2.
Immerse the devices in the disinfectant solution and agitate to ensure all air bubbles are
removed from the surface of the device.
3.
Allow the devices to soak in the disinfectant solutions for least the minimum contact time
listed in the disinfectant manufacturer’s instructions for use.
4.
Thoroughly rinse the device by immersing in a large volume of critical (purified) water for
a minimum of 1 minute.
5.
Repeat Step 4 two additional times, for a total of 3 (three) rinses using fresh volumes of
water for each rinse.
6.
Thoroughly dry the biopsy guide using a sterile, lint-free wipe. Visually inspect the biopsy
guide to ensure all surfaces are clean and dry.
Autoclave Sterilization
Note
Sterilization efficacy testing was performed using worst-case parameters for time, temperature
and load density. Parameters listed in the tables are the minimum required to ensure a Sterility
Assurance Level (SAL) of 10
-6
or better.
1.
Place the cleaned and disinfected biopsy guide in an approved autoclave pouch.
2.
Autoclave using the following parameters:
Parameter
Cycle Type 1
Cycle Type 2
Sterilizer
Pre-vacuum
Pre-vacuum
Preconditioning Pulses
3
3
Temperature (Minimum)
132 degrees C
121 degrees C
Exposure Time (Minimum)
3 Minutes
20 Minutes
Drying Time (Minimum)
15 Minutes
15 Minutes
Package Configuration
Tyvek Pouch (14 x 25 cm)
Tyvek Pouch (14 x 25 cm)
Table 5-4 Autoclave paramters
5.3 Probes
5.3.1 Intended use, contraindications and patient population
Intended use
Image Acquisition for diagnostic purposes including measurements on acquired image.
Extracting tissue samples with guided and freehand biopsy.
Contraindications
Probes are not intended for:
•
ophthalmic use or any use causing the acoustic beam to pass through the eye
Abdominal and linear probes are not intended for:
•
endocavity use
Patient population
•
Age: all ages (incl. embryos and fetuses)
•
Location: worldwide
•
Sex: male and female
Probes and Biopsies
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4
5-17
Содержание Voluson Swift
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