Probes - Intended Use, Contraindications And Patient Population; Autoclave Sterilization - GE Voluson Swift Instructions For Use Manual

Autoclave Sterilization

Note
Sterilizer
Preconditioning Pulses
Temperature (Minimum)
Exposure Time (Minimum)
Drying Time (Minimum)
Package Configuration
5.3 Probes
5.3.1 Intended use, contraindications and patient population
Intended use
Contraindications
Patient population
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4
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.
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
1. Place the cleaned and disinfected biopsy guide in an approved autoclave pouch.
2. Autoclave using the following parameters:
Parameter
Pre-vacuum
3
132 degrees C
3 Minutes
15 Minutes
Tyvek Pouch (14 x 25 cm)
Table 5-4 Autoclave paramters
Image Acquisition for diagnostic purposes including measurements on acquired image.
Extracting tissue samples with guided and freehand biopsy.
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
•
Age: all ages (incl. embryos and fetuses)
•
Location: worldwide
•
Sex: male and female
-6 or better.
Cycle Type 1
Probes and Biopsies
Cycle Type 2
Pre-vacuum
3
121 degrees C
20 Minutes
15 Minutes
Tyvek Pouch (14 x 25 cm)
5-17