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13. Infection at the access site
14. Death
15. DVT Deep Vein Thrombosis
HOW SUPPLIED
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your Vascular Insights™ representative. Do not use if labeling is
incomplete or illegible.
HANDLING AND STORAGE
Store in a cool dry place. This product is intended to be used in a typical office environment with a
temperature between 20°C and 40°C, RH <75% and <2000M Altitude.
DISPOSAL INSTRUCTIONS
After use, dispose of the products used in the procedure per institutional protocol.
PLEASE NOTE that the ClariVein® MDU unit contains a 9V DC battery, which is not intended for
removal. As such, the entire product, including the MDU is considered an infected medical device
and is fully disposable as medical/biohazard waste and is not intended to be included in used
electronic equipment recycling programs.
OPERATIONAL INSTRUCTIONS
Procedural Accessory Devices and Agents
Prior to use, carefully read and understand the respective manufacturer's instructions for procedural
accessory devices and solutions intended for use including warnings, cautions, potential side effects
and contraindications.
Patient Preparation
1.
Use sterile technique per institutional protocol.
2.
Medicate patient as appropriate.
3.
Prepare and drape the puncture site.
4.
Select an appropriately sized access device to accommodate the ClariVein® OC. Recommended
access device should be equal to or greater than a 4F introducer or 18G Short Peripheral
Catheter.
5.
Administer local anesthetic at puncture site as needed per institutional protocol.
6.
Prepare and place the access device per manufacturer's instructions.
Device Preparation
1.
Inspect the product package prior to opening. Do not use if package is opened or damaged.
2.
Use sterile technique to carefully remove the tray from the pouch and the contents from the tray.
3.
Inspect the device to be certain there are no visible signs of damage. Do not use if contents are
damaged.
4.
Remove Battery Terminal Insulator Tab from the MDU and discard. (Figure 2, Item 12)
5.
Confirm that the MDU has power by engaging the trigger (Figure 2, Item 10) and confirming the
Green Indicator Light is illuminated. (Figure 2, Item 13)
NOTE: The Dispersion Wire will not rotate if Green Indicator Light does not illuminate.
6.
To attach the Check Valve turn clockwise onto the Catheter Assembly injection port. (Figure 1,
Item 2; Figure 3, Item 14)
7.
Flush normal saline (USP 0.9%) through the Check Valve and Catheter Injection Port to confirm a
secure connection and patent catheter. (Figure 1, Item 2)
CAUTION: If leak is detected, reconfirm syringe and Check Valve connections. Do not use if a
leak persists.
8.
Fill the 5 mL syringe with agent to be infused. (Figure 3, Item 15)
Catheter Assembly Positioning
1.
Utilize vascular imaging guidance (e.g. ultrasound) to thread the ClariVein's OC coaxial Catheter
Sheath and Dispersion Wire through the access device to the desired position within the
peripheral vasculature.
Joining Catheter Assembly to the Motor Drive Unit (MDU):
1.
Maintain position of the catheter and dispersion tip within the peripheral vessel.
2.
Hold the Guide Wing and advance the MDU onto the Catheter Assembly's Cartridge for initial
mating in the alignment channel Position 1 (Figure 2, Item 7; Figure 4). Exercise care not to bend
or kink the proximal end of the catheter.
NOTE: Once placed into Position 2, the Catheter Assembly is not removable from the MDU.
3.
Using vascular imaging guidance confirm that the Dispersion Wire Tip remains in desired
position. Adjust as needed.
4.
Place the Cartridge in the final position on the MDU by simultaneously advancing the MDU while
applying slight pressure on the Syringe Locking Support. The Cartridge will snap into alignment
Position 2.
NOTE: The electrical circuit is now armed and the Dispersion Wire Tip is now unsheathed.
5.
Snap the syringe into the MDU Syringe Locking Support and ensure it is fully engaged. (Figure
2, item 9)
6.
Utilizing vascular imaging guidance, reconfirm that the Dispersion Wire Tip remains in desired
position within the vessel. Adjust as needed.
ROTATABLE DISPERSION WIRE ACTIVATION:
1.
