OptiCross™ 6 - Directions for Use
OptiCross 6
™
40 MHz Coronary Imaging Catheter
A flush port with a one-way check valve (Figure 1) is used to flush
the interior of the catheter body and maintain a flushed condition.
The catheter must be flushed with heparinized saline prior to use,
as this provides the acoustic coupling media required for ultrasonic
imaging. The one-way check valve helps retain saline in the
catheter during use.
Contents
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
WARNING
Contents supplied STERILE using a Radiation process. Do not
use if sterile barrier is damaged. If damage is found, call your
Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission
of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death
of the patient.
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
Carefully read all instructions prior to use. Observe all
contraindications, warnings, precautions and adverse events
noted in these directions. Failure to do so may result in patient
complications. Boston Scientific relies on the physician
to determine, assess and communicate to each patient all
foreseeable risks of the procedure.
DEVICE DESCRIPTION
The OptiCross 6 (40 MHz Coronary Imaging Catheter) is a
sterile, short rail imaging catheter.
It consists of two main assemblies:
1. Imaging Core
2. Catheter Body
The imaging core is composed of a hi-torque, flexible, rotating
drive cable with a radial looking 40 MHz ultrasonic transducer
at the distal tip. An electro-mechanical connector interface at
the proximal end of the catheter makes the connection to the
Motordrive Unit (MDU5 PLUS™) Instrument. The MDU5 PLUScatheter interface consists of an integrated mechanical drive
socket and electrical connection.
The catheter body is comprised of three sections:
1. Distal Imaging Window Lumen
2. Proximal Shaft Lumen
3. Telescoping Section
The distal imaging window lumen and proximal shaft lumen
sections comprise the “working length” of the catheter, and
the telescoping section remains outside of the guiding catheter.
The catheter body has a distal imaging window lumen with
proximal exit at 1.6 cm from the distal end (Figure 1). A radiopaque
(RO) marker is embedded in the catheter body at 0.5 cm from the
distal tip. In addition, two insertion depth markers are located
on the proximal shaft lumen at 90 cm and 100 cm from the distal
tip to aid in estimating catheter position relative to the distal
guide catheter tip. The proximal shaft lumen is attached to the
telescoping section via a strain relief connection.
The telescoping shaft (section) allows the imaging core to be
advanced and retracted for 15 cm of linear movement. The
corresponding movement of the transducer occurs from the
proximal end of the guidewire exit port to the proximal end
CV 01
OptiCross 6 (40 MHz Coronary Imaging Catheter)
MDU5 PLUS Sterile Bag
17.78 cm (7 in) extension tube
3 cm³ (3 cc) and 10 cm³ (10 cc) syringes
4-way stopcock
INTENDED USE/INDICATIONS FOR USE
This catheter is intended for ultrasound examination of coronary
intravascular pathology only. Intravascular ultrasound imaging is
indicated in patients who are candidates for transluminal coronary
interventional procedures.
CONTRAINDICATIONS
Use of this imaging catheter is contraindicated where introduction
of any catheter would constitute a threat to patient safety. The
contraindications also include the following:
• If resistance is met upon withdrawal of the catheter, verify
resistance using fluoroscopy, then remove the entire
system simultaneously. A catheter that is forcibly removed
may cause vessel injury or patient complications.
• When readvancing a catheter after deployment of stent(s),
at no time should a catheter be advanced across a
guidewire that may be passing between one or more stent
struts. A guidewire may exit between one or more stent
struts when recrossing stent(s). Subsequent advancement
of the catheter could cause entanglement between the
catheter and the stent(s), resulting in entrapment of
catheter/guidewire, catheter tip separation and/or stent
dislocation. Use caution when removing the catheter from
a stented vessel.
• Inadequately apposed stents, overlapping stents, and/or
small stented vessels with distal angulation may lead to
entrapment of the catheter with the stent upon retraction.
When retracting the catheter, separation of a guidewire
from an imaging catheter or bending of the guidewire may
result in kinking of the guidewire, damage to the catheter
distal tip, and/or vessel injury. The looped guidewire or
damaged tip may catch on the stent strut resulting in
entrapment.
• If multiple insertions are required, the catheter should not
be disconnected from the MDU5 PLUS to avoid possible
breach of catheter sterility.
• Bacteremia or sepsis
PRECAUTIONS
• Major coagulation system abnormalities
• Do not attempt to connect the catheter to electronic
equipment other than the designated Systems because the
catheter may not function properly.
• Patients diagnosed with coronary artery spasm
• Patients disqualified for CABG surgery
• Patients disqualified for PTCA
• Severe hemodynamic instability or shock
• Use of the imaging catheter to cross a total occlusion
WARNINGS
• Do not use device after indicated ‘Use By’ date. Use of an
expired device could result in patient injury due to device
degradation.
• Intravascular ultrasound examination of coronary anatomy
should be performed only by physicians fully trained in
interventional cardiology or interventional radiology and
in the techniques of intravascular ultrasound, and in the
specific approach to be used, in a fully-equipped cardiac
catheterization lab.
• The catheter has no user serviceable parts. Do not attempt to
repair or to alter any component of the catheter assembly as
provided. Using an altered catheter can result in poor image
quality or patient complications.
• No modification of this equipment is allowed.
• Air entrapped in the catheter and flushing accessories can
cause potential injury or death. Always verify that the catheter
and flushing accessories have been properly cleared of air
prior to inserting the catheter into the vasculature.
• Do not pinch, crush, kink or sharply bend the catheter at any
time. This can cause poor catheter performance, vessel injury
or patient complications. An insertion angle greater than 45° is
considered excessive.
• Never advance or withdraw the imaging catheter without
fluoroscopic visualization because it may cause vessel injury or
patient complications.
• Do not advance the catheter if resistance is encountered.
The catheter should never be forcibly inserted into lumens
narrower than the catheter body or forced through a tight
stenosis. A catheter that is forcibly advanced may cause
catheter damage resulting in vessel injury or patient
complications.
• When advancing the catheter through a stented vessel,
catheters that do not completely encapsulate the guidewire
may engage the stent between the junction of the catheter
and guidewire, resulting in entrapment of catheter/guidewire,
catheter tip separation, and/or stent dislocation.
• Never attempt to attach or detach the catheter while the
motor is running. To do so may damage the connector.
• If difficulty is encountered when backloading the guidewire
into the distal end of the catheter, inspect the guidewire
exit port for damage before inserting the catheter into the
vasculature. The use of a damaged guidewire exit port
could increase the resistance of catheter advancement or
withdrawal.
• Never advance the imaging catheter without guidewire
support because it can cause difficulty in reaching the
intended region of interest or can cause the distal catheter
tip to kink.
• Never advance the distal tip of the imaging catheter
near the very floppy end of the guidewire. This part of
the guidewire will not adequately support the catheter.
A catheter advanced to this position may not follow the
guidewire when it is retracted and cause the guidewire to
buckle into a loop which the catheter may drag along the
inside of the vessel and catch on the guide catheter tip. If
this occurs, it may be necessary to remove the catheter
assembly, guidewire and the guide catheter together. If the
catheter is advanced too near the end of the guidewire,
advance the guidewire while holding the imaging catheter
steady. If this fails, withdraw the catheter and guidewire
together.
• Never advance or withdraw the imaging catheter without
the imaging core assembly being positioned at the most
distal position of the imaging window because it may
cause the catheter to kink.
• During and after the procedure, inspect the catheter
carefully for any damage which may have occurred during
use. Multiple insertions may lead to catheter exit port
dimension change/distortion which could increase the
chance of the catheter catching on the stent. Care should
be taken when re-inserting and/or retracting catheter to
prevent exit port damage.
• Always turn the MDU5 PLUS “OFF” before withdrawing the
imaging catheter because it could cause the motor drive to
overload.
ADVERSE EVENTS
The risks and discomforts involved in vascular imaging include
those associated with all catheterization procedures. These
risks or discomforts may occur at any time with varying
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2015-11
< en>
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of the distal imaging window lumen. The telescope section has
proximal markers for lesion length assessment, consisting of a
series of marks spaced 1 cm apart on the telescope body.
• Allergic reaction
• Angina
• Cardiac arrest
• Cardiac arrhythmias including, but not limited to ventricular
tachycardia, atrial/ventricular fibrillation and complete
heart block
• Cardiac tamponade/Pericardial effusion
• Death
• Device entrapment requiring surgical intervention
• Embolism (air, foreign body, tissue or thrombus)
• Hemorrhage/Hematoma
• Hypotension
• Infection
• Myocardial infarction
• Myocardial Ischemia
• Stroke and Transient Ischemic Attack
• Thrombosis
• Vessel occlusion and abrupt closure
• Vessel trauma including, but not limited to dissection and
perforation
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: 30% to 85%
Atmospheric Pressure: Uncontrolled
Storage Environment
Ambient Temperature: 20°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 both the 3 cm3 (3 cc) and 10 cm3 (10 cc) syringes with
heparinized saline. Connect the 3 cm3 (3 cc) and 10 cm3 (10 cc)
syringes to 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
cm3 (10 cc) syringe is to be used as a reservoir for refiling the 3
cm3
(3 cc) flushing syringe.
4. Flush the imaging catheter TWICE on the prep table
continuously with 3 cm3 (3 cc) volume each time. DO NOT 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 cm3 (10 cc) syringe as needed and reattach to 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 3-5 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 still be present in the catheter. Flush the catheter
again with 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 cm3 (3 cc) volume syringe and coil the catheter and
set 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 cm3 (3 cc) volume syringe.
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.
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Boston Scientific (Master Brand DFU Template 8.2677in x 11.6929in A4, 91001201AA), eDFU, MB, OptiCross 6, en, 91062654-01A
frequency or severity. Additionally, these complications may
necessitate additional medical treatment including surgical
intervention and, in rare instances, result in death.
Imaging Catheter Information
Note: Since the iLab™ System are identical with respect to the ultrasound generator, the acoustic
output values provided above also apply to the iLab System with MDU5 PLUS.
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.
ACOUSTIC OUTPUT – COMPLIANCE TO IEC 60601-2-37
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).
Prudent-Use Statement
It is the responsibility of the system operator to understand the risk of the acoustic outputs
generated by the Imaging System and its associated imaging catheters. It is also the operator’s
responsibility to act appropriately to mitigate such risks. To that end, Boston Scientific Corporation
has reported Mechanical and/or Thermal Indices that may exceed the requirements of IEC 606012-37.
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:
Please note that the Mechanical Index (MI) displayed on the system’s screen has not been
corrected for finite amplitude effects.
Iin situ = lwaterexp(–0.069fczsp)
Imaging Catheter Information
where lin situ is the estimated in situ intensity, Iwater is the measured intensity in water, fc is the
center frequency of ultrasound in MHz, and zsp is the distance from the 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 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.
IEC requirements for measurements and definition of terms may be found in IEC 60601‑2‑37 –
“Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.”
ACOUSTIC OUTPUT REPORTING TABLE FOR TRACK 1
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.
Auto-Scanning Mode
Transducer Model: OptiCross™ 6 (40 MHz Coronary Imaging Catheter)
ACOUSTIC OUTPUT REPORTING TABLE
(In accordance with IEC 60601-2-37)
B
System Model: iLab™ Ultrasound Imaging System with MDU5 PLUS™
Application(s): Index Label
Fetal Imaging & Other
Maximum index value
Note: The US FDA guidance document “Information for Manufacturers Seeking Market Clearance
of Diagnostic Ultrasound Systems and Transducers” dated September 9, 2008 classifies
intravascular ultrasound within the application(s) “Fetal Imaging & Other” to determine the
maximum allowable acoustic output energy. The catheter is not intended for fetal imaging.
Associated
Acoustic
Parameters
ACOUSTIC OUTPUT
MI
ISPTA.3
(mW/cm2)
ISPPA.3
(W/cm2)
Global Maximum Value
0.302
5.89
100.01
0.026
0.026
40.30
40.30
pr.3
(MPa)
W0
(mW)
fc
(MHz)
zsp
(cm)
Beam
Dimensions
Operating
Control
Conditions
40.30
0.075
0.039
y-6
(cm)
0.040
(µsec)
0.054
(Hz)
(cm)
0.303
Elev.
(cm)
0.053
(mW)
min. of [Pα (zs), Ita,α (zs)]
(mW)
zs
(cm)
zbp
(cm)
zb
(cm)
z at max. Ipi,α
(cm)
Dim of Aaprt
7680
Az.
P
fawf
0.054
7680
(MPa)
deq (zb)
0.075
(cm)
PRF
EDS
1.37
x-6
PD
Associated
Acoustic
Parameters
pr,α
Other
Information
Operating
control
conditions
All intensities and total power have uncertainty of +28.7% to –23.4%.
All pressure values have uncertainty of +14.3% to –11.7%.
All center frequency values have uncertainty of +7.78% to –7.78%.
