Important Notice - CareFusion Diamond-Flex Manual Del Usuario

Packaging
Devices can be loaded into dedicated packaging systems.
Sterilization wrap material must be cleared for the applicable
sterilization modality by your country's regulatory body. Use in
accordance with packaging manufacturer's sterilization
instructions being sure to protect jaws and cutting edges from
damage.
Sterilization
All devices must be processed in the completely open
configuration.
IMPORTANT NOTICE: Articulating retractors must only be
sterilized in the fully relaxed (straight) position. Before
sterilization, the 'protective/sterilization sleeve' must be
placed over the flexible, segmented portion of the device
shaft. Failure to follow these instructions may significantly
impair the life of the retractors.
All flush ports shall remain in the fully open position.
All devices shall be positioned to allow sterilant contact of all
surfaces.
All devices with concave surfaces shall be configured so that
water pooling does not occur.
Parameters for Steam Sterilization (Autoclave)
Prevacuum Sterilization Cycle
Preconditioning Pulses: 3
Exposure Temperature: 132°C (270°F)
Exposure Time: 4 Minutes
Dry Time: 30 Minutes
Sterilization Configuration: Cleared (i.e. FDA, etc.) Sterilization
Wrap (2 layer 1-ply or 1 layer 2-ply)
Sterilization for outside United States market
Prevacuum Steam Sterilization Parameters
Minimum Preconditioning Pulses: 3
Minimum Temperature: 132°C (270°F)
Minimum Exposure Time: 3 minutes
Minimum Dry Time: 30 minutes
Sterilization Configuration: Cleared Steriliztion Wrap
(2 layer 1-ply or 1 layer 2-ply)
Storage
Note: Always store and sterilize the retractor in its protective
sterilizing sleeve. Figure 3
After sterilization, devices must remain in sterilization
packaging and be stored in a clean, dry environment.
Operating Instructions
See Figures 1 and 2 for descriptions of the device components
Prior to insertion – Ensure actuating knob rotated fully counter-
clockwise to completely relax the segmented portion.
INSERTION
1. Insert through port.
a. Always keep the tip of the retractor in the field of the
laparoscopic vision. Figure 4
4