Employ an aseptic technique during removal from the package and use.
a. L – low, 2,000 RPM
b. M1 – medium, 2,500 RPM
c. M2 – medium high, 3,000 RPM
d. H – high, 3,500 RPM
2.
Activate rotation of the Dispersion Wire by depressing the Trigger (Figure 2, Item 10).
Catheter Sheath Marking Guide
BLACK: A single 'hash' mark denotes 1 cm increment; and a double 'hash' mark denotes 10 cm
increment.
WHITE: A single 'hash' mark denotes approximately 8 cm from the Dispersion Wire Tip when the
Dispersion Wire is unsheathed.
Procedural Steps
1.
Slowly withdraw the device through the treatment area while simultaneously infusing the
physician-specified agent.
•
Recommended technique:
‐
Depress the syringe plunger with the thumb of the same hand that is holding the MDU.
(Figure 4).
‐
A pull back rate of 1-2 mm/second is recommended.
•
Recommendation: While the Dispersion Wire is rotating, hold the MDU with one hand,
while using the other hand to securely grasp the catheter proximal to the access site
between two fingers and pullback ensuring the catheter does not kink or become
damaged.
‐
Orient the Catheter/Wire to maintain a straight position and to avoid creating a kink or an
acute bend between the vascular access site and MDU.
CAUTION: A kink could cause damage to the device or patient injury.
CAUTION: Do not exert excessive force when withdrawing or advancing the catheter. If
resistance is encountered determine if remedial action is necessary. Failure to do so may
result in device damage or patient injury.
2.
Adjust the Dispersion Wire rotation speed as desired.
3.
Continue the infusion procedure.
4.
After approximately one third of the total treatment is complete, check to determine that
desired agent dispersion has been achieved. If adequate dispersion has not been achieved, it
may be necessary to repeat the infusion and dispersion of the agent.
NOTE: Resheath the Dispersion Wire by moving the Guide Wing from Position 2 to Position 1 in
the Mating Alignment Channel prior to advancing the Dispersion Wire Tip to the desired position
and repeat Procedural Steps 1-3.
5.
With approximately half of the vessel's targeted infusion length remaining, slide the access
device to the most proximal end of the Catheter Assembly.
6.
While the catheter is still within the vessel, use vascular imaging to verify that the desired
outcome has been achieved.
7.
Re-sheath the Dispersion Wire Tip by moving the Guide Wing to Position 1 before removing
catheter from the patient. Disable the MDU:
a. Disengage the syringe from the Syringe Locking Support on the MDU. (Figure 2, 9)
b. Rotate the Catheter Assembly to unlock from Position 2. (Figure 4)
c. Move the Catheter Assembly Guide Wing's Cartridge to the mating alignment channel
Position 1. (Figure 4)
NOTE: Moving the Guide Wing into mating alignment channel Position 1 will re-sheath the
Dispersion Wire Tip and prevent the wire from rotating while removing device from patient.
NOTE: The Catheter Assembly cannot be separated from the MDU.
Post-Procedure:
1.
Dispose of the products and packaging per institutional protocol.
2.
Institute appropriate post-procedural patient care.
ELECTROMAGNETIC COMPATABILITY
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the accompanying documents.
Portable and Mobile RF communications equipment can effect medical electrical equipment.
WARNING The use of accessories, other than those specified, may result in increased emissions
or decreased immunity of the equipment. The equipment should not be used adjacent to other
equipment; and if adjacent to the equipment should be observed to verify normal operation in the
configuration in which it will be used.
Guidance and Manufacturer's Declaration - Emissions
The ClariVein® OC is intended for use in the electromagnetic environment specified below. The
user should ensure that it is used in such an environment.
Emissions
Compliance
Electromagnetic Environment – Guidance
Test
RF Emissions
Group 1
The ClariVein® OC uses RF energy only for its internal function.
CISPR 11
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF Emissions
Class B
The ClariVein® OC is suitable for use in all establishments,
CISPR 11
including domestic, and those directly connected to the public
low-voltage power supply network that supplies buildings
Harmonics IEC
N/A
used for domestic purposes.
61000-3-2
Flicker IEC
N/A
61000-3-3
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