General Information; Indications For Use; Contraindications; Prescription Statement - Mcube CUBEscan BioCon-500 User Manual

2

GENERAL INFORMATION

2.1

Indications for Use

The BioCon-500
TM
500 is intended as a portable battery-operated device. The BioCon-500
projects ultrasonic energy through the abdomen of the patient obtaining images
of the bladder in order to calculate the urine volume non-invasively. The
TM
BioCon-500
Contraindications for the BioCon-500
patients.
2.2

Contraindications

Do not use the BioCon-500
a) Fetal use or pregnant patients.
b) Patients with ascites.
c) Patients with open or damaged skin.
d) Wounds in the suprapubic region.
2.3

Prescription Statement

Caution: Federal Law restricts this device to sale by or on the order of a
physician.
TM
is a B-mode pulsed-echo ultrasound device. The BioCon-
is intended to be used only by qualified medical professionals.
TM
on following cases:
TM
are fetal use and use on pregnant
2
TM