072919 JH 6/7/10 CLINIC AL MANUAL REF 1054728 CLINIC AL MANUAL
FOR CLINICIAN’S USE ONLY Accessing Prescription Setting Screens WARNING The information on this page is ONLY for health care professionals. Remove this page from the manual before giving the manual to the patient! Full Menu Access Mode The ventilator has two levels of menu access, Full and Limited. Full Menu Access allows you to alter all available settings.
REF 1054728 1072919 JH 6/7/10
© 2010 Koninklijke Philips Electronics N.V. All rights reserved.
i Trilogy200 clinical manual Table of Contents FOR CLINICIAN’S USE ONLY Accessing Prescription Setting Screens.................................................... i Chapter 1. Introduction....................................................................................................................................... 1 Package Contents.................................................................................................................. 1 Intended Use......................................
ii Chapter 3. Modes, Features, and Alarms......................................................................................................19 Therapy Modes.....................................................................................................................19 Breath Types.................................................................................................................20 Therapy Mode Table.......................................................................................
iii High Vti Alarm..............................................................................................................44 Low Vti Alarm ..............................................................................................................44 High Respiratory Rate Alarm..................................................................................44 Low Respiratory Rate Alarm ...................................................................................
iv Battery Disposal..........................................................................................................56 First Time Use...............................................................................................................56 Connect the Breathing Circuit to the Ventilator.......................................................57 Connect a Water Trap ........................................................................................................
v Viewing the Event Log..............................................................................................90 Viewing Device Information...................................................................................90 Updating Prescriptions Using the SD Card................................................................91 Changing and Viewing Settings in Limited Menu Access Mode........................94 Activating Your Primary or Secondary Prescription.......................................
vi Chapter 10. System Checkout Procedures.................................................................................................139 Tools Required................................................................................................................... 139 Visual Inspection............................................................................................................... 139 Initial Setup..........................................................................................
1 Trilogy200 clinical manual 1. Introduction This chapter provides an overview of the Trilogy200 device. Package Contents The Trilogy200 system may include the following components. Some components are optional accessories that may not be packaged with the device.
2 Intended Use The Philips Respironics Trilogy200 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
3 Warnings and Cautions Caution: U.S. federal law restricts this device to sale by or on the order of a physician. Warnings A warning indicates the possibility of injury to the user or operator. Patient Monitoring Prior to placing a patient on the ventilator, a clinical assessment should be performed to determine: •• The device alarm settings •• Needed alternative ventilation equipment •• If an alternative monitor (i.e.
4 Personnel Qualifications Trilogy200 is a restricted medical device designed for use by Respiratory Therapists or other trained and qualified caregivers under the supervision of a physician. The prescription and other device settings should only be changed on the order of the supervising physician. The operator of the ventilator is responsible to read and understand this manual before use.
5 Operating and Storage Temperatures Do not use this device if the ambient temperature is warmer than 40˚ C (104˚ F). If the device is used at room temperatures warmer than 40˚ C, the temperature of the airflow may exceed 43˚ C. This could cause system alarms, thermal irritation, or injury to the patient’s airway.
6 Remote Alarms When using a remote alarm, make sure you fully test the remote alarm connector and cable by verifying that: –– Annunciated alarms on the ventilator are also annunciated on the remote alarm. –– Disconnecting the remote alarm cable from the ventilator or from the remote alarm results in an alarm notification at the remote alarm. The remote alarm should be tested daily. Oxygen When administering fixed-flow supplemental oxygen, the oxygen concentration may not be constant.
7 Alarms Respond immediately to any alarm. It may indicate a potentially life-threatening condition. Refer to the Alarms and Troubleshooting chapters for more information. Visually monitor the patient and ventilator at all times during an Alarm Silence period. Allowing alarms to continue without intervention may result in harm to the patient. If the high priority “Low Internal Battery” message appears, immediately connect the ventilator to an alternate power source.
8 Maintenance Follow the service recommendations provided in Chapter 7 of this manual. Periodically inspect electrical cords, cables, and the detachable battery pack for damage or signs of wear. Discontinue use and replace if damaged. Repairs and adjustments must be performed by Philips Respironicsauthorized service personnel only. Unauthorized service could cause death or injury, invalidate the warranty, or result in costly device damage. Cleaning (Refer to Chapter 7 for detailed cleaning instructions.
9 Operating and Storage Temperatures The device may only be operated at temperatures between 5˚ C and 40˚ C (41˚ F and 104˚ F). Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the airflow delivered to the patient. Prolonged operation or storage at elevated temperatures may reduce the service life of the battery and other internal components of the ventilator. The ventilator has an internal and detachable Lithium-Ion Battery.
10 Patient Circuit Exhalation valves, patient circuits, and water traps are shipped clean, not sterile. Cleaning and disinfection of these parts should follow individual institution processes and conform to guidelines provided by Philips Respironics with each accessory. External DC Power Do not use the same external battery to operate both the ventilator and any other equipment such as power chairs.
11 Contraindications If the patient has any of the following conditions, consult their health care professional before using the device in a non-invasive mode: •• Inability to maintain a patent airway or adequately clear secretions •• •• •• •• At risk for aspiration of gastric contents Diagnosed with acute sinusitis or otitis media Epistaxis, causing pulmonary aspiration of blood Hypotension System Overview This ventilator provides both pressure control and volume modes of therapy.
12 Symbols The following symbols appear on the device. Front Panel Symbol Description Therapy Start/Stop Alarm Indicator/Audio Pause ~ AC Power Indicator Rear and Side Panels Symbol ~ Description AC Power Connector Secure Digital (SD) Card Slot Serial Port Connector Remote Alarm Connector Ethernet Connector DC Power Connector O2 Oxygen Inlet Consult accompanying instructions for use.
13 Drip Proof Equipment For Airline Use. Complies with RTCA-D0160F section 21, category M. How to Contact Philips Respironics To have your device serviced, contact Philips Respironics Customer Service department at 1-724-387-4000 or 1-800-345-6443.
14 Trilogy200 clinical manual
15 Trilogy200 clinical manual 2. System Description This chapter describes the front and rear panel device controls and features. 2 Front Panel Features The front panel contains the control buttons, visual indicators, and display screen. Buttons The following buttons are included on the front panel of the device. 1. Start/Stop Button This button turns the airflow on or off, starting or stopping therapy. 2.
16 4. Left and Right Buttons These buttons allow you to select display options or perform certain actions specified on-screen. Visual Indicators Several power and alarm indicators appear on the front panel. 5. AC Power LED In the lower right corner of the front panel, a green LED (~) indicates that AC power is applied to the device. This light remains on as long as adequate AC power is available. 6.
17 Side and Rear Panel Features 2 The ventilator’s side and rear panels contain the following connectors and features, shown at right. 3 1. AC Power Inlet You can plug the AC power cord into this connector, located on the right side of the ventilator. 2. Breathing Circuit Connection The breathing circuit connector is located on the right side of the device. You can connect your circuit tubing system here. See Chapter 4 for details. 1 Right Side Panel 3.
18 5. Serial Connector You can use this connector to connect the device to a computer running PC Direct or Sleepware software or to other Philips Respironics devices such as Alice 5 and AOM. Use the Trilogy RS232 Serial Cable to connect the ventilator to the external device or computer. 11 10 12 6.
19 Trilogy200 clinical manual 3. Modes, Features, and Alarms Therapy Modes The device provides Pressure Control Ventilation (PCV) and Volume Control Ventilation (VCV) for non-invasive and invasive patients. Pressure Control ventilation delivers a prescribed pressure to the patient according to set breath rate and set inspiration time parameters. This means that each breath is controlled so that a prescribed amount of pressure is delivered to the patient.
