Warnings & 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).
It is important to read and understand all of these Instructions For Use prior to using Peracidin Dialyzer Reprocessing Concentrate.
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).
It is important to read and understand all of these Instructions For Use prior to using Peracidin Dialyzer Reprocessing Concentrate.
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