause is when the sensor disconnects from thepatient or is misaligned with the sensor site. This alarm can also becaused by poor perfusion at the sensor site which doesn't allow fora reading. In these cases try another site. Replace the sensor ifanother sensor is available. If the alarm condition cannot beresolved the operator should turn off pulse oximetry monitoring.Mitigation/Info: Check SpO2Sensor Site, Check Patient forPeripheral Pulse, Change Site, Check Sensor Operation, ReplaceSensor**Turn Off SpO2Monitoring. **2401SpO2 LowAlarm occurs whenever the SpO2value drops below the Low SpO2Limit. The default value for the limit is 94%. Corrective actions areincreasing oxygenation by increasing the FIO2or PEEP settings.PEEP should only be changed based on consultation with theattending physician. When using low-flow O2the operator shouldincrease the flow of O2into the optional low flow O2reservoir.Mitigation/Info: SpO2Below Limit, Increase FIO2, Check O2Supply, Increase PEEP Per Physician Order**Consult Physician**2410Heart Rate HighAlarm occurs when the heart rate is greater than the High HeartRate Limit. The default value for the limit is 120 beats/minute. Theoperator should consult with the attending physician on how best toreduce the heart rate to an acceptable level.Mitigation/Info: Heart Rate Above Limit**Consult Physician**2411Heart Rate Low (Pulse Rate Low)Alarm occurs when the heart rate is less than the Low Heart RateLimit. The default value for the limit is 40 beats/minute. Theoperator should consult with the attending physician on how best toincrease the heart rate to an acceptable level.Mitigation/Info: Heart Rate Below Limit**Consult Physician**2421Input Protection Circuit FailedAlarm occurs when there is a failure of the input protection circuitand the unit is able to operate. The alarm will continue until theunit is turned off. The operator can mute the alarm for 30 secondsby pushing the MUTE/CANCEL button. The operator shouldreplace the unit and send it for service.Mitigation/Info: Input protection circuit failure, Power SystemNeeds Repair**Replace/Service Ventilator**2423Power Circuit Hardware FaultAlarm occurs when the internal power circuit has failed andexternal power is connected but cannot be used. The fault cannot berepaired by the operator. Pressing the Mute/Cancel button silencesthe audible alarm for 30 seconds.Mitigation/Info: Power System Needs Repair, Internal BatteryOperation** Replace/Service Ventilator**2430Low BatteryAlarm occurs when the unit detects that there is ≦5 minutes ofbattery operation remaining and external power is not connected.The operator should immediately seek a source of external powerand/or plan to provide manual ventilation. Attaching externalpower will immediately clear the alarm though a low priority alarmwill be maintained until the internal battery has recharged so thatthe unit can provide 30 minutes of operating time (~5 to 10minutes).Mitigation/Info: Less Than 5 Minutes Operation, Connect ExternalPower, Assure Ability to Manually Ventilate** Replace/Service Ventilator**2450Battery Fault - No External Power ConnectedAlarm occurs when the battery temperature reaches 70° C. (158°F.) which is 5° C. from its maximum operating temperature usingthe internal battery and external power is not connected. When thebattery temperature reaches 75° C. (167° F.) the battery will shutdown to prevent failure and the unit will sound a high priorityalarm and shutdown. If possible the operator should provide asource of external power which would allow operation to continueat the current and higher temperatures. In addition, the unit shouldbe removed from the soft case which acts as insulation. Shading thepatient and ventilator from direct sunlight may also help reduce thebattery temperature.Mitigation/Info: Battery Within 5° C. of High Limit, RemovePadded Case, Connect External Power, Assure Ability to ManuallyVentilate, Shade Patient and Ventilator**Move To Cooler Location**2455Battery Fault - No External Power ConnectedAlarm occurs when the EMV+ is not able to communicate with theinternal battery. When this occurs the device does not know thecurrent charge in the batter and operation could stop at anytime. Tocontinue operation and the operator should connect external powerand assure the ability to manually ventilate the patient. Whenexternal power is connected the alarm priority decreases to LowPriority.Mitigation/Info: Battery Comm Failure, Connect External Power,Assure Ability to Manually Ventilate Patient**Replace/Service Ventilator**3001Compressor FaultAlarm occurs when the compressor fails to operate or fails toprovide the flow required to deliver a breath within ±10% of thecurrent settings, HPO2is available to provide ventilation and theoperator has set the FIO2to 100%. While operating in this state theoperator should assure an adequate supply of HPO2. Failure tomaintain the HPO2supply will result in a high priority alarm.Mitigation: Assure 55 psig O2, O2 Operation Only!