20 Breath Types There are four breath types that apply to the Volume Control and Pressure Control ventilation therapy modes: •• •• •• •• Spontaneous Mandatory Assisted Sigh Spontaneous Breath A Spontaneous breath is triggered by the patient. Breaths are initiated by the patient’s inhalation effort, and air delivery is controlled based on the current pressure or volume setting. Breaths are terminated by either the ventilator settings or by the patient’s exhalation effort, depending on the mode selected.
21 Therapy Mode Table The following table summarizes all of the therapy modes and the settings available in each mode. Some settings in the table are dependent upon other settings. For instance, if the circuit type is set to Active with Flow, then the Flow Trigger Sensitivity, Leak Compensation, and Flow Cycle settings will display. Note: Pressure Support, referred to in the table below and later in this manual, is defined as IPAP - EPAP or Pressure PEEP (PC-SIMV).
22 Pressure Control Ventilation Therapy Modes Pressure Control ventilation modes deliver a prescribed pressure to the patient. Continuous Positive Airway Pressure (CPAP) Mode In the Continuous Positive Airway Pressure (CPAP) mode, the device delivers a continuous pressure to the patient at all times. All breaths in this mode are Spontaneous breaths. Spontaneous (S) Mode In Spontaneous (S) mode, the device delivers bi-level pressure support. This mode provides only spontaneous breaths.
23 Spontaneous/Timed (S/T) Mode In Spontaneous/Timed (S/T) mode, the device delivers bi-level pressure support. This mode provides Spontaneous and Mandatory breaths. A Mandatory breath is delivered if the patient does not spontaneously breathe within the prescribed Breath Rate (BPM) setting. This ensures that the patient receives a minimum number of breaths per minute. In this mode, an IPAP is delivered during inhalation and a lower EPAP is delivered during exhalation.
24 Timed (T) Mode In Timed (T) mode, the device delivers bi-level pressure support. This mode delivers Mandatory breaths only. A Mandatory breath is delivered according to the prescribed BPM and inspiratory time settings. This also means that the ventilator will not respond to patient effort. In this mode, an IPAP is delivered during inhalation and a lower EPAP is delivered during exhalation. The following illustration describes these concepts.
25 Pressure Control (PC) Mode In Pressure Control (PC) mode, the device delivers bi-level pressure support. This mode delivers Assist and Mandatory breaths. This mode is identical to S/T mode, except that all breaths have a fixed inspiratory time.
26 During the time window, if patient effort is detected, either a Spontaneous or an Assist breath is delivered for the first effort. If the last breath delivered was Mandatory, then a Spontaneous breath is delivered for the first patient effort of the window. If the last breath delivered was an Assist or Spontaneous breath, then an Assist breath is delivered for the first patient effort of the window. Assist breaths deliver the Pressure setting during inhalation and the PEEP setting during exhalation.
27 Volume Control Ventilation Therapy Modes Volume Control ventilation modes deliver a prescribed inspired tidal volume according to a set Breath Rate and a set Inspiratory Time. Control Ventilation (CV) Mode In Control Ventilation (CV) mode, the device delivers volume control therapy. This mode provides only Mandatory breaths. A Mandatory breath is delivered according to the prescribed BPM setting for the prescribed Inspiratory Time. This also means that the ventilator will not respond to patient effort.
28 Assist Control (AC) Mode In Assist Control (AC) mode, the device delivers volume control therapy. This mode provides Assist and Mandatory breaths. An Assist breath is started when there is patient effort, but it is ended when the Inspiratory Time setting has been met. A Mandatory breath is delivered if the patient does not spontaneously breathe within the prescribed BPM setting. This ensures that the patient receives a minimum number of breaths per minute.
29 During the time window, if patient effort is detected, either a Spontaneous or an Assist breath is delivered for the first effort. If the last breath delivered was Mandatory, then a Spontaneous breath is delivered for the first patient effort of the window. If the last breath delivered was an Assist or Spontaneous breath, then an Assist breath is delivered for the first patient effort of the window.
30 Therapy Mode Features The device has several additional features that enhance patient comfort. Flex Comfort Feature The device consists of a special comfort feature called Flex. The device provides the Flex feature in CPAP mode and S mode. This feature is only available when Auto-Trak is enabled. Note: Flex is not available if AVAPS is enabled or if an active circuit is used. C-Flex Note: The patient has access to this setting, if Flex is enabled.
31 Bi-Flex In S mode, the Bi-Flex attribute adjusts therapy by inserting a small amount of pressure relief during the latter stages of inspiration and during the beginning part of exhalation. In the following diagram, the bold lines represent Bi-Flex in comparison to the dashed line representing normal BiPAP therapy. Bi-Flex levels of 1, 2, or 3 progressively reflect increased pressure relief that will take place at the end of inspiration and at the beginning of expiration.
32 Rise Time In S, S/T, PC, T, PC-SIMV, and SIMV modes, rise time is the amount of time it takes the device to change from the expiratory pressure setting to the inspiratory pressure setting. Rise time levels of 1, 2, 3, 4, 5, or 6 progressively reflect slowed response of the pressure increase that will take place at the beginning of inspiration. Adjust the rise time to find the most comfortable setting for the patient.
33 PRESSURE IPAP Max IPAP Min EPAP 15 30 45 60 TIME VOLUME Target Volume AVAPS Feature 15 30 45 60 TIME Flow Pattern Types Two flow patterns are available in Volume Control ventilation therapy modes: •• Square •• Ramp Square With a square wave pattern, airflow is generally constant throughout inspiration of the breath.
34 Ramp With a ramp flow pattern, the airflow starts high and decreases throughout inspiration of the breath. FLOW 50% of Peak Flow Ramp Waveform Pattern TIME For the active circuit in volume modes, peak flow is required to be a minimum of 20 l/min. The wave form may be flattened when the combination of Inspiratory Time and Tidal Volume set points would result in a flow of less than 20 l/min.
35 Sigh Feature The sigh feature is available for Volume ventilation modes only. When the sigh feature is enabled, the ventilator delivers a sigh breath in place of every 100th mandatory or assisted breath delivered regardless of the mode of operation (i.e., AC, CV, and SIMV). The Sigh breath is delivered using a volume equal to 150% of the set volume that was in effect when the breath was initiated.
36 Triggering The device can be set to trigger breaths using the Auto-Trak or Flow Trigger sensitivity features. Digital Auto-Trak Sensitivity An important characteristic of the device is its ability to recognize and compensate for unintentional leaks in the system and to automatically adjust its trigger and cycle algorithms to maintain optimum performance in the presence of leaks. This feature is known as Digital Auto-Trak Sensitivity.
37 Auto-Trak Sensitivity An essential feature of the device while operating in all modes is its ability to effectively sense spontaneous breathing efforts, which causes the ventilator to trigger to inspiration and cycle to expiration.
38 A sudden change in patient flow will cross the shape signal, causing the pressure level to change. IPAP Pressure EPAP Shape Signal Flow Cycle to EPAP Crossover Point Estimated Patient Flow Trigger to IPAP Crossover Point Tracking the patient’s flow pattern with the Shape Signal provides a sensitive mechanism to trigger to inspiration or cycle to expiration in response to changing breathing patterns and circuit leaks.
39 Spontaneous Expiratory Threshold (Inspiration to Expiration): A second method used to cycle to expiration during spontaneous breathing in all modes except T, CV, AC, and SIMV, is called Spontaneous Expiratory Threshold (SET). The SET rises in proportion to the inspiratory flow rate on each breath. When the SET and actual patient flow value are equal, the unit cycles to expiration.
