GranberG 210.0026 Surgical Face Masks User Manual

: June 8, 2024
: GRANBERG

Table of Contents

Description
Medical Device Regulation
Performance
Material Performance
User guide
Storage
Use limitations and Disposal
References
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GranberG 210.0026 Surgical Face Masks User Manual

ART. 210.0026 – GRANBERG SURGICAL FACE MASKS TYPE IIR, BLACK

Description

Black surgical face masks Type IIR are made of non-woven polypropylene. Material in 3- layers with elastic loop for ears. The face masks are 100% latex free. >99% bacterial filtration efficiency

The face masks are made of following material:

Outer layer: Polypropylene.
Second layer: Meltblown fabric.
Inner material: Polypropylene.
Ear loops: Polyurethane.
Nose clip material: Polypropylene and steel.

Medical Device Regulation

This product is classified as a Class I medical device and meets the provisions of the Medical
Device Regulation (EU) 2017/745. Non-sterile.

Performance

This product meets the requirements of the European Standard EN 14683:2019+AC:2019:
Surgical face masks, type IIR.

Test	Type I a	Type II	Type IIR
Bacterial filtration efficiency (BFE), (%)	≥ 95	≥ 98	≥ 98
Differential pressure (Pa/cm2)	< 40	< 40	< 60
Splash resistance pressure (kPa)	Not required	Not required	≥ 16,0
Microbial cleanliness (cfu/g)	≤ 30	≤ 30	≤ 30

Type I medical face masks should only be used for patients and other persons to reduce the risk of spread ofinfections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements.

Face masks in compliance with the Regulation (EC) 1935:2004 and according to
Commission Regulation (EU) No. 10/2011 suitable for handling all types of foods for short period of time.

Material Performance

The performance of the face masks quoted above is based on laboratory data and may not reflect the actual duration of protection in the workplace due to other factors influencing the performance such as temperature, mechanical wear etc.

User guide

Wash your hands thoroughly before you put on the mask.
Hold the mask by its edges in front of you and identify the inner and outer side of mask by checking the ear loops. The ear loops are attached to the inner side of the mask. The nose clip should be upwards. Pull a rubber band behind each ear.
Pinch and stroke your fingers along the nose clip a couple of times to form it according to the shape of your nose ridge, preventing air from entering between the mask and your nose.
Pinch the nose clip while pulling the lower part of the face mask below your chin to achieve a better and tighter fit.
Do not touch the mask while wearing it, and only hold it by the rubber bands when removing it.
Discard the mask in a proper manner.
Do not use the mask for more than 4 hours. Remove it if breathing becomes difficult, it becomes damp or the fit of the mask becomes loose.

Storage

The face masks must be stored dry and under clean conditions where the temperature is between 10 °C-35 °C with humidity between 45%-65%. Preferably stored in original packaging under dry conditions.

When stored as recommended, the chemical properties will remain unchanged for up to 2 years from the date of manufacture. Lifetime cannot be specified as it depends on its use. It is the responsibility of the user to determine whether the face mask is suitable for intended use.

Use limitations and Disposal

The used raw materials are chosen to minimize the risk of allergy and hypersensitivity, but a guarantee for allergic reactions cannot be given. If any allergic reaction occurs, seek medical advice or visit a doctor immediately.
EU Declaration of Conformity is accessible at https://www.granberg.no/catalog/210.0026
For single use only. Do not re-use.
Before usage, inspect face mask for any defect or imperfections.
Dispose according to hospital policy and local regulation.
The manufacturer cannot be held responsible for improper use of the face mask