**Replace/Service Ventilator**3002Compressor FaultAlarm occurs when communication between the compressorcontroller and SPM is lost, HPO2is available to provide ventilationand the operator has set the FIO2to 100%. While operating in thisstate the operator should assure an adequate supply of HPO2.Failure to maintain the HPO2supply will result in a high priorityalarm.Mitigation: Assure 55 psig O2 Supply, O2 Operation Only!**Replace/Service Ventilator**3011O2 Valve FaultAlarm occurs when the signal to the O2valve is outside of thecalibration range for the required flow rate, the compressor isavailable to provide ventilation and the operator has acknowledgedthat ventilation is being provided using the compressor by settingthe FiO2to 21%. While operating in this state the operator shouldmonitor the SpO2to assure that adequate oxygenation is main-tained. If low flow O2is available it can be entrained through theFresh Gas/Emergency Air Inlet port using the optional O2reservoir.Maintain an acceptable SpO2by adjusting the O2supply up or downto increase or decrease the amount of O2delivered to the patient.Mitigation: Compressor Operation Only!, Keep FIO2at 21%,Connect Low Flow O2, Monitor SpO2**Replace/Service Ventilator**3012O2 Valve FaultAlarm occurs when communication between the O2valve is lost,the compressor is available to provide ventilation and the operatorhas set the FIO2to 21%. While operating in this state the operatorshould monitor the SpO2to assure that adequate oxygenation ismaintained. If low flow O2is available it can be entrained throughthe Fresh Gas/Emergency Air Inlet port using the optional O2reservoir. Maintain an acceptable SpO2by adjusting the O2supplyup or down to increase or decrease the amount of O2delivered tothe patient.Mitigation/Info: Operation Switched to Compressor!, Keep FIO2 at21%, Connect Low Flow O2, Monitor SpO2**Replace/Service Ventilator**3030Fresh Gas Intake FaultAlarm occurs when the Fresh Gas/Emergency Air Inlet is blockedso that the compressor is not able to deliver breaths within ±10% ofthe current settings, HPO2is available to support ventilation and theoperator has set the FIO2to 100%. To clear the alarm, clear theblockage and set the FIO2back to the original value. If the blockageis cleared operation with the compressor will restart. If theblockage is not cleared, the alarm will resound, set the FIO2to100%, continue ventilation and assure an adequate supply of HPO2.Mitigation/Info: O2 Valve Operation, Clear Blocked Intake &Retry Compressor, Keep FIO2 at 100%, Monitor SpO2**Replace/Service Ventilator **3031Fresh Gas Intake FaultAlarm occurs when the Fresh Gas/Emergency Air Inlet is blockedbut is still capable of delivering breaths within ±10% of the currentsettings. This could be caused by an external blockage or a dirtyexternal or internal filter (refer to instructions for changing theinternal filter). If the blockage is cleared the alarm willautomatically cancel.Mitigation/Info: Clear Restricted Intake**Replace/Service Ventilator **3032Fresh Gas Intake FaultAlarm occurs when communication between the FreshGas/Emergency Air Inlet pressure sensor has been lost. Normaloperation can continue but, if the condition is not cleared bypowering off and restarting the unit should be sent for service.When used during this alarm condition the operator should be sureto keep the Fresh Gas/Emergency Air Inlet clear and assure thatexternal filters are checked regularly.Mitigation/Info: Intake Pressure Sensor Failure, Unable to DetectFilter Obstruction**Replace/Service Ventilator **3041O2 Supply Pressure HighAlarm occurs when the O2supply pressure is ≧75 psig. The alarmautomatically cancels when the supply pressure drops below 66psig. Pressures above 80 psig could result in a catastrophic failure,harm to the patient and/or damage to the unit. The operator shouldseek to reduce the O2supply pressure, sometimes this requiresreplacing the regulator which is not functioning as required. If