TIS-Scan
0.005
1.37
0.026
0.075
(cm)
(MHz)
40.30
40.30
X (cm)
0.055
Y (cm)
0.057
td
(µsec)
0.054
prr
(Hz)
7680
pr at max. Ipi
(MPa)
1.53
deq at max. Ipi
(cm)
Ipa.3, at max. MI
No operator controls affecting
acoustic output
MI
0.302
(W/cm2)
100.01
There are no user controls that affect the catheter values provided in this table.
All intensities and total power have uncertainty of +28.7% to –23.4%.
All pressure values have uncertainty of +14.3% to –11.7%.
All center frequency values have uncertainty of +7.78% to –7.78%.
TERMINOLOGY
Term
Definition
Units
MI
Mechanical Index, defined as MI = pr.3 /(fc )
ISPTA.3
Derated Intensity, Spatial Peak Temporal Average
ISPPA.3
Derated Intensity, Spatial Peak Pulse Average
pr.3
Derated Peak Negative Pressure at a location of the maximum
derated pulse intensity integral
MPa
W0
Total Power
mW
fc
Center frequency
MHz
zsp
Distance in the z axis direction where the measurements were taken
cm
x-6 and y-6
–6 dB dimensions for In Plane (azimuth) and Out of Plane (elevation)
at the x-y plane where zsp is obtained
cm
PD
Pulse duration
µs
PRF
Pulse repetition frequency
Hz
EDS
Entrance dimensions of scanning for azimuth and elevation to a plane
cm
1/2
n/a
mW/cm2
W/cm2
3
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Operating Mode: WARRANTY
TERMINOLOGY
Term
MI
Definition
Mechanical Index, defined as MI =
n/a
pr,αfawf-1/2
CMI
CMI
1 MPa MHz-1/2
pr,α
Attenuated peak-rarefactional acoustic pressure
MPa
fawf
Acoustic working frequency
MHz
P
Output power
mW
TIS-Scan
Soft tissue thermal index
n/a
z
Distance from the source to a specified point
cm
Aaprt
–12 dB output beam area
cm2
td
Pulse duration
µs
prr
Pulse repetition rate
Hz
pr
Peak-rarefactional acoustic pressure
Ipa,α
Attenuated pulse-average intensity
Ipi
Pulse-intensity integral
J/m2
Ipi,α
Attenuated pulse-intensity integral
J/m2
n/a
MPa
W/cm2
9
1
4
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design
and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties
not expressly set forth herein, whether express or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of merchantability or fitness for a particular
purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors
relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s
control directly affect the instrument and the results obtained from its use. BSC’s obligation under
this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable
for any incidental or consequential loss, damage or expense directly or indirectly arising from the
use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any
other or additional liability or responsibility in connection with this instrument. BSC assumes no
liability with respect to instruments reused, reprocessed or resterilized and makes no warranties,
express or implied, including but not limited to merchantability or fitness for a particular purpose,
with respect to such instruments.(
Units
10
5
7
3
8
6
2
Figure 1. OptiCross™ 6 (40 MHz Coronary Imaging Catheter)
1. Telescoping Shaft
Boston Scientific (Master Brand DFU Template 8.2677in x 11.6929in A4, 91001201AA), eDFU, MB, OptiCross 6, en, 91062654-01A
2. Imaging Core
3.Transducer
4. Proximal Hub
5. Flush Port & Check Valve
6. Guidewire
7. Guidewire Exit Port
8. Radiopaque Marker
9. Distal Strain Relief
10.Hydrophilic Coating: 230 mm minimum
Figure 2. Normal test image
4
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MDU5 PLUS™
Sterile Bag
Sterile Bag for MDU5 PLUS
Motordrive Unit
3. The sterile operator unfolds the bag so the “Insert Here”
sticker is on one end and the faceplate is on the opposite end.
4. The sterile operator places their hands into the innermost folds
of the bag, opening the bag for MDU5 PLUS placement by the
non-sterile operator. The “Insert Here” sticker can be used to
easily locate the bag opening (Figure 3).
8. To attach the bag to the MDU5 PLUS, the sterile operator
should align the bag’s faceplate with the nose of the MDU5
PLUS (Figure 7), and gently push to secure the connection.
Do not trap material between the faceplate and the nose.
Extra bag material around and beyond the connection is
normal (Figure 8).
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
WARNING
For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
Ins
ert
He
re
Contents supplied STERILE using a Radiation process. Do not
use if sterile barrier is damaged. If damage is found, call your
Boston Scientific representative.
