Surgical Face Mask Transparent Type II MaXsmileSince the beginning of the coronavirus pandemic, the obligation to wear face masks in many public places has put people with hearing impairments who rely on lip-reading at a huge disadvantage. The Surgical Face Mask Transparent MaXsmile from Flawa makes lip-reading possible, which significantly facilitates communication. Also for teachers, psychologists, speech therapists, counsellors, employees in retirement homes and homes for disabled people, etc. Surgical face masks (Class I medical device) are primarily used to protect other people from being exposed to any infectious droplets exhaled by the person wearing the mask. Although these masks also provide the wearer with limited protection if they fit tightly, this is not the primary purpose of their use.
Areas of application of the transparent face mask type II
If used correctly in accordance with the information leaflet, the transparent Type II surgical face mask is suitable in the following situations:
- When dealing with people with hearing impairments
- Professionals in the field of education (teachers, counsellors, trainers, educators, etc.)
- Professionals in the medical sector and healthcare
- Public transport (buses, trains, trams, planes, etc.)
- Shopping, whether in stores or at a market
- Professionals in fields involving extensive/close contact with customers (retail stores, hairdressers, service providers, etc.)
- Periods of time spent in enclosed spaces (shops, train stations, public buildings, hotels, etc.)
If you’re interested in finding out more, a comprehensive overview with a comparison of different mask types can be found on this page.
Why choose the transparent Type II surgical face mask?
- Mouth area remains visible, which enables lip-reading
- Currently the only certified transparent surgical face mask on the Swiss market
- Tested in accordance with EN 14683:2019+AC:2019
- Bacterial filtration efficiency of ≥ 98%
- Produced in collaboration with the Swiss hearing impairment associations
- Elastic ear straps make the mask easier to put on and take off
- Swiss Engineered- Swiss Made
• Three-ply non-woven fabric – outer layer, filter layer/melt-blown, inner layer
• Elastic ear strap – polyamide/elastane
• Nose clip – metal/polypropylene
• Mask weight – approx. 3 grams
• Clear panel – CPP (cast polypropylene) film
What do I need to bear in mind when using a mask?
Instructions for use:
- The mask is intended for single use and cannot be reused
- Do not touch the mask while wearing it.
- Never hang the mask around the wearer’s neck.
- The mask may no longer be used:
- if it is damaged
- if it becomes damp through breathing
- after you have finished using it
Storage and transportation:
The product should be stored and transported in the original packaging. Refer to the instructions on the back of the folding box for further storage conditions and the shelf life.
How to put on and fit the mask:
Before putting on the mask, wash or disinfect your hands
- Only hold the mask by its outer edges and check for any defects
- Hold the mask by its straps and place these over each ear (coloured side of the mask facing outwards)
- Press down on the nose clip
- Pull the mask over the chin and check that it is in place. Check that the mask fits securely
Removal and disposal of the mask
Carefully remove the mask without touching the front or inside surface:
- Hold the ear straps with both hands and pull them over the ears. Hold the mask by just one of the ear straps and remove it
- Dispose of the mask in a sealed container
- Thoroughly wash or disinfect your hands afterwards
Testing and conformity:
Medical devices are subject to the Medical Devices Directive MDD 93/42/EEC, or the Medical Devices Regulation MDR (EU) 2017/745 and the corresponding conformity assessment procedure. This results in the declaration of conformity and the CE marking on the product, or on the packaging.
Surgical face masks comply with the standard EN 14683 “Medical face masks – Requirements and test methods”. The performance requirements are verified by an accredited test laboratory (and the results are documented in a test and inspection report).