Device Safety - Mcube CUBEscan BioCon-900S Operator's Manual


Do not attempt to open the system components. This may cause serious injury to the operator or
patients. All services must be made by a qualified technician only.

Use of components and cables other than those specified or provided by the manufacturer of this
device could result in increased electromagnetic emissions or decreased electromagnetic immunity
of this device and result in improper operation.

Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the BioCon-900S,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
device could result.
CAUTION

The BioCon-900S has been tested and found to comply with the electromagnetic compatibility (EMC)
limits for medical systems to IEC 60601-1-2. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation. Medical systems must be installed and
operated according to the instruction in this manual. For more information, see the section "9.2
ELECTROMAGNETIC COMPATIBILITY".

This device is suitable for use in the professional health care environment

Medical electric devices can be affected by portable or mobile RF communication devices. Turn off any
portable or mobile RF device before operating your system.

Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in
conditions of low humidity, which can be caused by heating or air conditioning.

Static shock is a discharge of electrical energy from a charged body to a lesser or non-charged body.
The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound
system. The following precautions can help reduce ESD: anti-static spray on carpet, anti-static spray on
linoleum, and anti-static mats.

The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required) this device might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-orienting the device.

Do not use the system if an error message appears on the display: note the error code; call Mcube
technology or your local distributor, shut down the system

DEVICE SAFETY

2.5
To protect your BioCon-900S, and components, follow these warnings and cautions.
WARNING

No modification of this device is allowed.

Do not use the system if the head of probe is damaged.

To avoid the risk of excessive heating or damage to the device, use the device in a well-ventilated
environment.

To avoid damage to cables, do not excessively twist or bend cables associated with the device.

Turn off the device and unplug the charger if it will not be used for a long period of time.

Do not use the system if there is evidence of leakage of internal liquids. Wash hands immediately in
warm, soapy water.

In the event that LCD is damaged, care should be taken to avoid contact with liquid crystal. Take the
urgent action indicated should any of the following situations arise:
- If liquid crystal comes in contact with your skin, clean the area with a cloth and then wash
thoroughly with soap and running water.
TM
CUBEScan BioCon-900S Operator's Manual
Page 9