5 equipment installation

The B4C System should be installed by a trained user, as such it is exempt from the checklist for warranty purposes.

ATTENTION - It is recommended to keep the original packaging in case the equipment needs to be transported. Improper use of the product will void warranty.

5.1 location choice

When selecting the location for installing the B4C System, consider the operating temperature, brightness, mains access (if a multi parameter monitor that requires the use of a power outlet is used), and the space for movement of professionals and patients.

The system should be used in a climate-controlled location with temperature, humidity and pressure within the environmental specifications given in Table 4.2-1.

For transportation or storage of equipment, environmental conditions must be maintained within the temperature, humidity and pressure tolerance range defined in Table 4.2-1.

The equipment must be installed and used in an electromagnetic environment in accordance with the information in Annex 3. The user must ensure that it is used in such an environment.

Portable and mobile RF communication equipment may affect the product and should therefore be kept at a calculated distance as defined in Table Appendix 3-4.

In coastal cities, attention should be paid to the damage that can be caused by salt spray. It is recommended to install the necessary equipment (air conditioner and dehumidifier) to maintain the ideal conditions for the equipment.

Equipment (especially sensors) must not be exposed to sunlight.

To facilitate monitoring, the patient should lie or sit still during a monitoring session.

Do not wet equipment nor come into contact with chemicals and / or flammables that could damage it.

WARNING - Do not leave the equipment near flammable chemicals such as alcohol, benzene, etc. Should they come in contact with electrical parts, this may result in fire or internal short circuit. The same is true with the use of some flammable disinfectants.

5.2 power supply

The sensor is powered by two lithium-ion batteries: one internal and another external removable battery. The first, with smaller capacity has enough autonomy to keep the sensor running while the removable battery is being charged, disconnected from the sensor.

ATTENTION - At no time should the sensor be connected to an external power supply.

5.3 patient environment compatibility

The patient environment is the place where diagnostics, monitorings or treatments occur and as such intentional and unintentional contact can occur between a PATIENT and parts of Electromedical Equipment or Electromedical System, or between a PATIENT and other people in contact with Electromedical Equipment of Electromedical System.

The wireless sensor BcSs-PICNIW-1000, its external battery BcAc-BATEX-1000, headbands kit BcAc-AF-1000 and receiver module BcAc-DG-1000 are adequate for use in this environment.

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