40 Volume Control Cycle (Inspiration to Expiration) (Only available during Volume Control Therapy) An Inspiratory Time setpoint limits the time spent in inspiration during breathing in all modes. Once the time limit is reached, the unit automatically cycles to expiration. Flow Trigger Flow trigger provides a manual setting that allows for breath initiation and termination based on a set flow trigger sensitivity and flow cycle sensitivity.
41 BTPS Compensation All flows and volumes used in Trilogy are expressed in BTPS - Body Temperature atmospheric Pressure Saturated with H2O. All pressures are expressed relative to atmospheric pressure. Ventilator Alarms This section describes all of the ventilator alarms and informational messages in order of priority, from high priority alarms to low priority alarms and finally informational messages. Refer to Chapter 6 for more information on alarms. Loss of Power Alarm This is a high priority alarm.
42 Check Circuit Alarm This is a high priority alarm. It occurs when the device detects a problem with the patient circuit, such as pinched or detached tubing, water condensation in the proximal pressure lines, or problems with the active exhalation device. Low Circuit Leak Alarm This is a high priority alarm that only occurs with the passive circuit. It occurs when the system detects a problem with the leak device in the passive circuit. High Expiratory Pressure Alarm This is a high priority alarm.
43 Circuit Disconnect Alarm This is a high priority alarm. It occurs when the breathing circuit is disconnected or has a large leak. The device continues to operate. The alarm will automatically terminate when the circuit is reconnected or the leak is fixed. Apnea Alarm This is a high priority alarm. It occurs when the patient has not triggered a breath within the time specified in the apnea alarm setting. The device continues to operate.
44 High Vti Alarm This is a high priority alarm. It occurs when the delivered tidal volume is greater than the High Vti alarm setting for three consecutive breaths. The device continues to operate. The alarm will automatically terminate when a breath occurs in which the delivered tidal volume does not reach the High Vti alarm setting. Low Vti Alarm This is a high priority alarm. It occurs when the delivered tidal volume is less than the Low Vti alarm setting for three consecutive breaths.
45 For pressure modes, the alarm occurs when the delivered pressure exceeds the target patient pressure by 5 cmH2O or more during the inspiratory phase. The device will automatically cycle to the expiratory phase and continue to operate. The alarm will automatically terminate when the delivered pressure falls within 5 cmH2O of the target patient pressure during the inspiratory phase. Low Inspiratory Pressure Alarm This is a high priority alarm.
46 Low Battery Alarm The Low Battery alarm occurs when the last battery available is low or nearly depleted. This alarm occurs in two stages. When approximately 20 minutes of battery run time remains, a medium priority alarm is generated, and the device continues to operate. If no action is taken and the battery continues to deplete, the alarm escalates to a high priority alarm when approximately 10 minutes of battery run time remains.
47 If the problem is not corrected, the device will generate a reminder message once per day, or whenever power is cycled, until the issue is corrected. Additionally, if the device is powered off, a reminder message will immediately appear when the device is turned on again. AC Power Disconnected Alarm This is a medium priority alarm.
48 Check External Battery Info Message This info message occurs when a bad connection exists to the external battery or the external battery failed. The device continues to operate using power from the detachable battery, if available, or the internal battery. Battery Depleted Info Message This info message occurs when the affected battery is fully depleted. The device continues to operate using the next available power source.
49 Trilogy200 clinical manual 4. Ventilator Setup This chapter provides instructions on how to assemble the ventilator. It includes the following setup information: •• •• •• •• •• •• Properly positioning the device Installing the air filter Supplying power to the device Connecting the breathing circuit Connecting a water trap (optional) Connecting a remote alarm (optional) WARNING Ventilator dependent patients should be continuously monitored by qualified personnel.
50 Position the Device Place the ventilator on a flat, level surface. Or, as an alternative, you can place the device in the optional in-use bag. The in-use bag is required for portable use in order to properly secure the ventilator. Do not operate the ventilator while on its side, upside-down, or in any other orientation. Make sure that the air inlet on the back of the device is not blocked. If you block the air flow around the device, the ventilator may not work properly.
51 Using AC Power Note: This device is activated (i.e., ‘powered on’) when the AC An AC power cord is provided with the device. power cord is connected or any of the three battery sources is 1. Plug the socket end of the AC power cord into the AC power inlet available. Pressing the Start/Stop on the side of the device. To prevent accidental removal of the button turns the airflow on or off.
52 4. If desired, secure the power cord using the cord retainer on the back of the device, as shown below. To secure the power cord, use a screwdriver to remove the screw on the cord retainer. Insert the cord as shown into the cord retainer, and then reattach the cord retainer to the device by re-attaching the screw. Securing the Power Cord Using the Cord Retainer Using DC Power You can operate the ventilator using an external battery, detachable battery, or the internal battery.
53 Detachable Battery Pack Philips Respironics offers a detachable Lithium-Ion battery pack. To use the detachable battery pack, snap the battery into place on the back of the ventilator, as shown in the following illustration. When the device is not connected to an AC power source or an external battery, the detachable battery will power the device, if attached.
54 One side of the detachable battery has a set of LEDs that indicate the amount of charge left on the battery.
55 DC Power Indicators The internal, detachable, and external battery symbols that will display on the Monitoring screen are shown below. The detachable and external battery symbols will only appear on-screen if a detachable or external battery is attached to the device. Battery Symbol Internal Battery Note: Under normal operating conditions, the internal battery symbol will always display on the Monitoring screen.
56 DC Power Indicator Description Red Low Battery Indicator When the device detects that an in-use battery’s charge is nearly depleted (has approximately 10 minutes of charge left), the inside of the box surrounding the battery symbol turns red. In addition to the battery indicator on the Monitoring screen, a high priority alarm message will display indicating “Low Battery.” See Chapter 6 for more information. The red indicator is for the last available battery source.
57 Connect the Breathing Circuit to the Ventilator Complete the following steps to set up your patient circuit. 1. If you are using a bacteria filter, connect one end of the flexible tubing to the outlet of the bacteria filter, and connect the bacteria filter inlet to the breathing circuit connection located on the side of the ventilator. If you are not using a bacteria filter, connect the tubing directly to the device’s breathing circuit connection.
58 b. If your circuit type is Active PAP: Active Exhalation Device with Proximal Pressure 1. Connect the flexible tubing to an active exhalation device with proximal pressure. A. Connect the active exhalation device with proximal pressure to the flexible tubing that attaches to the ventilator and to the patient interface (e.g., the tracheostomy tube). 2.
59 Exhalation Valve Port Proximal Pressure Line Proximal Pressure Port Exhalation Valve Line Universal Porting Block Trilogy Universal Active PAP Tube Adapter Exhalation Valve Port on Universal Porting Block Connecting an Active Device with Proximal Pressure Refer to the instructions included with the Active Exhalation Device for more information. c. If your circuit type is Active Flow: 1. Connect the Flow Sensor to an active exhalation device as shown below.
60 C. Connect the flow lines and the exhalation valve line to the Universal Porting Block on the ventilator as shown below. •• Connect the White Striped Flow Line to the top, striped port on the Universal Porting Block on the device. •• Connect the other Flow Line to the middle port on the Universal porting Block.
61 Connect Supplemental Oxygen (Optional) To attach supplemental oxygen to the device: 1. Connect the oxygen tubing to the Oxygen Inlet Quick Connect. Then, connect the Quick Connect to the Oxygen Inlet on the back of the ventilator. Oxygen Inlet Oxygen Inlet Quick Connect Oxygen Source Tubing Attaching the O2 Tubing 2. Make sure you press the Oxygen Inlet Quick Connect firmly into the inlet. You should hear a click, and the latch at the top of the inlet will pop up.
