Surface Cleaning; Surface Disinfection; Acoustic Energy; Electromagnetic Compatibility (Emc) - INTERSON ViewBladder 10 User Manual

Y
WARNING
Disinfect probes using only liquid solutions. Using autoclave, gas (EtO), or other non-Interson-
approved methods will damage the probe and void the warranty.
1. Mix the disinfection solution compatible with the probe according to label instructions for
solution strength. A disinfectant qualified by the FDA 510(k) process is recommended.
2. Immerse the probe into the disinfection solution per the manufacturer's recommendations
of duration.
3. Follow the instructions on the disinfection label for the duration of probe immersion.
4. Using the instructions on the disinfectant or sterilization label, rinse the probe up to the
point of immersion, and then air dry or towel dry with a clean cloth.
5. Examine the probe for damage such as cracks, splitting, fluid leaks, or sharp edges or
projections. If damage is evident, discontinue use of the probe and contact a customer
service representative.
3.6.

Surface Cleaning

The tablet surface can be easily cleaned using a microfiber towel or other soft wipe. If needed,
rubbing alcohol or another mild cleaner can be used, however never apply cleaner directly to the
tablet surface. Dampen the microfiber towel with the cleaner. Do not saturate the towel.
3.7.

Surface Disinfection

The tablet surface can be disinfected using the cleaners identified in 3.5.1.2 Probe Disinfecting.
Do NOT immerse the tablet and never spray the disinfectant directly on the tablet surface. Spray
a conservative amount onto a towel, being careful not to saturate the towel.
3.8.

Acoustic Energy

The effects of acoustic energy on human tissue have been widely reviewed and are still under
investigation. Therefore, it is recommended that diagnostic ultrasound output power be set to the
lowest possible levels in accordance with the principle of ALARA (As Low As Reasonably
Achievable). See section 6 of this manual for Acoustic measurements.
3.9. Electromagnetic Compa tibility (EMC)
The Interson GP, EC & SP family of USB powered ultrasound probes have completed and
passed EN 60601-1-2: 2007 standard.

3.10. Prescription Device Statement

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CAUTION
US Federal law restricts this device to sale by or on the order of a physician.

3.11. Training

This ViewBladder 10 system is intended to be used by trained medical professionals only. The
system's functions are described in this manual and are also available through the ViewBladder
10 system software Help Menu.
01-9932-00 ViewBladder 10 User Guide Revision 2 5