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READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE
INTENDED USE/ INDICATIONS FOR USE
InstruSafe® XL Transport Containers are intended to contain and
protect reusable medical devices during transport from the operating
room to the sterile processing department.
The InstruSafe® XL Transport Containers are used to collect used
instruments and materials for transportation. The transport container
can be used in a washer-disinfector and withstands repeated washing.
INTENDED USER
The InstruSafe® XL Transport Containers are intended to be used by
healthcare professionals in the operating room and sterile processing
departments for transportation of medical devices.
MATERIAL
The container is reusable and made of high temperature plastic.
It is highly durable against heat and chemicals.
DESCRIPTION
The container consists of a lid and base, silicone gasket and latches.
The gasket and latches can be removed to help facilitate cleaning and
can be easily replaced. The container base holds the instruments and
materials for transportation.
LID REMOVAL
Release the (4) silicone latches and remove the lid.
CONTAINER USE
1. Set container on stable surface
2. Add cleaning solution per the manufacturer's IFU to the container
3. Place instruments / materials in container for transportation
4. Place lid on container and engage (4) Silicone latches
5. Transport container
6. * For IN-PIC-20-D: To attach hose, press drain insert into coupling
to open the valve
7. * For IN-PIC-20-D: To remove hose and close the valve, depress
button and remove drain insert from coupling
8. * For IN-PIC-20-D: Drain should be flushed with water and air to
remove any residue
9. Open lid slowly to remove instruments / materials
10. Process instruments / materials per the manufacturer's IFU
WARNINGS
1. DO NOT autoclave
2. DO NOT use as a sterile barrier
3. DO NOT drop as this may cause damage to the instruments /
materials inside or damage the container resulting in possible
leakage
4. DO NOT shake the container with liquids inside. This can cause
damage to the contents or container leakage
Life Cycle: DO NOT use if container is cracked,
broken or missing the silicone gasket or latches
5. Clean and inspect prior to use. Container may be reused until
mechanical failure occurs
6. Be cautious of pinch points while lid is being opened and closed
to avoid harm to fingers and hands
7. Be cautious of container weight with liquid added
8. DO NOT wash container with a hard brush. This can cause
damage to the container
9. DO NOT use if package is damaged or unintentionally opened
prior to use
10. Remove cover before automated washing
11. DO NOT stack if optional drain is installed
12. DO NOT stretch the silicone gasket
MANUAL CLEANING
1. Use a neutral (6.0 - 8.5) pH detergent
2. Remove all visible soil and contaminates using a soft brush
3. Immerge the container while cleaning to aid in the removal of
contaminates and reduce splashing of detergent on personnel
4. Rinse thoroughly with clean water to remove detergent
AUTOMATED WASHER CLEANING
1. Container is safe for use in automated washers and can withstand
up to 230°F
Gasket and latches can be replaced without the use of tools.
Gasket Replacement
1. DO NOT stretch the silicone gasket
2. To insert, align gasket and press down
Latch Replacement
1. Insert on top
2. Position latch
over groove
DISPOSAL
In the event the InstruSafe® XL Transport Containers do not pass
inspection prior to use or have otherwise been deemed no longer
fit for purpose, the devices shall be disposed of in line with local
protocol. The method of disposal shall depend on the potential risks
of cross-contamination and infection when the need for disposal is
identified.
SERIOUS INCIDENT REPORTING
Any serious incident that has occurred in relation to the device should
be reported to the manufacturer and the FDA/competent authority of
the Member State in which the user and/or patient is established.
4
3. Pull latch down into
the groove
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