Summary of Contents for Hillrom Life2000 BT-20-0022
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Life2000® Ventilation System (Dockless) Instructions for Use Product No. BT-20-0022, MS-01-0118, MS-01-0121...
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First Printing, 2020 Bluetooth® is a registered trademark of Bluetooth SIG, Inc. Life2000® is a registered trademark of Breathe Technologies, Inc., a Hillrom Company. Hillrom™ is a trademark of Hill-Rom Services, Inc. Replace this manual (PL-20-0050) if it is damaged and/or can not be read.
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FDA does not intend to object to limited modifications to the FDA-cleared indications without prior submission of a 510(k) where the modifications do not create undue risks. Hillrom™ does not yet have FDA 510(k) clearance on the use of The Life2000® Ventilator Software version 06.08.00.00. Hillrom™ intends to adhere to FDA’s recommendations to market The Life2000®...
LIFE2000® VENTILATION SYSTEM INTRODUCTION LIFE2000® VENTILATION SYSTEM INTRODUCTION NDICATIONS FOR USE The Life2000® Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The Life2000® Ventilation System consists of the Life2000® Ventilator and the Life2000® Compressor.
LIFE2000® VENTILATION SYSTEM INTRODUCTION AFETY INFORMATION Please read the following safety warnings and cautions in their entirety before using the Life2000® Ventilation System. Warnings and cautions can also be found throughout this Instructions for Use. WARNING: • The Life2000® Ventilation System is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
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LIFE2000® VENTILATION SYSTEM INTRODUCTION • Use only approved accessories and replacement parts with the ventilation system. If unauthorized accessories or replacement parts are used with the system, the ventilation system may be damaged and performance may be degraded. • Do not connect the ventilation system components or accessories to any other equipment that is not described in this Instructions for Use.
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• Use only the Hillrom approved battery charger and cord set with the ventilation system. If an unauthorized battery charger or cord set is used with the ventilation system the system may be damaged.
LIFE2000® VENTILATION SYSTEM INTRODUCTION EATURES The Life2000® Ventilation System is a critical care, volume control mechanical ventilation system designed for a broad range of applications in critical care and home settings. The modular Life2000® Ventilation System (system) is composed of the Life2000® Ventilator (ventilator) and the Life2000®...
LIFE2000® VENTILATION SYSTEM INTRODUCTION ACKAGING CONTENTS For any accessories, read the label and accompanying document(s) before use. The ventilation system is shipped in specially designed, protective boxes. Do not TIP: throw away the boxes; keep them for future transportation needs. Life2000®...
LIFE2000® VENTILATION SYSTEM INTRODUCTION LIFE2000® VENTILATOR VERSIONS There are two released ventilator versions of the Life2000 Ventilator. You will be able to identify the version of the ventilator based on the REF number. The functionality of the ventilator’s Communication Port, Battery Charge Icon, and System Alarms differ for each version of the ventilator.
LIFE2000® VENTILATION SYSTEM INTRODUCTION YSTEM COMPONENTS ENTILATOR FRONT BOTTOM Battery charger connection 4 Touch screen 11 Interface connection Silence Alarm button Activity buttons 12 Gas inlet connection Communication Port High Activity Medium Activity Low Activity Power button for ventilator Power indicator light Alarm speaker Backup alarm buzzer 10 Breath indicator light...
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LIFE2000® VENTILATION SYSTEM INTRODUCTION Compressor FRONT Power button for compres- Battery charge status and indicator lights SIDE Interface connection BACK Handle Air inlet and filter Cooling filter cover Cooling vents Condensation tray Power supply connection and cover SIDE 10 Alarm buzzer (internal) Life2000®...
LIFE2000® VENTILATION SYSTEM INTRODUCTION ONFIGURATIONS The modular Life2000® Ventilation System (system) is composed of the Life2000® Ventilator (ventilator) and the Life2000® Compressor (compressor). The system can be used in two different configurations. XTENDED RANGE WEARABLE CONFIGURATION The ventilator is connected to the compressor with a gas supply hose to enable the activities of daily living.
The Life2000® Ventilation System can be used in different configurations of operation as the patient’s needs change. In Extended Range Configuration, the ventilator is connected to the compressor with a Hillrom oxygen hose to enable the activities of daily living. NOTE:...
EXTENDED RANGE CONFIGURATION OSITIONING AND CARRYING THE COMPRESSOR Position the compressor upright on a flat, level surface. Make sure that the cooling vents, cooling filter cover, and air inlet on the back of the compressor are not blocked, and there is sufficient clearance from surrounding objects.
EXTENDED RANGE CONFIGURATION CAUTION: • Keep in a clean environment to protect the ventilation system from ingress of dust, lint, and pests. • Do not leave the ventilation system exposed to the sun or other sources of radiant heat, it may overheat.
• Use only the Hillrom® approved AC power cord and external power supply with the compressor. Using an unauthorized AC power cord or external power supply may damage the compressor. ONNECTING THE VENTILATOR AND THE COMPRESSOR IN EXTENDED RANGE CONFIGURATION In this configuration, the ventilator and compressor are connected by an oxygen hose;...
EXTENDED RANGE CONFIGURATION Attach the oxygen hose to the outlet fitting on the compressor. NOTE: NOTE: The outlet fitting is to be used only for connecting the compressor to the Life2000 ® Ventilator with an approved source gas supply hose or during the purging of an interface. For more information about the purging process see "Purging the Universal Circuit®...
