PETERBOROUGH, N.H.--(BUSINESS WIRE)--SoClean, a pioneer in bacterial reduction systems for CPAP hoses and masks, is pleased to announce it has been granted De Novo clearance by the FDA for the SoClean 3+. The SoClean 3+ is the only FDA cleared product intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning.

新罕布什尔州彼得伯勒（商业新闻短讯）--SoClean是CPAP软管和口罩细菌减少系统的先驱，很高兴地宣布，它已经获得FDA对SoClean 3+的从头批准。SoClean 3+是唯一一种FDA批准的产品，用于在清洁后减少某些兼容家用CPAP口罩和通风软管上的细菌数量。

The SoClean 3+ has been demonstrated to achieve 99.9% bacterial reduction* in CPAP hoses and masks. SoClean is pleased to offer CPAP users this easy-to-use and convenient system to continually reduce bacterial build-up in CPAP hoses and masks..

SoClean 3+已被证明可在CPAP软管和口罩中实现99.9%的细菌减少*。SoClean很高兴为CPAP用户提供这种易于使用且方便的系统，以不断减少CPAP软管和口罩中的细菌积聚。。

SoClean is committed to CPAP users and the clinical need to develop products that are easy to use and significantly reduce bacterial populations in CPAP hoses and masks. “Sleep apnea is a growing issue worldwide, which impacts user’s ability to get a proper night’s rest. Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users,” says CEO Robert Wilkins.

SoClean致力于CPAP用户和临床需求，开发易于使用的产品，并显着减少CPAP软管和口罩中的细菌数量。首席执行官罗伯特·威尔金斯（RobertWilkins）表示：“睡眠呼吸暂停是全球范围内一个日益严重的问题，它会影响用户夜间休息的能力。确保CPAP软管和口罩中的细菌在清洁后可以很容易地减少，这对于用户的日常使用和维护至关重要。”。

SoClean has over 150 patents issued worldwide focused on SoClean’s bacterial reduction systems, methods, devices and designs..

SoClean在全球范围内拥有150多项专利，专注于SoClean的细菌减少系统、方法、设备和设计。。

The SoClean 3+ is an over-the-counter device. It can be purchased online at www.soclean.com, once marketing commences. The SoClean 3+ is currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for the ResMed AirSense 10.** Moving forward, SoClean is working to establish additional hoses and masks for use with the SoClean 3+ bacterial reduction device..

SoClean 3+是一种计数器设备。一旦开始营销，可以在www.soclean.com上在线购买。SoClean 3+目前已建立用于ResMed Mirage FX（鼻罩）、ResMed ClimateLine Air（管道）和ResMed AirSense 10的SlimLine（管道）。*展望未来，SoClean正在努力建立额外的软管和口罩，用于SoClean 3+细菌减少装置。。

SoClean is excited to introduce the SoClean 3+ home-use cleaning device for CPAP hoses and masks. SoClean will communicate to customers how to upgrade their current SoClean devices to a SoClean 3+ within the next 60 days. Additionally, SoClean will be offering an upgrade program to users of any other CPAP hose and mask cleaning devices.

SoClean很高兴推出用于CPAP软管和口罩的SoClean 3+家用清洁设备。SoClean将与客户沟通如何在未来60天内将其当前的SoClean设备升级到SoClean 3+。此外，SoClean将为任何其他CPAP软管和面罩清洁设备的用户提供升级计划。

For additional information on these programs please visit (www.soclean.com/upgrade)..

有关这些计划的更多信息，请访问（www.soclean.com/upgrade）。。

Questions regarding the SoClean 3+ for new or current users of SoClean devices should be addressed to info@soclean.com.

info@soclean.com.

* The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle.

*SoClean 3+设备旨在用作辅助设备，以减少清洁后某些兼容家用CPAP面罩和通风软管上的细菌数量。已经证明SoClean 3+对以下细菌的体外3-log（99.9%）细菌减少：金黄色葡萄球菌（ATCC 6538），产气克雷伯菌（ATCC 13048），溶血葡萄球菌（ATCC 29970），大肠杆菌（ATCC 11229），人葡萄球菌（ATCC 27844），肺炎克雷伯菌（ATCC 4352），铜绿假单胞菌（ATCC 15442）和化脓性链球菌（ATCC 14289）经过完整的加工周期。

Any correlation between in vitro results and clinical outcome has not been established..

体外结果与临床结果之间的任何相关性尚未确定。。

The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device.

SoClean 3+细菌减少装置是一种用于单一患者家庭使用的非处方设备。不得使用该设备替代CPAP面罩和软管制造商推荐的清洁程序。SoClean 3+已被测试用于ResMed Mirage FX（鼻罩），ResMed ClimateLine Air（管道）和SlimLine（管道）用于ResMed AirSense 10 CPAP设备。

The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established..

。。

**SoClean is an independent company not affiliated with ResMed Inc. Names and associated trademarks are solely owned by the respective companies and manufacturers. Depictions of brand logos are for informational and educational purposes only and are used for customer equipment recognition.

**SoClean是一家不隶属于ResMed Inc.的独立公司。名称和相关商标由各自的公司和制造商独家拥有。品牌标识的描述仅用于信息和教育目的，并用于客户设备识别。