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AAMI Level 4 procedures

AAMI Level 4 Gown

Satisfies EN13795 High Performance.

Manufactured as per Association for the Advancement of Medical Instrumentation (AAMI) standards.

Armour

– 1SG116

“Complete protection, With the Level 4 Gown you get the Maximum Protection from Pathogens, Every Medical Procedures where incisions are made the Level 4 Gown comes as a prerequisite.”

Worn by health professionals during High critical medical procedures,High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne).

Non-Reinforced, for More Fluid Contact and Protection

Soft, Lightweight, Skin Friendly Materials used.

Made of SMS Non-Woven Fabric, Premium Quality Fabric used.

AAMI Level 4 Gown Polyfilm Reinforced

Satisfies EN13795 High Performance.

Manufactured as per Association for the Advancement of Medical Instrumentation (AAMI) standards.

PolyfilmArmour

– 1SG117

“The epitome of Safety, Polyfilm Reinforced Level 4 Gown is the Ultimate Armour For the Health Professional, as conducting the procedures in the O.T  for continuous hours is no less than fighting a war.”

Worn by health professionals during High critical medical procedures,High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne).

Critical Area Reinforced for High Fluid Contact and Protection.

Soft, Lightweight, Skin Friendly Materials used.

Made of SMS Non-Woven Fabric, Premium Quality Fabric used.




Critical Area in Gown


AAMI Level 4 procedures

AAMI Level 4 Gown Breathable

Satisfies EN13795 High Performance.

Manufactured as per Association for the Advancement of Medical Instrumentation (AAMI) standards.

Serene

– 1SG118

“SAFE AND BREATHABLE, effective air circulation becomes the need of the hour in those long surgeries. It’s crucial that the health professional remains comfortable throughout the procedure.”

Choose Aavvie® Healthwear™ Best in Class Breathable Level4 Gown, Complying with the AAMI Level 4 standards along with providing superior Comfort and Breathability.

Worn by health professionals during Long High critical medical procedures,High risk, to be used, for example, during long hour surgeries, in fluid intense procedures when pathogen resistance is needed or infectious diseases are suspected (non-airborne), Also where Sweat Evaporation is in demand.

High-Performance Microbial and Viral Barrier fabric used in Exposure Area, Breathable Fabric used at the back to ensure proper ventilation.

Soft, Lightweight, Breathable Materials used.

Made of Breathable Fabric, Premium Quality Fabric used.

Details
Product Measurement and Spec
Details

Aavvie® Healthwear™ products are tested for and meet the AAMI Level 4 standard, European Standard: EN13795 High Performance.
-Suggested guidelines are not a substitute for clinician professional judgment and experience.

AAMI levels determined by ANSI/AAMI PB70:2012

Adopted by the U.S. Food and Drug Administration (FDA)

Product Measurement and Spec

Size Chart

Size (In cm) Length Girth
Medium (M) 125 150
Large (L) 135 155
Extra Large (XL) 145 165
Extra Extra Large 155 165

Specs

Colour Blue | Yellow
Material SMS | SMMS | SSMMS | Breathable Fabric
Reinforced Fabric | Poly film

Testing in AAMI Level 4

AAMI has identified American Society for Testing and Materials (ASTM) International3 F1671 as the key test requirement that a surgical gown must pass in order to be labeled AAMI Level 4.

ASTM F 1671- Synthetic Blood Penetration Resistance Test

ASTM International F1671: is the Resistance of Materials Used in Protective Clothing to Penetration by Blood Borne Pathogens Test. This is a pass/fail test that an AAMI Level 4 surgical gown must pass. The test method has been specifically designed for modeling penetration of HBV, HCV and HIV. Because these organisms are difficult to use, the test uses a bacteriophage, Phi-X174. Phi-X174 is one of the smallest known viruses, and it is similar in size and shape to HCV, the smallest bloodborne viral pathogen.

How it works

A surgical gown’s material is subjected to a nutrient broth containingPhi-X174 for a specified time and pressure sequence:

  1. Five min. at atmospheric pressure
  2. One min. at two PSI (pounds per square inch)
  3. 54 min. at atmospheric pressure

The test is terminated if visible liquid penetration occurs before the end of 60 minutes. If no visible liquid penetration is seen, then a sensitive microbial assay is performed to determine pass or fail. Any evidence of viral penetration for a test specimen constitutes a failure. If a production lot of surgical gowns passes this test in all four surgical gown critical zones, it qualifies as an AAMI Level 4 surgical gown.

Testing in European Standards

EN13795- High-Performance

EN13795- High Performance/Critical Areas Tests

– Resistance to microbial Penetration – Dry, Wet
– Cleanliness – Microbial, Particulate Matter
– Linting
– Water Resistance Hydro head
– Resistance to Liquid Penetration
– Bursting Strength – Dry, Wet
– Tensile Strength –Dry, Wet
– Breathability

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