EXTENDED RANGE CONFIGURATION THE COMBO ® HOSE The CombO ® hose may be used to connect the Life2000® Ventilation System in Extended Range Configuration and provide supplemental low-flow oxygen from an oxygen concentrator or other low-flow oxygen source. Oxygen tubing connector Outlet fitting connector Oxygen tubing Source Gas Supply hose...
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EXTENDED RANGE CONFIGURATION WARNING: The interface, source gas supply hose, and power cords should be positioned to avoid restricting movement, causing a tripping hazard, or posing a strangulation risk. NOTE: NOTE: A 20-foot source gas supply hose (available to order) is recommended when using a ventilator output volume greater than 350 ml.
This self test can take up to 15 seconds to complete. If you do not hear tones when you turn on the ventila- tor, contact your Hillrom service representative. When the Home Screen is displayed, the touch screen is ready to use.
EXTENDED RANGE CONFIGURATION ’ HECKING THE COMPRESSOR S INTERNAL BATTERY STATUS The compressor is equipped with an internal battery for temporary AC power disruptions. This internal battery: • charges when the compressor is attached to AC power. • has a maximum charge of one hour. When the compressor is powered on and the power source indicator lights surrounding the power but- ton are illuminated in orange the compressor is run-...
• Use only the Hillrom approved battery charger and cord set with the ventilator. If an unauthorized battery charger or cord set is used with the ventilator, the ventilator may be damaged.
EXTENDED RANGE CONFIGURATION Position the clip over the belt, and push down until it is secure. Line up the belt clip with the belt clip sockets on the ventilator. Push in the ventilator towards the belt clip until the ventilator audibly clicks into place. OLE MOUNT The ventilator may also be secured with the use of an optional pole mount.
EXTENDED RANGE CONFIGURATION OWER OFF SEQUENCE IN EXTENDED RANGE CONFIGURATION To power off the ventilator, press the ventilator's power button for three sec- onds until a confirmation screen appears. To continue to power off the ventilator, choose OK. NOTE: NOTE: If a selection is not made within 20 seconds or if the BACK button is selected, the previous screen will be displayed and the ventilation status will not be affected.
This chapter provides instructions about connecting the Life2000® Ventilator to an alternate pressure source (50- PSI, ≥ 40 LPM at 41 PSI), such as an oxygen cylinder, by using a Hillrom oxygen hose. A regulator is required to connect the ventilator to an oxygen cylinder.
STAND-ALONE CONFIGURATION TESTING THE VENTILATOR In a multi-patient setting, the ventilator must be tested before it is assigned to a new patient. For instructions on testing the ventilator, see “TESTING VENTILATOR ALARMS” on page 95. CONNECTING TO A CYLINDER An oxygen regulator is required to connect the ventilator to an oxygen cylinder. Ensure that the oxygen regulator meets the requirements below and is appropriate for the cylinder being used.
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STAND-ALONE CONFIGURATION TIPS: • If using a cylinder, make sure your oxygen supply is sufficient for your length of use. For more information about estimating oxygen usage, see “CYLINDER DURATION INFORMATION” on page 131. • If not connected to AC power, make sure the ventilator battery has sufficient charge for your length of use.
STAND-ALONE CONFIGURATION Ensure that the regulator is preset to 50 PSI [or adjust the regulator pressure to 41 PSI to 87 PSI (50 PSI nominal)]. Slide the regulator over the neck of the cylinder, and line up the pins on the regulator with the holes in the cylinder neck.
This self test can take up to 15 seconds to complete. If you do not hear tones when you turn on the ventilator, contact your Hillrom service representative. When the Home Screen is displayed, the touch screen is ready to use.
STAND-ALONE CONFIGURATION ASSEMBLING THE VENTILATOR BATTERY CHARGER AND CHARGING THE VENTILATOR Plug the ventilator AC power cord into the ventilator battery charger. Connect the ventilator AC plug into an AC power source. The ventilator battery charger indicator light will turn green or red when connected to AC power.
STAND-ALONE CONFIGURATION SECURING THE VENTILATOR BELT CLIP You can attach the ventilator to a belt or waistband using the included belt clip. The ventilator can be worn on either the right or left side. CAUTION: • Make sure the clip is securely fastened to the belt and the ventilator. If the clip is not securely fastened to the belt and the ventilator, the ventilator may fall and be damaged.
STAND-ALONE CONFIGURATION POLE MOUNT You can attach the ventilator to a pole using an optional pole mount. For information about ordering accessories and replacement parts, see “ACCESSORIES AND REPLACEMENT PARTS” on page 127. CAUTION: • Make sure the pole mount is securely attached to the pole, and the ventilator and clip are securely fastened to the pole mount and the ventilator.
STAND-ALONE CONFIGURATION VENTILATOR SILENCE ALARM BUTTON Silencing and clearing alarms is a multi-step process that depends on alarm priority and how many alarms are active. For more information see “ALARMS, ALERTS, AND TROUBLESHOOTING” on page 67. Silence Alarm button on ventilator. Press the Silence Alarm button to temporarily silence the alarm for 60 seconds.
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STAND-ALONE CONFIGURATION Life2000® Ventilation System Service (PL-20-0050 REV A)
The interface, source gas supply hose, and power cords should be positioned to avoid restricting movement, causing a tripping hazard, or posing a strangulation risk. CAUTION: Hillrom recommends a 90-day replacement schedule for the Universal Circuit® Connector. NOTE: NOTE: The Life2000® has been validated for use with a Bacterial Filter or a Heat and Moisture Exchanger (HME) with resistance up to 1.8 cmH₂O at 60 LPM of flow.
