Steris InnoWave Pro, Operator'S Manual

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Standard Title
CAN/CSA-C22.2
No. 61010-1-12 (2012-05), 3rd
Edition, with revisions through
2018-11 Safety requirements for electrical equipment for
measurement, control, and laboratory use — Part 1:
General requirements.
IEC 61010-2-040:2020, Ed. 3.0 Safety requirements for electrical equipment for
measurement, control, and laboratory use — Part 2-040:
Particular requirements for sterilizers and washer-
disinfectors used to treat medical materials.
EN 61326-1:2020
BS EN/IEC 61326-1:2021 Electrical equipment for measurement, control and
laboratory use. EMC requirements. General requirements.
IEC 62304:2006+AMD1:2015 Medical device software. Software life-cycle processes.
IEC 62366-
1:2015+AMD1:2020 Medical devices — Part 1: Application of usability
engineering to medical devices.
Table 2.1 Applied Standards (continued)
2.6 Compliance
This equipment has been designed to perform within the guidelines recommended
by international decontamination standards. A stringent quality control program
ensures that every machine is manufactured and tested under controlled conditions
to ensure that all products perform identically.
2.7 RoHS Requirements
The equipment manufacturer is committed to meeting or exceeding the
requirements of the RoHS Directive 2011/65/EU + (EU) 2015/863, "Restriction of
the Use of Certain Hazardous Substances in Electrical and Electronic Equipment".
2.8 Installation of Equipment
This equipment requires installation and commissioning before it can be operated.
In the event that the equipment owner chooses not to have a manufacturer-
approved installer prepare the equipment, installation procedures should be
requested from the supplier or local representative.
18 GENERAL INFORMATION
InnoWave Pro Sonic Irrigator Operator Manual