User manual

Blackrock Microsystems CereStim R96 - User Manual
Rev. 1.00 ® Page ii
LB-0432
Contraindications, Warnings and Cautions
IEC60101-0102
Danger of Electrostatic Discharge (ESD)
IEC 348
ISO7000-0434
Consult instructions for use
Attention, consult accompanying documents
IEC606417-5335
Type BF Applied Part
IEC60417-5172
Class II Equipment
YEAR
EN-980
Combined Manufacturer/Manufacturing Date
EN-980
Serial Number
Contraindications
 The CereStim R96 should not be used in clinical applications. The CereStim R96 is intended for
animal research applications only.
 The CereStim R96 should not be used in chronic applications. The CereStim R96 is intended for
acute (<30 days) operation only.
 Electrocautery should not be performed while the CereStim R96 is in use.
 The CereStim R96 should not be used if the device has been dropped. Dropping the device may
cause damage to internal components that affect system performance and 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 CereStim R96 User Manual).
 The CereStim R96 should not be used with any computer that has not been tested to the IEC 60950
standards.
Warnings
 The CereStim R96 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.
 The CereStim R96 stimulation parameters should only be used within the safe operating range of the
specific electrode being used.
 Use only the supplied CereStim R96 components (i.e. External Power Supply). Substitution of
components not supplied by Blackrock Microsystems may affect system performance and safety.
 The CereStim R96 should be disconnected from the Stimulation System during defibrillation. The
CereStim R96 is not defibrillator proof.
 Do not use the CereStim R96 in the presence of flammable anesthetic agents.
 Only connect CereStim R96 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 use damaged components (i.e. cables, external power supply). Damaged components may
compromise subject safety.
 Do not connect the CereStim R96 to an outlet controlled by a wall switch.