CONNECTING AN INTERFACE EXAMPLES OF PATIENT MASK AND TUBE CONNECTIONS The Universal Circuit® Connec- The Universal Circuit® Connector The Universal Circuit® Connec- tor with a full face mask with an endotracheal tube tor with a tracheal tube USING THE LIFE2000 COMPRESSOR WITH THE UNIVERSAL CIRCUIT CONNECTOR ®...
® AND PATIENT MASK OR TUBE CAUTION: • Hillrom recommends a 90-day replacement schedule for the Universal Circuit® Connector and Interface accessories. • Do not use a Universal Circuit® Connector that is cracked, odorous, broken, or kinked. If a damaged interface is used, the patient may not receive adequate respiratory therapy.
Do not use a Breathe Pillows Entrainment Interface that is cracked, odorous, broken, or kinked. If a damaged interface is used, the patient may not receive adequate respiratory therapy. • Hillrom recommends a 90-day replacement schedule for the Breathe Pillows Entrainment Interface. NOTE: NOTE: •...
CONNECTING AN INTERFACE WEARING THE BREATHE PILLOWS ENTRAINMENT INTERFACE 1. Place the interface in front of the patient with the curve of the interface towards the patient’s face and the entrainment ports facing up. entrainment ports (facing up) 2. Loop the interface tubing over the ears and position the nasal pillows snugly inside the nostrils.
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CONNECTING AN INTERFACE Life2000® Ventilation System Service (PL-20-0050 REV A)
VENTILATION SETTINGS VENTILATION SETTINGS INTRODUCTION TO VENTILATION SETTINGS All of the clinical and utility menus can be accessed, viewed, and edited by the touch screen on the ventilator. To use the touch screen, simply touch a button or an area of the screen you want to make active. An audible “click”...
VENTILATION SETTINGS MOVING BETWEEN THE HOME SCREEN AND MENU SCREEN 1. Touch the Wrench Button to go to the Menu Screen. 500 ml 20.0 PIP cmH Breath/min Air LPM 10:11a, Fri Jun 12, 2015 Values displayed on the screen are for illustrative purposes only.
VENTILATION SETTINGS DEFINING CLINICAL SETTINGS NOTE: NOTE: For facilities where trained healthcare professionals are the intended users, the password to access clinical settings may be enabled or disabled. For more information, contact customer service. ACCESSING THE SETTINGS MENU 1. On any screen, touch the Wrench button. 500 ml 20.0 PIP cmH...
VENTILATION SETTINGS DISABLING ACCESS TO THE CLINICIAN’S SETTINGS MENU There are two ways to disable access to the Clinician’s Settings menu to prevent unintended changes to the programmed clinical settings. AUTOMATIC TIMEOUT An Automatic Timeout disables access to the Clinician’s Settings menu after five minutes of inactivity in the Clinician’s Settings menu.
VENTILATION SETTINGS PRESCRIPTION SETTINGS Each Activity Icon on a button in the Prescription Settings screen represents a prescription that can be programmed by a clinician and made available to the patient. Each button on the Prescription Settings screen corresponds to an Activity Button on the ventilator.
VENTILATION SETTINGS ACTIVATING PRESCRIPTION SETTINGS 1. Each icon on the Prescription Settings screen represents a prescription. Check the box below a Prescription Settings button to make the prescription active (checked) or inactive (unchecked) for patient selection. Only active (checked) Prescription Settings buttons are available to the patient as therapy options.
VENTILATION SETTINGS FACTORY DEFAULT PRESCRIPTION SETTINGS The following table lists the Life2000® factory default Prescription Settings that may be edited. For a full list of factory defaults, see the “SUMMARY OF FACTORY DEFAULT SETTINGS” on page 66. DEFAULT VALUE DESCRIPTION MEDIUM HIGH ACTIVITY...
VENTILATION SETTINGS BREATH TYPES There are two breath types that apply to the Volume Control ventilation provided by the ventilation system: • Mandatory • Assisted MANDATORY BREATH A mandatory breath (or machine breath) is completely controlled by the ventilation system. The system controls both the beginning (triggering) and end (cycling) of the inspiratory phase.
VENTILATION SETTINGS SETTING VENTILATION PARAMETERS IN CONTROL VENTILATION MODE In this mode, the ventilation system delivers volume control therapy only for mandatory breaths. A mandatory breath is delivered according to the breath setting (BPM). This also means that a breath will not be triggered based on patient’s inspiratory effort.
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VENTILATION SETTINGS To set a Prescription Setting for Assist/Control Ventilation Mode, the following parameters need to be set according to the table below: VENTILATION MODE* SET TRIGGER SENSITIVITY TO: SET BREATH RATE TO: Control ≥1 * Settings based on prescription To set the Prescription Setting: 1.
VENTILATION SETTINGS SETTING VENTILATION PARAMETERS IN ASSIST VENTILATION MODE In this mode, the ventilation system provides Tidal Volume during inhalation for assisted and mandatory breaths. An assisted breath is started when there is patient effort, but it is ended when the Inspiratory Time setting has been met.
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VENTILATION SETTINGS To set a Prescription Setting for Assist/Control ventilation mode, the following parameters need to be set according to the table below: VENTILATION MODE* SET TRIGGER SENSITIVITY TO: SET BREATH RATE TO: Assist/Control 0 to 9 ≥1 * Settings based on prescription To set the Prescription Setting: 1.
