General Use Of The Steerable Sheath; For Transseptal Use Of The Steerable Sheath; Defl Ecting And Straightening The Steerable Sheath; Removing The Steerable Sheath - OSCOR DESTINO REACH Manual

steerable sheath" for instructions.

9.2 General Use of the Steerable Sheath

Warning: If the patient has left bundle branch block, back up pacing
should be readily available during insertion of the steerable sheath assembly. Use of the steerable sheath assembly may cause heart block.
1. Select appropriate size of the sheath for the device to be delivered.
2. Follow standard access procedures to the desired branch within the venous structure.
3. Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve. Note: Any device/component inserted through the
hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing of the seal and leakage.
4. When appropriate, insert the guidewire according to its own Instructions for Use.
5. Insert the sheath assembly over the guidewire to access the main branch being accessed.
6. Do not force the steerable sheath assembly if signifi cant resistance is encountered during the insertion or passage. If resistance is encountered, determine
the cause and correct before continuing the procedure.
7. Aspirate all air from the sheath by connecting the syringe to the sideport with stopcock.
8. When in desired position, snap off the dilator from the sheath and slowly pull it out to prevent air ingression.
9. Refer to "Defl ecting and straightening the steerable sheath" for instructions.
10. Remove slowly the dilator when access in desired vasculature is reached.
11. Remove slowly the guidewire.
12. Deliver the device through the sheath hemostatic valve following its own Instructions for Use.
13. The sheath sideport with stopcock can be used throughout the procedure to aspirate or deliver liquids.
14. Assemble the dilator and sheath together until the dilator hub snaps into the sheath hub.
NOTE: Any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing
of the seal and leakage. In some cases, a valve bypass tool (VBT) might be used to ease the insertion of the device through the valve. Improper use of a valve
bypass tool (VBT) can cause air embolism and back bleeding.

9.3 For Transseptal Use of the Steerable Sheath

Warning: If the patient has left bundle branch block, back up pacing should be readily available during insertion of the steerable sheath assembly. Use of the
steerable sheath assembly may cause heart block.
1. Follow the Instructions for Use that were supplied with the transseptal needle (not supplied) and the guidewire. If a transseptal needle is used, it is
recommended to use together with a stylet in order to prevent skiving of the inner lumen of dilator.
2. Select appropriate size of the sheath for the device to be delivered and appropriate sheath length to match the transseptal needle. Refer to transseptal
needle Instructions for Use for needed sheath length.
3. Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.
4. Place dilator inside the sheath and snap on both hubs together. Thread the dilator/sheath assembly over the guidewire, using a slight reaching motion.
Note: Any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent
tearing of the seal and leakage.
5. Aspirate all air from the sheath by connecting the syringe to the sideport.
6. Advance the sheath/dilator assembly into the superior vena cava, just above the right atrium.
7. Separate the dilator and sheath hub approximately 1 cm. This will aid the introduction of the curved transseptal needle.
8. Slowly remove the guidewire from the dilator. Remove all air from the dilator by slowly aspirating blood and then fl ush the dilator. Then completely fl ush
the transseptal needle.
9. Introduce the properly prepared transseptal needle into the dilator hub. Carefully advance the curved section of the needle into the dilator, being certain
not to restrict the movement of the needle.
10. Re-attach the dilator and sheath hubs.
11. While maintaining the sheath position, slowly advance the curved section of the needle until it is about to protrude from the dilator tip. Good right atrial
pressure should be observed before proceeding.
12. Position the needle and sheath set in the right atrium. Verify position under fl uoroscopy.
13. Position dilator and needle point against the atrial septum in the region of the fossa ovalis by gradually rotating the needle posterior and toward the left
scapula during withdrawal. Use continual pressure monitoring and repeated anterior-posterior and lateral visualization of the tip under fl uoroscopy during
all positioning procedures.
14. Advance the needle and complete the transseptal puncture.Measure the left atrium pressure immediately after needle penetration. Do not advance the
dilator if the pressure is not acceptable.
15. Advance the dilator with the needle in place through the septum. Acceptable left atrial pressure should be continually observed. A sequential increase in
resistance to movement followed by a sharp decrease in resistance will indicate location of the dilator in the left atrium.
16. Withdraw the needle point with the dilator tip. The dilator with the needle point within should be freely located in the left atrium. Verify with fl uoroscopy.
17. Advance the sheath slowly over the dilator-needle combination until it is in the left atrium. A slow rotating motion of the sheath as fi rm pressure is applied
will aid in this procedure. The sheath will be in position when a sharp reduction of resistance is felt.
18. Advance the sheath approximately 2 cm into the left atrium while maintaining the dilator/needle position.
19. After disconnecting the pressure monitoring line from the needle, slowly remove the needle from the dilator.
20. Slowly remove the dilator from the sheath. Caution: Rapid removal may damage the valve membrane resulting in blood fl ow through the valve.
21. Attach the sheath sideport to the monitoring line. Gently aspirate blood through the sideport for sampling and to make sure the sheath is clear of air. Blood
should aspirate freely through the sideport.
22. Under fl uoroscopy, frequently observe the location of the radiopaque tip marker to maintain the location of the sheath in the left atrium.
23. Refer to "Defl ecting and Straightening the Steerable Sheath" for instructions.
24. Introduce the catheter through the hemostatic valve into the left atrium. Improved catheter manipulation may be obtained by withdrawing the sheath into
the right atrium. The sheath should be returned to the left atrium over the catheter prior to removing the catheter.
25. For removal of the sheath please refer to the instructions "Removing of the Steerable Sheath."
26. After removal of the sheath, use standard technique to achieve hemostasis.
9.4 Defl ecting and Straightening the Steerable Sheath
The Destino Reach steerable guiding sheath features a defl ecting distal tip for site specifi c placement of the sheath and subsequent device(s) within the intra-
cardiac, renal or other periphery. The defl ection mechanism is controlled by operator manipulation of the rotating collar handle.
1. Twist the defl ection collar slowly and carefully to defl ect the distal tip. Caution: The sheath will defl ect at the speed which the defl ection collar is turned.
Avoid rapid defl ection that may cause vessel damage.
2. When the desired defl ection point or site access is achieved, stop turning the defl ection collar.
Caution: To ensure retention of the desired defl ection position(s), avoid contact with the defl ection collar that may cause the sheath to change defl ection
shape. Do not defl ect the sheath with dilator or with the device inserted.
Caution: When in the defl ected position, the steerable guiding sheath should not be rotated while encountering resistance since that could severely
damage the vessel, heart chamber, or anatomy of the patient.

9.5 Removing the Steerable Sheath

Warning: Before removing the steerable sheath, straighten the distal section to avoid damage during removal. Refer to "Defl ecting and Straightening the Steer-
able Sheath" for instructions.
1. Remove any device from the steerable sheath prior to retracting the sheath.
2. Straighten the distal tip by rotating the collar to the straight position.
3. Slowly retract the device from the body, if resistance is met, stop retracting the device and ensure that the tip is in the straight position.
4. Discard the steerable sheath after it has been removed from the body.

10. Storage

The sheath and dilator should be stored at temperatures between 5° C and 30° C (41° F - 86° F). Do not expose product to excessive light, including sun light
or ultraviolet light, or excessive humidity. Store product in a cool, dark and dry place.

11. Handling

• Avoid subjecting the device to unusual stresses. Handle the steerable sheath with care at all times.
• Before removing the steerable sheath from packaging, straighten the distal section as much as possible to avoid damage during removal. Refer to "Defl ect-
ing and straightening the steerable sheath" for instructions.
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