3
Precautions
•
Use of Mikro-Tip catheters should be restricted to specialists who are familiar with, and
have been trained to perform, the catheterization procedures for which the device is
intended.
•
Exercise care to prevent perforating or traumatizing the linings and associated tissue of the
cardiovascular system.
•
Inspect the Mikro-Tip catheter for damage (cracking, kinks, etc.) prior to each use.
•
Always make sure before insertion that the catheter is perfectly straight from the sensor tip
back to one inch from the tip. The presence of bends that do not straighten out in this area
are an indication the catheter has been damaged and should not be used.
•
Clean the Mikro-Tip catheter immediately after each use (see Cleaning).
•
Store Mikro-Tip catheters in a dark, cool, dry place.
•
Do not touch the sensor area with sharp objects. Do not make sharp bends in the catheter.
•
The catheter may be damaged if the sensor tip is subjected to a pulling force greater than
one pound. Do not apply excessive pulling force to the catheter.
•
Avoid electrostatic discharge to the Mikro-Tip sensor. Do not touch the sensor element
while the catheter is disconnected from monitoring equipment.
•
Insert and advance the Mikro-Tip catheter through a sheath introducer.
•
When the catheter is exposed to the vascular system, it should be manipulated while under
high-quality fluoroscopic observation. If resistance is met during manipulation, determine
the cause of the resistance before proceeding.
•
See package labeling information for expiration date allowing for safe use of the Mikro-
Tip catheter.
Adverse Events
None known.
Maintaining Device Effectiveness
Storage
Store the catheter in the plastic tray provided. Make sure the catheter has a plastic dome fitting over
each pressure sensor. Products for sterilization must be placed in a Tyvek® or similar ETO pouch.
Plastic Dome Fitting
•
All catheters are shipped with a protective tubing(s) and/or plastic dome fitting over the
pressure sensor(s) to protect the sensor from damage. Plastic Domes
ARE NOT
interchangeable.
•
When using the plastic dome fitting, the tip of the pressure sensor should be positioned
inside the plastic dome fitting as shown in Figure 2.
Routine Inspection and Testing
CAUTION:
If damage is found during inspection, DO NOT use the catheter. Contact Millar
Instruments or authorized distributor.
Catheter
Inspect each catheter thoroughly before and after each use. Carefully examine the catheter for defects.
Pressure Sensor(s)
Examine the pressure sensor active surface (diaphragm) for blood or materials not removed by
cleaning. A dirty sensor may cause short-term baseline drift. Follow cleaning directions in this IFU.
8
Method of Sterilization for Catheters and Extension Cables
CAUTION:
DO NOT sterilize by autoclaving, radiation (gamma or e-beam), plasma, peroxide
or formaldehyde vapor solutions.
Catheters must be completely cleaned and dried before sterilization. Aerate at room temperature or in
a heated aeration cabinet (max. 145 ºF, 63 ºC). Catheters may be sterilized in the white plastic
shipping tray. The plastic dome must be removed from the connector caps and placed alongside the
catheter inside the pouch during sterilization. The caps should be saved and reused each time the
catheter is cleaned.
The tray, with lid, should be placed in a breathable polyethylene pouch (e.g., 3M
™
Steri-Lok
™
).
CAUTION:
Catheter should be completely dry before sterilization.
Ethylene Oxide Sterilization Cycle Parameters
Preheat phase:
Starting Temperature 110 ºF (43ºC) min.
Duration
30
minutes
Initial Vacuum:
6.0 inHgA (20.3 kPa)
Rate:
3
minutes
Nitrogen Flush: 2 cycles
Nitrogen Addition to:
28.0
±
0.5 inHgA (94.8
±
1.7 kPa)
Rate:
1.4
±
0.5 inHgA/min. (4.7
±
1.7 kPa/min.)
Evacuation: 6.0
±
0.5 inHgA (20.3
±
1.7 kPa)
Rate:
1.0
±
0.5 inHgA/min. (3.4
±
1.7 kPa)
Conditioning
Humidification:
1.5
±
0.5 inHgA (5.1
±
1.7 kPa)
Steam
Conditioning:
10
min.
Humidity
Dwell:
30
±
5 min. at 7.5
±
0.5 inHgA (25.4
±
1.7 kPa)
Relative
Humidity:
15-70%
Ethylene Oxide Concentration:
500
±
50 mg/L
Dwell
Pressure:
16.5
±
1.0 inHgA (55.8
±
3.4 kPa)
Dwell Time:
2 hours
Temperature:
110-130
ºF
(43-54
ºC)
Relative Humidity:
30-70% (35-44% nominal)
After Vacuum
Vacuum:
6.0
±
0.5 inHgA (20.3
±
1.7 kPa)
Rate:
1.0
±
0.5 inHgA/min. (3.4
±
1.7 kPa)
Vacuum
Hold:
10
min.
Gas Wash A:
4 cycles (minimum)
Release:
30.0
inHgA/min.
(94.8
±
1.7 kPa)
Rate:
1.4
±
0.5 inHgA/min. (4.7
±
1.7 kPa)
Vacuum
6.0
±
0.5 inHgA (20.3
±
1.7 kPa)
Rate:
1.0
±
0.5 inHgA/min. (3.4
±
1.7 kPa)
Release
(Filtered
Air):
28.0
±
0.5 inHgA (94.8
±
1.7 kPa)
Rate:
2.0
±
0.5 inHgA/min. (6.6
±
1.7 kPa)
Aeration (Hot Cell)
Duration:
At
least
8
hours
Temperature:
110
±
10 ºF (43 ºC)
CAUTION:
The Mikro-Tip transducer should not be used earlier than 5 days after sterilization.