62 Connect the Remote Alarm (Optional) You can use a remote alarm as a nurse call system or in-house remote alarm system. It can generate an alarm at a distance of up to 91 meters (300 feet) from the ventilator. An audible tone sounds and a red light blinks to indicate that an alarm condition exists. The remote alarm will sound when any of the following conditions exist: •• The ventilator is off. •• Any alarm occurs and is not silenced or reset.
63 Trilogy200 clinical manual 5. Viewing and Changing Settings This chapter explains how to scroll through the ventilation screens and change ventilation settings. It also describes how to connect the ventilator to the patient once the settings are complete. Keypad Lock Feature There is a Keypad Lock feature that users can enable from the Options menu. It is intended to prevent accidental changes to device settings. This feature will lock the navigation keys (Up, Down, Stop, Left, and Right keys).
64 Accessing the Startup and Monitor Screens 1. After you press the button to begin therapy, the Startup screen appears momentarily, indicating the device name and the software version. 2. The next screen that appears is the Monitor screen. The appearance of this screen will vary, depending on how you set up the device. If Detailed View is turned off in the Options menu, your screen will look like the screen shown below.
65 If Detailed View is turned on in the Options menu, the Monitor screen will look like the screen shown below. Monitor Panel Measured Settings Panel Status Panel Monitor Screen – Detailed View On This screen contains more detailed information about the therapy. – The top Monitor panel contains the Prescription indicator if a dual prescription exists, the therapy mode, a graph displaying the current pressure, and the current date and time.
66 Monitor Screen Indicators Note: Dashes on the display screen indicate that the device was unable to compute the parameters. For example, when the device is first connected to a patient, the tidal volume, minute ventilation, and leak may be dashed until the device is able to accurately calculate these patient parameters.
67 Indicator Description Low Pressure Indicator L If you enable a volume therapy mode, this indicator appears below the manometer bar, indicating the low pressure alarm setting. High Pressure Indicator H If you enable a volume therapy mode, this indicator appears below the manometer bar, indicating the high pressure alarm setting. Pressure This indicator displays the current patient pressure. This only appears in detailed view.
68 Measured Settings Panel All of the indicators that may appear on the Measured Settings panel (available only in Detailed view), are described in the following table. Indicator Description PIP Peak Inspiratory Pressure displays the maximum pressure delivered to the patient during the previous breath. I:E Ratio Displays a comparison of the time spent in inspiration to the time spent in expiration during the previous breath.
69 Status Panel Indicators All of the indicators that may appear on the Status Panel are described in the following table. Indicator Description Indicates that the device is in Full Menu Access mode, which means you can adjust all prescription settings. Philips Respironics recommends that you change the device to Limited Menu Access mode before giving the device to the patient, so patients cannot adjust their prescription settings.
70 Indicator Description A black box displays around the battery that is currently supplying power to the ventilator when AC power is not available. (In the status panel shown above, the external battery is in use, so the symbol displays.) A yellow lightning bolt symbol displays with the Detachable or Internal battery symbol to indicate when the battery is charging. (In the status panel shown on the previous page, the detachable battery is being charged, so the symbol displays.
71 On-Screen Button Panel The illustration below shows the on-screen button panel on the Main Menu screen, in relation to the buttons on the front of the device. On-Screen Button Panel Example On-Screen Button Panel At the very bottom of the display screen is the on-screen button panel. This panel corresponds with the control buttons on the ventilator: Note: The on-screen buttons will vary depending on which screen is displayed and what settings are enabled on your device.
72 Changing and Viewing Settings in Full Menu Access Mode Clinicians can view and change settings using the Menu screens when the device is in Full Menu Access mode. To enter the Menu screens from the Monitor screen, press the Up button on the ventilator. The Main Menu screen shown below appears. Note: For some therapy settings, once you reach the highest or lowest setting available, pressing the Up/ Down button again will cycle back through the settings.
73 Changing the Device Settings and Alarms From the Main Menu screen, use the Up/Down button to highlight the Settings and Alarms menu, and press the Right button to select the menu. Device Settings Common to All Therapy Modes Note: In the Options menu described later in this chapter, you can specify the Pressure Units displayed by the device, choosing either cm H2O, hPa, or mBar. The default setting is cm H2O, so this manual uses cm H2O throughout.
74 Mode Setting You can change the Mode setting on the Settings and Alarms screen to one of the following therapy modes: •• •• •• •• •• •• •• •• •• CPAP S S/T T PC PC-SIMV CV AC Note: See Chapter 3 for detailed information about each therapy mode. Note: Refer to the chart in Chapter 3 to easily review all of the settings available in each therapy mode. Note: This chapter describes how to enable all of the device settings, including device alarms.
75 The Passive circuit provides leak compensation. When using the Passive circuit in Volume Ventilation, the set Vti is delivered to the patient above the calculated circuit and cuff (or mask) leak. This is different from traditional active circuit ventilation where the cuff (or mask) leak reduces the tidal volume delivered to the patient.
76 Low Vte This setting enables or disables the Low Vte alarm. The alarm activates when the estimated exhaled tidal volume is less than or equal to this setting. You can choose Off to disable this alarm, or you can increase or decrease the setting from 40 ml to 2000 ml in 5 ml increments. It cannot be set higher than the High Vte setting. Note: The High and Low Vte alarms are available when the Passive or Active Flow Circuit is selected.
77 Low Minute Ventilation This setting enables or disables the Low Minute Ventilation alarm. The alarm activates when the calculated minute ventilation is less than or equal to this setting. You can choose Off to disable this alarm, or you can increase or decrease the setting from 0.1 l/min to 99 l/min. Note: You can increase or decrease the Low Minute Ventilation setting in 0.1 l/min increments from 0.1 to 0.99 l/min and 1 l/min increments from 1 to 99 l/min.
78 Low Inspiratory Pressure This setting configures the Low Inspiratory Pressure alarm. It is only user-settable in CV, AC, and SIMV modes. It cannot be set lower than PEEP + 2 cm H2O or higher than the High Inspiratory Pressure. For passive circuits, you can increase or decrease the Low Inspiratory Pressure from 6 to 40 cm H2O in increments of 1 cm H2O. For active circuits, you can increase or decrease the setting from 2 to 40 cm H2O in increments of 1 cm H2O.
79 When Trigger Type is set to Flow Trigger, Flow Trigger Sensitivity Leak Compensation, and Flow Cycle Sensitivity become active, and the trigger initiates based on the Flow Trigger Sensitivity setting. 3. Flow Trigger Sensitivity If you set the Trigger Type to Flow Trigger, the Flow Trigger Sensitivity setting displays. You can increase or decrease the setting from 1 to 9 l/min in 1 l/min increments.
80 7. Ramp Start Pressure You can increase or decrease the ramp start pressure in increments of 1 from 4 cm H2O to the CPAP pressure setting. The patient also has access to this setting, unless the ramp length is set to Off. 8. Flex You can enable or disable the Flex setting. Off disables the setting and prevents the patient from using Flex. To enable the setting, set Flex to 1, 2, or 3. The patient also has access to this setting, if Flex is enabled.
81 2. IPAP The IPAP setting displays if AVAPS is Off. You can increase or decrease the Inspiratory Positive Airway Pressure (IPAP) from 4 to 50 cm H2O in increments of 1. IPAP is limited to a maximum of 25 cm H2O when Flex is enabled. You cannot set the IPAP setting lower than the EPAP setting. Note: IPAP, IPAP Max, or IPAP Min cannot be set to more than 30 cm H2O above EPAP. 3. IPAP Max Pressure The IPAP Max Pressure setting displays if AVAPS is enabled.
