Labels On The Device; Intended Use; User Qualifications/Safety - Civco Astra VR Manuel D'utilisation

ASTRA® VR Operator's Manual
F. LABELS ON THE DEVICE
G. INTENDED USE
The ASTRA VR automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or
endorectal ultrasound probes using FDA cleared and CIVCO Medical Solutions approved high-level liquid
disinfectants.
H. USER QUALIFICATIONS/SAFETY
The ASTRA VR Endovaginal/Endorectal Probe Reprocessor is intended for use in non-sterile healthcare settings by
trained, qualified healthcare personnel.
The operator of this equipment must be sufficiently trained in the use of this device and reprocessing of ultrasound
probes. The healthcare facility should ensure regular training of all personnel concerned with the operation and
maintenance of the equipment, including emergency procedures for any toxic, flammable, explosive or pathogenic
material released into the environment. Records of attendance at training must be maintained, and evidence of
understanding demonstrated. Thoroughly review and understand the following items prior to using this device:
CAUTION:
CAUTION:
M0066_J
Ensure proper use of Personal Protective Equipment to minimize exposure to
chemicals and infectious materials as defined by HLD manufacturer and facility
procedures.
Operators who exhibit symptoms of an allergic reaction or sensitivity to the
reprocessing chemicals should not operate this equipment. Before handling the
high-level disinfectant solution, carefully read the manufacturer's instructions
for use and the safety data sheet (SDS).
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