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Product Description; Intended Use; Regulation & Technical Spec; Limitations - Summit Medical CM-5001 Gebrauchsanweisung

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PRODUCT DESCRIPTION

Face shields are personal protective equipment devices that are used for protection
of the facial area and associated mucous membranes (eyes, nose, mouth) from
splashes, sprays, and spatter of body fluids. Face shields provide a barrier to
acutely-expelled aerosols of body fluids and protect a large area of the face.

INTENDED USE

The Summit Medical Face Shield is intended to provide top, side, and front face
protection from aerosols and to minimize airborne cross-contamination.
REGULATION & TECHNICAL SPECIFICATION
BSI's PPE for healthcare professionals 2020/403 eye protection.
ANSI Z87.1 Eye protection.

WARNINGS AND PRECAUTIONS

• DO NOT RE-USE OR RE-STERILIZE THIS DEVICE. It is designed for a
SINGLE-USE
• This device is supplied clean but is NON-STERILE
• It is recommended that this device is used as part of a PPE regimen
• Care should be taken when putting on and taking off the device to prevent
contamination
• Care should be taken if it is necessary to adjust the shield during use, as this
may lead to contamination
• Ensure that the shield conforms to the face/head and that the shield does not
slip while in use
• Check before use that the shield will not become detached from the elastic
headband
• After use, the shield should be carefully removed without contaminating the
eyes, mucous membranes, or clothing with potentially infectious materials and
discarded
• The product may come into contact with bodily fluids, which can be
contaminated. Care should be taken in the handling and disposal of the device
after use to prevent contamination
• Dispose of this device after use in accordance with standard hospital protocol
• Do not use five (5) years after date of manufacture
• This face shield is manufactured for COVID-19 protection only
• This face shield is not a PPE device for general use and shall not be used for
purposes other than protection against COVID-19
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