thepressure cannot be reduced and a low flow device like a flow meteris available the operator can provide supplemental O2via theoptional low flow O2reservoir. If not, the operator should monitorthe HPO2supply pressure and assure that the pressure does not risefurther.Mitigation/Info: Decrease O2Supply Pressure, Replace Regulator,Connect Low Flow O2, Monitor SpO2** Restart Ventilator without HPO2**3110RTC Battery FaultAlarm occurs when the real-time clock (RTC) battery is <~2.5volts. The alarm condition is checked at start up and if this alarmoccurs the unit is safe to operate but the operator should look totake the unit out of service when appropriate and send it for service.Changing the battery requires opening the unit and should only bedone by a trained service technician. The RTC battery providespower for the storage of critical information used by the ventilatorduring startup.Mitigation/Info: RTC Battery Low, Schedule Service Immediately**Replace/Service Ventilator**3120Self Check FaultAlarm occurs at start up when the preselected number of days haselapsed from the last calibration. When appropriate the unit shouldbe sent for service. The low priority message serves as a reminder.Calibration is due every 365 days. Operators should schedule theunit for service as soon as possible.Mitigation/Info: Calibration Due, Schedule Service Immediately**Replace/Service Ventilator**3130Ambient Pressure Fault (Excessive Altitude Sensor Failure)Alarm occurs when the ambient pressure transducer fails. Whenthis occurs, the unit is no longer able to automatically compensatefor changes in altitude especially in situations where the ambientpressure could change rapidly as during air transport. When used inthese conditions the operator should monitor the airway pressureand reduce the tidal volume to maintain the airway pressure asaltitude is increased. During descent, the tidal volume should beincreased to maintain Paw if it was adjusted while at altitude.Operators should also monitor chest rise and breath sounds toassure adequate ventilation.Mitigation/Info: Barometric Pressure Sensor, AltitudeCompensation Disabled, Maintain Airway Pressure, Check PatientChest Rise, Avoid Use At Varying Altitude**Replace/Service Ventilator**3131Ambient Pressure Fault (Excessive Altitude)Alarm occurs when the ambient pressure transducer detects analtitude >25,000 feet (7620 meters). Beyond this altitudecompensation remains fixed at the 25,000 ft compensation level.The operator should monitor the Paw and reduce the tidal volumeas altitude increases. During descent the tidal volume should beincreased to its original value once the unit has returned to thecompensated altitude. Where possible cabin pressure should bemaintained in the compensated range.Mitigation/Info: Excessive Altitude Detected, Beyond AltitudeCompensation Limit, Maintain Airway Pressure, Check PatientChest Rise, Monitor Ventilator/Patient**Reduce Altitude**3132Ambient Pressure Fault (Excessive Altitude)Alarm occurs when the ambient pressure transducer detects analtitude <−2,000 feet below sea level (610 meters, 15.8 psig or1089 mb). This state can be caused by use in subterranean rescueoperation or mistaken use in a hyperbaric chamber. Beyond thispressure level compensation remains fixed at the −2,000 ft level.NOTE: the EMV+ is not intended for use in hyperbaric chambersor at hyperbaric pressures.Mitigation/Info: High Barometric Pressure Detected, BeyondCompensation Limit, Maintain Airway Pressure, Check PatientChest Rise, Monitor Ventilator/Patient**Reduce Ambient Pressure**3140Operational Temperature Fault (Excessive Temperature High)Alarm occurs when the ambient temperature exceeds the normaloperating range (>131° F., 55° C.) for the ventilator. The unitallows operation at these temperatures but alerts the operator to thecondition. Operating above the specified range can affect thelongevity of the internal battery and the duration of operating time.When operating at high temperatures the operator should removethe softcase which insulates and increases the ventilator's internaltemperature.Mitigation/Info: High Temperature Detected, Remove PaddedCase,**Monitor Ventilator**3141Operational Temperature Fault (Excessive Temperature Low)Alarm occurs when the ambient temperature falls below the normaloperating range (<14° F., −10° C.) for the ventilator. The unitallows operation at these temperatures but alerts the operator to thecondition. Operating below the specified range