blog - Sleepnet Corporation

Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets due to Potential Interference with Certain Medical Implants

Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant, potentially resulting in serious injury or death.

Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets. This is a voluntary action based on information obtained from post market surveillance.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.

Read here for the for the full press release.

Read here for the customer recall letter.

March 13, 2024

Inside Sleepnet’s Service Approach

Articles, News & Updates

With a focus on customer satisfaction and patient well-being, our service team at Sleepnet is driven by a passion for improving patient care. Understanding the critical nature of our products, our dedicated team operates with precision, efficiency, and a patient-centric approach. Whether it’s routine maintenance, rapid responses to technical issues, or offering guidance, our dedicated service team is here to support patients, healthcare providers, and distributors in delivering the highest standards of care.

We take pride in offering personalized service, ensuring that every customer interaction is individual and meaningful. When you reach out to us, you will speak directly with a knowledgeable representative instead of an automated system. Our commitment to a personalized experience extends beyond a phone call. We ensure that when customers connect with us, they’re speaking to the same person who is familiar with their history and needs, eliminating the frustration of repeating steps with each interaction.

What sets our service team apart is our accessibility and expertise. Our team members possess a wealth of knowledge about Sleepnet products and parts, and this understanding allows us to provide informed answers to customers.

A key aspect of our service is the direct support we offer to hospitals and DMEs. From handling phone calls for new accounts to assisting with set-up, our team ensures a smooth onboarding process. Once a relationship is established, our customers gain direct access to a dedicated contact person, streamlining communication and providing a reliable point of contact.

Our commitment to comprehensive support extends beyond the basics. We assist customers with a variety of situations. In situations where queries require a more technical response, our team goes the extra mile by liaising with Sleepnet’s engineers to ensure accurate and detailed solutions. With a US-based team, our service, engineering, and manufacturing facilities all reside in the same building, making this possible. Whether it’s connecting hospitals with distributors, addressing patient queries, or offering guidance on product usage, our team is committed to going beyond expectations.

Sleepnet’s service team is not just a support function; they are a partner in ensuring that our customers receive the highest level of care, expertise, and personalized attention. To connect with a service representative, contact us or call 800.742.3646.

January 19, 2024

How to Find the Right Size CPAP Mask

Articles, How to Guides, News & Updates

Finding the right size CPAP mask is essential for effective sleep apnea treatment as well as comfort. Here’s a step-by-step guide to help you find the right size CPAP mask:

Consult Your Healthcare Provider: Before purchasing a CPAP mask, consult your healthcare provider, preferably a sleep specialist or a respiratory therapist. They can provide guidance based on your specific needs and facial features.

Use the Manufacturer’s Sizing Guide: CPAP mask manufacturers often provide sizing guides on their websites. These guides use the measurements you’ve taken to suggest the appropriate mask size. Compare your measurements to the guide and select the size that corresponds to your measurements. You can find Sleepnet’s mask size guides here.

Try On the Mask: If possible, visit a local durable medical equipment (DME) supplier or sleep clinic. They might have various mask sizes available for you to try on. Wear the mask and adjust the straps as if you were using it at home. This can give you a better sense of how comfortable the mask is and whether it fits properly.

Consider Different Styles: CPAP masks come in different styles, such as nasal masks, full-face masks, and nasal pillow masks. The right style for you depends on your breathing habits, comfort, and any specific requirements you have. Make sure to try different styles to see which one suits you best.

Check the Fit: A well-fitting CPAP mask should create a seal without causing discomfort or leaks. The mask should fit snugly but not too tight, and the cushion should seal comfortably around your nose or nose and mouth. It shouldn’t leave marks or cause pain.

Adjustable Masks: Some CPAP masks have adjustable features like headgear straps, forehead pads, and nasal cushion sizes. These can be beneficial for fine-tuning the fit.

Consider a Mask Fitting Service: Some CPAP suppliers offer mask fitting services where they assess your needs and help you choose the right mask size and style.

Trial Period: Many CPAP suppliers offer a trial period for masks, during which you can return or exchange the mask if it doesn’t work well for you. Take advantage of this trial to ensure the mask is comfortable and provides the right fit. Sleepnet has a 30-day Comfort Guarantee if you are not satisfied with your Sleepnet mask.

Remember that finding the right CPAP mask might take some trial and error. It’s crucial to find a mask that fits comfortably and effectively treats your sleep apnea. Regular follow-ups with your healthcare provider can help you adjust and optimize your CPAP therapy as needed.

