001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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Symbol Description
This symbol indicates the unique device Serial number. For the Pintuition Probe, the format
contains the manufacturing date as follows: 3YYWWD.
This symbol indicates the device’s reference code or catalog number
This symbol indicates that the Pintuition Probe is a type BF applied part according to the
IEC 60601-1 standard regarding electrical safety.
This symbol indicates that the device is developed in compliance with the European
Directive 93/42/EEC regarding medical devices.
“0344”
is the Notified Body identification.
This symbol indicates the legal manufacturer.
This symbol indicates the date of manufacture.
This symbol indicates a
warning.
Users should heed any warning closely to prevent serious
user or patient injury.
This symbol indicates a
caution
. Users should take any precaution to prevent minor or
moderate user or patient injury.
This symbol indicates calibration, it is also visible on the of the Pintuition Base Unit.
This symbol indicates a fuse.
℞
This symbol indicates that the device is intended for Prescription Use only.
2
S
AFETY
This section contains important safety information.
It is required that the user has read and understood all warnings, cautions, and
the complete Instructions for Use manual prior to using the Pintuition Detector.
2.1
W
ARNINGS
Warning.
Failure to thoroughly review and adhere to the information contained in
this Instructions for Use may pose a potential hazard to the patient and/or user.
Warning.
Do not use the Pintuition Detector in other tissues than named under
“Indications for Use”. Do not use in the central nervous system, vascular system,
heart, lung, eyes, brain or in tissue that is clinically proven to be infected.
Warning.
The Pintuition Base Unit must be properly grounded to ensure patient
safety. To avoid the risk of electrical shock, this equipment must only be
connected to a mains supply with protective earth. To avoid electrical shock, plug
the power cord into a properly wired receptacle, use only the power cord supplied
with the Base Unit and make sure the power cord is in good condition.
