User manual

Stim Switch User Manual
Rev. 2.00 ® Page iii
LB-0357
• Use only the Front End Amplifier and Neural Signal Processor (NeuroPort™ System) supplied by
Blackrock Microsystems. Substitution of systems not supplied by Blackrock may affect system
performance and patient safety.
• The Stim Switch and Amplifier/NSP should be disconnected from the patient electrodes during
defibrillation. The Stim Switch and its subcomponents, along with the Amplifier and NSP are not
defibrillator proof.
• Do not use the Stim Switch in the presence of flammable anesthetic agents.
• Only connect Stim Switch components to properly tested, grounded and dedicated AC outlets to
reduce the risk of electrical shock. Do not use an adapter for ungrounded wall outlets.
• Do not connect the Stim Switch to an outlet controlled by a wall switch.
• Avoid strong static discharges from sources like televisions or computer monitors because it can
damage the electrical parts of the system.
• Keep the Stim Switch away from liquids. Contact with water, shower spray, or wet surfaces can lead
to the patient receiving an electrical shock.
• Each component of the system must be plugged into a separate outlet (i.e. Stim Switch, Stim100,
subcomponents of the data acquisition system and all other accessory equipment). Using a power-
strip may cause leakage currents to exceed acceptable limits.
• Do not unplug the power supply to the Stim Switch while the system is in use.
• Do not leave the Stim Switch connected to the patient electrodes when the system is not in use.
• When connecting the Stim Switch to the Stim100 or patient electrodes, use caution to minimize the
likelihood of Electrostatic Discharge (ESD). Do not connect/disconnect any cables to/from the Stim
Switch while the system is in use.
• Ensure that the Stim Switch 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 results in failed ground
connections.
• Connecting equipment to and from the Stim Switch may result in a summation of leakage currents
that can lead to the patient receiving an electric shock.
• 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: