Airlock389 AV100 Pro Anti-Viral Respirator Instruction Manual

Airlock389 AV100 Pro Anti-Viral Respirator Instruction Manual

USER INSTRUCTION MANUAL Read Before Use

The wearer must read and understand the following instructions prior to using the Airlock389 AV100 Pro Anti-Viral Respirator (BETA). Keep these instructions for reference.

PRECAUTIONS:

1. Failure to follow all instructions and limitations on the use of this respirator and/or failure to wear this respirator during all times of exposure can reduce respirator effectiveness and may result in sickness or death.
2. Failure to properly use and maintain this product could result in injury or death.
3. Do not alter, abuse, or misuse this respirator. Never substitute, modify, add, or omit parts. Use only exact original replacement parts from Airlock389 Inc. in the configuration as specified by the manufacturer.
4. Inspect respirator before each use to ensure that it is in good operating condition. Examine all the respirator parts for signs of damage including the silicone face seal, protective filter housing, head strap, and attachment points. Conduct a user seal check before each use as specified in the Fitting Instructions section. If you cannot achieve a proper seal, do not use the respirator.

Intended Use and Environment for Use:

The Airlock389 AV100 Pro Anti-Viral Respirator is an elastomeric half facepiece filtering respirator intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, pathogens, and particulates when used with the Airlock389 AV100PE Anti-Pathogen Purification Element that perpetually deactivates viruses and kills bacteria during both inhalation and exhalation.

Limitations of Use:

1. This respirator does not supply oxygen. Do not use in atmospheres containing less than 19.5% oxygen.
2. Do not use in atmospheres immediately dangerous to life or health. Do not use when concentrations of contaminants are immediately dangerous to life and health, are unknown or when concentrations exceed 10 times the permissible exposure limit (PEL) or according to specific OSHA standards or applicable government regulations, whichever is lower.
3. Respirators can help protect your lungs against certain airborne contaminants. They will not prevent entry through other routes such as the skin, which would require additional personal protective equipment (PPE).
4. This respirator is designed for occupational/professional use by adults who are properly trained in its use and limitations in workplace settings and for general use by public pursuant to these use instructions. This respirator is not designed to be used by small children.
5. Individuals with a compromised respiratory system, such as asthma or emphysema, should consult a physician and must complete a medical evaluation prior to use.

AV100 Anti-Viral Respirator Parts:

1. – Face Piece
2. – Protective Housing [Back]
3. – AV100 PE [Purification Element]
4. – Protective Housing [Cover]
5. /6- Sliding Latch Attachment Point
6. /8 – Latches/Buckles
7.  – Adjustable Head Strap

Donning Instructions:

1. Cup the respirator in your hand, with the tip of the respirator pointing upward.
2. Pull the straps over your head and slide them down to your nape.
3.  To position the respirator properly, tuck the bottom of the facepiece under your chin and move the tip of the mask towards the bridge of your nose.
4. While holding the respirator firmly to your face with one hand, use your free hand to pull the top strap, and let it rest above your ears. You may adjust the tightness of the straps by pulling on the strap near the locks. Make sure that it fits snugly but not too tightly.
   

Check the seating of the mask to ensure a tight fitting seal

Replacement and Cleaning Instructions for Airlock™AV100PE Purification

Element Filters:

1. (OPTIONAL – Proceed to Step 2 if you do not want to remove the strap assembly). Gently push down the center button of the Buckle (8) and detach it from the Latch (7). Do this for both left and right sides. This will remove the strap assembly from the mask.
   Figure 1: Detaching the strap assembly from the Latches.

2. Push up (towards the nose bridge) the Latch (7) to unlock the Cover (4) from the Sliding Latch Attachment point (6). Do this for both left and right sides. This will detach/remove the cover from the main mask and exposes the Purification Element (3).
   Figure 2: Detaching/Removing the Latches from the Sliding Latch attachment point.
   

3. Remove the AV100 PE to either clean or change with a new one.

4. After cleaning the AV100 PE, or changing it to a new one, place the PE to the inside of the Cover as in the figure below. Ensure that the sides are firmly resting on the inside of the Cover cavity.
   Figure 3: AV100 Purification Element nestled inside the Protective Housing (Cover)

5. Place the Cover with AV100 PE on top of the Face Piece (1). Ensure that the Left and Right Sliding Attachment Points are properly aligned. Check that no part of the AV100 PE is protruding on all sides.
   Figure 4: AV100 Purification Element and Cover resting on top of the Face Piece.