January 18, 2024

Sleepnet NIV Mask Fitting Guide

Articles, How to Guides, News & Updates

Sleepnet NIV Mask Fitting Guide

Finding the right non-invasive ventilation (NIV) mask size for your patient involves careful evaluation, guided by both expertise and prompt action, to ensure an optimal fit and the most effective therapy. Below, you’ll find a step-by-step guide to help you choose the correct NIV mask size and get the best fit for your patients.

Assessment
First, determine the type of mask (e.g., full face or nasal) required. If needed, measure your patient’s face using appropriate tools and guides. Assess the distance between critical points like the bridge of the nose and the bottom of the chin, as well as the width of the nose.
Refer to Sizing Guides
Many mask manufacturers provide sizing guides that correlate facial measurements with the appropriate size. Check the mask’s packaging, user manual, or the manufacturer’s website for these guides. You can find Sleepnet’s size guides, instruction manuals, and videos here.
Consult Manufacturer Guidelines
Each NIV mask manufacturer may have specific guidelines for sizing. Review the manufacturer’s recommendations to understand how they correlate facial measurements to mask sizes.
Try Different Sizes
Depending on the patient’s measurements, having a few different sizes is a good idea. Start with the size that aligns with the measurements and have the next size up and down. Note that once a mask is opened or used, it must be disposed of. To help address fit issues, Sleepnet offers several masks with Custom Fit Technology. This unique feature allows users to mold, shape, and bend their NIV masks to match the unique contours of a patient’s face. The result is a personalized and snug fit that not only enhances comfort but also ensures an optimal seal.
Fit and Comfort Evaluation
Have the patient try on each mask size and assess the fit and comfort. The mask should create a secure seal without causing pressure points or discomfort. Ensure it covers the nose and/or mouth adequately and the patient can breathe comfortably. Additionally, tighten and adjust the headgear correctly.
Check Seal and Leaks
While the patient is wearing the mask, start the NIV device and observe for air leaks. A proper fit will minimize leaks and ensure effective therapy. Adjust the headgear and mask straps at all adjustment points if needed.
Patient Feedback
Ask the patient for their feedback. Are they experiencing any discomfort? Do they feel any air leaks? Their input is crucial for finding the most comfortable fit.
Document and Communicate
Keep thorough records of the mask type and size that best fits your patient. Documentation is helpful for future reference and helps to ensure consistent therapy.
Regular Reevaluation
Over time, a patient’s facial structure or preferences might change. It’s important to periodically reassess the mask fit and comfort to ensure continued effective therapy.

Remember that finding the right size NIV mask is crucial for the patient’s comfort and adherence to therapy. Additionally, each manufacturer’s mask may have different designs and sizing criteria, so it’s essential to follow the specific guidelines provided by the mask manufacturer.

January 4, 2024

Air Gel Technology for Respiratory Masks: Revolutionizing Comfort and Protection

Articles, News & Updates

In the face of increasing needs due to illness and chronic disease, demand for comfortable yet effective respiratory masks has never been higher. Traditional respiratory masks, often used as non-invasive (NIV) or Continuous Positive Airway Pressure (CPAP) masks, have served as essential tools for advancing human health, but they often come with discomfort and limitations that hinder long-term usage. Enter AIR°gel^® technology – a revolutionary advancement that combines comfort with a superior seal, addressing the shortcomings of conventional masks and offering a new level of user experience.

Understanding AIR°gel® Technology

AIR°gel^® technology is a cutting-edge innovation developed by Sleepnet that aims to enhance the comfort and effectiveness of respiratory masks. It involves the incorporation of a gel-like material into the mask’s design, which conforms to the contours of the wearer’s face, creating a secure and comfortable seal. This not only ensures a snug fit but also minimizes air leakage around the edges, which is a common issue with traditional Liquid Silicon Rubber (LSR) masks.

The gel material used in this technology is soft, flexible, and hypoallergenic, making it suitable for extended wear. It is engineered to maintain its shape and elasticity over time, ensuring consistent performance and a lasting seal. It also helps to minimize sores and irritation often caused by long-term wear.

