We are pleased to announce that we have received the CE Mark accreditation for our formal visor design! This follows the accreditation to the essential parts of EN166:2001 received in May. This is the required quality standard for PPE visors.
From the very beginning of the visor initiative, we made it our mission to create a high-quality and durable design that would give optimum comfort and protection from airborne particles. Late in March, and prompted by a post on LinkedIn, we had a late night/early morning conversation with the Californian based grass roots organisation Masks for Docs. We decided to follow their strategy and advice to free issue visors to front line healthcare staff based on “open source” designs they shared with us. During March, April and May we free issued over 30,000 visors directly to healthcare workers. These were distributed through our sister volunteer organisation the SSC Visor Bikes, volunteers from Midland Freewheelers and volunteers from Warwickshire Visor Bikes. These organisations are made up of Blood Bike riders who had an unrivalled knowledge of the NHS network of hospitals and knew day by day which hospitals had the acutest PPE shortages. We also teamed up with Orbital Direct for country-wide delivery.
Whilst part of the 3P team of volunteers focused on producing as many open source visors as we could, in parallel our design engineers volunteered to work developing our own design. We were fortunate enough to receive significant funding from a number of important 3P clients, which enabled us to fund investment in injection moulding tooling and CE marking and to purchase materials for visor production. Cambridge Design Partnership were also kind enough to volunteer to carry out a formative human factors study to ensure the comfort (ergonomics) of the design.
The end result is the CE marked “3PFS.A” Visor. It is comprised of a PETG visor and optional top cover, polypropylene headband and a silicone strap. With comfort and durability in mind, we have designed the visor to have the following features:
- High grade clarity for 180-degree visibility
- Medical grade PETG is used for the main ocular with large wrap around for coverage against Covid-19 beyond the standards
- Soft silicone strap to provide a secure, comfortable fit with full adjustment
- Offset from the face to allow space for masks and glasses
- Washable materials to allow reuse
- Extra wide visor for optimum coverage of face
- Optional top cover reduces risk of airborne particles entering from top of mask
- Lower visor support to ensure correct wrap-around and improved protection for the face
During the development, it became clear that only a limited number of materials could be used for the front screen (the ocular) that would pass both the strength and the optical clarity requirements of the relevant EN standards. Many clear plastic materials could not pass the optical requirements without thinning them to the point where the strength requirement could not be satisfied. We found that the relatively high cost but very clear medical grade PET G passed both criteria. The human factors study led to a few last-minute tweaks to improve comfort. This has meant that our visor design has received really positive feedback from the NHS, care-worker and key-worker communities. Many complimented the design for its robustness, cleanability and comfort during shifts of 13-hours or more.
More recently we have also been awarded with an Innovate UK Grant after being recognised for our manufacturing capabilities in producing PPE face visors. This grant will enable us to scale-up production for a lower cost visor design. We are also working with PPE test houses to help community-led initiatives to supply visors made from available and low-cost materials that can meet the relevant standards. This is a precaution to ensure UK manufacturing is ready, if and when there is a second Covid-19 wave. We really hope all our hard work and detailed engineering is not needed!