Dräger Bitrex - User Manual

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Bitrex

Qualitative Fit Test Kit

Instructions for use

Instructions for use | Bitrex® Qualitative Fit Test Kit

9300883 (A4-P) Page 1/2

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Bitrex

Qualitative Fit Test Kit

1 Safety-related information

– Observe the instructions for use.

– Fit tests may only be carried out by appropriately trained persons.

– Persons wearing a tight fitting respiratory protecting device must

perform a fit test prior to using the respiratory protecting device for

the first time.

– Before using any other facepiece (size, type, model, material or

make) a fit test must be performed again.

– National or regional regulations may require periodic repeat fit

testing. Dräger recommends carrying out at least one annual check.

– Dräger recommends repeating the fit test if a change occurs in an

individual that may affect the quality of the seal (e.g., significant

weight change, scars, facial surgery, dental changes).

2 Scope of supply

– Test hood

– Nebulizer #1 (sensitivity test)

– Nebulizer #2 (fit test)

– Sensitivity solution

– Fit test solution

– Two sets of replacement nebulizer inserts

3 Description

3.1 Intended use

The Bitrex

Qualitative Fit Test Kit can be used to perform qualitative fit

test procedures.

3.2 Approvals

The Bitrex

Qualitative Fit Test Kit meets the performance criteria for fit

testing half mask respiratory protecting devices under current OSHA

standards and DIN ISO 16795-3.

4 Use

4.1 Prerequisites for use

– Test subjects shall have medical clearance before starting the fit

test procedure.

– The test subject should not eat, drink, or chew gum for at least 15

minutes before the test.

4.2 Preparation for use

1. Connect snaps at the top of the hood.

2. Pour a small amount - approximately 1 teaspoon full - of the

sensitivity solution into the nebulizer labeled “No. 1 - Sensitivity Test

Solution”.

3. Pour the same amount of fit test solution into the second nebulizer

labeled “No. 2 - Fit Test Solution”.

4.3 Sensitivity test

This test is conducted to assure that the test subject being fit tested can

detect the taste of the Bitrex

solution at very low levels. The sensitivity

solution is a diluted mixture of fit test solution.

1. Explain the fit test procedures to the test subject.

2. Have the test subject don the hood without a respiratory protective

device.

3. Position the hood forward so there is about six inches between the

test subject’s face and the window. This is especially important for

the fit test — it helps to ensure even dispersion of the aerosol and

allows free movement of the test subject’s head while wearing a

respiratory protecting device.

4. Instruct the test subject to breath through their mouth.

5. Using the sensitivity test solution nebulizer #1, inject the aerosol

into the hood through the hole in the window. Inject ten squeezes of

the bulb, fully collapsing and allowing the bulb to expand fully on

each squeeze.

6. Ask the test subject if he/she can detect the bitter taste of the

solution. If tasted note the number of squeezes and proceed to the

fit test.

7. If the test subject does not taste the sensitivity solution, inject an

additional 10 full squeezes of the aerosol into the hood. Repeat with

10 more squeezes of the aerosol into the hood if still not tasted.

8. If 30 squeezes were inadequate to produce a response from the

test subject, the test should be ended and another type of fit test

must be used.

9. Remove the hood and give the test subject a few minutes to clear

the taste from his/her mouth.

4.4 Fit test

1. Have the test subject don and fit check the respiratory protective

device per the instructions provided with the respiratory protective

device.

The fit test is to be performed with the test subject using a

dust/mist respiratory protective device or prefilter.

2. Have the test subject don and position the hood as before, and to

breath through their mouth.

3. Using the fit test nebulizer #2, inject the fit test aerosol through the

hole in the hood using the same number of full bulb squeezes as

required in the sensitivity test, ie., 10, 20, or 30 squeezes.

4. To maintain an adequate concentration of aerosol during this test,

inject one-half of the number of squeezes used in Step #3 above,

every 30 seconds.

5. Instruct the test subject to indicate if he/she detects the bitter taste

of Bitrex

at any time during the test.

