TO PREVENT FIRE OR SHOCK HAZARD, DO NOT EXPOSE THIS IMAGER TO RAIN OR
MOISTURE.
EQUIPMENT IS NOT TO BE USED AS A COMPONENT OF A LIFE SUPPORT SYSTEM. Life
support devices or systems are devices or systems that support or sustain life, and whose failure to
perform can be reasonably expected to result in a significant injury or death to a person. A critical
component is any component of a life support device or system whose failure to perform can be
reasonably expected to cause the failure of the life support device or system, or to affect its safety or
effectiveness.
WARNING
Grounding reliability can be achieved only when the Horizon is connected to a
receptacle marked “Hospital Only” (that is, “Hospital Grade”).
WARNING
The power cord connected to the Horizon is the main disconnect for the system.
WARNING
To disconnect overall power to the Horizon prior to servicing it, power of the system.
WARNING
Do not modify this equipment without authorization of the manufacturer
WARNING
External equipment intended for connection to signal input, signal output, or other
connectors, shall comply with relevant IEC standard (e.g., IEC 60950 for IT equipment and the IEC
60601 series for medical equipment). In addition, all such combinations - systems - shall comply
with the IEC 60601-1 standard for Medical Electrical Equipment Systems. Equipment not
complying to IEC 60601 shall be kept outside the patient environment, as defined in the standard.
Any person who connects external equipment to signal input, signal output, or other connectors
has formed a system and is therefore responsible for the system to comply with the requirements of
IEC 60601-1-1. If in doubt, contact a qualified technician or Codonics Technical Support for
approved configurations.
WARNING
Do not touch a patient while also accessing the internal components that are under the
top cover or receive trays.
Laser Warning
The Horizon imager uses a laser to read barcode information on the media cassettes. The laser
module is a 650
–
670nm device of 1.26 mW or less. As such it has been found to comply with the 21
CFR 1040.10 and 1040.11 and IEC 60825 laser standards as a low power Class 1 device.
For safety reasons, the laser is turned on only for a short time when a cassette is inserted. Still, one
should use caution and never stare at the laser beam, should avoid exposure to the laser, and
should never override any of the interlocks and safety mechanisms. These measures are taken for
your protection.
WARNING
Use of controls or adjustments to the performance of procedures other than those
specified in this manual may result in hazardous radiation exposure.
The laser apertures are marked with a single label, shown below. There are three apertures that
correspond to the three cassette locations, one for each, on the same side of the Horizon imager as
this label.
Safety interlocks are marked by the following label. They are located on the same side of the
Horizon imager as this label.