BIS VISTA - Page 14

SECTION 1 SAFETY PRECAUTIONS
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IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND
IS IN DOUBT, THE BIS VISTA SYSTEM SHALL BE OPERATED FROM ITS
INTERNAL BATTERY POWER SOURCE ONLY.
BE SURE THE MONITOR IS MOUNTED SECURELY IN PLACE TO AVOID
PERSONAL OR PATIENT INJURY.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE SYSTEM LEAKAGE CURRENT MUST BE CHECKED
AND MUST BE LESS THAN THE IEC 60601-1-1 LIMIT.
THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE
EQUIVALENT SAFETY REQUIREMENTS OF THIS EQUIPMENT MAY
LEAD TO A REDUCED LEVEL OF SAFETY OF THE RESULTING SYSTEM.
CONSIDERATION RELATING TO THE CHOICE SHALL INCLUDE:
• USE OF THE ACCESSORY IN THE PATIENT VICINITY
• EVIDENCE THAT THE SAFETY CERTIFICATION OF THE
ACCESSORY HAS BEEN PERFORMED IN ACCORDANCE TO THE
APPROPRIATE IEC 60601-1 AND/OR IEC 60601-1-1 HARMONIZED
NATIONAL STANDARD.
DUE TO ELEVATED SURFACE TEMPERATURE, DO NOT PLACE BISx™ IN
PROLONGED DIRECT CONTACT WITH PATIENT’S SKIN, AS IT MAY
CAUSE DISCOMFORT.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND
CONNECTORS SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS,
INCLUDING EARTH.
TO REDUCE THE HAZARD OF BURNS DURING USE OF HIGH-
FREQUENCY SURGICAL EQUIPMENT, THE SENSOR OR ELECTRODES
SHOULD NOT BE LOCATED BETWEEN THE SURGICAL SITE AND THE
ELECTRO-SURGICAL UNIT RETURN ELECTRODE.
TO REDUCE THE HAZARD OF BURNS DURING USE OF BRAIN-
STIMULATING DEVICES (e.g., TRANSCRANIAL ELECTRICAL MOTOR
EVOKED POTENTIAL), PLACE STIMULATING ELECTRODES AS FAR AS
POSSIBLE FROM THE BIS SENSOR AND MAKE CERTAIN THAT SENSOR IS
PLACED ACCORDING TO PACKAGE INSTRUCTIONS.
THE SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR
PADS WHEN A DEFIBRILLATOR IS USED ON A PATIENT CONNECTED
TO THE BIS VISTA SYSTEM.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.