Mocom SUPREME 17 - Guidelines - Safety Test - Validation (If Required); Checks Required for the Drafting of Conformity Report

Sterilizers SUPREME - FUTURA - CLASSIC (17-22-28)
- TECHNICAL MANUAL
EN
GUIDELINES - SAFETY TEST - VALIDATION (IF REQUIRED)
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3. GUIDELINES - SAFETY TEST - VALIDATION (IF REQUIRED)
Periodical checks to be carried out every year and checks after repair/updates/settings with reference to Standard
IEC 61010.
Safety standards for medical electrical equipment classified according to IEC 61010 in Class 1.
3.1. CHECKS REQUIRED FOR THE DRAFTING OF CONFORMITY REPORT
a) Visual inspection
The purpose of visual inspection is to ensure that the equipment in use still complies with the specifications
released by the manufacturer through the following checks:
 condition of power cables and connectors
 condition of earth cables and correct tightening
 condition of covers
 condition of electrical board protections and correct value of the fuses
 conditions of warning plates
 conditions of light and sound indicators (display, buzzer, etc...)
 presence of liquid leaking out from ducts or on the bottom of the device
 presence of the updated user manual in printed or electronic format
b) Electric measure test (to be carried out with special instruments)
 Measurement of earth conductor resistance
 Measurement of the device’s earth-leakage currents:
1) current under normal conditions
2) current under single failure conditions
 Measurement of insulation resistance between network and earth conductor
c) Functional checks
 Check the door opening and closing controls
 Check the display and perform a test cycle