CUBAClinical

Equipment Classification

The equipment (as defined by EN 60601-1, Medical Electrical Equipment - General Requirements for Safety) is Class 1, Type B, Not AP/APG.

Class 1 means that the equipment is protectively earthed. Type B means the equipment provides a particular degree of protection against electric shock (as defined within EN 60601-1). Not AP/APG means unsuitable for use in the presence of flammable gases.

Note that the type B symbol (IEC symbol 878-02-02) is marked on the rear panel of the unit, next to the mains inlet.

The unit can be used in Continuous Mode as defined by EN 60601-1, i.e. may be operated for an unlimited period.

Ultrasonic Transducers

Broadband, single element, flat (unfocused), immersion type transducers are used.

Ultrasound Output Characteristics

The center frequency is approximately 1.0 MHz. The ultrasound is pulsed, at a maximum pulse repetition rate of 2.5 Hz.

Spatial peak-temporal average intensity (ISPTA) < 10 m Wcm-2

Spatial peak-pulse average intensity (ISPPA) < 5 Wcm-2

ISPTA and ISPPA levels conform to FDA Diagnostic Ultrasound Guidance.

Measurements

Broadband Ultrasound Attenuation (BUA), in vitro precision 0.44%

Broadband Ultrasound Attenuation (BUA), in vivo precision 1.3%

Patient Measurement Time

Typical measurement time of 1 minute (including a settling period).

Display of Patient Measurement Results

BUA (dB/MHz) and BUA Normative Data plot

QA tests

One QA phantom is provided. This is used in conjunction with the internal QA test circuit.

Database

Data can be exported in dBase IV compatible file format.

P.C. Specification

The CUBAClinical software can be run on just about any IBM compatible PC that has Windows 95, a spare serial port, at least 10 MB of free hard disk space, preferably Pentium class performance and is Year 2000 compliant.

The computer should comply with the requirements of EN 60950 (Specification for Safety of Information Technology Equipment).

Minimum performance of PC

Desktop or notebook PC + VGA display + (optional) mouse or pointing device

486 DX2 microprocessor @ 66 MHz

1.44 MB floppy disk and 10 MB of free hard disk space

Windows 95

16 MB RAM

Year 2000 compliant

Printer Options

Any printer supported by Microsoft Windows.

Mechanism

Motorized mechanism, opened and closed by the operator.

Automatic open feature, occurs approximately 5 seconds after a patient measurement has been taken.

CUBAClinical Unit Dimensions

Length x width x height: 46.2 x 38.3 x 32.2 cm (18.2 x 15 x 12.6 in).

Weight (CUBAClinical unit only)

Approximately 9 kg (20 lbs.)

Operating and Storage Conditions

The CUBAClinical can operate or be stored indefinitely within the following environment:

Ambient temperature range of +10oC to +40oC.

Relative humidity range of 30% to 95%.

An atmospheric pressure range of 700 hPa to 1060 hPa.

The CUBAClinical may be stored for a period not exceeding 15 weeks within the following environment:

Ambient temperature range of -5oC to +50oC.

Relative humidity range of 0% to 95%.

An atmospheric pressure range of 500 hPa to 700 hPa.

The equipment is not protected against ingress of water.

Electrical Power requirements

Factory preset to:

220 - 240 V AC, 50 - 60 Hz or 100 - 120 V AC, 50 - 60 Hz, both at ±10%

VA Rating = 72 VA maximum

Fuse Rating

220 V AC - 240 V AC

F1 and F2 which are located on the rear panel of the unit are 315 mA, anti-surge, 20 mm fuses.

100 V AC - 120 V AC

F1 and F2 which are located on the rear panel of the unit are 630 mA, anti-surge, 20 mm fuses