6. Lock the Cover to the Face Piece using the Left and Right Latches with the strap assembly. Do this on 1 side at a time. Follow the illustrations on the figure below. This process is the reverse of step #2
   Figure 5: AV100 Purification Element nestled inside the Protective Housing (Cover)

When to Change Airlock™AV100PE Purification Element Filters:

Particulate filter change schedules for AV100PE are determined by two main considerations: filter loading (clogging of the filter from captured particulates) and a facility’s infection control policy. If the AV100 respirator and AV100PE filter is being used to reduce exposure to airborne biological aerosols such as droplets containing viruses or bacteria, the filter will not typically load from these particles to the point that an increase in breathing resistance occurs. As a result, loading or clogging of AV100PE filters is typically not an issue when used to help reduce exposure to biological aerosols.

In healthcare facilities, AV100PE filter change schedules for airborne biological aerosols are primarily determined by the facility’s infection control policy. The infection control policy should be developed based on applicable national, state, and local guidelines. Most healthcare organizations develop their filter use and reuse policy based on the biological agent of concern, likelihood of the filter becoming contaminated, and potential for patient-to-patient and patient-to-worker cross- contamination.
While the outside mask body that encapsulates the AV100PE filters can be wiped down for cleaning, between patients, intermittently during extended use and/or daily, the AV100PE filter is continuously and perpetually self-

sterilizing. Cleaning the AV100PE filter daily using autoclave, isopropyl alcohol solution is sufficient.
Recommended disinfection methods for AV100PE Purification Filter:

• Autoclave
• Sodium hypochlorite solution (at a free chlorine concentration of 5,000 ppm) with 1-minute contact time
• 70% isopropanol solution with 1-minute contact time
• Hand wash with hot soapy water. Rinse thoroughly.
• Dishwasher. Do not place in dishwasher with any other material or objects

When changing the AV100PE filter, follow the hygiene and infection control practices established by your employer based on the specific contaminants to which the respirator assembly has been exposed and the cleaning agent used.
When it’s time to dispose of the filter according to your infection control policy and all applicable requirements, Airlock389 will accept used filters through our recycle program. Service Life and Cleaning Instructions for Airlock™ AV100 Anti-Viral Respirator
Service Life: Airlock™ AV100 Anti-Viral Respirator and headgear, when maintained and reprocessed per these instructions, are expected to stay in service for minimum of one year. Visual inspection of the components during reprocessing will identify any defects. If defects are identified dispose of and do not use. Airlock™ AV100 Purification Element when maintained and reprocessed per these instructions are expected to stay in service for minimum of 90 days and maximum of 120-180 days for optimum breathability. Visual inspection of the components during reprocessing will identify any defects. If defects are identified dispose of and do not use. Replacements may be ordered at www.airlock389.com

Cleaning and Disinfecting Airlock™ AV100 Anti-Viral Respirator:

1. Cleaning is recommended after each use. Nitrile or vinyl gloves should be worn during cleaning as well as other personal protective equipment (PPE) as indicated.
2. Remove filter if using an EPA Registered Disinfectant on mask.
3. Inspect the facepiece per these User Instructions to identify any damage or excessive wear. Replace components or the entire facepiece as necessary.
4. Clean the facepiece by immersing it in warm water not to exceed 120°F (49°C), and scrub with soft brush until clean. Add neutral detergent. Do not use cleaners containing lanolin or other oils. (NOTE: Solvents and strong detergents may damage AIRLOCK facepieces and should not be used for cleaning.)
5. Rinse thoroughly with fresh warm water.
6. Disinfect by soaking, wiping or spraying the facepiece according to these user instructions for the selected disinfectant, including usability, application and contact time.
7. Rinse, wipe, or spray the facepiece thoroughly with fresh warm water.
8. Air dry in a non-contaminated area.
9. Inspect and reassemble the respirator as described in the User Instructions.

Interim Wipe Cleaning of Airlock™ AV100 Anti-Viral Respirator:

Wipe cleaning of the facepiece can be considered as an interim cleaning method. This method is not to be the only method of cleaning. If gross contamination or facial oil is present, a cleaning step should be performed.

1. Follow these user instructions for the selected disinfectant, including usability, application and contact time. Wipe the interior and exterior of the facepiece including head harness.
2. Wipe all components with clean water to remove residual disinfectant.
3. Air dry or hand dry prior to next use in a non-contaminated area.
4. Inspect prior to use as described in these User Instructions.

NOTE: Failure to remove foreign material (soil, face oils, etc.) from an object can make the disinfecting process ineffective. Storage
Store the respirator away from contaminated areas when not in use.

Limited Product Warranty

AIRLOCK389, INC. (“AIRLOCK389”) warrants to the original purchaser that your respirator (the “Product”) shall be free from defects in materials and workmanship under normal use for a period of one (1) year from the date of purchase, except that if you reside in the European Economic Area (EEA) and you purchased your mask in the EEA, the warranty period is two (2) years from the date of purchase. (the “Warranty Period”). AIRLOCK389 does not warrant that the operation of the Product will be uninterrupted or error-free. AIRLOCK389 is not responsible for damage arising from failure to follow cleaning or operating instructions relating to the Product’s use.

