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THE FM930 MBF5PL95N Ace AceMask Ace AceFilter

THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

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Page 1: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

THE FM930 MBF5PL95N

AceAceMaskAceAceFilter

Page 2: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

89/686/EECCE Certified

Laboratory tested materials

Innovative patented design

Made in ISO certified medical devices facility

Save money smartly without compromising on safety

Fully transparent - Your face remains visible

Made of soft & flexible medical compound

Ultra light weight at only 40 grams

Easy breathability

Looks cool

A forever accessory

DISCARD FILTER AFTER USE

READ INSTRUCTIONS MANUAL

WASH HANDS BEFORE CHANGING FILTERS

DO NOT SHARE YOUR MASK WITH OTHERS

With the AceMask, you simply replace the filter which costs less than a tenth of an equivalent mask. Every time you change the filter, the mask is good as new in giving you the protection you need!

ACEMASK - AFFORDABLE PROTECTION

Page 3: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

Before understanding the problem that the AceMask solves, we need to blast some misconceptions around the use of masks.

FACT #1: CLOTH MASKS ARE GOOD, BUT NOT GREAT.

They are good to provide the first protection against aerosol splashes, but they do not stop virus from reaching your skin. They are too coarse on that scale.

This is how the fabric looks to the virus. One thousand coronavirus molecules can enter side-by-side through a single pore of this fabric.

FACT #2: N95 MASKS HAVE A LIMITED SERVICE LIFE.

Likewise, even if you get an N95 mask, it is NOT okay to keep washing and reusing it. The meltblown fabric layer simply deteriorates and stops giving you the needed protection.

We know that you do it because they cost a lot of money, and we as a race don’t believe in wastage. That’s exactly what AceMask is good for!

MYTH-BUSTING

(Source: https://imgur.com/gallery/noPpu/comment/335506533)

https://www.nanoscience.com/products/scanning-elec-tron-microscopes/testimonials/nonwoven-textiles/)

You need the protection of Melt blown fabric to stop the virus molecules from reaching you.

This is how a melt blown fabric looks like to the coronavirus. This image is taken at 10 times more magnification than the last image:

Page 4: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

HOW OFTEN DO I NEED TO REPLACE THE ACEMASK FILTER CARTRIDGE?

Long story short - Six filters per month.

Mark one filter cartridge for each weekday. Reuse the filter marked for that weekday for the whole month, then discard the entire set.

For a detailed analysis, keep reading.

I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG?

Nothing, really. The melt blown fabric inside the blue filter car-tridge (MBL5PL95N) has sub-micron pores, and it requires some effort to pull air through this filter. Don’t worry, this very layer is protecting you from the harmful virus particles!

You also have the option of using our Anti-pollution yellow filter cartridge (PP3PL25G) with the AceMask. Since it does not include the Melt blown fabric layer, inhaling will be softer. Just don’t use it in risky zones or crowded places.

FREQUENTLY ASKED QUESTIONS CAN I WASH THE FILTER AND REUSE IT?

No.

The melt blown fabric layer, which protects us against the harmful virus, gets ineffective upon washing.

The best way to reuse the filter is, let it rest for 72 hours or more. The virus is effectively incapacitated in this duration, and you can reuse the filter up to 5 times this way.

I’M NOT COMFORTABLE WEARING ANY MASK. IS THERE A WAY OUT?

As the meme gentry says, “If you hate wearing a mask, you’re re-ally not going to like the ventilator.”

Page 5: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

STEP 1: REMOVE THE EXISTING FILTER

Bend the lower face of the mask, so that the filter comes out.

INSERT BOTTOM EDGE

Next, insert the bottom edge of the filter as shown. It is OK to bend the filter and mask if required.

CHANGING THE FILTER

STEP 2: PUT THE NEW FILTER

Sterilize your hands. Now open a new filter. Keep the filter towards the grill of the mask, and the curved edge of the filter towards the top.

ENSURE COMPLETE FITTING OF FILTER

Apply pressure on the sides & corners of the filter to ensure it fits properly. When properly inserted, the filter will be flush against the inner surface of the mask.

INSERT TOP EDGE

Proceed by inserting the top round edge of the filter inside the mask as shown.

Page 6: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

Remove the filter pad and use one of the following recommended procedures:

Method 1: In a medical setting, you can autoclave the mask as per standard procedures.

Method 2: Put the mask in boiling water for 2 minutes.

Method 3: Steam the mask for 10 minutes using a steamer, commonly used to sterilize feeding bottles.

