General Information; Product Description; Intended Use / Indications For Use; Patient/User Characteristics - Mcube CUBEscan BioCon-900S Operator's Manual

GENERAL INFORMATION

1

PRODUCT DESCRIPTION

1.1
CUBEScan TM BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The
device consists of a probe, CUBEScan Charger, and various components. The probe is a B-mode
instrument, hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross–
sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon
those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during
Pre-scan makes it easier to detect the bladder before scanning. The CUBEScan Charger is used for
recharge of the probe's internal battery.

INTENDED USE / INDICATIONS FOR USE

1.2
CUBEScan TM BioCon-900S is a B-mode pulsed-echo ultrasound device. The BioCon-900S projects
ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the
urine volume non-invasively. BioCon-900S is intended to be used by a qualified medical professional to
non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-900S are fetal
use and use on pregnant patients.

PATIENT/USER CHARACTERISTICS

1.3
PATIENT POPULATION
1.3.1
1) Male (All other patients)
2) Female patient
- A female who has not had a hysterectomy
- A female who has had a hysterectomy
3) Pediatric patient; A child with height less than 47 inches (120cm) and weight less than 55 lbs (25kg)
USERS
1.3.2
1) Physicians
2) Medical Professionals
MEDICAL CONDITIONS INCLUDING TARGET GROUP AND DISEAS
1.3.3
Bladder volume measurement system measures bladder volume, and it provides the accurate data to aid
in the diagnosis of common urological condition, to assess urinary retention, to help unnecessary
catheterization and to reduce rates of catheter-associated urinary tract infection.
The benefits are as below;
BioCon-900S assists to;
a. Assess urinary retention
b. Evaluate post-operative urinary retention (POUR)
c. Reduce unnecessary catheterization
d. Reduce catheter-associated urinary tract infections(CAUTIs)
e. Identify a blocked Foley catheter
f. Evaluate the need to catheterize after Foley catheter removal
g. Evaluate the need to catheterize during intermittent catheterization
h. Support to train urination and self-cathererization
i. Measure PVR (Post Void Residual)

PRESCRIPTION STATEMENT

1.4
Federal (United States) law restricts this system to sale by or on the order of a physician.

SERVICE

1.5
TM
CUBEScan BioCon-900S Operator's Manual
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