VENTILATION SETTINGS SETTING VENTILATION PARAMETERS IN ASSIST VENTILATION MODE In this mode, the ventilation system provides Tidal Volume during inhalation for assisted breaths. An assisted breath is started when there is patient effort and is ended when the Inspiratory Time setting has been met.
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VENTILATION SETTINGS To set a Prescription Setting for Assist ventilation mode, the following parameters need to be set according to the table below: VENTILATION MODE* SET TRIGGER SENSITIVITY TO: SET BREATH RATE TO: Assist 0 to 9 * Settings based on prescription To set the Prescription Setting: 1.
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VENTILATION SETTINGS Sensitivity Control ventilation mode: Control ventilation mode: Assist or Assist/Control Assist or Assist/Control ventilation mode: 9 ventilation mode: 0 BR (/min) a. For software revisions before 06.08.00.00, PEEP Range is 0 to 10 cmH2O TIPS: Volume: You can set an output volume between 50 ml and 750 ml, in increments of 10 ml. •...
VENTILATION SETTINGS SETTING ALARM LIMITS FOR BREATH RATE AND PIP To view or edit critical alarms, access the Alarm Limits screen from the Clinician’s Settings screen. 1. On the Clinician’s Setting screen, touch Alarm Limits. Clinician’s Settings Ventilation Alarm Breath Settings Limits Timeout...
VENTILATION SETTINGS SETTING BREATH TIMEOUT (APNEA BACKUP VENTILATION MODE) On the Clinician’s Setting screen, touch Breath Clinician’s Settings Timeout. Ventilation Alarm Breath Settings Limits Timeout Source 10:11a, Fri 10:11a, Fri Jun 12, 2015 Jun 12, 2015 2. On the Breath Timeout screen, touch the Timeout Breath Timeout B B reath Timeout Period or Timeout Action box you want to change.
VENTILATION SETTINGS SELECTING THE SOURCE GAS The Life2000® Ventilation System uses Air as the factory set default source gas. If using an oxygen cylinder, select O2 as the Source Gas. OURCE GAS IS AIR OURCE GAS IS XYGEN Extended Range Configuration Stand-Alone Configuration with an Oxygen cylinder (or a wall Oxygen pressure source)
VENTILATION SETTINGS CHOOSING AN ACTIVITY BUTTON (PATIENT SELECTABLE) TO BEGIN VENTILATION When the ventilator is first powered on, you must select an Activity Button to begin ventilation. The three Activity Buttons on the ventilator are programmed to correspond to up to three different prescriptions as directed by a physician.
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VENTILATION SETTINGS “INCOMPATIBLE SETTINGS” MESSAGE If the selected Activity Button represents a prescription that is not available, this message will appear on the touch screen. If therapy had already started with a different Activity Button, the ventilator will continue delivering Incompatible Settings! therapy using the prescription represented by the previous Adjust Settings...
VENTILATION SETTINGS ADJUSTING THE TRIGGER SENSITIVITY (PATIENT ADJUSTABLE) Trigger sensitivity determines how easily a patient’s inspiratory effort triggers the breath delivery. For shallow breathing, set the trigger sensitivity to a low number. You can choose a setting between 0 and 9. Zero is the most sensitive and 9 is the least sensitive setting. An Activity Button must already be selected (the ventilator must be currently ventilating) to allow changes to the Trigger Sensitivity settings through the patient-accessible Settings menu.
VENTILATION SETTINGS CHANGING TRIGGER SENSITIVITY 1. While ventilating, on the Trigger Sensitivity screen, touch the Up arrow to increase the value or the Down arrow to decrease it. Pressing and holding an arrow button will continue to increase or decrease the value. NOTE: The lower the number, the more sensitive the setting.
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VENTILATION SETTINGS SETTING TIME AND DATE 1. On the Utilities Menu screen, touch Set Time/Date. 10:11a, Fri Jun 12, 2015 2. On the Set Time/Date screen, touch the box you want to change. 10:11a, Fri Jun 12, 2015 Values displayed on the screen are for illustrative purposes only.
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VENTILATION SETTINGS SETTING VIBRATION MODE The Set Vibration screen lets you change alarm notifications from audible tones to a vibration. However, if a low- or medium-priority vibrating alarm occurs and is not resolved in 60 seconds, an audible alarm occurs. For a high- priority alarm, an audible tone immediately occurs with a vibration alarm with no delay.
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VENTILATION SETTINGS SETTING AUDIO LOUDNESS WARNING: Ensure that the alarm loudness is set above the loudness of your surroundings. 1. On the Utilities Menu screen, touch Set Loudness. 10:11a, Fri Jun 12, 2015 2. Touch the Up arrow to increase the audio loudness level or the Down arrow to decrease it.
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VENTILATION SETTINGS ADJUSTING SCREEN BRIGHTNESS On the Utilities Menu screen, touch Set Brightness. 10:11a, Fri Jun 12, 2015 2. Touch the Up arrow to increase the brightness or the Down arrow to decrease it. Pressing and holding an arrow button will continue to increase or decrease the value.
VENTILATION SETTINGS VIEWING SOFTWARE VERSION INFORMATION The Information screen displays information about the ventilator and its operation. On any screen, touch the Wrench button. 500 ml 20.0 PIP cmH Breath/min Air LPM 10:11a, Fri Jun 12, 2015 Values displayed on the screen are for illustrative purposes only.
