Dorma 99 User manual

USER
INSTRUCTIONS
DORMA 99 RESPIRATOR

IMPORTANT
Before use, read these User Instructions. Keep these User Instructions
for reference.
WARNING
This respirator helps protect against certain particulate contaminants
but does not eliminate exposure to or the risk of contracting any disease
or infection. Misuse may result in sickness or death. For proper use, see
supervisor, or User Instructions.
IMPORTANT
Refer to the steps outlined below for instructions on how to properly
assemble, don, doff, clean, and reuse the Dorma 99 respirator ( 99M ) .
Keep these User Instructions for reference.
DESCRIPTION
The Dorma 99 respirator is designed to cover the nose and mouth of the
wearer in order to help provide respiratory protection for the wearer.
The respirator has at least 99 % filtration efficiency against particulate
aerosols free of oil (> 0.3 micron ) . + The Dorma 99 can be reprocessed for
reuse up to 30 times. ❖ *This product contains no components made
from natural rubber latex.
The Dorma 99 respirator is intended to be worn by healthcare
professionals to protect the wearer from transfer of microorganisms,
body fluids, and particulate material.
As a respirator, it is intended to reduce wearer exposure to certain
airborne particles. ⁺ For reuse in a healthcare setting, the device is
intended to be decontaminated using high - level decontamination
procedures, per the Spaulding scale. Complete cleaning ( see User
Instructions ) and high - level decontamination of the device using
hydrogen peroxide ( 30 %) for 30 seconds followed by a water rinse will
eliminate geobacillus stearothermophilus spores from the device
surface. ❖ The device is intended to be decontaminated ( per User
Instructions ) and reused up to 30 times.* The device must be discarded
after 30 uses.
+ Tested against 0.3 micron particle ( mass median aerodynamic
diameter ) per U.S. 42 CFR 84.
❖ Reuse tested with removal of geobacillus stearothermophilus spores
using 30 % hydrogen peroxide and a water rise.
*Tested for fit, Particulate Filtration Efficiency after 30 high - level
decontamination cycles. Sustained 99PFE standards at 30 high - level
decontamination cycles.
Dorma Filtration does not recommend this respirator for industrial use.
Not for use with beards or other facial hair that prevents direct contact
between the face and the sealing surface of the respirator. Does not
protect against gases or vapors. This respirator was not designed to be
used by children.
CONTRAINDICATIONS
INTENDED USE
WARNING: FAILURE TO PROPERLY USE AND MAINTAIN THIS
RESPIRATOR RENDERS THE RESPIRATOR INEFFECTIVE AND MAY
LEAD TO SICKNESS, INJURY AND/OR DEATH.

USE INSTRUCTIONS
1. Before occupational use of this respirator, a
written respiratory protection program must be
implemented meeting all the local government
requirements. In the United States, employers
must comply with OSHA 29 CFR 1910.134 which
includes medical evaluation, training, and fit
testing. Select and use respirator in accordance
with all applicable regulations, standards and
professional guidance. Fit testing must be
performed while the test subject is wearing any
applicable safety equipment that may be worn
during actual respirator use which could interfere
with respirator fit (e.g. eyewear, face shield). In
Canada, CSA standard Z94.4 requirements must
be met. Follow all applicable local regulations. This
respirator is designed for
occupational/professional use by adults who are
properly trained in its use and limitations. OSHA
and CSA accepted fit test protocols are
recommended for fit testing this respirator.
2. All components of filtering facepieces are to be
inspected prior to each use to assure that no
damage has occurred. Holes resulting in ripped or
torn filter or respirator material are considered
damage. If dirty, submit for cleaning and get a
replacement. If there is any damage, properly
dispose of the component and get a replacement.
3. Leave the contaminated area immediately and
contact your supervisor if dizziness, irritation or
other distress occurs.
4. The Dorma 99 respirator should be
decontaminated after every use or if
contaminated with blood or bodily fluids (up to 30
reuse cycles). Discard after 30 uses, if damaged, or
if breathing becomes difficult. Follow national,
provincial/state, local and facility infection control
guidance and policies.
DECONTAMINATE COMPONENTS BEFORE USE
DO NOT USE THE RESPIRATOR OR ANY
COMPONENTS IF THERE IS ANY VISIBLE
DAMAGE.
Note: Dorma Filtration recommends wearing a
face shield over the Dorma 99 Respirator to avoid
aesthetic damage (stains) from splash and spray of
bodily fluids.

