PadScan HD 2
Caresono Technology Co., Ltd
2
Urine volume setting and alarm setting
Multi-language selection
Injection olded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
Power supply with built-in battery.
1.2 Intended use & Indicatioins for use
Intended use:
The Bladder Scanner(model: PadScan HD2) projects ultrasound energy through the lower
abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume
noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by qualified medical
professionals.
Indicatioins for use:
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended
as a handheld battery-operated device. The PadScan HD2 Bladder Scanner projects ultrasound energy
through the lower abdomen of the patient to obtain images of the bladder which is used to calculate
bladder Volume noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by
qualified medical professionals.
1.3 ALARA
Users can not adjust the acoustic output energy of the PadScan HD2 Bladder Scanner. And the
output level is below than the levels which were referred in AIUM remarks in 1992 and there were no
reported biological effects under the level. However, to minimize exposure, measurements should be
kept as short as possible. Refer to the acoustic output section for more information.
1.4 Standards
This device is designed and manufactured in strict accordance with:
● AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And
A2:2010/(R)2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And
Essential Performance
