User's Manual

Document No.:
2 / 91
scanning surface of the bladder. The position of the bladder shall be found before
scanning (the operator does not need to have medical background, and moves the
probe according to the real-time projection position). Position before scanning.
During measurement, the instrument is non-invasive and comfortable to patients. It is
accurate, reliable, rapid and simple in operation. When the user releases the scan key,
within several seconds, it can get several 2D ultrasound images. It adopts complex
image processing technology to restore them to 3D images, and adopts complex
algorithm to calculate the bladder volume and display the results.
Two orthogonal images, patient information and volume value can be printed.
Adopt touch screen keyboard on tablet computer for operation.
Multi-language selection.
Volume preset alert
Bluetooth wireless print report
Information management, storage and printing
The instrument is composed of a handheld wireless scanning device with an injection
molding case and a tablet computer.
Adopt built-in battery for power supply.
1.2 Intended use
The 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 Bladder Scanner is
intended to be used only by qualified medical professionals.
1.3 Executive standards
The instrument shall be designed and manufactured strictly according to national
standards IEC/EN 60601-1 Medical Electrical Equipment Part 1: General Requirements for
Safety, IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements
for safety - Collateral standard Electromagnetic compatibility - Requirements and tests and
IEC/EN 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for