VENTILATION SETTINGS SUMMARY OF FACTORY DEFAULT SETTINGS The following table lists the factory default settings for the ventilator. DEFAULT VALUE CLINICIAN’S MENU SETTINGS MEDIUM HIGH ACTIVITY ACTIVITY ACTIVITY Ventilation Settings Volume 150 ml 180 ml 200 ml I-Time (Inspiratory Time) 0.75 sec PEEP (Positive End Expiratory Pressure) 0 cmH...
ALARMS, ALERTS, AND TROUBLESHOOTING ALARMS, ALERTS, AND TROUBLESHOOTING INTRODUCTION TO ALARMS AND ALERTS WARNING: • If the Life2000® Ventilation System is not functioning properly, respiratory therapy may be compromised and may result in patient harm or death. Always have an alternate means of ventilation or oxygen therapy available.
ALARMS, ALERTS, AND TROUBLESHOOTING ACTIVE ALARMS WINDOW Multiple on-screen alarms may occur at the same time. Touch the Active Alarms button at the top of the touch screen to display a list of active on-screen alarms. NOTE: NOTE: The Active Alarms button is only visible during ventilator on-screen alarm notifications. TIP: The Active Alarms window displays up to three on-screen alarms, from highest to lowest priority (red, yellow, blue).
ALARMS, ALERTS, AND TROUBLESHOOTING ILENCING AND CLEARING ON SCREEN ALARMS Alarm notifications that appear on the touch screen originate from the ventilator. Silencing and clearing on-screen alarms is a multi-step process that depends on alarm priority and how many alarms are active. Silence Alarm button on ventilator (when in Extended Range or Silence Alarm button on compressor (when in Stationary...
ENTILATOR ALARMS The following tables list high-, medium-, and low-priority alarms. For each alarm, the tables list the notification, the possible causes for the alarm, and possible options for resolving it. The sample screens are for illustrative purposes only. NOTE: •...
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HIGH PRIORITY ALARMS, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION High PIP Pressure Peak Inspiratory Pressure Check the interface or tubing for any obstruction. Check the interface or tubing for any obstruction. (PIP) exceeds the set limit Check all connectors for possible damage.
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HIGH PRIORITY ALARMS, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Low Gas Pressure Gas pressure drops below Check all connections for possible leak. Verify that the compressor is powered on. the allowable limit (20 PSI) Ensure that the source gas supply hose is not kinked or Check all connections for possible leak.
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HIGH PRIORITY ALARMS, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION System Fault Internal fault detected If a system fault occurs, in the message on the touch If a system fault occurs, in the message on the touch during operation screen to reboot, touch OK;...
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MEDIUM PRIORITY ALARMS CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Breath Timeout No breath is detected Patient is not breathing. Patient is not breathing. for 20 or 60 seconds, Patient is breathing through the mouth while using Check that the interface is connected to the ventilator, not the Breath Timeout depending on the...
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MEDIUM PRIORITY ALARMS, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Low Breath Rate Respiratory rate falls Patient is breathing through the mouth while using Check that the interface is connected to the ventilator, not the below set limit.
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MEDIUM PRIORITY ALARMS, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Low Gas Pressure Gas pressure drops Check all connections for possible leak. Verify that the compressor is powered on. below the allowable Ensure that the source gas supply hose is not kinked Check all connections for possible leak.
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LOW PRIORITY ALARMS CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Excessive Leak An excessive leak is present Ensure patient interface or mask is positioned to Ensure patient interface or mask is positioned to ensure a proper seal.
OMPRESSOR ALERTS The compressor has alerts that are independent of the ventilator. Compressor alerts must be resolved in order for the compressor alert notifications to be silenced; there is no Silence Alarm button for alerts originating from the compressor. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION...
ROUBLESHOOTING The following table lists situations that may occur during normal use of the ventilation system that do not have an alarm associated with them. The possible causes and options for resolving these situations are also listed. NOTES: • Options for resolving the situation are based on the configuration of the ventilation system. •...
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TROUBLESHOOTING, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION No volume output Compressor and/or ventilator is Turn the ventilator on. Ensure both the compressor and the ventilator are on. not on. An Activity Button has not been Press an Activity Button on the ventilator.
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TROUBLESHOOTING, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Ventilator is deliver- Ventilator is in Control or It is normal for the ventilator to deliver therapy based It is normal for the ventilator to deliver therapy based ing gas without Assist/Control ventilation mode.
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TROUBLESHOOTING, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Ventilator screen is Alarm Silence button might be Contact your service representative. Contact your service representative. unresponsive stuck. An on-screen alarm Low gas pressure. The cylinder is nearly empty;...
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TROUBLESHOOTING, cont’d. CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION NOTIFICATION CAUSE STAND-ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION Cylinder does not User breath rate is higher than Refer to “CYLINDER DURATION INFORMATION” on last as long as expected. page 131. expected Selected Activity Button requires Obtain a new or larger cylinder.
MAINTENANCE MAINTENANCE LEANING BEFORE FIRST USE It is not necessary to clean or sterilize the Life2000® Ventilation System before the first use. AILY CHECKS Look at the ventilation system components daily. If any of the following conditions are discovered, discontinue use of the ventilation system: •...
MAINTENANCE NOTE: If using PDI Super Sani-Cloth® Germicidal Disposable Wipes, allow for the manufacturer’s suggested wait time before you wipe off the residue. • Wipe the surface of the ventilation system with clean dry cloth to remove any residual cleaner. •...
MAINTENANCE WARNING: Do not subject source gas supply hoses to heat sterilization, hot water pasteurization, autoclaving, radiation sterilization, ethylene oxide gas sterilization, or attempt to clean them in a dishwasher or microwave oven. Doing any of these may damage the hoses and impair gas delivery. ®...