82 7. Rise Time You can adjust the rise time to find the most comfortable setting for the patient. Increase or decrease the setting from 1 to 6 until you find the right setting. The rise time levels from 1 to 6 progressively reflect slowed response of the pressure increase that will take place at the beginning of inspiration. 8. Apnea Rate If the Apnea alarm is enabled, you can set the Apnea Rate from 4 to 60 BPM in 1 BPM increments. In S mode, the Apnea Rate is greater than or equal to 1:2 I:E ratio.
83 Pressure Control (PC) Mode All of the settings available in S/T mode are available in PC mode, except for the Flow Cycle Sensitivity setting (when Flow Trigger is enabled). Please refer to the descriptions in the S and S/T Mode sections of this chapter for detailed information on the PC mode settings.
84 3. PEEP The Positive End Expiratory Pressure (PEEP) setting can be increased from 0 to 25 cm H2O in active circuits and 4 to 25 cm H2O in passive circuits, in increments of 1. PEEP is the positive pressure maintained in the patient circuit during exhalation. The PEEP must be less than or equal to the pressure setting.
85 Assist Control (AC) Mode The AC mode contains the following settings described in the S, S/T, PC-SIMV, and CV mode sections in this chapter. Please refer to the descriptions in those sections for detailed information. •• •• •• •• •• •• •• •• •• •• Tidal Volume Breath Rate Inspiratory Time Note: The Low Inspiratory Pressure is limited to PEEP +2 in CV, AC, and SIMV modes. Flow Pattern PEEP Trigger Type Flow Trigger Sensitivity Note: Flow Cycle Sensitivity is not available in AC mode.
86 Viewing and Changing Options Menu Items From the Main Menu screen, select the Options item. The Options menu appears, shown in the screen below. Options Menu The following settings are available on the Options menu. •• Menu Access – You can select Full or Limited menu access. Full menu access allows operators to access all ventilator and prescription settings. Limited menu access allows operators to access only certain settings and does not allow them to change prescription settings.
87 All pressure units on the screens will display in the unit of measure selected here. •• Alarm Volume – You can adjust the volume of the device WARNING alarms using this setting. Select either Loud or Soft as the alarm volume options. Make sure the alarm volume is set loud enough to be heard by the caregiver. Consider the use of a remote alarm. •• Keypad Lock – You can enable or disable the Keypad Lock feature, which is described in detail earlier in this chapter.
88 - Dim: The display’s backlight is decreased, so that the display is still visible but not as bright. If enabled, the screen saver will display after 5 minutes of no keypad activity. Pressing any button on the device will exit the screen saver. And, any alarm or informational message will also exit the screen saver. •• Date Format – You can choose either mm/dd/yyyy or dd/mm/yyyy as the date format that will display on the device screens.
89 •• Operational Hours – The operational hours displays the total number of hours that the device blower has been on since the last time this value was reset. You can reset this value to zero (0) if desired (e.g., each time you give the device to a new patient). This value helps you determine how often the patient is using the device. The Operational Hours shown here differs from the Blower Hours shown on the Information screens.
90 Viewing the Event Log From the Main Menu screen, you can select Event Log to access the Event Log screen. The event log displays a list of all events that have occurred, such as ventilator setting changes, ventilator inoperative conditions, alarms, etc., in chronological order with the most recent events displayed first. When the device is in Limited Menu access mode, the event log is not available. It can be viewed and cleared when in Full Menu access mode.
91 Updating Prescriptions Using the SD Card With the Trilogy200, you can update the patient’s prescription using the SD Card. This feature lets you update a single prescription or both prescriptions if the dual prescription feature is enabled. The prescription update can occur either when the ventilator is off or on. 1. Insert an SD Card with a valid prescription into the device. A “Change Prescription?” message appears on the display: 2.
92 3. Select Cancel to cancel the prescription update process and return the screen to the initial state before the prescription update started. Select Page to review the entire prescription. The Menu Banner will reflect the prescription being updated. 4. Once the entire prescription has been reviewed, a screen displays with the option to Cancel or OK the changes. Select Cancel to cancel the prescription update process and return the screen to the initial state before the prescription update started.
93 Message Cause Action Prescription Change Failed Displayed when an error occurs during the prescription update. This is caused by an attempt to set a value for a prescription parameter that is not valid for the therapy mode or an attempt to set a prescription parameter to an invalid value. Remove the card and have the prescription replaced with a valid prescription.
94 Changing and Viewing Settings in Limited Menu Access Mode After you press the button and access the Monitor screen, you can view and change settings using the Menu screens. To enter the Menu screens from the Monitor screen, press the Up button on the ventilator. The Main Menu screen appears, shown below. Note: If the Keypad Lock feature is enabled, a message will appear that says “Hold Right Key for 5 seconds to unlock.
95 •• My Settings: View and change certain prescription settings, such as rise time or ramp starting pressure, if these settings were enabled by your health care professional. •• Options: View and change certain device settings, such as your alarm volume, keypad lock, or keypad backlighting. Note: The Options, Alarm Log, and Information items are discussed in detail earlier in this chapter, in the “Changing and Viewing Settings in Full Menu Access Mode” section.
96 Viewing and Changing My Settings Menu Items To view or change the therapy settings available on the My Settings screen, use the Up/Down (Navigate) button to highlight the My Settings option on the Main Menu, and press the Right (Select) button. The My Settings Menu screen appears. Follow the general instructions below to navigate and change any of the therapy settings. Detailed information about each setting follows. 1.
97 If your health care professional has enabled Ramp on your ventilator, you can adjust the Ramp Start Pressure setting. The setting can be adjusted from 4.0 to your prescription pressure setting in increments of 1. •• Flex – The optional Flex feature allows you to adjust the level of air pressure you feel when you exhale during therapy. If this feature is enabled by your health care professional, you can adjust the setting from 1 to 3.
98 Connecting the Ventilator to the Patient After you have finished adjusting your ventilator settings, perform the following steps to connect the ventilator to the patient. 1. Perform System Checkout Do not connect the ventilator to the patient until you perform the system checkout procedures defined in Chapter 10. Note: Trilogy200 provides features to control access to the device (prescription) settings and to transfer new device settings onto the device using the SD Card.
99 Trilogy200 clinical manual 6. Ventilator Alarms This chapter describes the ventilator alarms and what you should do if an alarm occurs. There are three types of alarms: •• High Priority – Require immediate response by the operator •• Medium Priority – Require prompt response by the operator •• Low Priority – Require operator awareness. These alarms alert you to a change in the ventilator status.
100 Audible and Visual Alarm Indicators When an alarm condition occurs: •• The alarm LED indicator on the Alarm Indicator/Audio Pause button lights •• The audible alarm sounds •• A message appears on the screen describing the type of alarm •• The remote alarm (if applicable) is activated Each of these is described in detail below.
101 Audible Indicators An audible indicator sounds whenever a power failure or a high, medium, or low priority alarm is detected. Additionally, an audible indicator sounds for informational messages and to confirm that certain actions have occurred (for example, when an SD card is inserted or removed from the device). •• Ventilator Inoperative Audible Indicator – When a ventilator inoperative alarm occurs, a continuous audible alarm sounds.
102 •• Informational Messages and Confirmation Audible Indicators – When an informational message appears on screen, a brief, 1- beep audible indicator sounds. Additionally, when the device detects that a certain action has been completed (for example, when the Start/Stop button is pressed to start therapy, or when an SD card is inserted or removed from the device) a brief, 1- beep audible indicator sounds.
103 Alarm in Menu Banner Screen The Alarms and Messages Screen will automatically display in place of the Monitor screen when exiting from the menu system using the Exit soft key when an alarm is displayed in the menu banner. If an alarm is manually reset by the user or self-cancels, the menu banner on-screen before the alarm occurred will reappear. If a Ventilator Inoperative alarm occurs, the entire display screen turns red and the Ventilator Inoperative message appears on-screen, as shown below.
