NIPE Monitor V1 - Continuous monitoring system of comfort
.
/
.
discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020
3
DECREASED ELECTROMAGNETIC IMMUNITY OF THE NIPE Monitor V1 AND
MAY RESULT IN AN INAPPROPRIATE OPERATION.
CONSIDERATION RELATING TO THE CHOICE OF EQUIPMENT SHALL
INCLUDE:
- EVIDENCE THAT USING THE ACCESSORY IN THE PATIENT VICINITY AND
OR SURGERY VICINITY IS COMPLIANT
- EVIDENCE THAT THE ACCESSORY'S "CE" SAFETY CERTIFICATION
COMPLIES WITH STANDARD (IEC 60601-1) AND THAT THE ACCESSORY IS
COMPATIBLE WITH THE NIPE Monitor V1
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS
SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING GROUND
LOOP
.
TO MINIMIZE THE RISK OF STRANGULATION OF THE PATIENT, THE CABLE
OF THE PATIENT INTERFACE MUST BE CAREFULLY PLACED AND
SECURED.
ON ELECTRICAL SHOCK HAZARD :
-
DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET
HANDS.
-
DO NOT REMOVE MONITOR COVERS DURING OPERATION OR WHILE
POWER IS CONNECTED TO MONITOR.
-
THE MANUFACTURER OF THIS DEVICE HAS VERIFIED THAT THE
GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY CURRENT
WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY THE
APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE PRACTICE,
THE INSTITUTION SHOULD ALSO CONDUCT TESTS TO VERIFY THESE
CURRENTS
ESPECIALLY
WHEN
A
QUALIFIED
BIOMEDICAL