WARNING: Do not subject Hillrom interfaces to heat sterilization, hot water pasteurization, autoclaving, radiation sterilization, ethylene oxide gas sterilization, or attempt to clean them in a dishwasher or microwave oven. Doing any of these may damage the interfaces and impair gas delivery.
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MAINTENANCE ® C URGING THE NIVERSAL IRCUIT ONNECTOR After cleaning and completely drying the interface or when you suspect dust or debris has entered the airflow passage, purge the interface with the purge tube connector and purge tube. NOTE: NOTE: The ventilator is not required for the purging process.
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MAINTENANCE URGING THE REATHE ILLOWS NTRAINMENT NTERFACE Breathe Pillows purge tube Entrainment connector purge tube Interface compressor 1. Place the patient on an alternate means of ventilation, if necessary. 2. Connect the purge tube connector to the outlet fitting on the compressor by twisting on. purge tube connector outlet fitting...
2.5 Years from ship date REV C The ventilation system can only be serviced or repaired by Hillrom or an authorized service center. Trained personnel and authorized service centers are provided with the proper documentation to maintain the ventilation system.
8. Inspect the condensation tray and replace it if it has any damage or if the sponge shows signs of degradation, contamination, or odor. If replacing the condensation tray, obtain a replacement condensation tray from Hillrom. For more information about purchasing replacement condensation trays, refer to "“ACCESSORIES AND REPLACEMENT PARTS”...
Do not insert foreign objects into any part of the ventilation system. CAUTION: Use only a Hillrom approved condensation tray with the compressor. CHECKING AND REPLACING THE AIR INLET FILTER The air inlet filter is used to filter ambient air entering through the back of the compressor. The compressor air inlet filter needs to be changed every three to six months, or as needed.
If replacing the cooling filter assembly, obtain a replacement from Hillrom. For more information about purchasing replacement parts, refer to “ACCESSORIES AND REPLACEMENT PARTS” on page 127. 8. Replace the cooling filter assembly on the back of the compressor by pushing it back into place until it is secure.
MAINTENANCE TESTING VENTILATOR ALARMS This section gives instructions for testing ventilator alarms. Procedures described in this section are only to be performed by trained personnel. Connect the ventilator to an AC power source or ensure the battery has sufficient charge before beginning testing.
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MAINTENANCE NOTE: The Life2000® Compressor is not an adjustable air source. • An interface (either the Breathe Entrainment Pillows Interface® or Universal Circuit® Connector may be used for testing). NOTE: The interface will be handled during testing. Thoroughly clean the testing interface before using it on patient or purchase the Life2000®...
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MAINTENANCE Connect the adjustable source gas supply to the ventilator using an adjustable regulator set to 50 PSI. Turn on the source gas supply to 50 PSI nominal. Connect the interface. For more information, see “CONNECTING AN INTERFACE” on page 33. NOTE: The interface does not need to be worn during testing.
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MAINTENANCE ESTING THE HIGH DELIVERY PRESSURE ALARM MEDIUM PRIORITY 1. Begin by ventilating using the Low Activity button. Allow the ventilator to ventilate for a few breaths using the current settings. 2. As soon as the breath indicator light shows a breath being delivered by the ventilator, quickly pinch the interface tubing near the ventilator connection.
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MAINTENANCE ESTING THE HIGH PRESSURE ALARM HIGH PRIORITY 1. Begin by ventilating using the Low Activity button. Allow the ventilator to ventilate for a few breaths using the current settings. 2. Using the Clinician’s Settings Menu, navigate to the Low FLIP Set Alarm Limits Activity Prescription Setting Alarm Limits and change the...
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MAINTENANCE 3. Wait up to 20 seconds to allow the Breath Timeout to trigger. Breath Timeout The top of the touch screen should display the Breath Timeout alarm (in yellow), and you should hear a sequence of three tones indicating a medium-priority alarm or vibrate. PIP cmH NOTE: Breath/min...
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MAINTENANCE 4. The top of the touch screen should display the High Breath High Breath Rate Rate alarm (in yellow), and you should hear a sequence of three tones indicating a medium-priority alarm or vibrate. PIP cmH NOTE: 11.3 If a low- or medium-priority alarm occurs while the ventilator Breath/min is in vibration mode, and the alarm is not resolved within 60 seconds, an audible alarm occurs.
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MAINTENANCE ESTING THE BATTERY LOW ALARM MEDIUM PRIORITY AND VERY LOW BATTERY ALARM HIGH PRIORITY 1. If the ventilator is connected to an AC power source, disconnect the ventilator from the power source so it is running on its internal battery. 2.
BATTERY INFORMATION BATTERY INFORMATION HECKING THE VENTILATOR BATTERY CHARGE 1. Ensure that the ventilator is powered on. 2. Check the Ventilator Battery Charge icon on the touch screen to see the current battery charge level for the ventilator. Refer to the chart below to determine the approximate amount of ventilator battery charge.
BATTERY INFORMATION The Life2000® Ventilation System uses lithium ion batteries with the following specifications. ENTILATOR BATTERY SPECIFICATIONS SPECIFICATION DESCRIPTION Type Lithium ion, rechargeable, not user replaceable. Ampere/hour rating 1800 mAh Maximum current 450 mA Operating Voltage 7.4 V internal Duration Approximately 5-6 hours* Ventilator If the battery performance degrades to unacceptable levels contact your service representative.