104 To turn the ventilator off from a Ventilator Inoperative condition, use the normal power off sequence. When the Start/Stop button is selected, the following screen will display. Ventilator Inoperative Power Off Screen Select the Right button (Yes) to turn the ventilator off and stop the audible alarm. Selecting the Left button (No) will return the screen to the Ventilator Inoperative Alarm Screen without silencing the audible alarm.
105 Audio Pause and Alarm Reset Features This section describes the Audio Pause and Alarm Reset features. Audio Pause When an alarm occurs, you can temporarily silence the audible indicator by pressing the Alarm Indicator/Audio Pause button. The alarm is silenced for 60 seconds and then will sound again if the cause of the alarm has not been corrected. Each time the Alarm Indicator/Audio Pause button is pressed, the alarm silence period resets to one minute.
106 Alarm Volume Control As explained in Chapter 5, you can adjust the Alarm Volume from the Options menu. You can select Loud or Soft, depending on your preference. What to Do When An Alarm Occurs Complete the following steps when an alarm occurs: 1. Whenever an alarm occurs, first always observe the patient and ensure that adequate ventilation and oxygenation (if appropriate) are available. 2. Look at the alarm indicators and listen to the audible alarm sound.
107 Alarm Summary Table The following table summarizes all of the high, medium, and low priority alarms and informational messages. Alarm Loss of Power Priority High Audible • • Visual (Alarm Indicator Button and Display) Red flashing button; Blank screen Device Action Shuts down User/Clinician Action User: Press Start/Stop button and then press Right button to silence alarm. If using AC power, try plugging device into alternate AC power source.
108 Alarm Ventilator Service Required Priority High Audible ••• •• Visual (Alarm Indicator Button and Display) Red flashing button; “Ventilator Service Required” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. The alarm goes away until next reminder appears. Connect patient to alternate source of ventilation and contact your health care professional as soon as possible.
109 Alarm Low Circuit Leak Priority High Audible ••• •• Visual (Alarm Indicator Button and Display) Red flashing button; “Low Circuit Leak” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Check for occlusions in exhalation devices. Make sure exhalation device is clean and functioning properly. If alarm continues, contact your health care professional.
110 Alarm High Internal Oxygen Circuit Disconnect Priority High High Audible ••• •• ••• •• Visual (Alarm Indicator Button and Display) Red flashing button; “High Internal Oxygen” message Red flashing button; “Circuit Disconnect” message Device Action User/Clinician Action Continues to operate when internal oxygen concentration reaches 5% above ambient levels. User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm.
111 Alarm High Vte Priority High Audible ••• •• Visual (Alarm Indicator Button and Display) Red flashing button; “High Vte” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Continue using device. If alarm continues, contact your health care professional. Clinician: Verify patient status.
112 Alarm High Respiratory Rate Priority High Audible ••• •• Visual (Alarm Indicator Button and Display) Red flashing button; “High Respiratory Rate” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Continue using device. If alarm continues, contact your health care professional. Clinician: Verify patient status.
113 Alarm Low Inspiratory Pressure Priority High Audible ••• •• Visual (Alarm Indicator Button and Display) Red flashing button; “Low Inspiratory Pressure” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Check patient circuit for leaks or disconnects.
114 Alarm Priority Low Battery Escalates from Medium to High Audible ••• (Medium when approx. 20 minutes remains) ••• •• (High - when approx. 10 minutes remains) High Temperature Escalates from Medium to High • • • for Medium ••• •• for High Visual (Alarm Indicator Button and Display) Device Action Medium PriorityOperates Yellow flashing button.
115 Alarm Replace Detachable Battery Ventilator Service Recommended Priority Low or High, depending on cause of alarm Medium Audible • • for Low ••• •• for High ••• Visual (Alarm Indicator Button and Display) Device Action “Replace Detachable Battery” message appears. If battery is nearing end of useful life, message appears with yellow background and button is solid yellow. If battery fails, message appears with red background and button flashes red.
116 Alarm Keypad Stuck Priority Low Audible •• Visual (Alarm Indicator Button and Display) Solid yellow button; “Keypad Stuck” message. Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Check the keys to determine if they are lodged in the case. If alarm continues, place patient on alternate source of ventilation and contact your health care professional.
117 Alarm Battery Not Charging Due to Temperature Priority Info Audible • Visual (Alarm Indicator Button and Display) “Batt Not Charging – Temp.” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Make sure device is not close to a heat source. Make sure cooling vents are not blocked. Move device to a cooler location. If device is too cold, allow it to warm up.
118 Alarm Check External Battery Priority Info Audible • Visual (Alarm Indicator Button and Display) “Check External Battery” message Device Action Operates User/Clinician Action User: Press Alarm Indicator/ Audio Pause button to silence alarm. Or, press Left (Reset) button to reset alarm. Check connection to external battery. Replace external battery with another external battery, if available.
119 Alarm Detachable Battery Disconnected Priority Info Audible • Visual (Alarm Indicator Button and Display) “Detachable Batt Disconnected” message, and a box appears around battery in use. Device Action User/Clinician Action Switches to alternate power source User: Check connection of the detachable battery to ventilator. Check the charge available on detachable battery and recharge battery if necessary. Clinician: Check detachable battery and recharge if necessary.
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121 Trilogy200 clinical manual 7. Cleaning and Maintenance Cleaning the Ventilator The ventilator’s exterior surface and the exterior of the detachable battery pack (if using) should be cleaned before and after each patient use, and more often if needed. 1.
122 Cleaning and Replacing the Air Inlet Filter Under normal usage, you should clean the gray foam filter at least once every two weeks and replace it with a new filter every six months or sooner if needed. 1. If the device is operating, stop the airflow by pressing the button. Disconnect the device from the power source. 2. Remove the filter from the enclosure by gently squeezing the filter in the center and pulling it away from the device, as shown below.
123 Replacing the Air Inlet Path Foam Follow your institution’s protocol for how often you replace the air inlet path foam. To replace the foam, complete the steps below. 1. Using a screwdriver, remove the air inlet path cover by unscrewing the four screws as shown below. Removing the Air Inlet Path Cover 2. Remove the gray foam air inlet path by hand. The removed air inlet path is shown below.
124 3. Insert the new air inlet path foam in the slot, lining the large circular cutout on the foam up with the circular connection at the top of the air inlet path compartment on the device. Make sure the air inlet path foam is securely in place. 4. Replace the air inlet path cover, using a screwdriver to secure each of the four screws. Make sure all of the screws are firmly in place. Cleaning the Patient Circuit Cleaning the reusable circuit is important in the hospital and in the home.
125 5. Place the circuit on a clean towel to dry. Do not wipe dry. The circuit must be completely dry before storing. 6. Reassemble the circuit when dry. Store in a plastic bag or dustfree area. 7. Inspect components for deterioration prior to use. Cleaning the Exhalation Devices Disassemble the exhalation device from the patient circuit. Follow the detailed cleaning instructions included with your exhalation device.
126 4. Connect the patient circuit. Fit the ventilator-end of the flexible tubing onto the bacteria filter. Installing a New Bacteria Filter Preventive Maintenance Your new Philips Respironics Trilogy ventilator includes a blank PM Service Due label affixed to the bottom of your device. The label is blank, which allows you to document when service is due. Service is due every 10,000 hours or 24 months, whichever comes first depending on the usage of the device.
127 The following table provides information on recommended periodic maintenance for your device. Time / Hours of Service Prior to initial use on a patient Recommended Maintenance •• Charge Internal and Detachable Batteries to 100% capacity by plugging ventilator into an AC power source for up to 8 hours. Prior to long term storage after initial use •• Perform System Checkout Procedure in Chapter 10. •• Charge both Internal and Detachable batteries to 100% capacity prior to storage.
