Product Description
Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides,
conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.
Indications for Use
Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.
Pinpoint™ GT Needle Guides a provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to
assist the medical practitioner in placing the tip of a needle in a specific structure.
Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.
Warnings
• Use the sterile, legally marketed plastic probe cover(s) included in the kit.
• Never use probes that are out of alignment for needle guidance.
• Intended for single use. Do not reuse. Reuse and/or repackaging may create a risk of patient or user infection, compromise the
structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or
lead to injury, illness or death of the patient.
• Do not re-sterilize.
• Do not use if the sterile packaging is damaged.
Cautions
• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all
applicable laws and regulations.
• If the needle is advanced further than the channel end of the needle guide when preparing for a procedure, there is the
possibility of a premature needle stick to the patient or clinician.
• Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
• Only apply commercially available ultrasonic couplant, which has been specifically formulated for use in medical applications, to
the acoustic window (or face) of the probe.
• Use water or rubbing alcohol and a soft cloth to remove couplant from the acoustic window (or face) of the probe. Failure to do
so may scratch the acoustic window.
• Do not allow ultrasonic couplant to dry on the acoustic window (or face) of the probe. If the couplant should dry, use water or
rubbing alcohol and a soft cloth to remove it. Never use a tool of any kind to remove dry couplant from the acoustic window (or
face) of the probe.
• Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to the US FDA
alert titled:
“Medical Alert: Allergic Reactions to Latex-Containing Medical Devices”
. Probe covers included in Pinpoint™ GT Needle
Guide Kits are not made with natural rubber latex.
• Always snap the needle guides on to the probe hook. Do not slide the needle guide on to the needle guide hook, as the sterile
sheath may tear.
Note: For Site~Rite® Ultrasound System warnings and precautions, refer to the applicable Site~Rite® Ultrasound System
instructions for use.
Pinpoint™ GT Needle Guides
Pinpoint™ GT Needle Guides attach to the needle guide hook located on the
probe. Pinpoint™ GT Needle Guides provide guidance for a needle to
intersect an ultrasound beam at a fixed distance below the skin to assist
in placing the tip of the needle in a specific structure.
1— Ultrasound Plane: The ultrasound imaging area.
2— Intersection Depth: When placed through a needle guide,
the needle will intersect the ultrasound plane at the depth
indicated on the needle guide.
3— Example target structure
OK
3
2
1
Draping the Probe for Sterile Use
When using Site~Rite® Ultrasound System probe in a sterile environment, the probe and part of the probe cable must be covered
with a sterile, acoustically transparent plastic sheath.
Warning: Use the sterile, legally marketed plastic probe covers included in the kit.
Caution: Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to
the US FDA alert titled:
“Medical Alert: Allergic Reactions to Latex-Containing Medical Devices”
, issued March 29, 1991. Probe covers
included in Pinpoint™ GT Needle Guide Kits are not made with natural rubber latex.
To drape the probe for sterile use:
1.
Clean and disinfect probe. Refer to Site~Rite® Ultrasound System Instructions
for Use.
2.
Place the probe in a probe holder.
3.
(A) Apply a layer of ultrasonic coupling
gel on the acoustic window of the probe head.
4.
Ensure the probe cover is fully rolled up.
5.
Place the probe cover over the probe head, being careful not to wipe off the
coupling gel.
6.
(B) Cover the probe and cable with the probe cover.
7.
Gently smooth the probe cover over the acoustic window of the probe to
remove any air bubbles or folds in the probe cover.
8.
Secure the probe cover with provided fasteners.
9.
(C) If a second probe cover is provided, follow steps 2-6 to apply. Ensure gel is
applied between all layers of probe covers to assure good acoustic transmission.
10. Apply sterile coupling gel to the covered acoustic window.
11. Discard the probe covers after use, following hospital procedures.
Attaching the Needle Guide to the Probe
To attach the needle guide to the probe:
1.
Choose the appropriate needle guide based on the needle gauge and the
depth of the target structure.
2.
Ensure that a sterile probe cover has been placed over the probe.
See Draping the Probe for Sterile Use.
3.
(D) Clip the short end of the needle guide to the end of the needle guide
hook closest to the top of the probe.
4.
(E) Push the larger end of the needle guide toward the probe until the
needle guide snaps on to the needle guide hook. Do not slide.
Caution: Always snap the needle guide on to the probe hook. Do not slide
the needle guide on to the needle guide hook, as the sterile sheath may tear.
Using the Needle Guides for Vascular Access
Using the Pinpoint™ GT Needle Guides with Pinpoint™ GT Needle Technology
Note: Refer to the Pinpoint™ GT Needle Technology instructions for use included with your Pinpoint™ GT Needle Technology-
enabled Site~Rite® Ultrasound System’s Instructions for Use.
1.
Place the probe against the skin, perpendicular to the target structure, ensuring that the needle guide hook faces away from
the patient’s heart.
2.
While imaging the access target, complete calibration of the Pinpoint™ GT Needle Technology. Refer to the Pinpoint™ GT
Needle Technology instructions for use.
A
B
C
E
D
Pinpoint™ GT Needle Guide Kits
Instructions For Use