PRECAUTIONS AND WARNINGS
- VI -
When the battery is charged with AC power, it is prohibited to connect other devices onto the
same AC power socket.
Although the device complies with the requirements of electromagnetic immunity in IEC
60601-1-2, it should be kept away from strong interference sources, such as high-frequency
electric knife, magnetic resonance imaging equipment, microwave therapy instruments and
other RF treatment equipment.
According to FDA laws, the device is a prescription device and is to be used by or under the
supervision of a licensed physician.
The manufacturer reserves the rights to modify the device characteristics without previous
notice under FDA Laws and MDD (93/42/EEC).
Without written consent of the manufacturer, no individual or organization is allowed to copy,
modify or translate any part of the User Manual.
Do not scratch the surface of the probe cover.
Keep the original package properly. All detachable accessories should be put into the original
package before transportation.
For any question, please contact your local distributor.
Cautions
Federal (US) Law restricts this device to sale by or on the order of a physician.
How to prevent cross-infection:
Between uses on different patients, the probe cover must be cleaned to avoid cross-infection.
The manufacturer advocates a preventive action and a cleaning procedure in the Chapter 5
Cleaning and Disinfection.
Tissue exposure to ultrasound energy:
The device is designed for use in bladder scanning only.
The manufacturer is not aware of any reports of adverse effects from using bladder scan,
even at FDA pre-enactment levels; no other use is intended or implied.
For the acoustic output parameters, please refer to Annex B of the User Manual.
No control of ultrasound energy is available to the user other than the duration of exposure,
considering the current concern for possible unknown hazards, and despite the extremely low
output intensities used in this ultrasound system.
The manufacturer suggests that patient exposure time during measurement be minimized. In
other words, the principle of ALARA (As Low As Reasonably Achievable) should be
implemented to perform ultrasound procedure.
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