Use Instruction - GR200 for FDA EUA

Information of Manufacturer

Product name: Particle filtering half mask
Model: GR200
Manufacturer: Guangdong GangRong Medical Technology Co., Ltd
Address: Floor 2, Block 13, Building 2, No. 68, Zhenxing Road, Dabu village, Sanxiang Town, Zhongshan City
Tel: 18022083537
Email: 99322575@qq.com

EU-Type Examination Notified Body

Notified Body SGS Fimko Oy
Address: Takomotie 8, FI-00380 Helsinki, Finland
Notified Body No. 0598
Please read this User Information Sheet carefully before using this product. This product complies withthe requirements of EU Regulation (EU) 2016/425 for Personal Protective Equipment and meets therequirements of European standard EN149:2001+A1:2009.

Intend Use

These particulate respirators are designed to protect against solid and non-volatile liquid particles.

Check before use

1.The mask must be selected properly for intended application. Those who are allergic to non-woven fabric should use with caution. Check the mask that it is undamaged with no visible defects. 3.Check that the expiry date has not been reached (see the packaging). 4.Check the protection class is appropriate for the product used and its concentration. 5.Do not use the mask if a defect is present or the expiry date has been exceeded. It is recommended that the continuous use time should not exceed 4 hours.

Fitting Check

1.Unfold the mask. 2.Fit the mask to your face and stretch it to cover your mouth, nose and chin. 3.Put the head hardness around back of your head, fasten it with the plastic buckle , and adjust your comfort. 4.Adjust the nose piece, press it and fit the mask closely to your face.Before entering the work area, users must test the fit between the mask and face. A. Place both hands over the respirator without disturbing its position. B. If the respirator is not fitted with an exhalation valve, exhale sharply. If the respirator fitted with an exhalation valve, inhale sharply. C. If you detect air-leaks, please follow the step 4 and readjust your nose piece; If the air leaks from the edge of the mask, please readjust the head straps and/or the position. If it does not work, please repeat the above steps. D. If there are not air-leaks, you can enter the work area.

Usage/ Limitations

This respirator is suitable for use in protection against the non-toxic solid and liquid aerosols. Do not use out of the scope of use defined in the warnings. Failure to properly use this product may result in serious health damage or death. FFP1 NR: Filter Efficiency 80%; Allocated Protection Factor (FPA) is 4; Examples of applications are Handling of stone / rubble / cellulose. FFP2 NR: Filter Efficiency 94%; Allocated Protection Factor (FPA) is 10, Examples of applications are Sanding of soft wood, composite materials, rust, putty, plaster, plastics / cutting, deburring, grinding, drilling of metal. FFP3 NR: Filter Efficiency 99%; Allocated Protection Factor (FPA) is 20; Examples of applications are Sanding of hard wood (beech, oak) / treatment of wood using copper, chrome or arsenic based products / impact stripping of paint / sanding of cement.

End of shelf life

2 years after manufacture date (on packaging)

Warning:

1.Failure to follow all instructions and limitations on the use of this product, or failure to achieve proper fit, may result in damage to your health or death. 2.A properly selected respirator is essential to protect your health. Before using this respirator consult a suitably qualified safety professional to determine the suitability of the product for your intended use. 3.This product does not supply oxygen. Use only in adequately ventilated areas containing sufficient oxygen to support life. Do not use this respirator when the oxygen concentration is less than 19.5%. 4.Do not use when concentrations of contaminants are immediately dangerous to health or life. Do not use this product in an explosive atmosphere. 5.Leave the work area immediately if: a) breathing becomes difficult or b) dizziness or other distress occurs. 6.Facial hair, beards and certain facial characteristics may reduce the effectiveness of this respirator. 7.Never alter or modify this respirator in any way (except as indicated in the instructions). 8.“NR” means this particle filtering half mask shall not be used for more than one shift. No maintenance is necessary. Discard respirator after use or if damaged in any way. 9.The length of time this respirator can be used depends on contaminants present but should not exceed one shift. The respirator should be replaced sooner if breathing becomes difficult. 10.The head straps are made of non-woven fabric, which may cause skin allergies. Remove the mask immediately if irritation occurs. 11.Keep respirators in the display box away from direct sunlight or contaminants until use. Ambient storage conditions as temperature between -30℃ to +70℃, and relative humidity <80%. 12.Unless this is fitted according to the “Fitting Check” instructions the respirator will not provide the expected level of protection. 13.This respirator is suitable for use in protection against the non-toxic solid and liquid aerosols. 14.Failure to achieve proper fit may result in serious health damage or death. 15.See information supplied by the manufacturer. 15.See information supplied by the manufacturer.