BATTERY INFORMATION HEN THE COMPRESSOR IS CONNECTED TO POWER When the compressor is powered on and connected to AC power, the indicator lights surrounding the compressor’s power button are illuminated in green. TIP: When the compressor’s internal battery is charging, the blinking indicator light ( ) shows the current level of charge.
BATTERY INFORMATION ENTILATOR BATTERY CHARGER AND POWER CORD SPECIFICATIONS ENTILATOR BATTERY CHARGER SPECIFICATIONS CATEGORY SPECIFICATION Input AC voltage 100-240 VAC Input AC frequency 50-60 Hz Input AC current 0.3 A max. Output DC voltage 8.4 VDC Output DC current 1.3 A Insulation class Class II Electrical safety approvals...
SPECIFICATIONS SPECIFICATIONS OXYGEN MONITOR WARNING: To ensure accuracy of oxygen administration and to monitor for the presence of contamination (incorrect gas connected), use an external oxygen monitor to verify the oxygen concentration in the delivered gas. Recommended oxygen monitor: Teledyne MX300, or similar.
SPECIFICATIONS VENTILATOR ALTITUDE VOLUME ADJUSTMENT TABLE The volume output by the ventilator is not automatically adjusted for altitude. The following table shows the typical calculated volume output for several volume settings at different altitudes. Check the performance of the ventilator for adequate therapy delivery in the environment(s) in which it will be used and adjust the volume to compensate for altitude when necessary.
SPECIFICATIONS PERFORMANCE SPECIFICATIONS PARAMETER DESCRIPTION General Information Available ventilation modes Volume ventilation with Control, Assist/Control, and Assist ventilation modes Connection to patient Breathe Pillows Entrainment Interface or Universal Circuit®Connector Features And Description Ventilator can cycle at ≤40 BPM Frequency Accuracy: ±10% or 1 BPM, whichever is greater Tidal Volume Up to 2,000 ml Range: 50 ml to 750 ml...
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SPECIFICATIONS PARAMETER DESCRIPTION Control ventilation mode: The inspiratory phase is started and terminated by the ven- tilator based on set inspiratory time and respiratory rate. Assist/Control ventilation mode: The inspiratory phase is started based on the Means of initiating and terminat- patient’s breath triggering or by the ventilator based on set inspiratory time and termi- ing inspiratory phases nated by the set inspiratory time.
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Maximum current 450 mA Operating Voltage 7.4 V internal Duration Approximately 4 hours If the battery performance degrades to unacceptable levels contact your Hillrom service representative. Compressor Battery Specifications Type Lithium ion, rechargeable, not user replaceable. Ampere/hour rating 10200 mAh...
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SPECIFICATIONS PARAMETER DESCRIPTION Special Features Instead of an audio alarm, the user can enable the alarm to vibrate for medium- and Alarm vibrate low-level alarms. Touch screen flip User can flip the screen orientation 180°. Used to connect commercially available non-invasive masks (full face, nasal, and pil- Universal Circuit®...
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SPECIFICATIONS PARAMETER DESCRIPTION Low Delivery Pressure Interface pressure during delivery fails to exceed the minimum expected. Low Gas Pressure Source gas pressure drops below the allowable limit (20 PSI) High Priority Alarm Low Gas Pressure Source gas pressure drops below the allowable limit (35 PSI) Medium Priority Alarm. Low PIP Pressure PIP below set limit System Fault...
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SPECIFICATIONS PARAMETER DESCRIPTION Output DC voltage 8.4 VDC Output DC current 1.3 A Insulation class Class II Electrical safety approvals UL 60601-1, EN 60950, EN 60601-1, EN 60335-2-29 Dimensions 3.55” x 1.77” x 1.26” (90 x 45 x 32 mm) Weight 0.25 lb.
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SPECIFICATIONS PARAMETER DESCRIPTION Cord length 6 ft. Compliance IEC 320-C13 Compressor Output Pressure 58 PSI ±15% (at sea level and normal ambient conditions) Flow 17–21 LPM (at sea level and normal ambient conditions) Outlet Fitting 9/16" - 18 male threaded fitting Storage and Transport Environment Storage &...
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SPECIFICATIONS PARAMETER DESCRIPTION Ventilation system size 12.1” x 8.7” x 8.6” Ventilator weight 1.1 lb. Ventilator size 3.2” x 7.7” x 1.0” Compressor weight 14.9 lb. Compressor size 12.1” x 8.7” x 8.6” Latex The ventilation system does not contain natural rubber latex. Expected Service Life The Life2000®...
PRINCIPLES OF OPERATION PRINCIPLES OF OPERATION ENERAL OVERVIEW The Life2000® Ventilation System utilizes an electromechanical pneumatic system under the control of a microprocessor to deliver patient ventilation. The following descriptions and diagrams illustrate the major components of the ventilation system in each configuration. EXTENDED RANGE CONFIGURATION OPERATION SUMMARY AND PNEUMATIC DIAGRAM Ambient air enters through an inlet filter on the compressor.
PRINCIPLES OF OPERATION STAND-ALONE CONFIGURATION OPERATION SUMMARY AND PNEUMATIC DIAGRAM Compressed gas (oxygen or air) enters the ventilator through the inlet connector. The compressed gas is delivered to the safety valve and then to the flow valve, which controls all inspiratory gas flow to the patient.
(EMC) and needs to be installed and put into service according to the EMC information provided in this Instructions for Use. The use of accessories or cables other than those specified by Hillrom™ may result in increased emissions or decreased immunity of the Life2000® Ventilation System.
