Vascular Insights CLARIVEIN IC Скачать руководство пользователя страница 5

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Figure 1: Catheter Assembly

1. Cartridge

4. Catheter Sheath

2. Injection Port

5. Rotatable Dispersion Wire

3. Guide Wing

6. Dispersion Wire Tip

Figure 2: Motor Drive Unit

7. Mating Alignment Channel 11. Mating Alignment Channel

Position 1 Position 2

8. Speed Selector

12. Battery Terminal Insulator Tab

9. Syringe Locking Support 13. Green Indicator Light

10. Trigger

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ClariVein

is a registered trademark of Vascular Insights

™

, LLC in the United States.

Page 5

Содержание CLARIVEIN IC

Страница 1: ...is a specialty infusion catheter with 360 Rotatable Dispersion Wire connected to a proximally located integral battery powered Motor Drive Unit MDU The MDU includes the Speed Selector handle grip and...

Страница 2: ...ices and solutions intended for use including warnings cautions potential side effects and contraindications Before using ClariVein IC verify proper function and integrity of the device Refer to packa...

Страница 3: ...ral vasculature infusion procedure using the ClariVein IC are similar to those associated with any interventional procedure and include but are not limited to the following 1 Abrupt thrombosis and occ...

Страница 4: ...hnique 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 Ba...

Страница 5: ...ve Unit 7 Mating Alignment Channel 11 Mating Alignment Channel Position 1 Position 2 8 Speed Selector 12 Battery Terminal Insulator Tab 9 Syringe Locking Support 13 Green Indicator Light 10 Trigger __...

Страница 6: ...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 Pl...

Страница 7: ...Wire is unsheathed Procedural Steps 1 Slowly withdraw the device through the treatment area while simultaneously infusing the physician specified agent Recommended technique o Depress the syringe plu...

Страница 8: ...tient 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 Guid...

Страница 9: ...Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000 4 2 6kV Contact 8kV Air 6kV Contact 8kV Air Floors should be wood concrete or ceramic tile If floors are synthetic the r h sh...

Страница 10: ...r can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the ClariVein IC as recommended below according to the max...

Страница 11: ...ility has been foreseen or was foreseeable even if Vascular Insights has been advised of the possibility thereof if and to the extent that Vascular Insights notwithstanding the foregoing is liable for...

Страница 12: ...Sterilized utilizing EO Consult instructions for use Keep away from rain BF Applied part Fragile handle with care Do not resterilize Do not use if package damaged Do not reuse ________________________...

Страница 13: ...ghts com US Patents 7 862 575 7 967 834 8 465 508 8 696 645 and other United States and foreign patents pending 2016 Vascular Insights LLC All rights reserved IFU 001 Rev B ___________________________...