Directions For Use - Boston Scientific OptiCross HD Mode D'emploi

HOW SUPPLIED
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and Storage
Operating Environment
Ambient Temperature: 10 °C to 40 °C
Relative Humidity: 30% to 75%
Atmospheric Pressure: 70 kPa to 106 kPa
Transport Environment
Temperature: -29 °C to 60 °C
Relative Humidity: Uncontrolled
Atmospheric Pressure: Uncontrolled
Storage Environment
Ambient Temperature: 15 °C to 30 °C
Relative Humidity: Uncontrolled
Atmospheric Pressure: Uncontrolled

DIRECTIONS FOR USE

Note: Medical electrical equipment requires special
precautions regarding electromagnetic compatibility (EMC).
This equipment (device) needs to be installed and put into
service according to the EMC information contained within the
documents accompanying the system.
Note: Portable and mobile radiofrequency (RF) communications
equipment can affect medical electrical equipment.
A. Inspection Prior to Use
Before use, inspect the packaging for any violation of the sterile
barrier and inspect the catheter and accessories for any damage
or defects. Do not use potentially contaminated or defective
equipment. If the sterile barrier integrity is compromised
or the contents damaged, contact your Boston Scientific
representative. Prior to imaging, all equipment to be used during
the procedure should be carefully examined to ensure proper
performance. If device appears to be compromised, contact
your Boston Scientific representative.
Prior to use, verify product is within labeled shelf life. Do not
use product if the 'Use By' date has been exceeded. Dispose
of product and packaging in accordance with hospital,
administrative and/or local government policy.
B. Preparation for Catheter Use
1. Refer to the setup section of the User's Guide(s) or Direction
for Use for iLab™ Imaging System, MDU5 PLUS™, MDU5
PLUS Sterile Bag and Automatic Pullback Sled (if used).
Note: All of the following steps have to be performed using
Sterile Technique.
2. Using sterile technique, remove the catheter and
accessories from tray. Retract the movable imaging core
completely to the proximal position via the telescoping shaft.
DO NOT pull too hard while retracting the imaging core.
3. Fill the 3 cm 3 (3 cc) and 10 cm 3 (10 cc) syringes with
heparinized saline. Connect the 3 cm (3 cc) and 10 cm
3
cc) syringes to the 4-way stopcock, with the 3 cm
syringe connected to the inline port of the 4-way stopcock.
Then connect the assembly to the extension tube. Ensure
that all air is expelled from the assembly (syringes, stopcock,
and extension tubing) by flushing, using heparinized saline
in syringes. Connect the extension tube to the one way valve
on the catheter hub. The 10 cm (10 cc) syringe is to be used
3
as a reservoir for refilling the 3 cm (3 cc) flushing syringe.
3
4. Flush the imaging catheter TWICE on the prep table
continuously with 3 cm (3 cc) volume each time. DO NOT
3
USE EXCESSIVE PRESSURE. Move the imaging catheter
over to the procedure table. Ensure that all air is expelled
from the system.
5. Connect the imaging catheter to the MDU5 PLUS by aligning
the catheter hub and the MDU5 PLUS. Push the catheter hub
and MDU5 PLUS together until the hub clicks into place. To
ensure that the hub is fully seated in the MDU5 PLUS, gently
tug on the hub. If catheter identification is incorrect or
missing: See Section G2.
6. Remove catheter carefully from sterile hoop dispenser
coil. Confirm the imaging core is in the fully retracted
position and the catheter is not tightly coiled. Turn on the
MDU5 PLUS and confirm proper function of the catheter by
observing a pattern of partial bright concentric rings on the
monitor (Figure 2).
7. While imaging with MDU5 PLUS, advance the imaging core
to the fully distal position, via the telescoping shaft.
Note: Always turn the MDU5 PLUS "ON" before using the
telescope to advance the imaging core within the catheter.
8. Turn off the MDU5 PLUS. The MDU5 PLUS should remain off
from this point until the catheter is positioned in situ.
9. Refill the 10 cm (10 cc) syringe as needed and reattach to
3
the stopcock without introducing air into the line.
10. To prevent air from being introduced into the catheter
lumen, DO NOT retract the imaging core prior to catheter
placement. Any amount of retraction of the imaging core
prior to catheter placement will require additional flushing.
Note: Where pullback device use is desired, flush the catheter
one more time while the imaging core is in the full distal
position with the catheter installed on the pullback device.
Note: If flushing is difficult with the imaging core in the full
distal position, then manually retract the imaging core 3 mm
-5 mm and re-flush. Then, manually advance the imaging
core to the original full distal position.
Note: Exercise care not to kink catheter while handling.
C. Preparation for MDU5 PLUS Sterile Bag use
Refer to MDU5 PLUS Sterile Bag Directions for Use section.
D. Place Guide Catheter
1. Prepare the entry site with a sheath introducer according to
standard practice.
2. Before insertion of the imaging catheter, ensure the patient
has been prepared using standard procedure for interventional
treatment.
3. Place the guide catheter and Y-adapter. Introduce the
guidewire and advance it to the region of interest.
E. Introduce Imaging Catheter Into Guide Catheter
1. Wet the distal section (approximately 23 cm) of the imaging
catheter sheath with heparinized saline to activate the
lubricious coating. Always wipe down the guidewire with
heparinized saline prior to loading the catheter onto
the guidewire.
2. Backload the guidewire into the distal end of the imaging
catheter (Figure 1). Advance the guidewire into the imaging
