INTERSURGICAL 2019111 I-Pro Medical Mask Instruction Manual

INTERSURGICAL 2019111 I-Pro Medical Mask

Instructions For Use

The instructions for use (IFU) is not supplied individually. Only 1 copy of the instructions for use is provided per box and should therefore be kept in an accessible location for all users.
NOTE: Distribute instructions to all product locations and users.

These instructions contain important information for the safe use of the product. Read these instructions for use in their entirety, including warnings and cautions before using this product. Failure to properly follow warnings, cautions and instructions could result in serious injury or death.

WARNING: A WARNING statement provides important information about a potentially hazardous situation, which, if not avoided could result in death or serious injury.

CAUTION: A CAUTION statement provides important information about a potentially hazardous situation, which if not avoided could result in minor or moderate injury.

Intended Use
To limit the direct transmission of infective agents between healthcare personnel and patient during clinical and surgical procedures.

Intended user
For use by healthcare workers, first responders and other personnel working in the clinical environment.

Limitations in the intended use

• The oxygen content of the ambient air must not drop below 19.5% volume.
• The mask must not be used as a protection against anaesthetic gases, vapours or chemical, biological and radioactive agents.
• The mask may be used for a maximum period of one work shift and always in accordance with national and local infection control guidance.
• Observe the limit values and limitations of use for this mask.
• Not intended for patient use.

WARNING:

• The mask is not to be used if there is any confusion about the purpose of its use or the conditions in which it is to be used. Misuse can cause illness or death.
• The user must be familiar with its use. Observe the national rules and local regulations on the use of surgical masks and personal protective equipment.
• Protect the mask against moisture and contamination by storing in its original packaging.
• If the ambient air contains oily substances, the filter performance may be reduced.
• Do not use damaged or used masks, or masks which have damaged packaging.
• Do not use the mask after the date of expiry.
• Do not modify the mask.
• It must be ensured that the ambient atmosphere cannot change unfavourably.
• Leave the work area immediately if breathing becomes difficult or if dizziness, nausea or illness occurs.
• Removal of the mask in contaminated areas will compromise the level of protection the mask provides. The outer surface of the mask must always be treated as if contaminated. After removing the mask, wash your hands immediately in accordance with local infection control guidelines.
• The mask may not be worn by people with facial hair or having other characteristics preventing a tight seal between the face and the mask.
• People with breathing difficulties (e.g. asthma) or heart disease should consult a physician before use.
• The mask can mitigate the amount of biologically harmful substances inhaled, however, it cannot preclude the risk of an infection or illness. Inhaling an individual agent can be dangerous and can lead to serious illness.
• A Qualitative fit test shall be performed according to the employer’s protocol. When performing the fittest, the wearer shall wear any accessories, such as eyewear or visors, that they may be wearing during actual use. The fitting instructions and seal check shall be followed each time the face mask is worn.
• A seal check should be performed each time the mask is removed or adjusted.

Cautions

• The mask does not prevent infection by another route (e.g.contact of contaminated objects with the mouth, nose or eyes or via contaminated food).
• Frequent washing of hands can reduce the risk of infection, but not eliminate it.
• Always observe the recommendations of the responsible national and local authorities.
• FFP3 respirators are recommended where high risk aerosol-generating procedures (AGPs) are being performed. Where a risk assessment shows an FFP2 or N95 respirator is suitable, they may be used for some aerosol-generating procedures if FFP3 respirators are not available.

Instructions for use

Before use
The employer/user must ensure the following prior to first use:

• The mask must fit correctly to ensure an effective face fit seal.
• The mask must be compatible with any other personal protective equipment worn at the same time (e.g. eye protection).
• The mask must be suitable for the respective workplace conditions.
• The mask must match the ergonomic requirements and health requirements of the wearer.

Use

1. Wash hands before use and ensure the mask is undamaged and free of any obstructions or foreign bodies (Picture1).
2. Cup the mask in your hand, avoiding contact with the filter, allowing the straps to hang freely below your hand (Picture 2).
3. Position the mask under your chin with the nosepiece up. Pull the bottom strap over your head resting it around the neck below the ears (Picture 3).
4. Pull the top strap over your head and position it above the ears, at the back of your head (Picture 4).
5. Hold the front of the mask to the face and pull the elastic loop at the side to tighten the mask – take care to not contact the filter media while putting on the mask (Picture 5 and Picture 6).
6. To check the mask to face seal, hold both hands underneath and above the mask to check no air is escaping around the seal as you exhale (Picture 7 and Picture 8). Be careful not to disturb the position of the mask. If air leaks, adjust the position of straps and make certain mask edges fit snugly against the face.

WARNING:

• If the mask does not fit properly, do not enter the contaminated area. Improper use can cause illness or death.
• Single shift use only. Do not clean, store used masks, or reseal within the packaging. Reuse poses a threat to user safety in terms of cross-infection, malfunction and breakage. Cleaning can lead to malfunction and breakage.
• Leave the contaminated area immediately if the mask becomes damaged during use.

Technical and performance data

• Bacterial Filtration Efficiency (BFE)1

  98%

• Particulate filtration efficiency2

  95%

• Exhalation resistance3
  <2.5cmH2O

• Inhalation resistance4
  <3.5cmH2O

Tested according to ASTM F2101-19 – Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. EN 14683:2019 IIR.
2Tested according to TEB-APR-STP-0059-508 determination of particulate filter efficiency level for N95 series filters against solid particulates that do not contain oil.
Tested according to TEB-APR-STP-0003-508 exhalation resistance.
Tested according to TEB-APR-STP-0007-508 inhalation resistance.

Storage and care

Recommended storage at room temperature over the indicated product shelf-life.

Disposal
Following use, the product must be disposed of in accordance with the local hospital, infection control and waste disposal regulations.

References

• cn.com
• Home - Evans & Sutherland - A Cosm Company
• Intersurgical
• intersurgical.com/support

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