ANI Monitor V1 - Continouous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021
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THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE
MANUFACTURERS REQUIREMENTS MAY INFLUENCE THE SAFETY OF THE
RESULTING SYSTEM. CONSIDERATION RELATING TO THE CHOICE OF
EQUIPMENT SHALL INCLUDE:
- USE OF THE ACCESSORY IN THE PATIENT VICINITY AND OR SURGERY
VICINITY
- EVIDENCE THAT THE SAFETY CERTIFICATION « CE » OF THE ACCESSORY AS
BEEN PERFORMED IN ACCORDANCE TO THE HARMONIZED STANDARD (IEC
60601-1 AND/OR IEC 60601-1-1)
APPLIED TO THE
ANI Monitor V1.
BE SURE NOT TO PLACE THE INTERFACE EQUIPMENT DIRECTLY IN
PROLONGED CONTACT WITH SKIN TO AVOID PERSONAL OR PATIENT INJURY
DUE TO HIGH SURFACE TEMPERATURE.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS
SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH
.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE MUST BE CAREFULLY PLACED AND SECURED.
ENSURE PROPER CONTACT OF THE ELECTROSURGERY RETURN ELECTRODE
TO AVOID POSSIBLE BURNS ON THE PATIENT VIA ANI ELECTRODES.
THE CHARACTERISTICS OF ANI Monitor V1 EMISSIONS ALLOW IT TO BE USED
IN INDUSTRIAL AREAS AND HOSPITALS (CISPR 11 CLASS A). WHEN USED IN
RESIDENTIAL ENVIRONMENTS (FOR WHICH CISPR 11 CLASS B IS REQUIRED),
ANI Monitor V1 CANNOT GUARANTEE PROVISION OF ADEQUATE PROTECTION
