medisana RM 100 Particle Filtering Half Masks Instruction Manual
- June 6, 2024
- medisana
Table of Contents
RM 100
Particle Filtering Half Masks
User Instructions
FITTING INSTRUCTION
- Hold the particle half mask in position over the nose and mouth.
- Pull the ear loops behind the ears and attach the two straps with the clip behind the head.
- Ensure the nose clip is securely molded around the nose, resting the ends against the cheek to obtain a good seal.
- To check for proper fit, cup both hands over the mask and exhale vigorously. If air leaks around the nose, tighten the nose clip, if air leaks around the edge, reposition the ear loops for a better fit.
- Repeat adjustments until the mask is sealed properly.
- If a proper seal cannot be achieved do not enter the contaminated area or it may cause illness.
User Instructions
Failure to follow the instructions and warning on the use of this mask during
all times of exposure can reduce the effectiveness of the mask and could
result in illness or disability. A copy of the Declaration of Compliance will
be supplied/provided with every smallest commercially available package. As
with any respiratory device, the wearer must be adequately trained prior to
use. Before use, the wearer should always check the mask is in good condition
– no dirt, no damage to ear loops, etc.
Limitation
Do not use the respirator or enter or stay in a contaminated area under the
following circumstances:
- The atmosphere contains less than 19.5 % oxygen.
- If you smell or taste contaminant.
- For protection against gases or vapors.
- Contaminants or their concentrations are unknown or immediately dangerous to life or health.
- For sandblasting, paint-spray operations, and asbestos treatment.
- In explosive atmospheres.
Warnings
The Mask holder clip may have an influence on the leakage of the mask. Overly
tightening of the ear loops through the clip may lead to the inaccurate
fitting of the mask. Please check leakage with the attached mask holder clip
as described in FITTING INSTRUCTION again.
- This mask marked “NR” is for single use only.
- Never substitute, modify, add, or omit parts in the configuration as specified by the manufacture.
- This mask helps protect against certain particulate contaminants but does not completely eliminate exposure to the risk of contracting disease or infection.
- It is unlikely that the requirements for leakage will be achieved if facial hair passes under the face seal.
- Change the mask immediately if breathing becomes difficult or the mask becomes damaged or distorted.
- Change the mask if a proper face seal cannot be achieved.
Storage
- Store the mask in a sealed container away from contaminated areas when not used.
- Store the mask in the original packing during transport.
Protection level: FFP2 NR with a degree of protection 95 %
Shelf life: intended for single short-term use;
when stored in closed bag: 3 years.
Size (folded): 106,7mm x 155mm
Art. No.: 33333 (VPE 10), 33335 (VPE 5), 33337 (VPE 25)
Storage: dry, <80% humidity, -30°C to +50°C
medisana GmbH
Carl-Schurz-Str. 2,
41460 NEUSS
DEUTSCHLAND
2834
Authorized manufacturer:
Medical Device Branch of Zhangzhou Easepal Industrial Co., Ltd.
4th Floor of Building #7, No.228, Jiaotong Road,
Taiwanese Investment Zone, Zhangzhou, Fujian
Standards: EN 149:2001 +A1:2009; R 2016/425
CCQS Certification Service ltd., Block 1 Blanchardstown Corporate Park,
Ballycoolin Road, Blanchardstown, Dublin 15, D15 AKK1, Dublin, Ireland, phone:
0035315886920, email: [email protected]
You can request the complete EU Declaration of Conformity from medicine GmbH,
Carl-Schurz-Str. 2, 41460 Neuss, Germany, or you can also download it from the
medicine homepage (www.medisana.com).
IM_04-2021_Ver.2.1