User manual

Stim Switch User Manual
Rev. 2.00 ® Page ii
LB-0357
Contraindications, Warnings and Cautions
IEC60101-0102
Danger of Electrostatic Discharge (ESD)
ISO7000-0434
Warning (potentially hazardous condition);
consult accompanying documents
ISO7000-1641
Attention, consult accompanying documents
IEC60417-5019
Protective earth (ground)
IEC60417-5021
Equipotentiality Connector
IEC606417-5335
Type BF Applied Part
|
IEC60417-5007
ON (power)
IEC60417-5008
OFF (power)
Contraindications
• The Stim Switch should not be used with any stimulating systems that are not approved by
Blackrock Microsystems. Currently, the Stim Switch is only approved for use with Blackrock
Microsystems Stim100 neurostimulator.
• The Stim Switch should not be used with any amplifier or neural signal processing system that is not
approved by Blackrock Microsystems. Currently, the Stim Switch is only approved for use with
Blackrock Microsystems Front End Amplifier and NSP (NeuroPort™ System).
• The Stim Switch should not be used on any patient whom the physician/surgeon considers at
elevated risk of infection.
• Electrocautery should not be performed while the Stim Switch is in use.
• The Stim Switch should not be used if the device has been dropped. Dropping the device may
cause damage to internal components that affect system performance and patient safety. A
dropped device must be returned to Blackrock Microsystems for inspection and recalibration before
it can be used again (See Section 6 and 7 of the Stim100 User Manual).
• The Stim Switch should not be used with any computer that has not been tested to the IEC 60950
standards.
Warnings
• The Stim Switch must only be used by medically trained and highly qualified personnel. This
manual is to be used in support of device use by personnel who have received device training from
Blackrock Microsystems.
• Use only the supplied Stim Switch components (i.e. power cord, Stim100 Interconnection Cables,
Headstage Cables, Headstages). Substitution of components not supplied by Blackrock
Microsystems may affect system performance and patient safety.
• Do not use damaged components (i.e. power cord, Stim100 Interconnection Cables, Headstage
Cables, Headstages). Damaged components may compromise patient safety.