Benefits of AIR°gel^® Technology

Enhanced Comfort: One of the most significant advantages of AIR°gel^® technology is the unparalleled comfort it provides. The gel molds to the user’s face, reducing pressure points and minimizing discomfort caused by tight straps or rough edges. This comfortable fit encourages longer wear times, which is crucial for individuals who need to wear a respiratory mask for extended periods.
Reduces Marks & Irritation: AIR°gel^® significantly reduces marks and irritation caused by long-term wear and movement. While other masks may leave painful sores, the soft gel in Sleepnet masks minimizes skin inflammation and discomfort.
Better Seal & Fit: Proper fit is vital for the effectiveness of any respiratory mask. AIR°gel^® technology helps create an airtight seal, which prevents leaks. This feature significantly enhances the mask’s efficiency and reduces health risks. AIR°gel^® masks provide a snug fit that adapts to individual contours, accommodating a broader range of face shapes and sizes.
User Compliance: Uncomfortable masks often lead to users adjusting or removing them, which compromises their health. With AIR°gel^® technology, users are more likely to adhere to mask-wearing protocols due to the increased comfort and minimized irritation.

AIR°gel^® technology marks a revolutionary leap in the field of respiratory mask design, addressing comfort and protection in a single package. By creating a custom fit, minimizing leakage, and enhancing overall wearability, this innovation has the potential to improve the efficacy of respiratory masks across various hospital and homecare settings.

September 7, 2023

Ensuring Excellence: The Importance of Quality Control in Manufacturing Respiratory Masks for CPAP and NIV devices

Articles, News & Updates

Ensuring Excellence: The Importance of Quality Control in Manufacturing Respiratory Masks for CPAP and NIV devices

By: Skylar Carr

Introduction

After the Industrial Revolution and the emergence of mass production, it became crucial to establish clearer definitions and exert greater control over the quality of products. Initially, the main objective was to ensure that production met engineering standards during the final stages of product development. As manufacturing processes became more intricate, the discipline of quality control and standards evolved to manage process variations and produce products of superior quality (American Society for Quality, www.asq.org, Accessed 7/10/2023).

According to the American Society for Quality, “Quality control (QC) is defined as a crucial component of quality management that focuses on meeting quality requirements. While quality assurance pertains to the way a process is executed or a product is manufactured, quality control primarily concerns itself with the inspection aspect of quality management” (www.asq.org, Accessed 7/10/2023).

Quality control plays a vital role in every aspect of manufacturing. When it comes to producing critical healthcare products like CPAP (Continuous Positive Airway Pressure), NIV (Non-Invasive Ventilation), and pediatric masks, it is paramount. At Sleepnet, we understand the significance of quality control in ensuring the safety, reliability, and effectiveness of our respiratory masks. In this article, we delve into the essential role of quality control within manufacturing and shed light on how our company maintains rigorous quality standards to provide exceptional products to our customers.

Why is Quality Control Important?

Ensures Customer Satisfaction: Quality control guarantees that the end products meet or exceed customer expectations. Our quality standards build trust and confidence in our brand by ensuring customers receive reliable and quality respiratory masks for their sleep therapy and ventilation needs.
Compliance with Regulatory Requirements: Adherence to regulatory standards and guidelines is crucial in the healthcare industry. Quality control requirements ensure that products meet the necessary regulations, providing peace of mind to both distributors and end-users.
Risk Mitigation: Quality control helps identify and mitigate potential risks or defects in the manufacturing process. By identifying issues early on, manufacturers can implement corrective actions to prevent further problems, minimize product recalls, and protect end-users from adverse effects.

What is Sleepnet’s Quality Control Process?

Material Selection: An important step in the quality control process is carefully sourcing and selecting materials during the product design and development phase. We design and manufacture our products in the United States with US and globally sourced components that meet or exceed industry standards to ensure the integrity and durability of our masks.

Manufacturing Processes: Our manufacturing facilities employ robust processes that adhere to strict guidelines and best practices. From precise molding techniques to advanced assembly procedures, we prioritize quality through rigorous training and adherence to best-in-class manufacturing protocols for medical devices.

In-Depth Testing and Inspections: Our masks undergo comprehensive testing and inspections to maintain the highest standards. This includes evaluating structural integrity, ensuring proper seal and fit, and verifying compliance with regulatory requirements.

Continuous Improvement: At Sleepnet, we continuously strive for excellence. We routinely collect and analyze data looking for ways to improve our products, processes, and customer experience.

Certifications and Compliance: Our commitment to quality is demonstrated through certifications, such as the ISO 13485 certificate, which is a quality management certification. As well as being compliant with domestic and international standards, our masks ensure that they meet the highest quality standards set by international regulatory bodies.

