User manual

Blackrock Microsystems CereStim R96 - User Manual

Rev. 3.00 ® Page iv

LB-0314

 Avoid strong static discharges from sources like televisions or computer monitors because it can

damage the electrical parts of the system.

 Keep the CereStim R96 away from liquids. Contact with water, shower spray, or wet surfaces can

lead to the subject receiving an electrical shock.

 Do not unplug the power supply to the CereStim R96 while the system is in use.

 Do not connect/disconnect any cables to/from the CereStim R96 while the system is in use.

 Do not leave the CereStim R96 connected to the microelectrode array(s) or Stim Switch when the

system is not in use.

 Do not change CereStim R96 Output Voltage values while connected to the subject. Doing so may

result in an electric shock to the subject.

 When connecting the CereStim R96 to the Stim Switch or microelectrode array(s), use caution to

minimize the likelihood of Electrostatic Discharge (ESD).

 Ensure that the CereStim R96 is securely positioned on a flat surface during use.

 Use caution when placing power cords, cables, and other connectors to minimize the likelihood of

tripping or accidentally pulling on cables. Damaged cables may result in failed ground connections.

 Each component of the system must be plugged into a separate outlet (i.e. CereStim R96, Stim

Switch, subcomponents of the data acquisition and any other accessory equipment). Using a power-

strip may cause leakage currents to exceed acceptable limits.

 Connecting equipment to and from the CereStim R96 may result in a summation of leakage currents

that can lead to the subject receiving an electric shock.

 Care should be used in selecting equipment for connection to the Monitor port as it could potentially

transmit large voltage transients directly to the microelectrode array(s). Devices connected to this

port must be isolated from earth ground in compliance with IEC 60601-1.

 Risk of Electrical Shock Hazard: Accessory equipment connected to the SIP/SOP port must be

certified according to the respective IEC standards, i.e., IEC 60950 for data processing equipment or

IEC 60601-1 for electromedical equipment in order to reduce the risk of electrical shock. All

combinations of equipment must be in compliance with IEC 60601-1-1 systems requirements.

Anyone connecting additional equipment to the SIP/SOP port configures a medical system, and

therefore is responsible that the system complies with the requirements of the system standard IEC

60601-1-1.

 IEC 60950 approved Information Technology Equipment must be placed outside the “patient

environment.” The patient environment is defined as an area 1.5m (4.92 feet) from the patient.

 The following options are recommended if there is a need to remediate system leakage current:

 Redundant protective earth connection shall be made to either the medical device or the

other equipment.

 The other equipment shall be powered from a medical grade (IEC 60601-1 compliant)

separating transformer.

Cautions

 Federal law restricts this device to sale, by or on the order of a physician.

 The CereStim R96 is ONLY recommended for use with low impedance (<100 kΩ) electrodes such as

the NeuroPort SIROF array provided by Blackrock Microsystems.