catheter until the guidewire exits from the guidewire
exit port.
Note: Guidewires that supply more stiffness near the distal
tips are recommended.
3. Continue to advance the imaging catheter into the guide
catheter up to the exit point using the appropriate proximal
marker as a reference if needed. Tighten the hemostasis
valve on the guide catheter's Y-adapter. Tighten only enough
to prevent fluid/blood leakage. AN EXCESSIVELY TIGHTENED
HEMOSTASIS VALVE MAY DISTORT THE IMAGE DUE TO
BINDING OF THE ROTATING DRIVE CABLE.
4. Turn on the MDU5 PLUS and check to see that the catheter
produces an image. If the image is flickering, some air may
(10
3
still be present in the catheter. Flush the catheter again with
(3 cc)
3
the MDU5 PLUS "ON" (Imaging). DO NOT USE EXCESSIVE
PRESSURE. The image should appear as a single bright
concentric ring. After confirmation of stable image, press
imaging button on MDU5 PLUS to stop imaging.
F. Catheter Placement and Imaging
1. With MDU5 PLUS "OFF" and using fluoroscopy, advance the
imaging catheter over the guidewire until the distal marker
crosses a minimum of 3 cm beyond the region of interest in
the vessel/lesion.
2. Keeping the catheter body and guidewire fixed, turn MDU5
PLUS "ON" and retract the imaging core slowly along its
length of travel (up to maximum of 15 cm) either manually
or using the optional Automatic Pullback Sled to image the
region of interest. Retract and advance as desired.
Note: Always turn the MDU5 PLUS "ON" before advancing
or retracting the imaging core within the catheter.
Note: If the image fades: See Section G3 and G4.
3. When done imaging, fully advance the imaging core and
turn "OFF" the MDU5 PLUS. Maintain the position of the
guidewire and remove the imaging catheter.
4. If the imaging catheter is to be re-inserted, flush once with
3 cm
aside the MDU5 PLUS and Automatic Pullback Sled, if used.
Note: If multiple insertions are required, the catheter should
not be disconnected from the MDU5 PLUS to avoid possible
breach of catheter sterility.
5. When ready to reinsert the imaging catheter, flush one more
time with 3 cm
6. Inspect guidewire exit port prior to re-inserting to verify no
damage occurred during withdrawal.
7. After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
G. Troubleshooting
1. If there is vibration from the catheter telescope section during
advancement of the imaging core, stop imaging. Adjust the
location of the sheath such that the imaging window is as
straight as possible. Reactivate MDU5 PLUS and re-advance
the imaging core. Be aware of potential imaging core
entanglement if catheter is utilized subsequently.
2. If imaging catheter is not recognized by the system, contact
your Boston Scientific representative
before proceeding.
3. If the image fades during use, or if shadowed areas persist
after flushing in situ, the distal imaging window lumen may
contain air bubbles. Remove catheter and repeat flushing
procedure in Section B, Preparation for Catheter Use, step 4.
4. If the image cannot be recovered as a result of flushing,
a drive cable failure or MDU5 PLUS disconnection may
have occurred. Stop imaging and verify that the hub is fully
seated in the MDU5 PLUS. If the hub is fully seated and the
condition persists, withdraw the catheter. Restart the MDU5
PLUS and visually inspect for rotation of the imaging core. If
it is not rotating, return the catheter to your Boston Scientific
representative for analysis.
ACOUSTIC OUTPUT – COMPLIANCE TO US FDA GUIDELINES
ALARA Precaution
There is one scan parameter that can be varied which can
cause a change in the radiated ultrasound field. The motor
speed (frame rate) can vary downwards from its preset value
of 30 frames per second. The maximum in situ intensities will
be generated when the motor speed is 30 frames per second. It
should also be noticed that the gain setting cannot change the
in situ intensity.
Additional acoustic output information can be found in the
operator's manual or user's guide.
Imaging Catheter Information
Acoustic Power Output varies between different models of
imaging catheters. Each imaging catheter supplied by Boston
Scientific Corporation is supplied with Directions for Use (DFUs)
that include statements and tables specifying their acoustic
power outputs.
US FDA guidelines for measurements and definitions of terms
may be found in FDA publication: Information for Manufacturers
Seeking Market Clearance of Diagnostic Ultrasound Systems
and Transducers (September 9, 2008).
Where Mechanical and/or Thermal Indices are reported, the MI/
TI is displayed on the lower right of the IVUS image next to the
imaging catheter identification.
Calculation of Estimated in situ Intensities
The estimated spatial peak in situ intensities are calculated from
the spatial peak water values using the following equation:
I = l
in situ
intensity, I
frequency of ultrasound in MHz, and z
catheter surface to the measurement point in centimeters, 0.075
cm in this case. It should be noted that because of the complex
acoustic properties of living tissue, the estimated in situ intensity
may not be the same as the actual in situ intensity, and therefore,
it should not be interpreted as such.
ACOUSTIC OUTPUT REPORTING TABLE FOR TRACK 1
Auto-Scanning Mode
Transducer Model:
Operating Mode:
System Model:
Application(s):
3
(3 cc) volume syringe and coil the catheter and set
3
(3 cc) volume syringe.
3
exp(–0.069f z ) where l is the estimated in situ
water c sp in situ
is the measured intensity in water, f is the center
water c
is the distance from the
sp
OptiCross ™ HD and OptiCross
(60 MHz Coronary Imaging Catheters)
B
iLab Ultrasound Imaging System
with MDU5 PLUS
Fetal Imaging & Other
™ 6 HD
Black (K) ∆E ≤5.0