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129 Trilogy200 clinical manual 8. Troubleshooting The ventilator is designed to respond to most issues with an appropriate alarm or information message. These messages appear on the display screen. Chapter 6 describes many of the alarms and what action you should take when the alarms occur. This chapter provides additional troubleshooting information for other common issues you may have. Issue Device does not turn on. Nothing happens when you press Start/Stop to begin therapy.
130 Issue Why It Happened What To Do The batteries are not charging. The device is plugged in, but the detachable (if installed) and internal batteries are not showing full capacity and are not charging. The batteries may not charge if the device is too hot or too cold or is operating at an ambient temperature outside of the specified valid range. The device cooling fan may not be working properly. If this continues for more than 15 minutes, an error will occur.
131 Issue Why It Happened What To Do Excessive Warm Air Out of Mask The air out of the mask is much warmer than usual. The air filter may be dirty. Or, the device may be operating in direct sunlight or near a heater. Clean or replace the air filter as described in Chapter 7. The temperature of the air may vary based on the room temperature. Make sure the device is properly ventilated. Keep it away from bedding or curtains that could block the flow of air around the device.
132 Issue Why It Happened What To Do Dryness The patient has throat or nose dryness. The air is too dry. This only applies to non-invasive therapy and will not occur during invasive therapy. Increase the room humidity. Consult with the patient’s health care professional about using a humidifier with the device. If using a humidifier, refer to the instructions included with the humidifier to make sure it is working properly. Sinus or Ear Pain The patient experiences nasal, sinus, or ear pain.
133 Trilogy200 clinical manual 9. Accessories There are several accessories you can use with the ventilator. Adding a Humidifier Use of a humidifier may reduce nasal dryness and irritation by adding moisture to the airflow. If you are using a humidifier with the ventilator, refer to the instructions provided with the humidifier for complete setup information. Adding Supplemental Oxygen to the Device The delivered oxygen concentration varies with changes in flow in the circuit.
134 Supplemental Oxygen Warnings •• When administering fixed-flow supplemental oxygen, the oxygen concentration may not be constant. The inspired oxygen concentration will vary, depending on the pressures, patient flows and circuit leak. Substantial leaks may reduce the inspired oxygen concentration to less than the expected value. Appropriate patient monitoring should be used, as medically indicated, such as an alarming pulse oximeter. •• This device DOES NOT alarm for loss of the low flow oxygen supply.
135 Using a Nurse Call System You can use an institutional Nurse Call system with your device. There are several Philips Respironics cables available to connect a nurse call system to the device. Refer to the instructions included with your cable assembly if you have questions on how to connect it to the device. WARNING Ensure that the Nurse Call systems used do not exceed SELV (Safety Extra Low Voltage) levels as described in IEC 60601-1.
136 2. Push the SD card completely into the card slot until the card clicks into place. Note: The SD card does not need to be installed for the device to work properly. Inserting the SD Card To remove the SD card, select the “Safely Remove SD Card” option from the main menu. After the “Remove SD Card” confirmation message appears, remove the card by pushing the card in until the card clicks to release. The card will be slightly ejected from the device.
137 Traveling with the System When traveling, the carrying case is for carry-on luggage only. The carrying case will not protect the system if it is put through checked baggage. For your convenience at security stations, there is a note on the bottom of the device stating that it is medical equipment and is suitable for airline use. It may be helpful to bring this manual along with you to help security personnel understand the device.
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139 Trilogy200 clinical manual 10. System Checkout Procedures This chapter details the test procedures that should be performed by the clinician prior to connecting the device to the patient. Test the Active PAP, Active Flow, and Passive circuit types if you want to do a complete checkout on the device. The tests should be performed as described in order to verify proper operation of the device. Some of the procedures in this chapter require you to change settings on the device.
140 2. Verify that the device handle, SD Card door, and detachable battery are secure and in good working order. 3. Verify that the rubber feet are on the bottom of the device. Initial Setup 1. Connect the power cord to the device and then to an AC outlet. 2. Attach the test lung to the patient connection end of the desired circuit (Active PAP, Active Flow, or Passive). 3. Follow the instructions in Chapter 5 to access the Setup Screen.
141 Setting Value Trigger Type (passive circuit type) Auto-Trak Flow Trigger Sensitivity (Active PAP or Active Flow circuit type) 6.0 l/min Leak Compensation (Active Flow circuit type) On Flow Cycle Sensitivity (Active PAP or Active Flow circuit type) 20% Rise Time 1 Ramp Length Off All other alarms Off B. Options Menu Modify the settings in the Options menu to match those shown below in Table 2.
142 2. Verify the High Tidal Volume Alarm This procedure verifies that the High Tidal Volume alarm is working properly. For Passive and Active Flow circuits, this will verify the High Vte alarm. For Active PAP circuits, this will verify the High Vti alarm. It assumes that you have attached the test lung, verified the ventilator settings, and turned on ventilator power as described in the Initial Setup section. A.
143 E. Restore Ventilator Settings Modify the ventilator settings and change the following value shown in Table 5. Setting High Vte/High Vti Value Off Table 5 - Restore Ventilator Settings 3. Verify the Low Tidal Volume Alarm This procedure verifies that the Low Tidal Volume alarm is working properly. For Passive and Active Flow circuits, this will verify the Low Vte alarm. For Active PAP circuits, this will verify the Low Vti alarm.
144 D. Verify Reset Wait 40 seconds and verify the following auto-reset conditions: •• The High Priority audible indicator has stopped sounding •• The red light on the Alarm Indicator/Audio Pause button has stopped flashing E. Restore Ventilator Settings Modify the ventilator settings and change the following value shown in Table 8. Setting Low Vte/Low Vti Value Off Table 8 - Restore Ventilator Settings 4.
145 •• The Circuit Disconnect alarm condition appears on the screen, highlighted in red D. Reconnect Test Lung Reconnect the test lung to the circuit. E. Verify Reset Wait at least 40 seconds and verify the following auto-reset conditions: •• The High Priority audible indicator has stopped sounding •• The red light on the Alarm Indicator/Audio Pause button has stopped flashing F. Restore Ventilator Settings Modify the ventilator settings and change the following values shown below in Table 10.
146 Setting Value PEEP 4 cm H2O Sigh Off Circuit Disconnect Off Low Inspiratory Pressure 6 cm H2O High Inspiratory Pressure 10 cm H2O Apnea Off All other alarms Off B. Verify the Alarm Wait up to 40 seconds and verify the following alarm signals: •• The Medium Priority audible indicator sounds •• A yellow light flashes on the Alarm Indicator/Audio Pause button •• The High Inspiratory Pressure alarm condition appears on the screen, highlighted in yellow C.
147 A. Change Ventilator Settings Modify the ventilator settings and change the following values shown below in Table 13. Setting Value Mode CV Tidal Volume 500 ml Breath Rate 12 BPM Inspiratory Time 1.0 seconds Flow Pattern Ramp PEEP 4 cm H2O Sigh Off Circuit Disconnect Off Low Inspiratory Pressure 40 cm H2O High Inspiratory Pressure 60 cm H2O Apnea Off All other alarms Off Table 13 - Ventilator Settings B.
148 D. Verify Reset Wait 40 seconds and verify the following auto-reset conditions: •• The High Priority audible indicator has stopped sounding •• The red light on the Alarm Indicator/Audio Pause button has stopped flashing Battery Function Verification Make sure the batteries are functioning properly and fully charged before patient use. 1. Verify the Detachable and Internal (Lithium-Ion) Batteries Function A. Connect AC Power to the device and verify that the green AC LED on the front panel is lit. B.
