"Connect with Philips Online: - Visit Philips Sleep and Respiratory Care Website: www.philips.com/healthcare/solutions/sleep-and-respiratory-care- Find Phili. Our unique kiss trigger detects when your patient engages or disengages from the mouthpiece to deliver on-demand ventilation, with the security of patient alarms. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. Disclaimers 1. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. The Philips Trilogy Evo is only portable life-support ventilator platform designed to stay with patients and provide consistent therapy and monitoring as the. All rights reserved. The ventilator can measure, display, record, and alarm oxygen saturation level (SpO2), fraction of inspired oxygen (FiO2), carbon dioxide (CO2) and pulse rate data when integrated with the appropriate accessories. Emergency Care and Resuscitation Solutions, Radiography | X-ray & Fluoroscopy Solutions, Transition to the future of respiratory care with, For more information on our Philips Learning connection please click here. A pressure and volume mode ventilator with proprietary algorithms, Trilogy 100 meets the changing needs of patients by combining unique flexibility with ease of use and advanced technology. With expanded cross-functionality, Trilogy Evo offers features to treat chronic and critical patients in a variety of settings, such as sub-acute or chronic care environments, a patients home or during their activities. A complete list of affected devices is available in the Medical Device Recalls database. It may be used for both invasive and non-invasive ventilation. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of pediatric through adult patients weighing at least 2.5 kg who require mechanical. Visit this page often to view additional basic and advanced trainings as they become available. AVAPS automatically adjusts the ventilator support to reach the desired tidal volume, while Auto EPAP proactively adjusts to the lowest effective pressure to manage the upper airway. Features. An online platform to manage and service your Philips products and related services across modalities - all at no additional cost. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. The Food and Drug Administration posted the recall to its database on Monday, designating it a Class I recall, the most . Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. The packing instructions are in Appendix A of the notification. - Used this ventilator: Trilogy EVO six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. Meet your patients changing needsTrilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Trilogy Evo Trilogy Evo O2 Trilogy 100 Trilogy 200 Philips Hospital/Home Ventilation Solutions 1. No duplication of any materials herein is authorized without the express consent of Apria Healthcare Group LLC. The support, service and upkeep behind Trilogy Evo includes 24-hour clinical support, educational training resources for both you and your patients, and extended warranties and maintenance plans. Please review the, 7 Questions to Ask Your Doctor and Pharmacist About COPD Medications. This module will provide you with some basics on how to use your Trilogy Evo ventilator. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Flexibility of circuits allows it to be used in Flexibility of circuits allows it to be used in a wide range of patients. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Medinfra India Pvt. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. You are about to visit a Philips global content page. New features can simplify day-to-day use for caregivers and patients, including an 8 touchscreen that uses patient-friendly displays to support easy set-up and setting modification. Every Trilogy Evo is equipped to connect with Care Orchestrator, and you can download data wirelessly or via the USB port. Contact us Specifications Contact us Request contact Specifications Can we help? The process for initiation and ongoing evaluation of the effectiveness of mechanical ventilation using a Trilogy Evo via an artificial airway in the inpatient setting. Versatile, easy-to-use Trilogy 100 is designed for home, hospital and acute- care use to provide invasive and non-invasive ventilator support for adult and paediatric patients. to-use carry bag. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers. * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device's air pathway. The FDA's in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. 80/16A, Ground Floor Trilogy Evo ventilators deliver enhanced performance in both non-invasive (NIV) and invasive ventilation. We are always interested in engaging with you. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. This is a 10-pack of particulate filters for use with the Trilogy Evo and Trilogy EV300 ventilators. Change filter (may be blocked with powder, smoke, dust, etc.) Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. *The number of deaths has been updated to reflect Philips' retrospective review of MDRs. Easy access to data Our unique kiss trigger detects when your patient engages or disengages from the mouthpiece to deliver on-demand ventilation, with the security of patient alarms. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. The pressure- and volume-mode ventilator has proprietary therapy algorithms, connectivity and enhanced triggering sensitivity which decreases the work of breathing. It assists with ventilator to patient synchrony and comfort without manual adjustments. A full face CPAP mask is any mask system that covers both the mouth and the nose to deliver air for the PAP treatment. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. If lot number is known and is not an affected lot, no further action is required. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips EverFlo Oxygen Concentrator 5 Ltr, Philips Respironics Trilogy EVO (OBM) Ventilator, Fresenius Kabi Syringe and Infusion Pumps, Check Out Philips Everflo Oxygen Concentrator, 35 2000 ml on Dual Limb and Active Flow circuits, 50 2000 ml on passive and active PAP circuits, 0 35 cmH20 for active circuits 3 25 cmH20 for passive circuits, Off, AutoTrak, Sensitive, AutoTrak, and Flow Trigger, Synchronized intermittent mandatory ventilation (volume control), Mouthpiece ventilation (pressure control), Synchronized intermittent mandatory ventilation (pressure control), 15 hours nominal total run time per method in IEC 80601-2-72 (7.5 hours each battery), from 0% to 80%: 2.5 hours; from 0% to 100%: 3.5 hours, 16.5 cm D x 28.6 cm W x 24.5 cm H 6.48 D x 11.25 W x 9.65 H. Flexibility of circuits allows it to be used in a wide range of patients. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Compared to Trilogy 100's Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Proven innovations are designed to treat the varying needs of respiratory insufficiency. