ORSAIR-N95-RV3 Medical Grade N95 Particulate Respirator

The ORSAIR N95 is a disposable particulate respirator that is designed to help provide reliable respiratory protection of at least 95 percent filtration efficiency against certain non oil based particles. This respirator can also help reduce inhalation exposures to certain airborne biological particles (examples: mold, Bacillus anthracis, Mycobacterium tuberculosis).

Soft inner material provides added comfort while the cup shape design makes the respirator spacious and durable. Braided headbands and an adjustable Metal nose clip helps provide a custom and secure seal. This respirator is ideally suited for work situations involving heat, humidity, or long periods of wear. The valve is designed to release hot, humid exhaled breath quickly, helping to prevent an unpleasant build up of heat inside the face piece a significant cause of discomfort to respirator wearers.

The ORSAIR N95 Reduces the risk to get infected. By filtering 95.99% of viruses (coronavirus), bacteria, dust, chemicals, particles, pollen, and smoke. N95 level Respiratory protection, filtering efficiency up to 95%, mesh breathable composite fabric, suitable for all seasons (basically no need to consider season changing factors). 3-dimensional Respirator mask with three-dimensional filter, tight fit, anti-pollen, anti-dust, anti-fog Mask. Our Respirator is made of non-woven composite fabric, moisture-proof, non-toxic, non-irritating.

GOST approved for at least 95 percent filtration efficiency against certain non-oil based particles, including Virus carriers.

Metal Shaped Nose clip adjusts easily for fewer pressure points and greater comfort.

Center welded Exhalation Valve recognized to reduce heat build-up inside the respirator

Braided elastic two-strap design, cross connected, with dual point attachment does provide a secure seal

Internal Nose Foam Band Protection

Use For Use for solid particulates and liquid mists in concentrations not exceeding 10X PEL/OEL Always follow User Instructions and use in manners as indicated.

> DO NOT use for gases and vapors, oil aerosols, asbestos, arsenic, cadmium, lead, 4,4-methylene dianiline (MDA), or abrasive blasting

DO NOT use for particulate concentrations exceeding 10X PEL/OEL

DO NOT use in any manner not indicated in the User Instructions

Key Features

GOST approved N95 rating, Adjustable nose clip. Nose foam, Ultrasonically welded headbands Material Composition Straps, Thermoplastic Elastomer, Nose Clip - Aluminum, Nose foam- Polyurethane, Filter - Polypropylene, Shell - Polyester, Coverweb - Polyester.

This respirator contains no components made from natural rubber latex.

Approximate weight of product: 0.35 oz. Time Use Limitation Replace the respirator when it becomes dirty, damaged, or difficult to breathe through. Shelf Life and Storage 5 years from the date of manufacture. Use By date on box in MM/YYYY format.

Store respirators in the original packaging, away from contaminated areas, dust, sunlight, extreme temperatures, excessive moisture, and damaging chemicals

Store in temperatures between -4°F (-20°C) and +86°F (+30°C) and not exceeding 80% RH

WARNING! This respirator helps reduce exposures to certain airborne contaminants. Before use, the wearer must read and understand the User Instructions provided as a part of the product packaging. Follow all local regulations. Disclaimer as per FDA:

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The N95 designation means that the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death. N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection.

And:

>ORSAIR-FFP2-S3P Medical Grade FFP2 Surgical Face Mask

A Fluid Resistant Surgical Mask, the ORSAIR-FFP2-S3P is a FFP2 level Mask, 3 ply, a disposable lightweight earloop Mask that is designed to help provide reliable Surgical Mask protection of at least 95 percent filtration efficiency against certain non oil based particles. Masks are designed to Protect the sterile field around the user.

This Surgical Mask can also help reduce inhalation exposures to certain airborne biological particles (examples: mold, Bacillus anthracis, Mycobacterium tuberculosis) and provides Surgical Mask typical protection.