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COMPLIANCE AND IEC CLASSIFICATION GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY The Life2000® Ventilation System is intended for use in the electromagnetic environment specified below. The cus- tomer or user of the ventilation system should ensure that it is used in such an environment. IEC 60601 Compliance Electromagnetic...
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COMPLIANCE AND IEC CLASSIFICATION GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY The Life2000® Ventilation System is intended for use in the electromagnetic environment specified below. The cus- tomer or user of the ventilation system should ensure that it is used in such an environment. BREATHE TECHNOLOGIES®...
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COMPLIANCE AND IEC CLASSIFICATION The Life2000® Ventilation System is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled. The clinician can help prevent electromagnetic interferences by maintaining a minimum dis- tance between portable and mobile RF communications equipment (transmitters) and the ventilation system as recommended in this table, according to the maximum output power of the communications equipment.¹...
ICONS ICONS ICON WHERE USED MEANING Ventilator Indicates communication port. This port is only used by the man- ufacturer. Ventilator Indicates power-in port. Ventilator and Indicates direct current. compressor Ventilator, venti- The Silence Alarm button silences a vibration or audible alarm for lator label, and 60 seconds.
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ICONS ICON WHERE USED MEANING Purge tube con- Indicates that the product is not sterile. nector label, purge tube label, pole mount label, source gas sup- ply hose label, and interface labels Ventilator touch Displayed on touch screen if ventilator battery status is unknown screen or charge is critically low (<...
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ICONS ICON WHERE USED MEANING Ventilator label, Indicates disposal of device must conform to WEEE Directive compressor label, (Waste in Electrical and Electronic Equipment) 2011/65/EU. compressor external power supply Ventilator battery This symbol is used to support the Battery Directive 2006/66/EC. charger label Ventilator battery Indicates the battery charger meets European Economic Area...
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ICONS ICON WHERE USED MEANING Compressor Indicates the unlocking knob is in the unlocked position. Compressor When lit, indicates the locking knob is in the locked position. Compressor Battery Charge Status button Compressor Power on/off button Ventilator Power on/off button Ventilator and On the ventilator, the Low Activity Button delivers prescription ventilator touch...
APPENDIX APPENDIX ACCESSORIES AND REPLACEMENT PARTS WARNING: For any accessories, read the label and accompanying document(s) before use. PART NUMBER PRODUCT DESCRIPTION Interfaces (for single patient use only) BT-60-0010 Universal Circuit® Connector BT-60-0013 Breathe Pillows Entrainment Interface, Extra Small BT-60-0014 Breathe Pillows Entrainment Interface, Small BT-60-0015...
APPENDIX ABLES UNIVERSAL CIRCUIT® CONNECTOR USING AIR AS THE PRESSURE SOURCE* based on 0.9 sec iTime *entrained with supplemental oxygen in the volumes (LPM) shown Life2000® Ventilation System Service (PL-20-0050 REV A)
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APPENDIX UNIVERSAL CIRCUIT® CONNECTOR USING OXYGEN AS THE PRESSURE SOURCE* based on 0.9 sec iTime *entrained with supplemental oxygen in the volumes (LPM) shown Life2000® Ventilation System Service (PL-20-0050 REV A)
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APPENDIX ABLES BREATHE PILLOWS ENTRAINMENT INTERFACE USING AIR AS THE PRESSURE SOURCE* 75.0 30 LPM 25 LPM 70.0 based on 0.9 sec iTime 20 LPM 15 LPM 65.0 10 LPM 7 LPM 60.0 5 LPM 3 LPM 55.0 0 LPM 50.0 45.0 40.0...
APPENDIX CYLINDER DURATION INFORMATION The duration of compressed medical oxygen cylinders depends on the volume of the cylinder and the breathing pattern of each patient, which can change throughout the day. Observe your daily oxygen consumption a few times before estimating typical use. The following tables can be used to obtain approximate values only.
APPENDIX CYLINDER SIZE E: 660 LITERS (M24) BREATHS PER MINUTE (BPM) Volume (ml) Duration in hours 18.3 15.7 13.8 12.2 11.0 10.0 For other cylinder sizes, use the following gas usage chart to estimate your cylinder duration. OXYGEN USAGE (LPM) TABLE BREATHS PER MINUTE (BPM) Volume (ml) Oxygen Usage (LPM)
APPENDIX REPLACING THE SOURCE GAS CYLINDER When the source gas cylinder needs to be replaced: Place the patient on an alternate means of ventilation, if necessary. Power off the ventilator. NOTE: NOTE: Alarms might be encountered and/or the selected Activity Button might be inadvertently changed if the ventilator is not powered off before replacing the cylinder.
APPENDIX POTENTIAL TIDAL VOLUMES The potential tidal volumes for the corresponding set volumes on the Life2000® Ventilator are shown in the following graph. The graph can be used to obtain approximate values only. The potential patient volume per breath is a combination of ventilator settings (Volume and I-Time) plus the amount of room air entrained to the patient interface plus the amount of supplemental oxygen (if any) that is injected into the patient interface.
APPENDIX LIMITED WARRANTY Breathe Technologies, Inc. warrants that Breathe Technologies® ventilators and compressors will be free from defects in material and workmanship for a period of one (1) year from the date of shipment. Products that are repaired or replaced under this Limited Warranty will be covered by this Limited Warranty for the greater of the remaining balance of the original warranty or ninety (90) days.
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Breathe Technologies, Inc, a Hillrom Company. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without the express written permission of Breathe Technologies, Inc.
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