6. After the initial aerosol is injected, instruct the test subject to

perform the following exercises for 60 seconds each.*

57449

Regulation Exercise

OSHA DIN ISO

16975

x x Normal breathing

x x Deep breathing - breaths should be deep and regu-

lar.

x - Turning head from side to side - movement should

be complete with one turn every second.

- x Turning head from side to side while standing. The

head shall be turned as far as possible. The head

shall rest on every turning point so that the test

subject can breath in.

x - Nodding head up and down - movement should be

complete and made about once per second.

- x Nodding head up and down while standing. The

head shall rest on every turning point so that the

test subject can breath in.

x x Talking, reciting the alphabet, counting backward

from 100 or reciting a memorized poem or song.

Need help?

Do you have a question about the Dräger Bitrex and is the answer not in the manual?

The Bitrex® Qualitative Fit Test Kit is a device designed for qualitative fit testing of respiratory protective devices, ensuring compliance with current OSHA standards and DIN ISO 16795-3. This kit is crucial for verifying that a respirator provides an adequate seal to protect the wearer from airborne hazards.

Function Description

The primary function of the Bitrex® Qualitative Fit Test Kit is to assess the fit of a respirator on an individual. It utilizes a bitter-tasting aerosol, Bitrex®, to determine if there are any leaks in the respirator's seal. If the wearer can taste the bitter substance while wearing the respirator, it indicates a poor fit, and adjustments or a different respirator are necessary. The test is qualitative, meaning it provides a pass/fail result rather than a numerical measurement of fit.

The kit includes components for both sensitivity testing and fit testing. Sensitivity testing is performed first to ensure the individual can detect the bitter taste of Bitrex® at very low levels. This step is crucial because if the individual cannot taste the Bitrex®, the fit test itself would be invalid. Once sensitivity is confirmed, the actual fit test is conducted to check the respirator's seal.

Important Technical Specifications

The kit is designed to meet specific regulatory standards, including OSHA 29 CFR 1910.134 and DIN ISO 16795-3. These standards dictate the procedures and requirements for qualitative fit testing.

Key components of the kit include:

Sensitivity solution (No. 1 - Sensitivity Test Solution): Used to determine the individual's ability to taste Bitrex®.
Fit test solution (No. 2 - Fit Test Solution): Used during the actual fit test to check the respirator's seal.
Nebulizers: Devices used to generate the Bitrex® aerosol. The kit typically includes two nebulizers: one for sensitivity testing and one for the fit test.
Test hood: A hood that encloses the wearer's head and the nebulizer during the test, creating a controlled environment for the aerosol.
Two sets of replacement nebulizer inserts: For maintenance and continued use of the nebulizers.

The solutions are prepared by mixing a small amount (approximately 1 teaspoon full) of the sensitivity solution into the nebulizer labeled "No. 1 - Sensitivity Test Solution" and the same amount of fit test solution into the nebulizer labeled "No. 2 - Fit Test Solution."

Usage Features

The Bitrex® Qualitative Fit Test Kit is designed for straightforward use, following a structured procedure to ensure accurate results.

Safety-Related Information:

Observe instructions: Users must carefully read and follow all instructions provided in the manual.
Hair and facial features: Persons wearing a tight-fitting respiratory protective device must perform a fit test prior to using the respiratory protecting device for the first time. Facial hair, such as beards or sideburns, can interfere with the respirator's seal.
Medical evaluation: Before using any other facepiece (size, type, model, material) or before a fit test can be performed again, a medical evaluation must be completed.
Regular fit testing: Draeger recommends carrying out one annual fit test.
Re-testing: Draeger recommends repeating the fit test if a change occurs in an individual that could affect the fit of the device (e.g., significant weight change, scars, facial surgery, dental changes).

Scope of Supply: The kit includes:

Test hood
Nebulizer #1 (sensitivity test)
Nebulizer #2 (fit test)
Sensitivity solution
Fit test solution
Two sets of replacement nebulizer inserts

Preparation for Use:

Connect snaps at the top of the hood.
Pour a small amount (approximately 1 teaspoon full) of the sensitivity solution into the nebulizer labeled "No. 1 - Sensitivity Test Solution."
Pour the same amount of fit test solution into the nebulizer labeled "No. 2 - Fit Test Solution."