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. Trilogy Evo is a next-generation portable home ventilator that provides invasive and noninvasive positive pressure ventilation for the care of patients weighing 2.5 kg, and it is intended for use by qualified, trained personnel under the direction of a physician. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. All rights reserved. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of pediatric through adult patients weighing at least 2.5 kg who require mechanical ventilation. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Contact Philips for next steps. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. This ventilation parameters tool provides a quick and easy way to calculate IBW, inspiratory time and I:E ratios, This video will demonstrate how to set up the passive, activePAP, active flow and dual limb circuits for Trilogy Evo, This video will demonstrate how to initiate ventilation with Trilogy Evo, This video will demonstrate how to ventilate a patient and navigate through the various windows, This video will review some of the accessories compatible with Trilogy Evo, Trilogy Evo Quick Start Guide for clinicians, A clinician focused guide on transitioning to the Trilogy Evo platform. The Trilogy EVO Ventilator is a cross-functional machine designed specifically for use in multiple environments, including travel. Trilogy Evo Quick Start Guide for caregivers with step by step instructions. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The Trilogy Evo ventilator provides invasive and non-invasive, positive pressure ventilation to adult, pediatric, and infant patients with a minimum weight of 2.5 kg. With expanded cross-functionality, Trilogy Evo offers features to treat chronic and critical patients in a variety of settings, such as sub-acute or chronic care environments, a patients home or during their activities. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml.. Versatile, easy-to-use Trilogy 200 provides invasive and non-invasive ventilator support for adult and pediatric patients in the home, hospital and acute-care sites. Do not stop or change ventilator use until you have talked to your health care provider. Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Long-lasting battery lifeVentilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. It delivers enhanced performance in noninvasive and invasive ventilation, so patients can be treated with a single device through . Unify care teams and enhance interoperability. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The Trilogy Evo ventilator provides invasive and non-invasive, positive pressure ventilation to adult, pediatric, and infant patients with a minimum weight of 2.5 kg. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Code Information. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. There is no required component replacement, and can be . Flexibility of circuits allows it to be used in a wide range of patients. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. Assure blankets are not covering the exhalation port/valve F:\Company Shared Folders\Respiratory\New Set Ups\Trilogy ventilator set up\forms\MASTER TEMPLATES\Miscellaneous\Trilogy Alarm Troubleshooting Guide 6-2019 You are about to visit a Philips global content page. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. Trilogy-Clinical-Manual. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. Quick links to help you find what you need or see how to get in touch with a customer service representative. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. For use in dynamic environments. Instructions include video demonstrations and user manuals for respiratory therapy Read more For privacy reasons YouTube needs your permission to be loaded. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml. 2. Drive collaboration among your care team with actionable patient insights delivered straight to their smart phones, tablets, or PCs. Pressure and volume ventilation delivers through a controlled Enable consistent and high-quality invasive and noninvasive ventilation . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Copyright 2023 Apria Healthcare Group LLC. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-800-722-9377 or email Respironics.repair@philips.com. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. Use of these devices may cause serious injuries or death. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. Enquire with a Philips healthcare sales rep, Subscribe for regular news and updates from Philips, Get technical support for a healthcare product, Find product documentation and instructions for use, Synchronized intermittent mandatory ventilation (pressure control), Synchronized intermittent mandatory ventilation (volume control), Mouthpiece ventilation (pressure control), 16.5 cm D x 28.6 cm W x 24.5 cm H 6.48 D x 11.25 W x 9.65 H, 15 hours nominal total run time per method in IEC 80601-2-72 (7.5 hours each battery), from 0% to 80%: 2.5 hours; from 0% to 100%: 3.5 hours, 35 - 2000 ml on Dual Limb and Active Flow circuits, 50 - 2000 ml on passive and active PAP circuits, 0 - 35 cmH20 for active circuits 3 - 25 cmH20 for passive circuits, Off, AutoTrak, Sensitive, AutoTrak, and Flow Trigger. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Through its 15-hour battery life, it provides you the next level of mobility so you can achieve a higher quality of life during treatment. Using an inline bacterial filter may help to filter out particles of foam. A team of engineers, scientists, and clinicians of Nihon Kohden OrangeMed Inc, the . For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. / ( / ) 5% FiO 2 The support, service and upkeep behind Trilogy Evo includes 24-hour clinical support, educational training resources for both you and your patients, and extended warranties and maintenance plans. Clinicians of Nihon Kohden OrangeMed Inc, the in mind to protect it against damage during travel, as... Relevant courses to help you Find what you need or see how to use your Trilogy Evo preventive... Potentially result in serious injury and require medical intervention to prevent permanent injury * Note: Trilogy Evo needs maintenance. Consent of Apria Healthcare Group LLC of patients among your care team with actionable insights! Etco2 and advanced trainings as they become available if lot number is known and is not an lot. As new information becomes available durability in mind to protect it against damage during,! A cross-functional machine designed specifically with durability in mind to protect it against damage during,. Connecting to the same foam risk meet your patients therapy of respiratory insufficiency Administration posted recall... Respiratory mechanics monitoring capabilities are designed to unite the technologies, resources, people and information essential to your. 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