Intersurgical I-Pro Medical Mask User Manual
- June 5, 2024
- INTERSURGICAL
Table of Contents
I-Pro Medical Mask
User Manual
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@intersurgicalNL /intersurgical N
www.intersurgical.be
Airway Management • Personal Protection
Information Sheet
• Airway Management
i-Pro™ medical mask
Designed for clinicians, working in the clinical environment.
Intersurgical has developed, manufactured,ured, and supplied innovative
respiratory and filtration solutions into the healthcare setting for over 30
years. This expertise has allowed us to design a medical mask specifically for
clinical personnel. Utilizing our proven mask and filtration technologies, the
new i-Pro™ mask is designed to provide comfortable, high-quality protection
for clinicians working in the clinical environment.
Traditional personal protective masks were originally designed to be used in
the industrial environment and are therefore not always suited for the
population of healthcare workers, this has resulted in a number of reported
issues.
The i-Pro™ mask has been designed with clinicians in mind. Using our breathing
system filter media, with proven bacterial and viral efficiency in the
clinical environment, and a soft, flexible TPE seal, featured in our range of
respiratory products, the i-Pro™ mask combines a high-level of protection with
a comfortable and effective fit.
Soft, flexible seal| Filter media| Protective shield
Dependent upon the type of mask, and where it is intended to be used, there are a variety of methods used to determine the overall effectiveness. The level of protection that a mask provides will be dictated by three key functional elements:
Filtration efficiency
Depending upon where the product is being tested, protective masks are subject to different testing methods. There are two main classifications of protective masks and these both require slightly different test methods and performance levels
- N95 standard requires >95% efficiency
- FFP2 standard requires >94% efficiency
- The i-Pro™ medical mask provides >99% efficiency
In addition, the filter media used in the i-Pro™ mask has been independently
tested to provide an indication of effectiveness against a microbial challenge
commonly found in the clinical environment and proven to provide: >99.999%
efficiency against a bacterial and viral challenges.
The challenge presented in the viral protocol allows us to provide a statement
of effectiveness against a viral challenge of similar size to COVID-19. The
filter media used in the i-Pro™ will provide >99.999% efficiency against a
COVID-19 viral challenge.
ISO 23328-1 Medical filter test standard
To allow a correlation, between the filters routinely used in the Intensive
Care and Operating Room, we have tested the i-Pro™ filter media in accordance
with ISO 23328-1 and it is 99.98% against this challenge.
Quality of the face fit
The overall protection a mask can offer is also reliant upon the quality of fit to the wearer’s face. If there are leaks or gaps in the seal, it will not fully protect the wearer. The quality of this seal can be quantified as the face fit factor.
Usability studies with the i-Pro™ have shown that 74% of participants were
able to achieve a fit factor of over 200 and 100% of participants achieved a
minimum face fit factor of 116.
The standard for an FFP mask allows up to an 8% inward leakage for FFP2
masks and a 2% inward leakage for FFP3 masks. This means with an FFP2 mask,
potentially 8% of the air breathed in will not be effectively filtered.
Independent testing has shown the i-Pro™ to have <1% inward leakage, meaning
99% all of the air you breathe, will be filtered.
Inward leakage <1%| Inward leakage <8%| Inward leakage <2%
The effective and comfortable seal created on the wearer’s face means that the inward leakage of i-Pro™ is significantly lower than that required by either the FFP 2 or FFP 3 test standards improving overall protection.
Comfortable protection
The overall comfort of wearing a mask is also very important. Low resistance
to flow characteristics has shown that it can be worn for the duration of a
shift without increasing the work of breathing. The unique flexible seal also
makes it comfortable to wear which helps with user compliance.
Low work of breathing helps improves compliance of the wearer.
The flexible soft seal creates a comfortable and effective seal to the wearer’s face, minimizing the risk of potential trauma associated with wearing PPE masks as reported by some clinicians during the pandemic.
There have been many reports of clinicians with facial sores as a result of wearing PPE masks. The i-Pro™ provides a high-quality effective seal whilst being soft and comfortable on the wearer’s face for the duration of use.
iPro’s high-quality seal limits air leakage and eliminates fogging of spectacles.
| Code | Description | Box Qty. |
|---|---|---|
| 2019111 | i-Pro™ medical mask, medium/large | 20 |
| 2019222 | i-Pro™ medical mask, small/medium | 20 |
Accessories
The i-Pro™ Vision protective visor is fully re-useable headwear designed for use in the clinical environment, providing optimum visibility, with a full range of movement.
| Code | Description | Box Qty. |
|---|---|---|
| 2019333 | i-Pro™ Vision protective visor | 1 |
| 2019334 | i-Pro™ Vision replacement visors | 20 |
Intersurgical Benelux B.V. Vluchtoord 28, 5406 XP, Uden, Nederland
T: +31 (0)413 243 860 F: +31 (0)413 243 869
info@intersurgical.nl www.intersurgical.nl
The manufacturer Intersurgical Ltd is certified
to ISO 9001:2015, ISO 13485:2016,
ISO 14001:2015 and MDSAP
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Documents / Resources
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Intersurgical I-Pro Medical
Mask
[pdf] User Manual
I-Pro Medical Mask, I-Pro Mask, Medical Mask, Medical Face Mask
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