Overview
PRIMUS is required by the US Food and Drug Administration (FDA), Underwriters Laboratories (UL), ASME Code, Canadian Medical Device Regulations (CMDR), ISO 9001 and ISO 13485 laws, regulations, and requirements to affix a variety of labels to all steam sterilizers prior to shipment to end-user customers.
In addition to the labels discussed below, PRIMUS also provides an electrical diagram with each sterilizer. The electrical diagram is adhered to the inside of the control box. Operator Manuals are provided on CDs. One copy is located in the control box. The second copy is located in the chamber in an envelope labeled
“Please Save! Operator CD Manual.” The respective PRIMUS Job Number is also written on the envelope. This process may vary if special shipping is required by the customer.
An Uncrating work instruction is affixed to the door of the sterilizer. Inside every chamber is a “PRIMUS Care Kit” containing two (2) extra rolls of printer paper, a can of stainless steel polish, and one replacement gasket.
Labels
Examples of the labels on each sterilizer are:
- ASME Name Plate
- UL Listing Label
- Serial Number Plate
- Control Cover Shock Hazard Warning Label
The following describes the purpose of each label and where each is normally located for ease of visibility.
ASME Name Plate ADD PHOTOS
All sterilizers have an ASME nameplate identifying PRIMUS Sterilizer Company, LLC as the manufacturer. The label includes the Manufacturer’s Location, Jacket, and Chamber Maximum Working Pressure rating, Minimum Design Temperature, Serial Number for the vessel, Year Built, and the Canadian Registration Number (C.R.N.)
Location: On vertical door units, the nameplate is located above the door. If the door is a double-door unit with a bio-seal, the nameplate is located on the non-bio-seal side. On horizontal door units, the nameplate is located on the service side of the chamber.
If an end-user customer does not know a sterilizer’s respective Job Number, the customer should look on the nameplate for the serial number. Having the serial number when contacting PRIMUS is very important, for it will help the company quickly locate the sterilizer’s Device History Record (DHR).
Have a question or having difficulties? Talk to Dave Schall, our PRIMUS sterilizer expert who is here to assist you anytime at 877.679.7800 extension 1212 or email at dschall@spire-is.com.
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