TopBioShield The Israeli Mask Biological Personal Protective Device
- 250.00 Grams
- Calculated at Checkout
The TopBioShield masks line should only be applied by trained medical personnel, first responders, rescue teams, police, and military forces!
- Reusable for single user.
- Providing >99% filtration of both solid and aerosolized biological agents.
- The TopBioShield mask line is P2 ﬁltration respiratory protection masks, built for long-term use In environments containing high concentrations of particles. It is speciﬁcally designed to protect users against airborne biological agents.
- The mask's construction incorporates several features meant to provide maximum protection and ease of use. Its ﬁlters are ﬁtted ﬂat with electrostatically charged capture media layers, providing >99% ﬁltration of both solid and aerosolized biological agents.
- The rubber hood covers the entire head and seals around the upper neck, providing crucial protection against contaminants that can enter through both the airways and eyes.
- The mask's inward leakage rating far surpasses that of N95 masks.
- Made in Israel.
On average, only 1% of breathed contaminants bypass the ﬁltration system of The TopBioShield (inward leakage rate) an order of magnitude in comparison with the allowed maximum of 10% with the N95 respirator. The neck-seal design also makes it usable for people with facial hair, and it can be used even while wearing glasses with the TopBioShield Superior model. The respiration device allows comfortable breathing and prevents a build-up of CO2 and humidity within the mask. Maximal wideﬁeld, clear visibility is ensured by a transparent visor specially treated against fogging. The TopBioShield line allows for easy breathing with clear vision facilitating comfortable performance of even precise activities with safer ﬁltered air.
Instructions for Use of the TopBioShild Personal Mask:
The main port of penetration of the coronaviruses and other respiratory infective contaminations to the human body is through the upper airways and exposed mucosa. The TopBioShield personal protective mask can provide a whole face, eyes, nose, and mouth, all-in-one effective protection. All users must read and understand the TopBioShield Instructions for Use, including indications, contraindications, operating instructions, warnings, and precautions before using the mask. Failure to do so may result in a malfunction, injury or death.
- The TopBioShield mask provides an all-in-one solution. Its neck- seal design covers the entire head, protecting the eyes and all respiratory paths. It has a wide- angle condensation-resistant visor and flat filters that reduce particle penetration by 99%.
- The TopBioShield mask is intended to reduce the risk of exposure to infective particles during short-term exposure.
- The TopBioShield masks line should only be applied by trained medical personnel, first responders, rescue teams, police, and military forces.
- To be used only by trained personnel in good physical and medical condition and operated in a comfortable environment.
- Working with the hood in conditions of excessive physical strain, stress, heat, dust or inconvenient atmosphere might cause heatstroke and severe breathing and cardiovascular disturbances. In case of feeling shortness of breath, unease, or discomfort, seek safe shelter and remove the mask.
- The TopBioShield masks line Should not be used under the age of 16.
- Suffocation hazard! Do not nap or sleep while wearing the mask!
- Clearly tag any new mask with your name or identifier to make it strictly personal.
- The TopBioShield is a non-sterile device. The mask can be reused by a single user only or disposed of after use according to biohazard protocols and in accordance with institutional procedures and local, state, and environmental regulations.
- For reuse of the mask carefully follow the reuse of mask instructions.
- Users with long hair should contain their hair with a surgical head-cover before applying the mask.
- The TopBioShield is contraindicated in potential users known to suffer from chronic or acute respiratory diseases and/or claustrophobia.
- The mask does not provide patient protection.
- It is recommended to use the mask with assistant’s support, for safety and better management of complex situations
- The current models of the TopBioShield mask may not fit certain head sizes.
- Potential users should test if the mask fits them and train its use prior to its clinical application.
Reuse Mask Instructions
- Following exposure to suspected COVID-19 infective materials during crisis situation.
- Always consult your infectious disease advisor for the proper method and effectivity of your protection, handling and the disinfection process of the mask, related to specific or suspected infectious materials that will be encountered.
- The TopBioShield personal mask can only be reused by meticulously adhering to biohazard handling protocols of your local institution and infectious disease advisors.
- The filter and the rest of the TopBioShield mask components were tested to substantially retain their initial properties (above N95) flowing decontamination by vaporous hydrogen peroxide (VHP) for limited repeated cycles. Initial results demonstrated that decontamination of the filter by ethylene oxide (ETO) did not substantially alter the filter's filtration performance.
- The filter was found to substantially retain its initial properties following a single wipe and with 30 repeated cycles by Mediwipe specific disinfectant composition.
- Gently wipe the filter area once with the designated wipe and thoroughly disinfect.
- Wait at least 10 minutes before reuse the rest of the entire mask surface.
Health care providers should take the following precautionary measures prior to using the decontaminated mask:
- Clean hands with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the mask.
- Avoid touching the inside of the mask.
- Use a pair of clean (non-sterile) gloves when handling and putting on the mask.
- Visually inspect the mask to determine if its integrity has been compromised.
- Check that components such as the inner mouth nose unit, visor, and covering rubber did not degrade, which can affect the quality of the fit, and seal.
- If the integrity of any part of the mask is compromised, or if a successful user neck seal check cannot be performed, discard the mask.
- Users should perform a neck seal check immediately after they get into the mask and should not use a mask with a loose neck seal check.
- For cleansing of the TopBioShield personal mask use wipes designed to clean medical instruments and other surfaces for the deactivation of human viruses. Wipes composition of Ethanol + isopropyl alcohol 70% v/v, chlorhexidine digluconate 0.5%,נ hydrogen peroxide 0.45%, water or equivalent are recommended.
- After the use and removal of the mask following exposure to bio-infective materials, properly remove and discard contaminated protective garments and gloves according to local biohazard materials management protocols and carefully wash disinfect your hands.
- During this COVID-19 crisis situation IVT Medical is researching details of decontamination conditions for the TopBioShield mask. We will constantly update these conditions on our website. Also, please refer to other sources of information as in: https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html