Sensitivity Test Procedure: The sensitivity test is crucial to ensure the test subject can detect the taste of the Bitrex® solution at very low levels. The sensitivity solution is a diluted mixture of fit test solution.

Explain the fit test procedures to the test subject.
Have the test subject don the hood without a respiratory protective device.
Position the hood forward so there is about six inches between the test subject's face and the window. It is especially important for the fit test to ensure even dispersion of the aerosol and allow free movement of the test subject's head while wearing a respiratory protecting device.
Instruct the test subject to breathe through their mouth.
Using the sensitivity test solution nebulizer #1, inject the aerosol into the hood through the hole in the window. Inject ten squeezes of the bulb with collapsing and allowing the bulb to expand fully on each squeeze.
Ask the test subject if he/she can detect the bitter taste of the solution. If tasted note the number of squeezes and proceed to the fit test.
If the test subject does not taste the sensitivity solution, inject an additional 10 full squeezes of the aerosol into the hood. Repeat with 10 more squeezes of the aerosol into the hood if still not tasted.
If 30 squeezes were inadequate to produce a response from the test subject, the test should be ended/aborted and type of fit test must be used.
Remove the hood and give the test subject a few minutes to clear the taste from his/her mouth.

Fit Test Procedure:

Have the test subject don and fit check the respiratory protective device per the instructions provided with the respiratory protective device.
- The fit test is to be performed with the test subject using a dust/mist respiratory protective device or prefilter.
Have the test subject don and position the hood as before, and to breathe through their mouth.
Using the fit test nebulizer #2, inject the fit test aerosol through the hole in the hood using the same number of full bulb squeezes as required for the sensitivity test, i.e., 10, 20, or 30 squeezes.
Maintain an adequate concentration of aerosol during this test, inject one-half of the number of squeezes used in Step #3 above, every 30 seconds.
Instruct the test subject to indicate if he/she detects the bitter taste of Bitrex® at any time during the test.
After the initial aerosol is injected, instruct the test subject to perform the following exercises for 60 seconds each:
- Normal breathing: Breathing deeply - breaths should be deep and regular.
- Turning head from side to side: Movement should be complete with one turn every second. Turning head from side to side with standing. The head shall rest and be turned as far as possible. The head shall rest at every turning point so that the test subject can breath in.
- Nodding head up and down: Movement should be complete and made about once per second. Nodding head up and down while standing. The head shall rest at every turning point so that the test subject can breathe in.
- Talking: Reciting the alphabet, counting backward from 100 or reciting a memorized poem or song.
- Bending over: The test subject shall bend forward, as if to touch their toes, and return into an erect position. This procedure shall be repeated for 60 seconds. If the test hood makes this exercise impossible, this exercise shall be replaced by running.
- Normal breathing:
If the entire test is completed without the test subject detecting the bitter taste of the Bitrex® solution, the test is successful and the respiratory protective device fit is deemed adequate.
If the test subject does detect the bitter taste of the Bitrex® aerosol, terminate the test, (this indicates an unsuccessful fit). Wait 15 minutes and perform the tests over, starting with the sensitivity test.

Certain OSHA standards require specific exercises in addition to the ones listed. Examples include:

Asbestos (CFR 1910.1001): Jog in place.
Benzene (CFR 1910.1028): Grimace, bend over or jog in place.
Formaldehyde (CFR 1910.1048): Grimace, bend over or jog in place. Individual standards should be referenced for other specific exercises required.

Maintenance Features

The kit is designed for easy maintenance to ensure its longevity and proper functioning.

Cleaning: Immediately after completing the test, pour the unused solutions back into the respective bottles.
Rinsing: Rinse the nebulizers with clean water to prevent clogging.
Drying: Wipe out the inside of the hood with a damp cloth or paper towel to remove any deposited test solution.