ASSEMBLY INSTRUCTIONS
Find a clean disinfected environment to work in. Practice hand hygiene using hand
sanitizer or soap and water.
Don a pair of clean gloves and don a face mask for the assembly process.
Inspect the respirator body (including filter), clips and strap, to ensure nothing is
damaged or dirty, as above.
On the respirator body, identify the nose feature, this will indicate the top part of the
respirator (Fig. 1). Select a strap. With the printed lot number facing up, thread the
end of the strap under the upper left strap eyelet (Fig. 2) and then through the lower
left strap eyelet. Take the other end of the strap, check the strap is not twisted, and
thread through the upper right eyelet, then lower right strap eyelet (Fig. 3).
Thread the left strap through clip A (Fig. 4, 5) . Thread the right strap through clip B
(Fig. 4, 5).
Do a final inspection of the respirator with all components assembled to ensure
everything has been assembled properly.
Once final inspection is complete (Fig. 6), this respirator is ready to be used.
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Fig. 1 Fig. 2 Fig. 3
Fig. 4 Fig. 5 Fig. 6
A B

DONNING INSTRUCTIONS
MUST BE FOLLOWED EACH TIME THE RESPIRATOR IS WORN
Perform hand hygiene using hand
sanitizer or soap and water.
Inspect the assembled respirator prior
to use to assure there are no holes in
the breathing zone and no damage has
occurred. Discard and replace if
damaged.
Cup the respirator in your hand, with the
nosepiece at your fingertips, allowing
the head strap to hang freely below your
hand (Fig. 7).
With the nosepiece up, place the
respirator over your nose and mouth.
Pull the top strap over your head, resting
it high at the top back of your head (Fig.
8).
Adjust the strap length through the
eyelets so that the respirator
comfortably covers both your mouth
and nose (Fig. 9).
Fasten the clips behind your neck (Fig.
10) and pull the loose strap ends to
tighten to an appropriate tension (Fig.
11).
Perform a user seal check each time you
put on the respirator. Use one or both
hands to completely cover the respirator
filter (Fig. 12), and exhale. The respirator
should budge slightly. If air leaks at the
respirator edges, reposition the
respirator on face (Fig. 13) and/or
readjust tension of head strap to
eliminate the leakage. Once the seal
check is successful, the respirator is
ready for use (Fig. 14).
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ALWAYS PUT ON DECONTAMINATED RESPIRATOR WITH CLEAN HANDS
WARNING: If you CANNOT achieve proper seal, DO NOT USE
AND SEE YOUR SUPERVISOR.
Fig. 7 Fig. 8
Fig. 9 Fig. 10
Fig. 11 Fig. 12
Fig. 13 Fig. 14

Fig. 15 Fig. 16
Perform hand hygiene using hand sanitizer or soap and water.
Do not touch the front of the respirator (Fig. 15).
Undo the strap clip. Touching only the strap, grasp the top head strap and bring it
carefully over the head (Fig. 16). Pull the respirator away from the face without
touching the front of the respirator.
Submit the respirator for cleaning and disinfecting, per User Instructions.
Perform hand hygiene after removing the respirator and before putting it on again
when practicing reuse.
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EXERCISE HAND HYGIENE BEFORE AND AFTER HANDLING YOUR DORMA 99
RESPIRATOR
Use Limitations
DO NOT use the Dorma 99 respirator continuously for more than 8 hours. In heavily
contaminated or humid environments the respirator may reach its filtration load more
rapidly. The user must be aware of the respirator’s filter load throughout use. If
breathing becomes difficult, immediately leave the contaminated area and don a
new/clean Dorma 99 respirator.
REMOVAL INSTRUCTIONS