Conclusion

Quality control is the backbone of Sleepnet’s manufacturing process, especially when producing critical healthcare products like CPAP, NIV, and pediatric masks. We dedicate ourselves to delivering exceptional products that meet the needs of our customers and adhere to the highest standards through rigorous material selection, robust manufacturing processes, comprehensive testing, and continuous improvement. By prioritizing quality control, we aim to produce best-in-class products that exceed our customers’ expectations.

About Sleepnet

We believe in building products that help people lead healthier lives. Our passion for innovation is at the core of everything we do, laying a foundation for creating new ideas and building better products. As a company with BAA-compliant products, we are experienced manufacturers focused on developing best-in-class products that improve the health and well-being of our customers. For more than 25 years, Sleepnet has manufactured gel masks and respirators built to help customers breathe easier. Our products include Continuous Positive Airway Pressure masks, Noninvasive Ventilation masks, Pediatric masks, and Respirators. With comfort and safety top of mind, we proudly design and manufacture our products in the United States.

August 14, 2023

What are NIV masks?

Articles, News & Updates

What are NIV masks?

Non-invasive ventilation (NIV) masks are a type of respiratory support used to treat patients with breathing difficulties. They provide mechanical ventilation without the need for intubation, which is the insertion of a breathing tube into the patient’s airway. NIV masks help to treat a wide range of respiratory conditions, including chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), pneumonia, and more.[1] As hospitals and medical professionals move away from intubation due its risks, the demand for NIV masks continues to grow.

How do NIV masks work?

NIV masks deliver pressurized air or oxygen through a mask placed over the patient’s nose and/or mouth. The pressurized air helps to keep the patient’s airway open, allowing them to breathe more easily. The mask stays in place with straps that wrap around the patient’s head, and healthcare staff adjust pressure levels to meet the specific requirements of each patient.

What types of NIV masks are available?

There are several types of NIV masks, which include nasal masks, full-face masks, total face masks, pediatric masks, cannulas, and nasal pillows. The type of mask medical professionals select depends on the patient’s condition and individual preferences. Nasal masks cover only the patient’s nose, while full-face masks cover both the nose and mouth. Nasal pillows are small, cushioned inserts that fit into the patient’s nostrils.

What are the benefits of NIV Masks?

One of the benefits of NIV masks is that they are non-invasive, meaning that they do not require the insertion of a breathing tube. Using an NIV mask reduces the risk of complications associated with invasive treatment, such as infections or lung damage which occasionally arise with intubation. NIV masks are also generally more comfortable for patients than invasive treatments, and they potentially reduce the time a patient spends in acute care.

NIV masks are utilized in diverse settings such as hospitals, long-term care facilities, and homes. Within hospital environments, they are commonly used in the intensive care unit (ICU) to offer respiratory support to patients who are critically ill. In long-term care facilities, NIV masks help manage chronic respiratory conditions. In the home, NIV masks function as respiratory support for patients with COPD and other chronic diseases.

While NIV masks are generally safe and effective, it’s important to note that there are potential risks associated with their usage. These include skin breakdown, pressure ulcers, discomfort, and mask leaks. This is why it is important for patients using NIV masks to be closely monitored by healthcare professionals.

NIV masks are a vital tool in treating respiratory conditions. They offer a non-invasive way to provide mechanical ventilation to patients without requiring intubation. NIV masks are generally safe and effective, but patients should be closely monitored for potential complications. If you or a loved one has a respiratory condition, talk to your healthcare provider about whether NIV masks might be a suitable treatment option.

Does Sleepnet offer NIV masks?

Sleepnet specializes in manufacturing respiratory masks, including NIV masks designed to provide comfortable and effective respiratory support for adult and pediatric patients. Sleepnet offers multiple NIV mask options, each with unique features that meet the needs of various types of patients. For more information on Sleepnet NIV masks, go to https://www.sleepnetmasks.com/respiratory-masks/.

[1] Laurent Brochard, Dan Adler, Ricardo Luiz Cordioli, Evangelia Akoumianaki, 102 – Noninvasive Ventilation,

Editor(s): V. Courtney Broaddus, Robert J. Mason, Joel D. Ernst, Talmadge E. King, Stephen C. Lazarus, John F. Murray, Jay A. Nadel, Arthur S. Slutsky, Michael B. Gotway, Murray and Nadel’s Textbook of Respiratory Medicine (Sixth Edition), W.B. Saunders, 2016, Pages 1778-1793.e6, ISBN 9781455733835, https://doi.org/10.1016/B978-1-4557-3383-5.00102-0. (https://www.sciencedirect.com/science/article/pii/B9781455733835001020)

July 7, 2023

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