Материалы расходные к стерилизаторам STERRAD: адаптеры STERRAD:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Advanced Sterilization Products, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Advanced Sterilization Products

Дата Авторизация:

2022-04-01

Характеристики продукта

INSTRUCTIONS FOR USE
INDICATIONS FOR USE
The STERRAD Booster (REF 15400-020) is designed to deliver hydrogen
peroxide into the interior of a lumen when used with the STERRAD™
Sterilization System (STERRAD™ 100S). The STERRAD Booster is
inserted
into a STERRAD Adaptor. The STERRAD Adaptor, (REF 15401, 15402,
15403, & 15407) (Adaptors I, II, III, IV) are to be attached on
medical device
ports containing lumens. Please read these instructions carefully
before
proceeding.
WARNING
DO NOT ATTEMPT TO STERILIZE ITEMS OR MATERIALS THAT DO NOT
COMPLY WITH THESE INSTRUCTIONS. IN ADDITION, YOU SHOULD
READ THE MEDICAL DEVICE MANUFACTURER’S REPROCESSING
INSTRUCTIONS OR CALL YOUR ASP REPRESENTATIVE TO DETERMINE
WHETHER AN ITEM CAN BE STERILIZED BY THE STERILIZER.
There are three general steps to follow:
Step 1 –
Determine the dimensions (Inside Diameter and Total Channel Length)
of each lumen in your medical device using information from the
Medical Device Manufacturer. Note that “Working Length” is
typically
shorter than the “Total Lumen Length” for most medical devices.
Step 2 – Determine if a STERRAD
Booster Adaptor is required for processing
in the STERRAD
Sterilization System by referring to Section A. Note
that more than one STERRAD
Booster /Adaptor may be required
for some devices. A STERRAD
Booster/Adaptor is required for
each proximal port on the device if one of the lumens of the device
require a Booster/Adaptor.
Step 3 – If a device requires a STERRAD
Booster/Adaptor, follow steps
and illustrations in section B for selection and attachment of the
Booster/Adaptor.
Use Personal Protective Equipment (e.g. Chemical Resistant Gloves) at
all
times when handling.
WARNING
FAILING TO USE A STERRAD BOOSTER / ADAPTOR WHEN REQUIRED,
COULD RESULT IN A LUMEN WHICH IS NOT STERILE.
SECTION A:
Determine if lumen dimensions of the medical device being processed
need
a STERRAD
Booster/Adaptor for processing in the STERRAD
Sterilization
System. There are four different medical device lumen configurations
listed
in th