Pressure: APAP 9.5 min/11 max, A-Flex x2, Additional Comments:Mask Bleep Eclipse https://bleepsleep.com/the-eclipse/. Location: United States, Machine: Resmed Aircurve 10 VAuto After registration, we will notify you with additonal information as it becomes available. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Gold Digger Frvr Tips, Lynx Kittens For Sale In Alabama, Ford Mile Club Badge, Philips is recommending that customers and patients do not use ozone-related cleaning products. Turpentine Oil For Maggots In Dogs, More than half of the affected devices in use globally are in the US. We repair allSystem One models, including: REMstar 160P, REMstar Plus 260P, REMstar Pro 460P, REMstar Auto 560P, BiPAP Pro 660P, BiPAP Auto 760P, and AutoSV.What a fantastic place! Product Support: 800-685-2999 Product Support: 541-598-3800 Email: respironics.service10@philips.com. In the US, the recall notification has been classified by the FDA as a Class I recall. I think I would find another tech (and stop by Soi Cowboy on the way home for a few beers with my machine fixed!) The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. by Pap-Daddy Sun Dec 04, 2016 12:57 pm, Return to CPAP and Sleep Apnea Message Board. The "fake" APAP, but at least it records full efficacy data, even after the limited 30 days of APAP is used up. The place I purchased it from says they can't service it or send it in for service (their policy). Ford Mile Club Badge, I built a 20ah for the bike and can run from there. The notification advises patients and customers to take the following actions: Recall notification (U.S. only) / field safety notice (Outside of U.S.), Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use, Physicians and other medical care providers. Below you will find important information regarding the service of your devices. I live in the Northeast and it was like dealing with someone next door. I have a Phillips System One, but can only be set to CPAP Check or CPAP. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . This system has proven to work for the past 2 seasons. The 5A figure is the maximum current the machine draws at any time, which is what has to be on the label. Guess I'll throw this one away and buy a Resmed S9. Philips Respironics System One REMStar Auto CPAP with A-Flex and integrated heated humidifier 10 Review (s) | Questions about this item? Click here to read moreClick here to read less. Lonely Eyes Lauv Chords, Machine: Respironics Series M For camping I turn the humidifier OFF. by Drowsy Dancer Sun Apr 07, 2013 3:09 pm, Post Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. This recall notification / field safety notice has not yet been classified by regulatory agencies. Other Comments: The type of ventilators used depends on the therapeutic needs of a patient. CPAP Pressure: 15-20 afaik data on the card is automatically deleted as needed such that the card never fills up. I just bought the new PR System One 60 Series REMstar Auto with Heated Humidifier DS560HS, and on the first morning it gave the message "Service Required". I came back here to see if there were any recent resolutions, and found none. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The recall notification (U.S. only) / field safety notice (Outside of U.S.) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 1-888-391-9973 Mon - Fri 8am - 5pm EST | Closed Saturday & Sunday Thanks Altra and many thanks to Tony Inham!Mark Linebaugh THANK YOU ALTRAI was getting run around from Medical West in St. Louis found Altra CPAP Repair and they are the best!! Date of Manufacture. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. Humidifier: Unsure To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Choice of setting pressure to relieve obstruction while on my back (18 cm, which has its own problems ) , or get a APAP. I may have to RISE but I refuse to SHINE. What Do Baby Swallows Eat, I may have to RISE but I refuse to SHINE. Philips recalled its CPAP, BiPAP and ventilator devices in June 2021 because of potential health risks. THANK YOU ALTRAWhat a positive experience at Altra! JK about throwing xPAP away. 5A for 8 hours is 40 AH. Is There A Spiritual Meaning For Gnats, Philips Respironics REMstar Auto 560P - Service RequiredINFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. Where are you located, in case someone can help. I removed smart card and unplugged machine for a long period of time and still get massage when plugged back in. Other Comments: The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Please Note: Preventative Maintenance and Battery Changes are not covered by the Manufacturing Warranty. Location: United States. Other Comments: Published on 2018-06-26. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. Philips CPAPs cannot be replaced during ship hold. Watch A Cinderella Story 2004 123movies, We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. Down By The Bay Endings, -- Marcus Aurelius Philips Respironics REMstar Auto 560P - Service Required If you can afford the difference, get the Resmed. The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects. Live Chat - American Medical Sales and Rentals. My machine worked again as normal. Call877-907-7508 if you cannot visit the website or do not have internet access. Taxa Tigermoth Trek For Sale, How did this happen, and what is Philips doing to ensure it will not happen again? Thanks for all your help. The System One technologies like Humidity Control with Dry Box and Resistance Control are helping users achieve effective therapy. Swimming Pool Codes And Regulations Louisiana, To continue use of the device due to lack of alternatives, consult with a physician to determine if the benefit of continuing therapy with the device outweighs the risks identified in the "Urgent: Medical Device Recall" letter. Machines for home use include the Respironics CPAP machine. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. Data Federal Information System Controls Audit . Pronosoft Loto Foot, My medicare provider was no help. Calling Philips Respironics, they say that I have to send it in through the place we purchased it. by alanc151 Sun Apr 07, 2013 2:52 pm, Post Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. Registered Number On Birth Certificate Massachusetts, The PR 150 CPAP machine is the entry level solution for treating sleep apnea. The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. RE: Philips Respironics REMstar Auto 560P - Service Required If your insurance requires a substantial copay or deductible, and your machine (most likely) is out of warranty, your bet bet is to grab the Respironics Dreamstation Auto DSX500T11 ($330) or Resmed Airsense 10 Autoset ($440) off of Amazon, and don't look back. With the model 460 you can reset the therapy hours to zero and you get another 30 days of APAP mode available. For more information, please see the Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. So neither appears to be an option! You can also use the following address: Respironics, Inc. System One Heated Humidifier. Post Other Comments: Have diabetes Type II I'm investigating the use of one of those Battery Jumper Systems. Mask Make & Model: Nuance Is this a recall? Pronosoft Loto Foot, It's as if we asked you what make and model of car you have and you answered, "It's a Ford." Not enough information. The products were developed according to the required standards and regulatory registrations at the time of initial release. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Spy Instagram Viewer, Product Support: 800-685-2999 Product Support: 541-598-3800 Email: respironics.service10@philips.com Affected devices may be repaired under warranty. We are one of three Factory Authorized Service Centers for ResMed providing Warranty and Non-Warranty repair services for all AirSense 10 and S9 models. An honest and efficient repair center. Any help in resetting or repairwould be helpful. On June 14, 2021, Philips Respironics sent customers an Urgent: Medical Device Recall letter requesting them to take the following actions: BiPAP and CPAP customers and patients should review the age of their BiPAP and CPAP devices, as they are recommended to be replaced after five years of use. Please watch the complete step-by-step video below on how to send us your data (applies to ResMed, Philips or Respirinics device only). Cudos & much thanks to you. PR model names are very confusing. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Periodically inspect the humidifier for signs of wear or damage. Mask Type: Nasal pillows Mask Type: Full face mask Mask Make & Model: ResMed Airfit P10 Philips continues to monitor complaints received following the recall / field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve. It was the happiest repair service experience ever. Philips is recommending that customers and patients do not use ozone-related cleaning products. The new material will also replace the current sound abatement foam in future products. Mask Type: Nasal pillows Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Discontinue use of the device and work with a physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. We are trained in the proper testing, diagnosis, updates, repair, and calibration of the PR System One REMstar CPAP and BiPAP machines. What is the safety hazard associated with this issue? Do affected units exhibit features that customers / users should watch out for? CPAP Camping - 12v Source - Amp Hour Requirements. Are there any steps that customers, patients, users and/or clinicians should take regarding this issue? General Discussion on any topic relating to CPAP and/or Sleep Apnea. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. Dana Lee Connors, Humidifier: Respironics For us, innovation in sleep apnea management, oxygen therapy, noninvasive ventilation, and respiratory drug delivery is driven by gaining insight into the needs . #header_main { Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips Respironics is een wereldleider op de slaap- en beademingsmarkt en biedt oplossingen die leiden tot gezondere patinten, praktijken en bedrijven. My CPAP (Phillips Respironics System One, Remstar Pro 460P) can be powered from an external 12 volt source. Customers and patients that do not use unapproved cleaning methods are also at risk of exposure of harmful particulates and chemicals as a result of PE-PUR degradation. The battery kit includes the Li ion battery, cable, travel battery case and adapter. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements. Respironics Shielded DC Cord for System One 60 Series CPAP BIPAP AUTO Car Truck Auto RV by Philips Respironics. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements. Once those screws are removed the top enclosure of the CPAP machine pops right off (figure 2). An official website of the United States government, : As each country authorizes regulatory agency approvals, our global repair and replacement program for affected devices will be operational. Your machine was issued between 2005 and 2008, and by now has far exceeded its expected life. You are about to visit the Philips USA website. An Evaluation fee of $50.00 USD may be applied for devices not currently under warranty. This is the exact same CPAP I use. Max pressure for the machine is 21 cm H20. Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US *Market specific numbers as of October 25, 2022 and will be updated monthly. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Sure enough they had it repaired and back to me within 1 week. We can help you resume your CPAP therapy quickly while saving you money.Does your Philips CPAP machine restart in the middle of the night? Allen And Roth 5x7 Rugs, This factor does not refer to heat and humidity generated by the device for patient use. Patients with affected devices currently in use are requested to register their products on this website to facilitate the repair and replacement program. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. At this time, Philips is unable to set up new patients on affected devices. It runs on 12V. As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices. Philips Respironics is een wereldleider op de slaap- en beademingsmarkt en biedt oplossingen die leiden tot gezondere patinten, praktijken en bedrijven. #1. Philips will provide further clarity on projected dates for implementation of the correction to begin when this information is available. Once Philips Respironics has confirmed payment details and your acceptance of the estimate our service department will complete the repair or service and return the device to the shipping address you provide on the "Request for Service" form. Ofcourse my prescription is older than a year and I need a new one. Trec Third Party Financing Addendum, To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). When I use a 10ah LiFe battery I can run one night with the humidifer set on level 1. OSCAR Affected devices may be repaired under warranty. Mask Make & Model: ResMed Swift FX How Do Pimps Recruit, . Humidifier: built-in Triumph Daytona 765 Top Speed, Products listed in this notification include: The recall notification (U.S. only) / field safety notice (Outside of U.S.) provides customers with information on how to identify affected products. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Selected products Raleigh Rowdy 20 Used, I just bought the new PR System One 60 Series REMstar Auto with Heated Humidifier DS560HS, and on the first morning it gave the message "Service Required". This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Step 2 Up And Down Coaster, Are Blueberry Plants Toxic To Dogs, Without the humidifier the current draw is 0.7A. CPAP Software: Not using software Pycharm Vs Spyder Vs Vscode, Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The new material will also replace the current sound abatement foam in future products. + APAP spare. Call877-907-7508 if you cannot visit the website or do not have internet access. Follow the recommendations above for the affected devices used in health care settings. Philips Foam CPAP Filters for PR System one/M Series (Black, Reusable) $12.32 $14.49. Mask Make & Model: Resmed Airfit P10 Mask Type: Full face mask Below you will find important information regarding the service of your devices. I have positional sleep APNEA. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals, Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, Continuous Ventilator, Non-life Supporting: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+, Noncontinuous Ventilators SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto, report adverse reactions or quality problems, Durable Medical Equipment (DME) and sleep laboratories. Bosch Dishwasher Not Starting Red Light Flashing, Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. If you are located outside of the United States, you will receive the letter shortly thereafter. A Data Recovery fee of $25.00 USD may be applied for data recovered from devices not currently under warranty. Mask Make & Model: Resmed f20 Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Use that as a benchmark against getting a prescription renewal ($?? The Giver Of Stars Book Club Questions, As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. So I began playing around with it and stumbled upon a fix which works every time on my machine the fix is this: To tommagic1 : Thank you so much for eliminating what would have been a restless night with no sleep. You are about to visit a Philips global content page. I have a heart condition that is largely brought on by the lack of sleep. Turned the power off and at night, after powering it back on, it worked. Click the link below for additional clinical details on the issue and other information to help you advise your patients who have been impacted. Please contact Product Support or your Sales Representative for additional details. Apnea Board is an educational web site designed to empower Sleep Apnea patients. Please Note: Preventative Maintenance and Battery Changes are not covered by the Manufacturing Warranty. respironics humidifier pdf manual download. High heat and high humidity environments may also contribute to foam degradation in certain regions. Machine: REMstar Auto M Series FREE delivery Sat, Mar 4 on $25 of items shipped by Amazon. Philips is notifying regulatory agencies in the regions and countries where affected products are available. border-bottom: none; My pressure is 12 cm H20. The Widow's Broom Full Text Pdf, As a result, higher levels of humidity can be achieved for patients who could benefit from humidification. It is the System One. If you are in the United States, you will receive a letter by June 23, 2021 from Philips about this issue that containslog-in credentials for the registration website. Down By The Bay Endings, Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Bosch Dishwasher Not Starting Red Light Flashing, New advanced machines with heated humidifier and heated hose. The recall notification (U.S. only) / field safety notice (Outside of U.S.) provides customers with information on how to identify affected products. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. kidneys and liver) and toxic carcinogenic affects. Review the recommendations above with patients who use the affected devices. Customer/Consignee/Facility Name: Street Address: . This response is probably way to late for most folks. I doubt it will make a difference but it might. Philips anticipates rework to commence in the course of September 2021. At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues. Other Comments: I started CPAP in 2008. Sanditon Episode 1 Dailymotion, We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. You May Have Sleep Apnea, that may assist the conversation between patients and their healthcare providers and/or physicians for alternatives. Other Comments: Ehlers-Danlos Syndrome, Hypermobility Type; chronic sarcasm Harness Horses For Sale In Ohio, Apnea Board is an educational web site designed to empower Sleep Apnea patients. Turned the power off and at night, after powering it back on, it worked. This factor does not refer to heat and humidity generated by the device for patient use. However, Tony Ingham who I have had the pleasure of working with directly with their company in the past told me to send it in and they would dig up some parts to get it working again. Koninklijke Philips N.V., 2004 - 2023. Machine worked great and turned off normally in the AM. As each country authorizes regulatory agency approvals, our global repair and replacement program for affected devices will be operational. The website provides current information on the status of the recall and how to receive permanent corrective action to address the issues. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. Has Philips received any reports of patient harm due to this issue? It was nice to see some real names to make the experience personal. The possible fly in the ointment with these is I do not think they are deep cycle, and I don't know what kind of life you will get. Red Leaf Spiritual Meaning, Try unplugging it from the wall. Lonely Eyes Lauv Chords. Look into powered wheelchair batteries. Devante Swing Hands, Location: Murrysville, Machine: A10 Autoset Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Allen And Roth 5x7 Rugs, Or fastest delivery Wed, Nov 2. by Pugsy Sun Apr 07, 2013 5:42 pm, Return to CPAP and Sleep Apnea Message Board. News about Philips can be found at, https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210901-philips-starts-repair-and-replacement-program-of-first-generation-dreamstation-devices-in-the-us-in-relation-to-earlier-announced-recall-notification.html. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Your FIX on the REMstarplus m-series of not turning on & the lights flashing was right on. Joe Lara And Gwen Shamblin, Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Humidifier: Respironics Series M Ozone cleaners may worsen the breakdown of the foam, and there are other. - but that's just me. Koninklijke Philips N.V., 2004 - 2023. Ijust hate the process on getting a new machine. How we squander our hours of pain. by alanc151 Sun Apr 07, 2013 3:17 pm, Post . Mask Make & Model: Respironics Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification. $14.99. Ted Lieu Net Worth, 24-Pack Reusable CPAP Foam Filters - CPAP Filters Compatible With Philips Respironics M Series PR System One and SleepEasy Series - Made in the USA - By Impresa Products. CPAP Pressure: 14 Philips Respironics Service Representative will also be contacting you to schedule an appointment to . For the Philips Respironics 50 / 60 Series line of CPAPs, when you try and power the unit up, the motor will briefly attempt to spin and then stop. FWIW, online prices for a new Philips Respironics Dreamstation on Amazon is about $400. Are affected devices continuing to be manufactured and/or shipped? Is There A Spiritual Meaning For Gnats, Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Are customers entitled to warranty replacement, repair, service or other mitigations? The .gov means its official.Federal government websites often end in .gov or .mil. by OkyDoky Sun Dec 04, 2016 9:51 am, Post INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Divergent Movie Google Drive Mp3, Additionally, the device Instructions for Use provide product identification information to assist with this activity. fact In July 2021, the FDA classified the Philips CPAP recall as a Class I recall. "The object in life is not to be on the side of the majority, but to escape finding oneself in the ranks of the insane." Husqvarna 1640 6 5x55, Here are the Error Codes for REMstar Machines: Has Anyone Experienced Malicious Hacking of Their CPAP Machine Remotely? Did your humidifier stop working? Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries.

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