AFFLOVEST® MOBILE MECHANICAL OSCILLATION THERAPY
THE CUSTOM FIT
AffloVest® is a proven high frequency chest wall oscillation (HFCWO) therapy designed to provide patients the freedom and mobility to customize and enhance airway clearance therapy, help mobilize lung secretions, and promote treatment adherence for patients with Bronchiectasis, Cystic Fibrosis, COPD,MS, MD (muscular dystrophy), ALS, and other neuromuscular and respiratory diseases.
Patient-specific therapy with 8 anatomically positioned oscillating motors to create individual pressure waveforms to target all lobes of the lungs, posteriorly and anteriorly, to loosen, thin and mobilize lung secretions. It is designed to mimic the gold standard CPT.
With eight, lightweight custom fit size variations (XXS-XXXL) and adjustable shoulder and chest straps, the ergonomic fit of the AffloVest can accommodate different patients’ needs for tailored therapy that fits young children and adults.
The battery-powered AffloVest is designed to increase therapy adherence through mobility. The ability to do airway clearance therapy on the go while performing normal, daily activities can provide more consistent therapy compliance and an improved quality of life.
The AffloVest puts control in the patient’s hands. Unique features include:
Anatomically targeted therapy
Fully mobile during use – Mobile CPT
Digital, programmable controller
3 modes of oscillation treatment (Percussion, Vibration, Drainage)
3 adjustable intensity levels (Soft, Medium, Intense)
Quiet during operation
Designed to increase patient adherence
Freedom of movement utilizing the latest technology
AffloVest is the pioneer in portable and mobile mechanical HFCWO vest therapy! It does not use bulky generators and air bladder technology first developed in the 1980’s.
By incorporating eight oscillating motors into AffloVest, our patented Direct Dynamic Oscillation™ technology creates eight individual pressure waves that target the lobes of the lungs, much like manual Chest Physical Therapy (CPT)—in order to help effectively mobilize secretions.
Patient home treatment plans can be customized for the targeted motors using the digital controller to specify different levels of intensity for 3 different treatment options.
A recently completed independent lab Noise Study demonstrated that AffloVest is the quietest HFCWO vest currently available on the market and a Peak Magnetic Field test showed that Afflovest is 4x lower than the threshold limit value for active medical device wearers and implants, in comparison to other portable HFCWO options which were significantly higher than the threshold limit.1
Direct Dynamic Ocsillation™ Technology
Anatomically targeted therapy
Engineered to mimic manual CPT
Engineered to increase patient compliance
Patented mechanical oscillation technology
1. The comparison measurements were conducted at F2 Labs, an independent, 3rd party, ISO/IEC 17025 accredited testing laboratory. 16740 Peters Road, Middlefield, Ohio 44062. www.f2labs.com
How is AffloVest Prescribed?
The AffloVest requires a doctor’s prescription for treatment by HFCWO. Once your healthcare team has decided AffloVest is the airway clearance therapy for you, they can fill out the AffloVest Order form, provide all necessary insurance and medical documentation and contact a DME distributor to place the AffloVest order.
The AffloVest has received the FDA’s 510k clearance for U.S. market availability, and is approved for Medicare, Medicaid, and private health insurance reimbursement under the Healthcare Common Procedure Coding System(HCPCS) code E0483 – High Frequency Chest Wall Oscillation. The AffloVest is available through the U.S Department of Veterans Affairs/Tricare. Patients must qualify for coverage and meet their individual insurance’s eligibility requirements.
Coverage criteria and documentation requirements can vary for patient to patient, largely depending on their medical condition and their health insurance carrier and plan.
If the primary diagnosis is Bronchiectasis, Signs & Symptoms of one of the following must be met:
- Daily productive (mucus) cough for at least 6 continuous months in the year prior to the date of the order; OR
- Frequent (i.e. more than 2/year) exacerbations/chest infections (such as Pneumonia) requiring antibiotic therapy in the year prior to the date of the order
- HRCT scan confirming diagnosis
If Cystic Fibrosis or an approved Neuromuscular diagnosis is primary: chart notes to support the diagnosis are required. Learn more about reimbursement coverage for AffloVest here.
No Size Limitations
With 8 sizes to choose from and no age restrictions, AffloVest is the most inclusive portable HFCWO vest available for cystic fibrosis and bronchiectasis patients. We understand the importance of precise placement when it comes to anatomically targeting the upper and lower lung lobes with directed therapy. So you can be sure that regardless of size, shape, or body type, AffloVest delivers targeted therapy that fits. The AffloVest ranges from XXS (18″ chest circumference) for young children up to the largest size, XXXL for adults (up to 75″ chest circumference).
AffloVest Size Exchange Program
Beyond being inclusive, AffloVest is adaptable too. Adjustments can be made with the AffloVest Size Exchange Program, which allows patients to go up or down in AffloVest size as needed, to provide tailored and targeted airway clearance therapy. See Terms and Conditions for program details.
Review the AffloVest Specification Sheet for more information on proper measurement requirements and AffloVest sizing or download the AffloVest Order Form to provide to your doctor.
|XXS||18”– 23” (46 – 58 cm)|
|XS||23”– 29” (58 – 74 cm)|
|S||29”– 35” (74 – 89 cm)|
|M||35”– 41” (89 – 104 cm)|
|L||41”– 48” (104 – 122 cm)|
|XL||48”– 55” (122 – 140 cm)|
|XXL||55”– 65” (140 – 165 cm)|
|XXXL||65-75″ (165-190.5 cm)|
*Note: Fit and sizing vary from person to person.
AffloVest requires a prescription from a physician and is available to U.S. patients through Durable Medical Equipment (DME) and Home Medical Equipment (HME) retailers.
AffloVest is approved for Medicare, Medicaid and private health insurance reimbursement under the Healthcare Common Procedure Coding System (HCPCS) code E0483 – High Frequency Chest Wall Oscillation.
The AffloVest mimics manual CPT by using mechanical oscillation to help loosen and thin mucus in the lungs.
Yes. The AffloVest is lightweight and is equipped with a rechargeable battery, giving the user full mobility during treatments. When not in use, the AffloVest is easy to store and carry; perfect for someone who travels.
- Fully mobile during use – Mobile CPT
- Digital, programmable controller
- Nine total setting variations
- Three modes of oscillation treatment (Percussion, Vibration, Drainage)
- Three adjustable intensity levels (Soft, Medium, Intense)
- Compliance monitoring
- Quiet during operation
- AC/DC power
AffloVest is available in a full range of 8 sizes—to serve both children and adults. XXS to XXXL (18″ circumference chest to 75″)
Nebulizer treatments can be administered while using the AffloVest, however users should first consult their physician for guidance.
Treatment times can vary depending on physician prescription, however they generally take 20-30 minutes and are conducted twice daily.
The AffloVest is lightweight, ~5.1-9.0 lbs and is the lightest device of its kind on the market.
The AffloVest has a limited warranty. We are committed to ensuring the highest quality standards. Full details are found in the User Manual.