CLEANING INSTRUCTIONS
NOTE: Track decontamination cycles using the unique ID number on the respirator (9-digits,
starting with “S”).
Disassembly: Remove and separate strap and clips from the respirator body.
Inspection: inspect the respirator components per User Instructions to identify any damage or
excessive wear:
Gloves should be worn during cleaning as well as other personal protective equipment (PPE) as
indicated by internal protocols.
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2.
a. Damage to the surfaces of the elastomer, polymer, elastics, clips or filter (barb, curvature,
discoloration, etc.);
b. Cracks, cuts, lacerations or abrasions;
Discard damaged components or the entire respirator as necessary. CAUTION: Use of a damaged
respirator may result in sickness or death.
3. Pre-cleaning: Failure to remove foreign material can make the decontamination process
iiiiiiineffective.
a. Prepare a pH-neutral enzymatic cleaner (without Prolystica®) according to the manufacturer's
instructions.
b. Rinse the Dorma 99 respirator components thoroughly with purified/deionized water for 30
seconds.
c. Clean the internal/external surfaces and components of the Dorma 99 respirator (elastomer and
polymer parts) with a soft-bristled cleaning brush for a minimum of one (1) minute or until the
Dorma 99 respirator is visibly clean. DO NOT use abrasive cleaners or solvents.
d. Remove the Dorma 99 respirator and their components from the purified water.
e. Retirer l'APR Dorma 99 et ses composantes de l'eau purifiée.
f. Discard the rinse water.
4. High-level decontamination with 30% hydrogen peroxide:
a. Prepare a bowl containing a 30% hydrogen peroxide solution;
b. Immerse the Dorma 99 respirator and its components in the 30% hydrogen peroxide solution for
30 seconds, ensuring the device is completely submerged;
c. Remove the respirator and its components from the hydrogen peroxide solution;
d. Rinse the Dorma 99 respirator and its components with purified water for 30 seconds;
e. Wipe the Dorma 99 respirator and its components with a clean, dry towel;
5. Drying: Respirators may be slightly damp after reprocessing. Reprocessed respirators must not
iiiiibe used until dry.
a. Place the Dorma 99 respirator and its components in a medical dryer for 2 hours at 60 degrees
Celsius.
or
b. Place each respirator in an individual, clean, breathable receptacle to prevent cross
contamination. Air dry time will depend on room humidity and may take up to 48 hours.
6. Reassembly: Once dry, inspect and reassemble the respirator as described in User Instructions.
iiiiiiBetweeniuses, store dry Dorma 99 in a sealed 10”x10” sterilization bag.
IMPORTANT: To optimize the life of the Dorma 99 respirator, clean the Dorma 99 respirator
immediately after use: a maximum time frame of 4-6 hours is recommended. DO NOT allow organic
substances (blood, mucus, tissue, etc.) to dry on the Dorma 99 respirator or any of its components.

This respirator does not supply oxygen. DO NOT use in atmospheres containing less than 19.5%
oxygen.
Do not use in atmospheres immediately dangerous to life or health.
Do not exceed maximum use concentrations established by regulatory standards.
Failure to properly use and maintain this product could result in injury or death.
All approved respirators shall be selected, fitted, used and maintained in accordance with OHSA,
CSA and other applicable regulations.
Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration
as specified by the manufacturer.
Follow established replacement and decontamination schedules, as above. Follow User Instructions
for reprocessing and replacing the respirator.
Special or critical User Instructions and/or specific use limitations apply. Refer to User Instructions
before donning.
ALWAYS inspect the respirator and conduct a user seal check before use as specified in User
Instructions. If you cannot achieve a proper seal, DO NOT use the respirator.
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If the user has ANY reaction to any part of the respirator, discontinue use immediately. Refer to User
Instructions for information on use and maintenance of these respirators.
CAUTIONS AND LIMITATIONS
For more information: Visit www.dormafiltration.com or call [phone].
Dorma Filtration: 1055 Beaver Hall Hill, 400, Montreal, QC, H2Z 1S5.
Health Canada IO #315359
MADE IN CANADA
Device Storage & Lifecycle
Before use, store the Dorma 99 respirator in its original packaging, away from contaminated areas,
dust, sunlight, extreme temperatures, excessive moisture and damaging chemicals.
Between uses, store the Dorma 99 in a clean, dry environment, free from contaminated areas, dust,
sunlight, extreme temperatures, excessive moisture and damaging chemicals. Dorma Filtration
recommends storing the clean Dorma 99 respirator in a sealed 10”x10” sterilization bag between
uses. The Dorma 99 respirator and its components may be stored and reused according to the
facility’s infection control policy, up to 30 reuse cycles.
Discard the Dorma 99 after 30 reuse cycles, if damaged, or if breathing becomes difficult.
Discolouration can be an indication that respirator replacement is needed.
All Dorma 99 components may be recycled.