001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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Warning.
Always replace any external fuse with the type and rating specified in
Section 7 (Technical Specifications).
Warning.
Be aware that the Pintuition Seed may be attracted towards and stick to
metallic objects such as knifes or scalpels when brought within approximately 5
mm of the seed.
Warning.
The Pintuition Detector is not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or with nitrous oxide.
Warning.
Do not touch the Pintuition Probe connector port contacts and the
patient simultaneously.
2.2
C
AUTIONS
Caution.
Care should be taken to remove all magnetic disturbances from the
vicinity of the Probe during routine use.
Caution.
Calibrate the Pintuition Detector before each clinical use and when the
device provides unexpected output.
Caution.
Care should be taken not to drop the Pintuition Probe, or subject it to
any form of rough physical handling, either during normal use or during storage
and transportation. If the Probe is dropped confirm correct functioning each with
the supplied Test Kit following the System Test Procedure.
Caution.
Care should be taken not to drop the Pintuition Base Unit, or subject it to
any form of rough physical handling, either during normal use or during storage
and transportation. If the Pintuition Base Unit is dropped confirm correct
functioning with a specialist.
Caution.
Handle the Pintuition Probe with care, do not bend the cable sharply.
This could lead to cable damage.
Caution.
For best results, care should be taken when using the Pintuition
Detector in the proximity of foreign magnetic or metallic objects, as they may
generate confounding signals. If in doubt, the user should undertake an in situ
assessment of the operating environment before using the instrument.
Caution.
The detection distance of the Pintuition Detector is up to 50mm.
Caution.
The Pintuition Detector is intended for use by suitably qualified, trained,
and authorized physicians and/or operating room staff.
Caution.
Use the Pintuition Base Unit only with the Pintuition Probe and Pintuition
Seed manufactured by Sirius Medical Systems.