>>Distributed by:

ORLANDO Systems Kft, 1119 Budapest, Hungary,

Cell: +36-20-932-2042, Email to: theo.orsys@gmail.com,

Web: www.orsair.com

Our ORSAIR PhoenixDX 2019-NCOV is a real-time RT-PCR-based detection system for the 2019 Wuhan coronavirus (2019-nCoV). 2019-nCoV is considered a novel human coronavirus that is genetically distinct from the common human coronaviruses (229E, NL63, OC43, HKU1), which cause seasonal acute respiratory illness. It is also genetically distinct from the two newer human coronaviruses, MERS-CoV and SARS-CoV.

Our Test Kit (50 tests) ORSAIR PhoenixDX 2019-NCOV detects the presence of 3 different and highly specific gene sequences of 2019-nCoV: E gene, N gene and RdRP gene. All 3 assays must be tested positive to confirm the sample as 2019-nCoV-positive.

Additionally, a non-infectious positive control and a negative human extraction control are included. The positive control is used to confirm functionality of the assays and overall PCR performance, the negative human extraction control is included to evaluate the quality of the RNA isolation independently from the 2019-nCoV assays.

The first step in the detection of 2019-nCoV is the conversion of viral RNA into cDNA. Afterwards, the target sequences unique for 2019-nCoV are specifically amplified with amplification monitored in real time through the use of fluorescently labelled probes: upon incorporation into the newly amplified DNA strands, the fluorophore (FAMTM) is released and an increase in fluorescence signal can be observed. Due to the intrinsic mutation rate of coronaviruses, it is possible that mutations in the target sequence occur and accumulate over time. This can lead to false-negative results with a PCR- based detection approach.

ORSAIR PhoenixDX 2019-NCOV addresses this issue by using 3 detection assays on 3 different target sequences to minimize the chance of false-negative results caused by an altered target sequence. If samples are tested negative in one or more assays, additional complementary testing may be required. The original target sequences for 2019-nCoV are included as a non-infectious target positive control (TPC) to check the integrity of the detection assays.

Samples tested positive should always be confirmed through complementary methods and additional analysis in an independent laboratory.

3.3) SPECIMENS - HANDLING AND STORAGE

Specimens can be stored at 4°C for up to 72 hours after collection.

If a delay in extraction is expected, store specimens at -70°C or lower. Extracted nucleic acids should be stored at -70°C or lower. Do not use specimens if: they were not kept at 2-4°C (≤ 4 days) or frozen at -70°C or below. they are insufficiently labelled or lack documentation. they are not suitable for this purpose (see above for suitable sample material). the specimen volume is insufficient.

3.4) SAMPLE PREPARATION / NUCLEIC ACID EXTRACTION

The performance of RT-PCR assays strongly depends on the amount and quality of sample template RNA. It is strongly recommended to qualify and validate RNA extraction procedures for recovery and purity before testing specimens.

Suitable nucleic acid extraction systems successfully used in combination with ORSAIR PhoenixDX DETECTION KITS include: bioMérieux NucliSens® systems, QIAamp® Viral RNA Mini Kit, QIAamp® MinElute Virus Spin Kit or RNeasy® Mini Kit (QIAGEN), EZ1 DSP Virus Kit (QIAGEN), Roche MagNA Pure Compact RNA Isolation Kit, Roche MagNA Pure Compact Nucleic Acid Isolation Kit, and Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit, and Invitrogen ChargeSwitch® Total RNA Cell Kit. Store and keep residual specimens and extracted nucleic acids at -70°C.

Only thaw the number of specimen extracts that will be tested in a single day. Do not freeze/thaw extracts more than once before testing as each freeze/thaw cycle will decrease the RNA quality. It may be possible to use patient samples directly, depending on the sample type. However, this may require a prior lysis step and titration of the amount on sample that can be used without inhibiting the reaction. This procedure has not been validated, use of isolated RNA is recommended.

Please email for more information and a ask QUOTE = always indicate if you are a End-User or not and WHICH MODEL of PCR are your using?

Mr.Theo BASCH, theo.orsys@gmail.com

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