Method 4: Wipe the mask thoroughly with a tissue dipped in sanitizer.

STERILIZING THE MASK

Page 7: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

Cost (INR) N95 Mask

Cost (INR) AceFilter

You save

First Purchase 4000 799 80%

One month usage cost as per CDC extended

use protocol10400 442 >99%

One month usage cost as per CDC Reuse

protocol2400 102 >95%

One month usage cost as per CDC Reprocess

protocol800 34 >95%

Spend only Rs 100 per month and get best recommended

safety!

The above calculations assume Rs 400 for an N95 mask and Rs 17 for an AceFilter cartridge. Disinfecting the AceMask is required daily.

SAVINGS WITH ACEFILTER CARTRIDGESSERVICE LIFE OF THE ACEFILTER

It is all too common to find friends using their same N95 mask over and over with or without washing. This is not only unsafe, but down-right risky due to the misplaced confidence.With regards to reuse of the mask, the CDC (Centre for desease Control and Prevention, USA) dictates the following three protocols:

EXTENDED USE PROTOCOLIt dictates discarding a mask after an 8 hours use.You will need 26 AceFilters a month if you follow this protocol.

REUSE PROTOCOLUse a separate mask for every weekday, reuse up to 5 times.Because the coronavirus loses its viability after 72 hours, the CDC endorses a set of 5 or more masks, to be used in rotation, allowing a mask to rest for at least 72 hours between consecutive usages.Additional precautions are -• The masks must be stored safely between usages• A mask must be re-used not more than 5 times• Proper donning/doffing procedures must be used• Masks must not be swapped among personsYou will need 6 AceFilters a month under this protocol.

REPROCESS PROTOCOLThis involves re-sanitizing the mask by washing, disinfecting or heat-ing the mask for up to 3 times.You need 2 AceFilters per month as per this protocol.

This table assumes the cost of Rs. 400 for the N95 Mask &

Rs. 17 for the AceFilter.

11 AceFilters included in the box.

Page 8: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

THE PROBLEM

When the COVID-19 pandemic started, the first and the most im-portant thing that we ran out with was - N95 Masks.

The masks were direly needed, but the supply was never enough. The companies which were making such, or equivalent masks, were overbooked for months. The frontline fighters were not hav-ing enough, what to say of the common man. Also, not to speak of the prices that the N95 masks have sold for. We set out to see if we can do something about it.

The root cause that we came to understand was the scarcity of “Melt Blown” fabric, and that the mask had to be disposed off after a few times.

Melt-blown fabric is THE key component of a high quality mask which can protect us against tiny viral particles, like the Coronavi-rus. Factories which make the melt-blown fabric are scarce, and it isn’t easy to set up new factories as fast as the demand of the masks has risen.

With the lock down lifting, and social life resuming, a shortage of good protective equipment can mean putting ourselves at risk. We are making do with what is available, but this isn’t medical-grade protection. The only reason we aren’t availing the best protection is, short supply of the right masks, their high prices, and risk of buying counterfeit products.

STORY OF AceMask THE SOLUTION

Prudence and re-use was what became our focus of work.

If melt-blown fabric is all that costly, why do we have to make an entire disposable mask out of that? Why can’t we just use a filter pad which needs only a small piece of this fabric, so we get best protection at a fraction of the cost. Also, we won’t have to discard the entire mask, but only the filter cartridge.

The concept of using filter cartridges was not new. But existing solutions were available for entirely different applications. Rowan University and USC in the US started work to 3D print such masks, but there are certain disadvantages, it is not possible to produce them in bulk, they are inherently prone to contamination, and hard in texture. The material used is also not necessarily fit for pro-longed human contact.

We set the bar high for ourselves. We used the best medical-grade flexible resin for the mask, adhered to strict specifications to manufacture the filter pad, and did several design iterations till we were fully satisfied with the product.

We are very happy to present the result to you! Proudly and confidently use this quality product, lovingly made for you by your fellow Indians.

Page 9: THE FM930 AceMask AceFilter MBF5PL95N · For a detailed analysis, keep reading. I NEED TO INHALE HARDER TO BREATHE THROUGH THE MASK. WHAT’S WRONG? ally not going to like the ventilator.”

   

                                         

This is computer generated report, hence does not require signature.