can affect thelongevity of the internal battery and the duration of operating time.At extreme cold temperatures operating time can be significantlyreduced. When operating at low temperatures the operator shoulduse the softcase which insulates and increases the ventilator'sinternal temperature.Mitigation/Info: Low Temperature Detected, Use Padded Case**Monitor Ventilator**3143Self Check FaultAlarm occurs when the failure of the internal temperature sensors.When this occurs the unit is not longer able to detect if it isoperating outside of the allowable temperature range. If operatinginside of the standard temperature range −25° C. to 49° C. (−13° F.to 120° F.) there is not affect on operation. If operating outside thisrange the operator should monitor the unit continuously. Whenappropriate the operator should replace the ventilator and send itfor service.Mitigation/Info: Temperature Sensor Fault, Temperature ChangesDo Not Affect Autocal Cycle, Schedule Service Immediately**Replace/Service Ventilator**3300SpO2 Shutdown (MS 11 Failure - Monitor Not In Use)Alarm occurs when the pulse oximeter module fails and theoperator has turned off pulse oximeter monitoring acknowledgingthe condition. When this is done “off” appears in the data windowsfor SpO2and HR as those parameters are no longer available. Whenappropriate the operator should replace the ventilator and send itfor service.Mitigation/Info: Internal Failure, SpO2/HR Not Available**Replace/Service Ventilator**3301SpO2 Shutdown (Comm Failure EMV-Pulse Ox - Monitor Not InUse)Alarm occurs when the communication between the pulse oximetermodule and unit fails and the operator has turned off pulse oximetermonitoring acknowledging the condition. When this is done “-- --”appears in the data windows for SpO2and HR as those parametersare no longer available. When appropriate the operator shouldreplace the ventilator and send it for service.Mitigation/Info: Pulse Oximeter Module Failure**Replace/Service Ventilator**3310No SpO2 Sensor Connected (No Sensor Connected)Alarm occurs when the pulse oximeter detects that no SpO2sensoris connected after a period of successful operation.NOTE: during start up the unit automatically detects if a sensor isconnected. If it is, the unit begins operation with the pulse oximeteractive. If no sensor is detected the unit turns off this function.If the sensor is properly connected this failure can also be the resultof a broken or defective sensor. If the alarm condition cannot beresolved the operator should remove the sensor and turn off pulseoximetry monitoring in the user menu.Mitigation/Info: Check Pulse Ox Sensor, Check Sensor/VentilatorConnection, Reinsert Sensor, Cable/Sensor Damaged?, ReplaceSensor**Turn Off Pulse Ox Monitoring**3311Defective SensorAlarm occurs when the pulse oximeter cannot identify theconnected sensor or the sensor has failed. Causes for this alarminclude broken sensor cable, inoperative LEDs and/or faultydetector. If the alarm condition cannot be resolved the operatorshould turn off pulse oximetry monitoring.Mitigation/Info: Check SpO2Sensor, Check Sensor Connector atVentilator, Reinsert Sensor, Cable/Sensor Damaged?, ReplaceSensor**Turn Off SpO2Monitoring**3312SpO2 Pulse SearchAlarm occurs when the pulse oximeter is searching for a pulse. Ifvalues are not displayed within 30 seconds disconnect andreconnect sensor and reapply to patient. If pulse search continues,remove sensor and replace on a better perfused site. Replace thesensor if another sensor is available. If the alarm condition cannotbe resolved the operator should turn off pulse oximetry monitoring.Mitigation/Info: Please Wait, Check Sensor Placement/ChangeSite, Minimize Patient Movement, Check SensorOperation/Replace**Turn Off SpO2Monitoring**3313SpO2 Signal InterferenceAlarm occurs when an outside signal or energy source preventaccurate reading by the device. When this occurs the patient shouldbe moved from the location or pulse oximeter turned off.Mitigation/Info: External Signal Interfering With Measurement,Remove Patient From Location**Turn Off SpO2Monitoring**3315Too Much Ambient LightAlarm occurs when there is too much ambient light on the SpO2sensor or there is inadequate tissue covering the sensor detector.Most often this alarm condition can be resolved by shielding thesensor from ambient light.Mitigation/Info: Shield Sensor From Light, Change SensorLocation, Check Sensor Operation, Replace Sensor**Turn Off SpO2Monitoring**3316Invalid SpO2 Sensor (Unrecognized Sensor)Alarm occurs does when the pulse oximeter does not recognize theconnected sensor. The alarm can also occur when there is a brokensensor cable, inoperative LEDs, a fault is detected and/or the sensorhas failed. To resolve the alarm condition the sensor should bereplaced. If the alarm condition cannot be resolved the operatorshould turn off pulse oximetry monitoring.Mitigation/Info: Replace Sensor**Turn Off SpO2Monitoring**3317Low SpO2 Perfusion (Low Perfusion)Alarm occurs whenever the amplitude of the arterial pulsation isweak. Low perfusion typically occurs in patients with poorcirculation or when the sensor is applied to the same limb as thenoninvasive blood pressure (NIBP) cuff. To resolve the alarmcondition, move the sensor to a better perfused site or to anotherlimb if the interference is from the NIBP cuff.Mitigation/Info: Arterial Pulsation Weak, Check Sensor Site,Change Sensor Site, Check Sensor Operation**Turn Off SpO2Monitoring**3318Low SpO2 Perfusion (poor SpO2 signal)Alarm occurs when the pulse oximeter determines the quality of theinput signal is low due to excessive motion or artifact. To resolvethe alarm minimize patient movement and make sure the sensor isproperly applied.Mitigation/Info: Signal Artifact, Minimize Patient Movement,Check Sensor Placement, Check Sensor Operation**Turn Off SpO2Monitoring**3421External Power Fail/DisconnectAlarm occurs when the external power (either AC or DC) dropsbelow minimum level (5 VDC as supplied by either the AC/DCPower Supply or a direct DC source) or power is intentionallydisconnected. Since the unit is designed to operate with eitherexternal power or using its internal battery this is a low priorityalarm that clears when the operator presses the MUTE/CANCELbutton. Pressing the MUTE/CANCEL button is the operator'sacknowledgement that the unit is operating on internal battery. Ifthis alarm occurs and the operator believes that the unit is stillconnected to external power the operator should investigate theexternal power source.Mitigation/Info: Internal Battery Operation, Check PowerConnection/Supply, Monitor Battery Status**Replace/Service Ventilator**3422Missing BatteryAlarm occurs when the internal battery has been removed orcommunication between the battery and CPU has failed. Whenexternal power is applied the unit is capable of operation however,loss of external power will result in loss of ventilation and a highpriority alarm. Operating in this state should only be done when noother alternatives are available.Mitigation/Info: No Battery Detected, DO NOT Remove ExternalPower!, Maintain External Power**Replace/Service Ventilator**3430Low Battery (Low Battery - Warning)Alarm occurs when the unit detects that there are ≦30 minutes ofbattery operation remaining and no external power is connected.The operator should seek a source of external power and/or plan toprovide manual ventilation. Attaching external power willimmediately clear thealarm to a low priority alarm and will bemaintained until the internal battery has recharged so that the unitcan provide at least 30 minutes of operating time.Mitigation/Info: Less Than 30 Minutes Operation, ConnectExternal Power, Assure Ability to Manually Ventilate** Replace/Service Ventilator**3431Low BatteryAlarm occurs when operating with external power and the unitdetects that there are ≦30 minutes of internal battery backupavailable. The unit is warning the operator that in the event of anexternal battery failure the unit ≦30 minutes of backup.NOTE: The unit does not charge the internal battery when attachedto an external battery.To resolve the alarm condition the operator must attach the unit to acontinuous external AC or DC source to recharge the internalbattery. If this is not possible operation can continue as long aspower is supplied by the external battery.Mitigation/Info: Less Than 30 Minutes Internal Backup, OperatingWith External Power, Continue Charging With External Power,Assure Ability To Manually Ventilate**Replace/Service Ventilator**3441External Power Failed (External Power High)Alarm occurs when the supplied DC power is >33 VDC. When thisoccurs the unit automatically switches to operation using theinternal battery. If the supplied power drops to <30 VDC theunit automatically returns to operation using external power. If theexternal power source is known to be good then the AC/DC PowerSupply may be faulty and need replacement.Mitigation/Info: External Voltage Too High, Internal