English
3
• Reference
Viperslide
®
Lubricant product IFU for
product handling.
11. Equipment, Setup, and Test
11.1. Equipment
In addition to the OAS components, equip the
operating room with the following:
• Introducer, guide sheath, or guide catheter - see
Appendix B for sizing recommendations
•
Standard IV pole with five wheels and a 20 inch
diameter base
• 1000 mL bag of normal saline
• Fluoroscopic imaging equipment
• Standard hospital grade, electrical wall outlet
• Other equipment, as needed, for interventional
procedures
11.2. OAS Pump Set Up
1. Use the IV pole screw clamp to attach the
OAS pump to a standard IV pole making sure
to attach the OAS pump to the IV pole at a
distance not greater than 60 in (153 cm) from
the floor to the top edge of the OAS pump.
2. Hang the low saline level sensor and cord, by
the closed loop, from the horizontal arm of the
standard IV pole.
3. Plug the low saline level sensor connector into
the back of the OAS pump (Figure 5).
Figure 5.
Plug in the low saline level sensor
4. Verify that the power cord is connected to the
back of the OAS pump.
5. Insert the other end of the power cord into the
electrical wall outlet.
Warning:
To avoid risk of electric shock, this
equipment must only be connected to a supply
mains with protective earth.
Warning:
Ensure the power cord connection
to the OAS pump and the on/off switch is
accessible at all times.
Caution:
Do
not
allow fluid to leak onto
electrical connections of the OAS pump.
11.3. Preparing the Bag of Saline and
Lubricant
Ensure that the OAS pump is powered off by
pressing the
Master Power
switch on the back
of the OAS pump to off and ensure that no LEDs
are illuminated on the OAS pump control panel
(Figure 6).
Figure 6.
OAS Pump control panel
A. Low saline red LED indicator
B. Prime button
C. Start button and green LED indicator
D. Status yellow LED indicator
1. Prepare a full 1000 mL bag of normal
saline solution with lubricant. Refer to the
ViperSlide
®
Lubricant Instructions for Use for
lubricant preparation instructions.
2. Hang the prepared saline bag with lubricant
from the low saline level sensor on the
standard IV pole.
Caution:
Do
not
use glass bottles for the
saline solution with lubricant or hang multiple
saline bags from the low saline level sensor
as this will disable the Low Saline Information
signal.
11.4. Connecting the OAD to the OAS Pump
Remove the sterile saline tubing from the OAD
package and pass the saline bag spike end of the
saline tubing out of the sterile field. Connect the
other end of the saline tubing luer to the device
luer. Additionally, pass the OAD power cord out of
the sterile field.
Perform the following:
1. Connect the saline tubing to the saline bag
with lubricant using standard institution
procedures.
2. Open the door, located on the front of the OAS
pump, by rotating the door in the direction of
the arrow (Figure 7).
3. Place the saline tubing over the pump rollers
so that the tubing positioners align with the top
and bottom V-guides on the pump (Figure 7).
Figure 7.
Placing the saline tubing within the OAS
Pump
A. Saline tubing positioners
B. Saline tubing
C. V-guides
D. OAS Pump door
4. While closing the door, verify that there is no
pinching of the saline tubing and ensure that
there is slack in the saline tubing between the
OAS pump and saline bag with lubricant.
5. Verify that the saline tubing is properly
inserted into the saline tubing V-guides and
that there are no kinks or damage to the saline
tubing.
6. Press the
Master Power
switch, on the back
of the OAS pump, and verify that the red or
yellow LED is illuminated on the OAS pump
control panel.
7. Connect the OAD power cord to the OAS
pump.
8. Remove the driveshaft from the dispenser coil.
9. Purge air from the OAD and the saline tubing
as follows:
a. Verify that the saline tubing is connected
to the OAD.
b. Press the green
Start
button on the OAS
pump control panel to start saline flowing
through the saline tubing. Verify that the
green LED illuminates.
c. Press and hold the
Prime
button on the
OAS pump control panel to purge air from
the saline tubing. Continually pressing the
Prime
button will pump saline through the
tubing at an increasing flow rate. Releasing
the
Prime
button will decrease the flow to
the low flow rate after two seconds.
d. Verify that saline is exiting from the OAD
sheath near the crown.
e. Continue priming to ensure there are no air
bubbles within the saline tubing and use
standard hospital procedures to aspirate or
purge air from the lines.
f. After verifying there are no air bubbles
within the saline tubing, discontinue
priming.
Warning:
Do
not
attempt aspiration
through the OAD or saline line while
placed within the body. If saline is pulled
out through the OAD or saline line, air may
enter the system.
