Transonic TS420 - TS420 Module Directions for Use

24 AU-OPR-400Ser-EN,
Rev D
CHRONIC APPLICATION
For chronic implants, the Probe must be secured in place to maintain its proper alignment with the vessel
without impeding ow once the preparation is closed. Standard Probe/reector combinations come
factory-prepared with suture holes and eyelets to allow for this suturing. The proper method to secure
a Probe in place depends on the application site: Transonic
®
Surgical and Technical Application Notes
offer some tried and proven methods. Generally, three sutures sufce to secure a Probe’s position and
orientation (often for an PS-Series Probe with sliding cover, two sutures through the reector brackets
and one around the Probe cable). For Probes supplied with silicone sheathing, sutures also may be made
through the silicone. If standard suture placements are not satisfactory for your application, contact
Transonic
®
for a custom Probe modication. For only chronic measurements, no ultrasonic couplant is
necessary during implantation. Fibrous encapsulation of the Probe within the rst week of implant will
yield a stable, air bubble-free coupling.
FLOW MEASUREMENTS
The digital display presents the average volume ow value in mL/min or L/min. The analog meter registers
ow proportional to the Flowprobe scale (at low ow range the needle deection will increase four fold).
Choose the appropriate [Filter] setting for average or pulsatile applications.
INVERT FLOW
Use the [Invert] button to change the display and outputs to the correct polarity. Some Probes have
arrows on the Probe head indicating the positive direction of ow. To determine direction of ow in
unmarked Probes, place the Probe head in water and move the Probe back and forth noting when the
Module reads positive and negative ow. It is recommended to place the Probe according to easiest
surgical access and [Invert] the ow if necessary.
LOW FLOW RANGE
Use the [Range] button to switch to “Low Flow” for increased sensitivity at low ow rates. Before
switching to “Low Flow” check to ensure that peak pulsatile ows will not be cut off as this will cause
inaccurate readings. The maximum value at the low ow scale is ve times the 1 volt scale value.
CLEANING AND STERILIZATION
For complete cleaning instructions see “Cleaning & Sterilization of Transonic
®
Research Flowprobes”
(AU-IFU-RProbeSteril-EN) provided with each Probe.
Disassemble Probe before use, keeping all of the parts of each Probe together because parts are not
interchangeable among Probes. Thoroughly wash the Flowprobe and its reector bracket in soap and
warm water (≤ 55°C, 130°F). Remove any visible foreign material with a soft-bristled brush. Reinstall the
reector bracket in the alignment groove recessed on either side of the Probe body taking care not to
distort the shape of the groove or bracket. Proper reector alignment is crucial for measurement accuracy.
The CM4-style (4-pin) implantable connectors can be cleaned following standard scrubbing procedures
but cannot be taken apart because it is hermetically sealed. The CRA10 (10-pin) connector should not be
submerged but may be cleaned with alcohol-wipes. The Flowprobe should never be boiled or autoclaved.
STERRAD
®
or standard cold (≤ 60°C, 140°F) ethylene oxide gas sterilization is acceptable. The Probe may be
rinsed and wiped in 70% isopropyl alcohol before sterilization.
● If a connector becomes wet, drying overnight in an incubator oven (≤ 60°C, 140°F) is recommended.
● Inspect cables routinely for damage.
● Store the dry Probe at room temperature.
PAU Ultrat Liners are single use and should be properly disposed of according to local regulations.
TS420 Module: Directions For Use