ISO13485 Approved Full Face Silicone BIPAP CPAP
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Product Description
GoldHealth Medical presents a revolutionary sleep solution designed to redefine comfort and performance for users. Engineered with precision, this product is tailored for medical professionals, caregivers, and patients seeking an unparalleled experience in respiratory support.
Key Advantages
- Deft Design
- A brand-new forehead support frame offers a dynamic adjustment range, ensuring flexibility and lightweight comfort.
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The 360º rotating elbow allows unrestricted movement, enhancing user comfort during sleep.
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Unmatched Comfort
- Utilizes high-end double-layer liquid silicone technology for a soft, secure fit that prevents air leakage and ensures restful sleep.
- Self-adaptive pleated silicone cushion design flexibly adjusts to the user’s face, relieving pressure on the nasal bridge.
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A redesigned exhaust valve disperses airflow gently and quietly, minimizing disturbances for both users and their partners.
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Ease of Use
- Quick-detachable headgear buckles simplify wear and removal.
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Modular components allow effortless assembly, disassembly, and maintenance, ensuring hassle-free cleaning.
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Safety First
- Made from medical-grade, odorless silicone, ensuring safe and reliable use.
- Soft headgear materials are rigorously tested and approved for sensitive skin, offering peace of mind for all users.
Technical Specifications
- Frame: Lightweight, adjustable forehead support frame with a wide dynamic range.
- Cushion: Self-adaptive pleated silicone cushion with double-layer liquid silicone technology.
- Exhaust Valve: Advanced design for quiet and gentle airflow dispersion.
- Elbow: 360º rotation for maximum freedom of movement.
- Headgear: Quick-detachable buckles with soft, skin-friendly materials.
About GoldHealth Medical
GoldHealth Medical is a leader in the research, development, and distribution of advanced medical devices. Our team of experts includes software and hardware engineers, mechatronics specialists, and healthcare professionals dedicated to delivering innovative solutions.
Our commitment to quality is reflected in our certifications, including ISO9001, ISO13485, and CE. These standards ensure that our products meet the highest levels of safety and performance.
GoldHealth Medical products are trusted worldwide for their reliability, ease of use, and consistent quality. We take pride in serving hospitals, clinics, research institutions, and home users with cutting-edge technology designed to improve lives.
Why Choose GoldHealth Medical?
- Backed by a robust R&D team and a dedicated marketing and after-sales service team.
- Proven track record of delivering high-quality products at competitive prices.
- Global recognition for simple operation, steady performance, and customer satisfaction.
GoldHealth Medical is your trusted partner in advancing healthcare solutions.
Common Shipping and Delivery Considerations
- Packaging:
Medical devices need secure packaging to avoid damage during transit, including shock-absorbing materials or custom foam inserts. - Compliance with Regulations:
Ensure compliance with local and international standards (e.g., FDA, CE) and shipping regulations like Good Distribution Practice (GDP). - Temperature Control:
Some devices require temperature-controlled shipping (e.g., refrigerated trucks or special packaging) to maintain product integrity. - Tracking and Documentation:
Shipments should be tracked with necessary documents like invoices, certificates, and import/export paperwork. - Lead Time:
Plan ahead for lead times, which can vary depending on the equipment size and delivery location. - Insurance: Due to the high value of medical equipment, consider insurance to protect against loss or damage during transit.
- Customs and Import Regulations: Account for customs procedures and tariffs when shipping internationally, ensuring proper documentation.
- Special Handling:
Fragile or hazardous medical devices may require special handling, with clear labeling to ensure proper care. - Delivery Method:
Choose the appropriate shipping method (air, sea, or ground) depending on the equipment’s size, value, and urgency. - Returns and Reverse Logistics:
Have a clear process in place for returns, repairs, and warranty claims if necessary.
Frequently Asked Questions
39
Stores In World
97
Cities With Free Shipping
300+
Five Star Rating
Our mission and vision
At Gold Health Medical, our vision is to revolutionize healthcare by providing high-quality medical equipment that enhances patient care and improves healthcare efficiency. We are committed to being a trusted partner for medical professionals and institutions, ensuring they have access to the latest and most reliable medical technology.
Our goal is to bridge the gap between innovation and accessibility, making advanced healthcare solutions available to providers worldwide. Through excellence in service, integrity, and continuous improvement, we strive to empower healthcare professionals with the tools they need to deliver superior patient outcomes.
Together, we are shaping the future of medical care—one innovation at a time.
What Our Customers Say
At Gold Health Medical, we take pride in delivering high-quality medical equipment and exceptional customer service. Here’s what our satisfied clients have to say about their experience with us:
Product Overview
GoldHealth Medical presents the EaseFit FMII, a meticulously engineered medical solution designed to deliver precision, comfort, and reliability. Crafted with advanced materials and adhering to the highest industry standards, this Class II medical instrument is ideal for hospitals, clinics, research institutions, and home care environments.
Key Features and Benefits
- Superior Material Composition: Constructed from high-grade plastic and medical-grade silicone, ensuring durability, hygiene, and user comfort.
- Manual Power Source: Designed for simplicity and reliability, eliminating dependency on external power sources.
- Compact and Portable Design: Lightweight at just 1.000 kg with dimensions of 100x20x20 cm, making it easy to store, transport, and deploy in any setting.
- 6-Month Shelf Life: Ensures product integrity and performance when stored under recommended conditions.
Certifications and Compliance
- Class II Instrument Classification: Meets rigorous safety and performance standards for medical devices.
- CE Certification: Validated for quality, safety, and compliance with European health and safety regulations.
Support and Service
- Comprehensive After-Sales Support: Backed by GoldHealth Medical’s commitment to customer satisfaction.
- Online Technical Support: Access expert guidance and troubleshooting assistance whenever you need it.
Packaging Details
- Selling Units: Single item
- Package Dimensions: 100x20x20 cm
- Gross Weight: 1.000 kg
GoldHealth Medical’s EaseFit FMII is more than a product—it’s a reliable partner in delivering exceptional care. Designed with precision and built to last, it’s the ideal choice for professionals and caregivers seeking uncompromising quality.