11.5. Testing the OAD
11.5.1 Testing OAD Crown Advancement
Before inserting any portion of the OAD into the
body, ensure that axial movement of the OAD
crown advancer knob will produce smooth travel
of the crown.
Caution:
Do
not
spin the crown during this test.
1. Ensure that the crown advancer knob is in
the unlocked position as this will allow free
axial travel of the crown advancer knob.
2. While visually monitoring the crown, slowly
move the crown advancer knob in a back
and forth motion. The maximum travel
of the crown advancer knob, and the
corresponding maximum travel of the shaft
tip, is 5.9 inches (15 cm).
11.5.2 Optional: Testing OAD Crown Rotation
This test is optional, but is performed
chronologically after testing crown
advancement.
Note:
Hold the guide wire firmly during the test.
When the test is complete, the OAD is ready for
use and the guide wire can be inserted through
the introducer, guide sheath, or guide catheter.
1. Push the crown advancer knob fully
proximal, away from the nose of the handle,
and release the guide wire brake before
threading the guide wire through the OAD
drive shaft.
2. Grasp the proximal end of the guide wire
and thread the guide wire through the
opening in the OAD drive shaft distal tip.
Caution:
Do
not
operate the OAD if there is
a bend, kink, or tight loop in the guide wire.
A bend, kink, or tight loop in the guide wire
may cause damage to and malfunctioning of
the OAD during use.
3. Continue feeding the guide wire into the
OAD drive shaft until the guide wire appears
at the rear of the OAD.
4. Lock the guide wire in place by pressing
down on the guide wire brake lever as the
crown will not spin if the guide wire brake is
unlocked.
5.
Verify that saline is still flowing freely out of
the saline sheath tip. Verify that the saline
tubing is properly connected to the saline
bag, that the saline tubing routes correctly
through the saline tubing guides, and that
the saline tubing is properly connected to
the OAD.
6. Hold the OAD sheath a few centimeters from
the crown while making sure that the crown
is not in contact with any objects. Verify
there is no pinching of the OAD sheath at
any time during OAD operation.
7. Press and release the
On/Off
button located
on top of the crown advancer knob to
activate crown rotation. The OAD is preset
to low speed, and the illuminated LED on the
OAD will indicate that the OAD is operating
at low speed.
8.
Check that the flow of saline is increasing
and that the shaft and crown are beginning
to spin.
9. Immediately press and release the
On/Off
button to stop the shaft and crown from
spinning and to complete the test.
11.6. Initiating the Atherectomy Procedure
1.
Gain vessel access using the physician’s
preferred methodology.
2. Access the treatment site with an
appropriately sized introducer, guide sheath,
or guide catheter.
Note:
For radial access, use a preferred guide
catheter or guide sheath of an appropriate
length.
3. Use angiography to locate, visualize, and
evaluate the lesion.
4.
If desired, use the thumb and index finger to
gently impart a slight curve or J-shape to the
distal spring tip of the
ViperWire
®
Peripheral
Guide Wire.
5. If use of the guide wire torquer is desired,
attach the torquer to the guide wire by holding
the distal end of the torquer and rotating the
proximal end counterclockwise to tighten.
6. Approach and cross the lesion, with the
ViperWire
®
Peripheral Guide Wire, using the
physician’s preferred methodology.
12. OAS Directions for Use
12.1. Performing the Atherectomy Procedure
1. Ensure that the OAD guide wire brake lever is
open (in the up position).
2. Lock the crown advancer knob at 1 cm from
the fully proximal position.
3. While keeping guide wire placement
stationary, advance the OAD drive shaft over
the
ViperWire
®
Peripheral Guide Wire and
through the hemostasis valve.
4. Under direct visualization, gently advance the
OAD crown over the
ViperWire
®
Guide Wire
to a position approximately 1 cm proximal to
the lesion. Verify that the OAD distal tip is not
within the lesion when the crown and drive
shaft begin to spin.
(Optional)
Use the
GlideAssist
®
mode feature
to facilitate advancing the OAD crown over the
ViperWire
®
peripheral guide wire. This feature
is only available on 1.25mm Micro OAD.
a. Enable
GlideAssist
®
mode by pressing
and holding the low speed button. Release
the button once the low speed light begins
to slowly blink. The slowly blinking light
indicates
GlideAssist
®
mode is enabled.
b. Ensure the
guide wire is secure
by
locking the guide wire brake or by holding
the guide wire with either fingers or the
guide wire torquer.
c.