149 E. Disconnect the detachable battery pack from the device. •• Verify that the Detach Batt Disconnected alarm message appears on the display. Press Reset. •• Verify that the internal battery symbol shows the same level of charge as noted in Step C and the device continues to operate. •• Verify that the internal battery symbol has a black box around it to indicate that it is in use. F. Reconnect the Detachable Battery and AC Power source. 2. Verify the External Battery Function (If Available) A.
150 Alarm and Event Log Clean-Up 1. In the Setup Menu, select Alarm Log. A. Press Clear to clear the log file. B. Press Yes to confirm. C. Press Finish to complete. 2. In the Setup Menu, select Event Log. A. Press Clear to clear the log file. B. Press Yes to confirm. C. Press Finish to complete. Results All portions of this checkout procedure should be completed prior to connection to the patient.
151 Trilogy200 clinical manual 11. Technical Specifications Environmental Operating Storage Temperature 41° F to 104° F (5° C to 40° C) -4° F to 140° F (-20° C to 60° C) Relative Humidity 15 to 95% (non-condensing) 15 to 95% (non-condensing) Atmospheric Pressure 110 kPa to 60 kPa N/A The operating range for the charging of the internal and detachable batteries is 10° C to 30° C. The internal and detachable batteries will power the ventilator for the full operating range of 5° C to 40° C.
152 Electrical AC Voltage Source: 100 to 240 VAC, 50/60 Hz, 2.1 A Detachable Battery: Voltage: 14.4 VDC Capacity: 4176 mAh Chemistry type: Lithium-Ion Internal Battery: Voltage: 14.
153 Control Accuracy Parameter Range Accuracy IPAP 4 to 501 cm H2O2 Greater of 2 cm H2O or 8% of setting EPAP 0 to 25 cm H2O for Active Circuits 4 to 25 cm H2O for Passive Circuits Greater of 2 cm H2O or 8% of setting CPAP 4 to 20 cm H2O Greater of 2 cm H2O or 8% of setting PEEP 0 to 25 cm H2O for Active Circuits 4 to 25 cm H2O for Passive Circuits Greater of 2 cm H2O or 8% of setting4 Pressure 4 to 50 cm H2O Greater of 2 cm H2O or 8% of setting Pressure Support 0 to 30 cm H2O3 Greater
154 Measured Patient Parameters Parameter Range Accuracy Vte/Vti 0 to 2000 ml Greater of 15ml or 15% of reading Minute Ventilation 0 to 99 l/min Calculation based on measured Vte or Vti and Respiratory Rate Estimated Leak Rate 0 to 200 l/min N/A Respiratory Rate 0 to 80 BPM Greater of 1 BPM or 10% of reading Peak Inspiratory Flow 0 to 200 l/min 3 l/min plus 15% of reading Peak Inspiratory Pressure 0 to 99 cm H2O Greater than 2 cm H2O or 10% of reading Mean Airway Pressure 0 to 99 cm H
155 Trilogy200 clinical manual 12. Glossary The following terms and acronyms appear throughout this manual. Term/Acronym Definition AC Power Alternating Current power AC Assist Control therapy mode; AC mode delivers Assisted and Mandatory breaths with a user-defined inspired tidal volume. This is a Volume Control mode. Apnea A condition marked by the temporary cessation of spontaneous breathing.
156 Term/Acronym Definition BTPS Body Temperature and Pressure Saturated; A standardization for lung volumes and flows to barometric pressure at sea level, body temperature, and saturated with water vapor reflecting the condition of air in the lung. CPAP Continuous Positive Airway Pressure CV Control Ventilation therapy mode; CV mode delivers Mandatory breaths with a user-defined inspired tidal volume. This is a Volume Control mode.
157 Term/Acronym Definition Mandatory Breath A Mandatory Breath is completely controlled by the ventilator. Breaths are initiated by the ventilator according to the breath Rate (BPM) setting. Breaths are cycled according to the Inspiratory time setting. MAP Mean Airway Pressure. This is the average airway pressure over a full breath cycle. The MAP value displayed on the screen represents the average MAP value over six breaths and is updated at the end of each exhalation.
158 Term/Acronym Definition PEEP Positive End Expiratory Pressure Pressure Control Ventilation (PCV) Ventilation in which breaths are controlled by operator-defined Pressure, Inspiratory Time, and Rise Time. PS Pressure Support Ramp A feature that may increase patient comfort when therapy is started. The ramp feature reduces pressure and then gradually increases the pressure to the prescription setting so patients can fall asleep more comfortably.
159 Term/Acronym Definition Spontaneous (S) Mode Therapy mode in which all breaths are spontaneous. The ventilator supports breathing with user-defined Pressure Support (PS) and Rise Time values. Spontaneous/Timed (S/T) Mode Therapy mode that is similar to S mode, except that it can also deliver a mandatory breath if the patient does not spontaneously breathe within a set time. Tidal Volume The amount of air passing in and out of the lungs for each breath.
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161 Trilogy200 clinical manual 13. EMC Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test RF emissions Compliance Group 1 CISPR 11 Electromagnetic Environment Guidance The device uses RF energy only for its internal function.
162 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test Electrostatic IEC 60601 Test Level ±6 kV contact Compliance Level ±8 kV contact Discharge (ESD) Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile.
163 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
164 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
165 Trilogy200 clinical manual Index A AC Power 51 AC Power Inlet 17 Air Filter Installation 50 Air Inlet Air Inlet Filter Cleaning 122 Replacing 123 Air Inlet Path Replacing 123 Alarm and Event Log Clean-Up 148 Alarm Log 89 Alarms 102 Alarm Indicators 104 Alarm Messages 104 Alarm Reset 105 Alarm Volume Control 106 Patient Alarms High Exhaled Tidal Volume 44 High Minute Ventilation 45 High Peak Inspiratory Pressure 46 Low Exhaled Tidal Volume 44 Low Minute Ventilation 45 Low Peak Inspiratory Pressure 44
166 DirectView Software 134 I E Inspiratory Time 82 In-Use Bag 134 IP Address Mode Setting 88 IPAP 81 IPAP Max Pressure 81 IPAP Min Pressure 81 EMC Information 159 EPAP 81 Ethernet Connector 18 Event Log 90 Exhalation Devices Cleaning 125 Exhalation Porting Block 18 F Flex 97 Flex Comfort Feature 30, 80 Bi-Flex 30 C-Flex 30 Flow Cycle Sensitivity 79 Flow Pattern 84 Ramp 33 Square 33 Flow Trigger Sensitivity 79 Front Panel AC Power LED 15 Audio Pause Button 16 Keypad Backlight LEDs 16 Left/Right Buttons
167 P Passive Exhalation Device 57 Patient Circuit Cleaning 124 PC-SIMV Mode 25, 83 Positive End Expiratory Pressure (PEEP) 84 Pressure Control Mode 24 Pressure Control Ventilation 85 Pressure Setting 83 Pressure Support 83 Pressure Units 86 R Ramp Feature 31 Ramp Length 79 Ramp Start Pressure 80, 96 Remote Alarm 62, 104 Remote Alarm Connector 18 Rise Time 32, 82, 96 S Environmental 149 Pressure 150 Standards Compliance 149 T Tidal Volume 81 Timed Mode 82 Time Format 88 Trigger Type Auto-Trak 78 Flow T
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169 Trilogy200 clinical manual Limited Warranty Respironics, Inc. warrants that the Trilogy200 system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two (2) years from the date of sale by Respironics, Inc. to the dealer. If the product fails to perform in accordance with the product specifications, Respironics, Inc.will repair or replace – at its option – the defective material or part. Respironics, Inc.
170 To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact Respironics, Inc.
