Preventative Maintenance; Electrical Safety Testing - Fresenius Medical Care CRIT-LINE III User Manual

based on warranty, contract, tort, and negligence or otherwise. Its liability being hereby
limited solely to repair or replacement. This warranty is expressly in lieu of any other
express or implied warranties, including any implied warranty or merchantability or
fitness for any particular purpose and of any other obligation on the part of Fresenius
Medical Care.
No person has the authority to bind Fresenius Medical Care to any other representation
or warranty with respect to these products, and the purchaser accepts the products
subject to all terms hereof. Any product returned to Fresenius Medical Care for
replacement becomes the property of Fresenius Medical Care.
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8.6 Preventative Maintenance

The CRIT-LINE Monitor does not require any preventative maintenance. It is calibrated
by the manufacturer and should require no further calibration. However, the instrument
is equipped with a verification filter to access and insure accuracy. The monitor will
force you to perform the verify accuracy test every 30 days if the internal clock battery is
active. If the verify accuracy test has not been performed for 30 days, the Calibration
Menu will appear when the CRIT-LINE is turned ON and a verify accuracy test must be
performed (see section 5 – Calibration Procedures). The last date when the verify
accuracy test was performed will appear on every treatment printout.
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8.7 Electrical Safety Testing

The CRIT-LINE monitor does not require electrical safety testing. If the location where it will be used wants
to perform this test, they may do so at their discretion. See below for an explanation on why the electrical
safety testing is not required.
The UL STD 60601-1 is the governing standard for electrical medical products. Testing to this standard
protects you from items such as electrical shock, excessive energy output, fire or other hazards, and mechanical
hazards such as pinching, moving parts, and crushing.
Locate the grey label on the bottom of the CRIT-LINE. You will see the "ETL" mark, which is a circle with
the letters ETL inside of it. Next to this mark is the phrase "ETL Listed, Conforms to UL STD 60601-1" This
means that the device was tested to the 60601-1 safety standard as established by UL (Underwriters
Laboratory) and that is equivalent to other safety testing for Europe and Canada.
Also on the label are two boxes, one inside the other. This symbol demonstrates that the device is a "Class II"
electrical equipment device. The UL 60601-1 standard, which we are compliant to, defines Class II as
"equipment in which protection against electric shock does not rely on basic insulation only, but in which
additional safety precautions such as double insulation or reinforced insulation are provided, there being no
provision for protective earthing or reliance upon installation conditions". This means that the device does not
use the ground (third) prong of the AC cord to rely on grounding. Some buildings do not have good ground
systems in their building wiring and so it is hit or miss as to the quality of the ground connection of the device.
Again, the CRIT-LINE monitor will always read passing values because it is Class II device.
Instrument Maintenance
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