Press and release the On/Off button on
top of the crown advancer knob to activate
crown rotation. The low speed light
will rapidly blink indicating the crown is
spinning in
GlideAssist
®
mode.
d. Stop the OAD crown rotation by pressing
and releasing the On/Off button on top of
the crown advancer knob. The low speed
light will slowly blink indicating the OAD
is no longer spinning but continues to be
in i mode.
e. Disable
GlideAssist
®
mode by pressing
and immediately releasing any speed
button while the crown is not spinning.
The low speed light will stop blinking, yet
remains illuminated indicating the OAD is
now in treatment mode.
Warning:
Spinning the crown using
GlideAssist
®
mode can be done with
the OAD guide wire brake lever in either
the locked or unlocked position. If using
GlideAssist
®
mode with the guide wire
brake in the unlocked position, the
guide
wire must be held
using either fingers or
the guide wire torquer. If using the guide
wire torquer, ensure that it is securely
fastened to the guide wire before starting
to spin using GlideAssist
®
mode.
Note:
If the brake configuration is changed
from either the locked or unlocked position
while spinning in GlideAssist mode, the
crown will automatically stop spinning yet
the OAD will remain in GlideAssist mode.
5. Inject contrast medium through a port in the
hemostasis valve to verify that the size of the
crown is compatible with the treatment area
diameter (see Appendix C).
6. Verify that the guide wire spring tip is distal to
the lesion and is not in danger of coming in
contact with the advancement of the spinning
crown and drive shaft tip.
7. Push down on the guide wire brake lever to
engage the guide wire brake. The crown will
not spin if the guide wire brake is not locked.
8. Unlock and move the crown advancer knob
to the fully proximal position to relieve any
compression in the driveshaft.
9. Press and release the
On/Off
button on top
of the crown advancer knob to activate crown
rotation. The OAD is preset to low speed, and
the illuminated LED on the OAD will indicate
that the device is operating at low speed.
10. Audibly verify that the OAD drive shaft and
crown are orbiting at a stable speed.
11. Slowly advance the crown advancer knob to
begin atherectomy of the lesion at a travel
rate between 1 mm per second and 10 mm
per second. Using imaging, continually verify
that the crown and the crown advancer knob
are moving 1:1 with one another. Ensure that
the OAD handle remains horizontal during the
procedure to minimize saline leakage from
the OAD.
12. Using a series of intermittent treatment
intervals and rest periods, slide the crown
advancer knob to move the crown back and
forth across the lesion always returning to the
proximal side of the lesion when the interval
set is complete.
Warning:
Once the OAD has reached full
speed (as indicated by a stable pitch), do
not
allow the orbiting crown to remain in one
location as it may lead to vessel damage.
Continue to maintain a travel rate between
1 mm per second and 10 mm per second.
A rest period of 30 seconds, is recommended
for every 30 seconds of treatment, with a
maximum treatment time of 8 minutes per
OAD. The OAS pump will emit a beep after
every 25 second interval of treatment time.
Use contrast injections through the introducer,
guide sheath, or guide catheter only during rest
periods to fluoroscopically evaluate results.
Warning:
Maximum total treatment time
should not exceed 8 minutes per OAD.
If
maximum total treatment time is exceeded,
the OAD shaft, crown, and ViperWire
®
Peripheral Guide Wire may begin to
exhibit signs of wear and result in a device
malfunction and possible injury to the patient.
13. Evaluate the reduction of the stenosis.
14. If reduction of the stenosis is not adequate,
perform one of the following:
• Continue to treat the lesion by moving the
crown back and forth across the lesion per
the instructions above.
• Increase the rotational speed of the crown
by using the crown rotation speed buttons
on the handle of the device.
15.
Perform a final angiogram.
12.1.1 Replacing the Bag of Saline and
Lubricant
The low saline level sensor triggers an audible
information signal every 5 seconds, for a total
of 30 seconds, if there is less than 200 mL
(± 100 mL) remaining in the bag of saline and
lubricant during a treatment period. If the low
saline level sensor triggers during a rest period,
only the red low saline LED is illuminated.
Perform the following to replace the bag of
saline and lubricant:
1. Ensure that the OAS pump is stopped by
pressing the green
Start
button on the OAS
pump control panel and verify that the green
LED, on the OAS pump control panel, is not
illuminated.
2. Prepare a new 1000 mL bag of normal
saline solution with lubricant. Refer to the
ViperSlide
®
Lubricant Instructions for Use for
lubricant preparation instructions.
3. Remove the low bag of saline and lubricant
from the low saline level sensor on the IV
pole.