Warnings and Precautions
Warnings:
- Federal law (USA) restricts this device to
sale by or on the order of a physician.
- Federal law prohibits use of this product
in a manner inconsistent with its labeling.
- Danger: Keep out of reach of children.
- Danger: Corrosive. Harmful if swallowed.
May cause eye or skin irritation. Do not get in eyes, on skin
or on clothing. Wear safety glasses and rubber gloves when handling.
Wash with soap and water after exposure. If exposed to concentrations
greater then 3.5%, remove clothing and launder before wearing
again.
- In case of contact, immediately flush skin
or eyes with large amounts of water. For eye contact prompt medical
attention is necessary.
- If swallowed, drink water immediately. Possible
muscosal damage may contraindicate the use of gastric lavage.
- If spilled, flush affected area with large
quantities of water.
- For chemical emergencies, call CHEMTREC at
1-800-424-9300.
- Avoid contact between Peracidin concentrate
or solution and combustible materials.
- Peracidin undergoes rapid decomposition if
allowed to contact metal, dust or organic materials, or if it
is diluted with water failing to meet the Association for the
Advancement of Medical Instrumentation (AAMI) Standards for Hemodialysis
Systems (May 14, 1982).
- All diluted Peracidin should be used within
seven days.
Precautions:
- All users should be adequately trained in
the decontamination and disinfection of medical devices and the
handling of toxic substances such as liquid chemical germicides.
All personnel must be thoroughly familiar with the cautions and
"Instructions for Use" of Peracidin before use.
- To avoid contact with skin and eyes, wear
gloves, eye covering and other appropriate protective equipment
or clothing.
- A hollow fiber dialyzer that is cleaned,
reprocessed and disinfected with this chemical is filled with
a solution of Peracidin (hydrogen peroxide and peracetic acid).
The Peracidin solution must be thoroughly rinsed from the dialyzer
prior to clinical use.
- To optimize the effective reprocessing of
dialyzers, use of Peracidin must be part of a reprocessing procedure
validated by the manufacturer of the dialyzer reprocessing system
for use with peracetic acid. Since Peracidin is formulated to
be used only for dialyzer reprocessing, the user should follow
the dilution instructions recommended by the system manufacturer
for the use of peracetic acid concentrates intended for dialyzer
reprocessing.
- Any modifications of the "Instructions for
Use" will affect the safety and effectiveness of Peracidin. It
is the user's responsibility to validate any deviations from the
"Instructions for Use."
- Always store Peracidin in the original shipping
container and shipping box. Never tamper with the vent cap.
- Do not store in direct sunlight. Peracidin
is provided in a translucent container in a shipping carton. Since
Peracidin is light-sensitive, the user must not remove the container
from the shipping carton except during dilution prior to use.
The container should be replaced in the shipping carton following
dilution.
- Maintain storage temperature at or below
86 o F (30o C).
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