Remedies

If a hardware defect arises and a valid claim is received by AIRLOCK389 within the Warranty Period, AIRLOCK389 will, at its option and to the extent permitted by law, either: (1) repair the Product at no charge, using new replacement parts; or (2) replace the Product with a new Product. In the event of a defect, to the extent permitted by law, these are your sole and exclusive remedies. Shipping and handling charges may apply except where prohibited by applicable law.

This Limited Warranty is valid only in the jurisdictions where the Products are sold by AIRLOCK389 itself or through its authorized reseller or agent and is valid to the extent permitted by applicable laws of such jurisdictions. Any replacement hardware product will be warranted for the remainder of the original Warranty Period or thirty (30) days, whichever is longer, or for any additional period of time that may be applicable in your jurisdiction.

How to Obtain Warranty Service

To obtain warranty service, you must deliver the Product, in either its original packaging or packaging providing an equal degree of protection, to the address specified by AIRLOCK389. In accordance with applicable law, AIRLOCK389 may require that you furnish proof of purchase details and/or comply with registration requirements before receiving warranty service. For specific instructions on how to obtain warranty service on your Product, contact us by visiting: airlock389.com/support.

Exclusions and Limitations

This Limited Warranty applies only to the Product manufactured by or for AIRLOCK389 that can be identified by the “AIRLOCK™” trade name, or logo affixed to it. The Limited Warranty does not apply to any: (a) AIRLOCK389 products and services other than the Product; or (b) non-AIRLOCK389 hardware products, even if packaged or sold with the Product or embedded in the Product. This warranty does not apply to a Product or part of the Product that has been altered or modified (e.g. to alter functionality or capability) by anyone who is not a representative of AIRLOCK389.

In addition, this Limited Warranty does not apply: (a) to damage caused by use with non-AIRLOCK389 products; (b) to damage caused by accident, abuse, misuse, flood, fire, earthquake, or other external causes; (c) to damage caused by operating the Product outside the permitted or intended uses described by AIRLOCK389; or (d) to damage caused by service (including upgrades and expansions) performed by anyone who is not a representative of AIRLOCK389.

No AIRLOCK389 reseller, agent, or employee is authorized to make any modification, extension, or addition to this Limited Warranty. If any term is held to be illegal or unenforceable, the legality or enforceability of the remaining terms shall not be affected or impaired.

Implied Warranties

EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, ALL IMPLIED WARRANTIES (INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE) SHALL BE LIMITED IN DURATION TO THE DURATION OF THIS LIMITED WARRANTY.

Some jurisdictions do not allow limitations on the duration of an implied warranty, so the above limitation may not apply to you.

Limitation of Damages

EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, AIRLOCK389 INC. SHALL NOT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, REVENUE, OR DATA, RESULTING FROM ANY BREACH OF EXPRESS OR IMPLIED WARRANTY OR CONDITION, OR UNDER ANY OTHER LEGAL THEORY, EVEN IF AV100 MASTER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Some jurisdictions do not allow the exclusion or limitation of special, indirect, incidental, or consequential damages, so the above limitation or exclusion may not apply to you.

Governing Law

This Limited Warranty shall be governed by the laws of the State of Delaware, United States, without giving effect to any conflict of laws principles that may provide the application of the law of another jurisdiction.

National Statutory Rights

Consumers in some jurisdictions may have legal rights under applicable national or local legislation governing the sale of consumer goods, including without limitation, national laws implementing EC Directive 99/44. These rights are not affected by the warranties in this Limited Warranty.

Inspect Before Each Use

This product must be inspected for use to ensure it has not been damaged in shipment. If damaged, do not use, and immediately return the product to AirLock389 Inc. for a replacement.

Entire Obligation

The PRODUCT LIABILITY DISCLAIMER document states the entire obligation of AirLock389 Inc. with respect to the products. If any part of this disclaimer is determined to be void, invalid, unenforceable or illegal, including, but not limited to the warranty disclaimers and liability disclaimers and liability limitations set forth above, then the invalid or unenforceable provision will be deemed superseded by a valid, enforceable provision that most closely matches the intent of the original provision and the remainder of the agreement shall remain in full force and effect.

Applicable Law

Your order from AirLock389 Inc., and this disclaimer statement are governed by the laws of the State of Delaware, USA. You hereby consent to the exclusive jurisdiction and venue of the United States District Court for the District of Delaware, in all disputes arising out of or relating to the use of this product. Use of this product is unauthorized in any jurisdiction that does not give effect to all provisions of these terms and conditions, including without limitation this paragraph.

Modification of Terms and Conditions

AirLock389 Inc. reserves the right to change the terms, conditions, and notices under which its products are offered.

Airlock389, Inc.

16192 Coastal Highway
Lewes, DE 19958 USA
For more information, visit: www.airlock389.comFor customer support, e-mail: support@airlock389.com

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