PVC COLOURING COMPOUNDING AND PROCESSING 64, GIDC Naroda, Phase-1, Opp. Citizen Industries, Ahmedabad-382330, Gujarat State, India. Phone: +91 7922812204, Fax: +91 7922822006, Email: [email protected]

This analysis report is issued by the Company subject to its Terms and Conditions. The information given herein is based on the present state of our knowledge. This report shall not be produced, except in full, without prior written consent of the Company. The test results presented in this report are related only to the object tested.

CERIFICATE OF ANALYSIS - MEDICAL COUMPOUND

Party Name: AHA 3D Innovations Material Name: PVC COMPOUND Type and Grade: OXYGEN MASK, MNH-75

CHARACTERISTICS TEST METHOD UNIT SPECIFICATION TEST VAUE

PHYSICAL PROPERTIES

Pellet Size(min) and Shape Visual - 2-4 mm 2-4 mm, cylindrical

Specific Gravity ASTM D792 - 1.21±0.02 1.20 Hardness ASTM D2240 Shore A 75 ±2 75

Color Appearance Visual - Blue Tint Blue Tint Surface Finish Visual - Smooth Smooth

MECHANICAL PROPERTIES BEFORE AGEING

Tensile Strength (Min) ASTM D638 N/mm2 - 14.8 Elongation at Break (Min) ASTM D638 % - 355PHYSICO CHEMICAL

PROPERTIES

Difference in pH - 1.5 (max) 0.5 mlNon Volatile Matter mg/L 50 mg/L (max) 4 mg/L Residue on Ignition % 0.1% (max) Complies Heavy Metal Ions ppm 1 ppm (max) Complies Buffer Capacity ml 10 ml (max) 0.9 ml

Oxidisable Substances ml 1.5 ml (max) 0.3 ml

PREPARED BY: LAB IN-CHARGE (QA)

Test Date: 20.5.20 Invoice No: 17/2020-21 Quantity: 50 Kgs Batch No: E2-118MY20D

As per ISO 3826/ IP-2018

Of Compliance

This is to Certify that the Technical Documentation of

AHA 3D INNOVATIONS PVT. LTD.OFFICE: 166, JANAKPURI, II IMLY PHATAK, JAIPUR – 302015, RAJASTHAN, INDIA

WORKS: I/F – 2, SOLITAIRE PARK II, AJMER ROAD, BARGU, JAIPUR – 303007, RAJASTHAN, INDIA

has been independently assessed and is compliant with the requirements of:

Directive 89/686/EEC (PPE)This certificate is applicable to the following products:

N 95 MASK, AIR FILTRATION MASK, 3/4 PLY SURGICAL MASK AND KN95 MASK INCLUDING BRAND NAMES FM930 MASK, FM930+ MASK,

MBL5PL95N CARTRIDGE, PP3PL25G CARTRIDGE AND PM3HEPA CARTRIDGE

Certificate No.: SPC20C4140 Date of Initial Registration: 30-05-20201st Surveillance audit on or before: 29-05-20212nd Surveillance audit on or before: 29-05-2022Date of Re-Certification: 30-05-2023

This certificate refers to the information examined and read with manufacturer’s declaration of conformity. Further, the product liability rests with the manufacturer or his representative in accordance with the councildirective 89/686/EEC to regulation (EU) 2016/425. The CE Mark as shown below can be used, under the responsibility of manufacturer, after completion of a CE Declaration of conformity and compliance with the

relevant CE Directives.

This is to Certify that the

Medical Device Quality Management System of

AHA 3D INNOVATIONS PVT. LTD.OFFICE: 166, JANAKPURI, II IMLY PHATAK, JAIPUR – 302015, RAJASTHAN, INDIA

WORKS: I/F – 2, SOLITAIRE PARK II, AJMER ROAD, BARGU, JAIPUR – 303007, RAJASTHAN, INDIA

has been independently assessed and is compliant with the requirements of:

ISO 13485:2016(Medical devices - Quality management systems - Requirements for regulatory purposes)

This certificate is applicable to the following scope of operations:

MANUFACTURER, EXPORTER AND SUPPLIER OF N 95 MASK, AIR

FILTRATION MASK, 3/4 PLY SURGICAL MASK AND KN95 MASK INCLUDING BRAND NAMES FM930 MASK, FM930+ MASK, MBL5PL95N

CARTRIDGE, PP3PL25G CARTRIDGE AND PM3HEPA CARTRIDGE

Certificate No.: SPC20M4139 Date of Initial Registration: 30-05-20201st Surveillance audit on or before: 29-05-20212nd Surveillance audit on or before: 29-05-2022Date of Re-Certification: 30-05-2023

IISSOO 13485