BatteryOperation, Check/Replace Power Supply, Change Power Source**Replace/Service Ventilator**3444External Power FailedAlarm occurs when the voltage polarity is reversed when the unit isattached to an external DC source. When this occurs the unitautomatically switches to operation using the internal battery. Thiscondition is most likely caused by a faulty DC source. The operatorshould seek an alternate power source.Mitigation/Info: DC Voltage Reversed, Internal Battery Operation,Disconnect Power Source**Replace Power Source**3450Battery Fault (Battery Nearly Too Hot for Discharge - w/ExternalPower Connected)Alarm occurs when the battery temperature reaches 70° C. (158°F.) which is 5° C. from its maximum operating temperature andexternal power is connected. When the battery temperature reaches75° C. (167° F.) the battery will shut down to prevent failure. Whenthis occurs the unit will continue operation using external poweronly. The unit should be removed from the soft case which acts asinsulation. Shading the patient and ventilator from direct sunlightmay also help reduce the battery temperature.Mitigation/Info: Battery Within 5° C. of High Limit, RemovePadded Case, Continue External Power Operation, Shade Patientand Ventilator**Move To Cooler Location**3451Battery Fault (Battery Too Hot for Discharge w/External PowerConnected)Alarm occurs when the battery temperature reaches ≧75° C. (167°F.) and external power is connected. Discharging the batterybeyond this temperature could destroy the battery and damage theunit. During the alarm condition the unit will continue operationusing external power. The unit should be removed from the softcase which acts as insulation. Shading the patient and ventilatorfrom direct sunlight may also help reduce the battery temperature.Mitigation/Info: Battery Too Hot to Discharge, Do Not RemoveExternal Power!, Remove Padded Case, Assure Ability toManually Ventilate Patient, Shade Patient and Ventilator**Move To Cooler Location**3452Battery Fault (Battery Too Hot for Charging)Alarm occurs when the battery temperature is >45° C. (122° F.).Charging the battery above this temperature could destroy thebattery and damage the unit. During the alarm condition the unitcontinues to operate using external power and if external power islost the unit will operate using internal battery power. The unitshould be removed from the soft case which acts as insulation.Shading the patient and ventilator from direct sunlight may alsohelp reduce the battery temperature.Mitigation/Info: Battery Too Hot To Charge, Remove PaddedCase, Shade Patient and Ventilator**Move To Cooler Location**3453Battery Fault (Battery Too Cold For Charging)Alarm occurs when the battery temperature is ≦0° C. (32° F.).Charging the battery below this temperature could destroy thebattery and damage the unit. During the alarm condition the unitcontinues to operate using external power and if external power islost the unit will operate using internal battery power. The soft caseshould be used because it provides insulation.Mitigation/Info: Battery Too Cold To Charge, Connect ExternalPower, Use Padded Case**Move to Warmer Location**3455Battery Fault - With External Power Connected (BatteryCommunication Failure)Alarm occurs when the EMV+ is not able to communicate with theinternal battery and external power is connected. To continueoperation and the unit should remain connected external power.Mitigation/Info: Battery Comm Failure, DO NOT Remove ExternalPower!, Assure Ability to Manually Ventilate Patient**Replace/Service Ventilator**3470Internal Communication (Comm) Failure Fault - PIM CommAlarm occurs when the EMV+ is not longer able to communicatewith the Power Interface Module (PIM). When this occurs theoperator should monitor operation continuously, seek to replace theventilator as soon as possible and assure the ability to manuallyventilate the patient.Mitigation/Info: Power Management Failure, Assure Ability ToManually Ventilate Patient, Monitor Power Source**Replace/Service Ventilator**3480SPM Compatibility FaultAlarm occurs when the EMV+ software detects that it has not beencalibrated with the SPM that is inside the unit. This fault occurswhen the biomedical technician fails to recalibrate the unitfollowing an SPM change or service. When this occurs the unitshould be removed from use when appropriate and sent for service.Mitigation/Info: Hardware Compatibility Failure, UpdateCalibration Records** Replace/Service Ventilator **