Sirius Medical Pintuition Detector, Инструкция по эксплуатации

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001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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3.
The system will start the calibration procedure and the balance icon on the display (2)
will turn blue. The calibration procedure takes approximately 5 seconds.
4.
After successful calibration, the Pintuition Base Unit (1) will proceed to normal
operation and the display (2) will show a millimeter indication (‘mm’) (10)
Note. Take care to hold the Probe still during calibration, otherwise performance
may deteriorate.
Note. The calibration procedure may be repeated during use if the system
provides insufficient detection range.
4.3 S
YSTEM
T
EST
: U
SING THE
T
EST
K
IT
The Pintuition Detector is supplied with a Pintuition Test Kit (17).
The Pintuition Test Kit (17) contains a Pintuition seed at a fixed and predetermined distance
of 20 mm. The device can be used to confirm correct functioning of the Pintuition Detector.
To perform the System Test, see Figure 9:
1.
Calibrate the Detector following the
instructions in Section 4.2 (Calibrating the
Pintuition Detector).
2.
Place the Probe tip (13) in the cavity of the
Test Kit (17).
3. Hold the Probe with Test Kit in the air.
4. The base unit display (2) provides a distance
in millimeters.
4a.
If the distance on the display (2) deviates
less than 2mm (acceptable range: 18 –
22mm) from the distance indicated on the
Test Kit label
(18) , the system is
performing correctly.
4b.
If the detected distance deviates more than prescribed, please repeat the System
Test procedure. If the problem persists, see Section 8 (Troubleshooting).
4.4 A
DJUSTING THE VOLUME
Output volume of the Pintuition Base Unit can be adjusted by turning the volume control knob
(3) on the Base Unit (1) .
A clockwise motion will increase the volume.
A counterclockwise motion will decrease volume.
If the volume is fully turned down, the left bottom screen volume indicator
(12) will show that
the audio is muted.
4.5 A
PPLICATION OF STERILE SHEATH
Warning. Always apply a suitable and legally marketed sterile sheath before
using the Pintuition Probe in a sterile field.
The Pintuition Probe (13) may only be used without a sterile sheath on the intact skin prior to
the start of surgery, for example to plan the incision.
The Probe
(13) is not a sterile medical device and should always be covered using a legally
marketed, suitable sterile sheath for use within the sterile field.
To use the sterile sheath:
Figure 9: Performing a System Test (inset: display (2) )