Philips PV018OTW Instrucciones De Uso página 16

Precautions:
The Reconnaissance PV .018 OTW Digital IVUS catheter is a delicate scientific instrument
and should be treated as such. Always observe the following precautions:
• Protect the catheter tip from impact and excessive force.
• Do not cut, crease, knot, or otherwise damage the catheter.
• Protect the electrical connections from exposure to fluid.
• Do not handle the transducer.
• The outside diameter along the entire length of the guide wire should not exceed
the maximum specified.
• During use, ensure that the placement of the catheter does not preclude blood flow
through the vessel.
• Clean guide wire and flush catheter thoroughly with sterile heparinized normal
saline before and after each insertion.
• Keep the exterior of the catheter wiped down with sterile heparinized normal saline
during prolonged use.
• When inserting the guide wire both catheter and wire must be straight with no
bends or kinks, or damage to inner lumen may occur.
• Do not advance the guide wire against significant resistance. If binding occurs
between the catheter and the guide wire while inside the patient, CAREFULLY
REMOVE BOTH the wire and catheter and do not use. If binding occurs outside of
the patient, remove the catheter and do not use.
• When advancing or re-advancing the catheter over a guide wire and through a
stented vessel, in the event that the stent is not fully apposed against the vessel
wall, the guide wire and/or catheter may become entangled in the stent between
the junction of the catheter and guide wire or within one or more stent struts. This
may result in entrapment of catheter/guide wire, catheter tip separation, and/or
stent dislocation. Never use force to advance the catheter.
• Use caution when re-advancing a catheter over a guide wire and into a stented
vessel, in the event that the catheter may come in contact with one or more stent
struts. Subsequent advancement of the IVUS catheter could cause entanglement
between the catheter and the stent(s) resulting in entrapment of catheter/guide
wire, catheter tip separation, and/or stent dislocation.
• Use caution when removing the catheter over the guide wire from a stented vessel
to minimize patient risk.
• The catheter should never be forcibly inserted into lumens narrower than the
catheter body or forced through a tight stenosis.
• If resistance is encountered during pullback, remove the entire system (guide
wire, IVUS catheter, sheath/guide catheter) at the same time.
• The use of an anticoagulant is recommended as per the local standard angiographic
protocols and at the discretion of the physician to prevent thrombus formation.
• Do not expose the device to a magnetic resonance environment. Device may not
perform as intended and may present additional risks to patient..
Instructions for use:
The Reconnaissance PV .018 OTW Digital IVUS catheter may be introduced into the
vascular system percutaneously or surgically and advanced to the desired location. The
frequency and duration of administration is subject to the discretion of the physician
and depends upon the procedure and information required.
• Review the Imaging System Operator's Manual thoroughly prior to use of this device.
Check system operation prior to the use.
• Open the Reconnaissance PV .018 OTW Digital IVUS catheter packaging using sterile
technique and place the hoop in the sterile field.
• Prepare the catheter by flushing the guide wire lumen through the port at the
catheter's Y-connector, and then wipe down the entire working length with sterile
heparinized normal saline.
• Remove the clear/white cap from the PIM connector.
• Connect the PIM connector of the Reconnaissance PV .018 OTW Digital IVUS catheter
to the Patient Interface Module as described in the imaging system Operator's
Manual. Verify that the device is imaging.
• Place the Reconnaissance PV .018 OTW Digital IVUS catheter onto the intravascular
guide wire. A guide wire of 0.014" (0.35 mm) or 0.018" (0.45 mm) can be used.
• Activate the hydrophilic coating using sterile heparinized normal saline.
• Advance the Reconnaissance PV .018 OTW Digital IVUS catheter over the guide
wire to the site of the vasculature to be imaged. The guide wire should always be
advanced ahead of the IVUS catheter.
• Check the Monitor for an image. Once the image has been obtained, the catheter
can be advanced over the guide wire to image additional segments of vasculature.
• If an image is not obtained or is not satisfactory, consult the Imaging System
Operator's Manual.
• Once imaging has been completed, remove the Reconnaissance PV .018 OTW Digital
IVUS catheter and flush thoroughly with sterile heparinized normal saline.
• For subsequent imaging, clean guide wire and flush catheter thoroughly with sterile
heparinized normal saline before re-insertion.
• When the procedure is completed, remove and discard the catheter in accordance
with local regulations.
Storage and handling:
Products should be stored indoors at room temperature in their original packaging.
Product specifications :
Model Reconnaissance PV .018 OTW Digital IVUS catheter
Catalog Number 018OTW
Maximum shaft outer diameter 0.068" (1.723 mm)
Maximum scanner diameter 0.046" (1.17 mm)
Maximum guide wire 0.018" (0.46 mm)
Minimum guide sheath 5F (0.074", 1.88 mm)
Usable length 150 cm
Acoustic Output B-Mode
Parameter
I (mW/cm ) 2.93x10
2
SPTA.3
I (W/cm ) 7.5x10
2
SPPA.3
Pr.3 (MPa) 20.0x10
PD (μs) 161.0x10
PRF (Hz) 53760
Center Freq (MHz) 18.6
MI* 4.5x10
TI** 2.06x10
* Maximum overall uncertainty + 33.9%/ ¬- 30.5%
** As estimated in tissue
TI:
Thermal Index defined as TI = W
W : Bounded-square Output (mW)
01x1
f : Center Frequency (MHz)
c
MI: Mechanical Index defined as MI= Pr.3/(f
I : Derated Intensity, Spatial Peak Pulse Average (W/cm
SPPA.3
I : Derated Intensity, Spatial Peak Temporal Average (mW/cm
SPTA.3
Derated Peak Negative Pressure at a location of the maximum derated pulse intensity
integral (MPa)
16
Chromaflo
7.98x10
-3 -2
175.0x10
-3 -3
81.5x10
-3 -3
125.0x10
-3 -3
75368
17.9
1.92x10
-3 -2
1.56x10
-5 -4
f
01x1 c
210
)
1/2
c
)
2
)
2