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A
•
Use of the connector tool protects the terminal from alligator clip damage and prevents bridging
between terminal contacts.
•
Fully engage the alligator clips on the anode (+) and cathode (-) spring contacts to avoid inaccurate
baseline measurements.
11. Evaluate the lead position as described in the Physician's Lead Manual.
NOTE: Pulse generator measurements may not exactly correlate to the PSA measurements due to
signal filtering.
12. If the measurements do not conform to those stated in the Physician's Lead Manual, remove the PSA
alligator clips from the connector tool, reinsert the stylet and reposition the lead.
•
For an active fixation lead, use the connector tool to retract the helix before repositioning the lead.
Engage the fixation knob on the terminal pin and retract the helix by rotating the fixation knob
counterclockwise. Refer to the Physician's Lead Manual for the expected and maximum number of
rotations to retract the helix.
•
Repeat steps 6-11 until an acceptable position is obtained.
13. Once acceptable measurements are obtained, remove the PSA alligator clips and remove the stylet.
14. Pinch the terminal boot levers and slide the connector tool off of the proximal end of the lead.
For additional information on how and when to use this accessory (including any warnings, precautions,
and other safety information related to its use for the specific procedure being performed), see the literature
accompanying the lead to be implanted.
Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the
relevant local regulatory authority.
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
For customers in the European Union, use the accessory name found in the labeling to search for the
device's Summary of Safety and Clinical Performance, which is available on the European database on
medical devices (Eudamed) website:
https://ec.europa.eu/tools/eudamed
DISPOSAL
CAUTION: Dispose of all items used during a procedure using standard biohazard handling techniques
since they are considered biohazardous.
All items used during a procedure, such as accessories, consumables, and packaging, may be contaminated
with infectious substances. Consider the following to minimize the risk of infection, microbial hazards, or
physical harm:
• Biohazardous waste should be disposed in a biohazard container that is labeled with the biological
hazard symbol and taken to a designated facility for biohazardous waste for proper treatment in
accordance with hospital, administrative, and/or local government policy
• Biohazardous waste should be treated with an appropriate thermal or chemical process
NOTE: Untreated biohazardous substances should not be disposed of in the municipal waste system.
WARRANTY DISCLAIMER
Boston Scientific disclaims all expressed and implied warranties for this product, including without
limitation any implied warranties of merchantability or fitness for a particular purpose. Buyer assumes
all risk of loss or damages arising from use of this product.
B
C
Figure 5.
4
A Partially withdrawn stylet
B Cathode (-) spring contact
C Anode (+) spring contact
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