Figure 7. Attaching the Faceplate
Figure 3. Opening the Bag
5. The non-sterile operator then places the MDU5 PLUS into the
opening, positioning the MDU5 PLUS so that the top of the unit
is aligned with the “This Side Up” sticker on the bag (Figure 4).
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
Carefully read all instructions prior to use. Observe all
contraindications, adverse events, warnings, and precautions
noted in these directions. Failure to do so may result in patient
complications. Boston Scientific relies on the physician
to determine, assess and communicate to each patient all
foreseeable risks of the procedure.
DEVICE DESCRIPTION
Figure 8. Attached Faceplate
This device provides an efficient, conformal covering to fit the
MDU5 PLUS motordrive.
9. When ready to insert the MDU5 PLUS compatible catheter,
remove the sticker from the faceplate and discard
appropriately (Figure 9).
Contents
MDU5 PLUS Sterile Bag (referred to as “bag”)
INTENDED USE/INDICATIONS FOR USE
The MDU5 PLUS Sterile Bag is intended to cover the motordrive
during intravascular ultrasound procedures to maintain the
sterile field and prevent transfer of microorganisms, body fluids
and particulate material to the patient and healthcare worker.
Figure 4. Inserting the MDU5 PLUS
6. The sterile operator then grasps the covered MDU5 PLUS. The
non-sterile operator grips and pulls the tabs until the bag is
unfolded to its full length (Figure 5).
CONTRAINDICATIONS
ADVERSE EVENTS
None known.
PRECAUTIONS
None known.
Figure 9. Removing Sticker
HOW SUPPLIED
10.The bagged MDU5 PLUS is now ready for use.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and Storage
Store in a cool, dry, dark place.
DIRECTIONS FOR USE
A. Inspection Prior to Use
Before use, inspect the packaging for any violation of the
sterile barrier and inspect the bag 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.
WARRANTY
Figure 5. Unfolding the Bag
7. To position the bag, stop advancing the MDU5 PLUS into the
bag as soon as a snug fit is obtained. The sterile operator does
not need to advance the MDU5 PLUS all the way to the bag’s
faceplate. It is normal to have space between the nose of the
MDU5 PLUS and the faceplate on the bag (Figure 6).
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. Covering the MDU5 PLUS
Covering the MDU5 PLUS requires two people – one inside
and one outside the sterile field. Using appropriate sterile
technique:
1. The non-sterile operator opens the pouch containing the bag.
2. The sterile operator removes the bag from the pouch.
Figure 6. Positioned Bag
Boston Scientific Corporation (BSC) warrants that reasonable
care has been used in the design and manufacture of this
instrument. This warranty is in lieu of and excludes all other
warranties not expressly set forth herein, whether express
or implied by operation of law or otherwise, including, but
not limited to, any implied warranties of merchantability
or fitness for a particular purpose. Handling, storage,
cleaning and sterilization of this instrument as well as other
factors relating to the patient, diagnosis, treatment, surgical
procedures and other matters beyond BSC’s control directly
affect the instrument and the results obtained from its use.
BSC’s obligation under this warranty is limited to the repair
or replacement of this instrument and BSC shall not be liable
for any incidental or consequential loss, damage or expense
directly or indirectly arising from the use of this instrument.
BSC neither assumes, nor authorizes any other person to
assume for it, any other or additional liability or responsibility in
connection with this instrument. BSC assumes no liability with
respect to instruments reused, reprocessed or resterilized and
makes no warranties, express or implied, including but not
limited to merchantability or fitness for a particular purpose,
with respect to such instruments.
5
Black (K) ∆E ≤5.0
Boston Scientific (Master Brand DFU Template 8.2677in x 11.6929in A4, 91001201AA), eDFU, MB, OptiCross 6, en, 91062654-01A
None known.
EC
REP
EU Authorized
Representative
AUS
Australian
Sponsor Address
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone 1800 676 133
Free Fax 1800 836 666
ARG
Argentina
Local Contact
Para obtener información de
contacto de Boston Scientific
Argentina SA, por favor, acceda al
link www.bostonscientific.com/arg
Legal
Manufacturer
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
Do not use if package
is damaged.
Recyclable
Package
© 2015 Boston Scientific Corporation or its affiliates.
All rights reserved.
Black (K) ∆E ≤5.0
Boston Scientific (Master Brand DFU Template 8.2677in x 11.6929in A4, 91001201AA), eDFU, MB, OptiCross 6, en, 91062654-01A
Boston Scientific Limited
Ballybrit Business Park
Galway
IRELAND
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