User Manual, neoBLUE
®
compact, English 4
P/N 061083 Rev A
2 Safety Information
2.1 Explanation of Terminology
This manual presents three types of precautionary information. The three
types of statements carry equal weight; that is, they are of equal importance
to the safe and effective use of the light. Each statement is categorized by
using an introductory word in boldface as follows:
Warning! Identifies conditions or practices that might present danger or
possible injury to the patient and/or user.
Caution: An instruction that, if not followed, can result in a condition
that could damage the light.
Important! An instruction provided to help ensure correct clinical results and
provide quality assurance to the phototherapy procedures.
Other explanatory information is highlighted with the word Note. Information
in this category is not considered precautionary.
Note: Background information provided to clarify a particular step or
procedure.
2.2 General Safety Information
The neoBLUE compact LED Phototherapy System can be used in three
different configurations: the light source (light) can be used alone, with the
neoBLUE compact Arm, and with the neoBLUE compact Rollstand. All
configurations were tested for safety and stability and no differences were
noted between various configurations.
Before administering phototherapy, read all sections of this manual carefully.
Observe all precautions to ensure the safety of the patient and those near the
instrument. In addition, please refer to your hospital policy and procedure for
phototherapy administration.
Do not use the light if any parts appear damaged or if there is any reason to
believe that it is not functioning properly. Contact Natus Medical Technical
Service or your authorized service provider.
Note: Refer to the jaundice management guidelines or regulations in your
country to determine the best treatment path for neonatal hyperbilirubinemia;
such as the AAP Guidelines (American Academy of Pediatrics Clinical
Practice Guideline – Management of Hyperbilirubinemia in the Newborn
Infant 35 or More Weeks of Gestation); or NICE guidelines (National Institute
for Health and Clinical Excellence – Neonatal Jaundice).
Note: Any serious incident that has occurred in relation to the device should
be reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
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