Cook Medical G21363 - PROBE, DOPPLER, COOK-SWARTZ, DP-SDP001, EACH
Cook-Swartz Doppler Probe Standard Cuff
The Cook-Swartz Doppler Flow Probe contains at its distal end an ultrasound transducer (20 MHz) assembly that is attached to a silicone cuff which is designed to be secured around a blood vessel. Proximal to the cuff, a flexible wire connects the transducer to stress retention tabs and finally to a terminal connector. The CookSwartz Doppler Extension Cable connects the proximal connector of the Probe to either of the Cook Doppler Blood Flow Monitors output channels.
| Order Number | Reference Part Number | MR Status | Cuff Length (mm) |
| G21363 | DP-SDP001 | MR Unsafe | 17.4 |
Intended Use
For monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.
Device Characteristics
| What MRI safety information does the labeling contain? | MR Unsafe |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): | No |
| Device labeled as "Not made with natural rubber latex": | No |
| For Single-Use: | Yes |
| Prescription Use (Rx): | Yes |
| Over the Counter (OTC): | No |
| Kit: | No |
| Combination Product: | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |
Warnings
The Cook-Swartz Doppler Flow Probe emits and detects 20 MHz signals. External 20 MHz signals may also be detected.
MR Unsafe - Do Not expose patient to an MRI procedure while Cook-Swartz Doppler Flow Probe is implanted. Substantial MRI-related heating of the Doppler Flow Probe may occur. Doppler Flow Probe must be removed prior to any MRI procedure. The Cook-Swartz Doppler Flow Probe is not to be used with High Frequency surgical equipment.
Precautions
Not intended for fetal use.
The Cook-Swartz Doppler Flow Probe is NOT FOR USE ON THE CENTRAL CIRCULATORY SYSTEM.
The Cook-Swartz Doppler Flow Probe should only be used with the Cook Doppler Blood Flow Monitor. During use of all ultrasound devices, the operator should minimize the exposure of ultrasound energy to the patient using the principle of ALARA (As Low As Reasonably Achievable). Avoid use of excessive force to remove the transducer assembly from the patient, which may cause injury to the blood vessel. If the transducer assembly can not be removed using gentle traction, the transducer assembly should be removed surgically. Changes in audio signals produced by the Cook Doppler Blood Flow Monitor system should be immediately documented and reported to the responsible healthcare provider.
Caution: Do Not remove the probe conductor wire and crystal assembly (leaving only the cuff in situ on the vessel), until vessel monitoring is completed (commonly 3-5 days). Probe conductor wire and crystal assembly placement must not exceed 29 days. Cuff alone may remain within the patient indefinitely. Avoid the application of electrosurgical energy on or near a connected Cook-Swartz Doppler Flow Probe or extension cable as damage to the monitor may occur.
Potential Adverse Events
Use of the Cook-Swartz Doppler Flow Probe involves potential risks normally associated with any implanted device, e.g., infection, perforation or laceration of vessels, erosion, implant rejection, or device dislodgement/migration. Device specific risks include separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal after monitoring is complete, loss of reception or transmission of ultrasound monitoring signal.
Instructions for Use
IPX7 - Ingress Protection Rating. The distal 28cm of the Cook Doppler Flow Probe which contains the crystal transducer is rated IPX7 - Water Immersible.
- Confirm proper operation of the Cook Doppler Blood Flow Monitor system. (See Suggested Instructions for the Cook Doppler Blood Flow Monitor.)
- Trim curved silicone cuff to accommodate vessel size. The cuff length should allow close approximation of the crystal to the vascular adventitia. Position the silicone cuff around the targeted blood vessel, ensuring that the transducer assembly is directed towards the targeted vessel.
- Secure the free ends of the silicone cuff together around the target vessel, using appropriate sutures or clip to maintain cuff position.
- Stabilize the location of the probe by suturing the braided wire adjacent to the skin incision site, leaving some slack to alleviate tension on the cuff transducer assembly. Enough wire length should be provided so that there is no tension on the vascular anastomosis. Loop any remaining braided wire, and suture or tape to the skin. The retention tab may be placed over the braided wire and sutured or taped to the skin providing additional strain relief.
- Attach the metal connector end of the extension cable (DPCAB01) into either of the two channels by pushing it firmly into place. Attach the proximal (red plastic) connector of the probe to the distal (red plastic) connector of the extension cable, aligning the black dots. Verify appropriate position of the Cook-Swartz Doppler Flow Probe by turning on the flow monitor and adjusting the volume until an adequate audible signal is obtained.
Note: The proximal connector of the Cook-Swartz Doppler Flow Probe should not be attached to the flow monitor/extension cable until the retention tabs are secured to the skin. This helps ensure that accidental tugging of the wires does not disrupt the attachment of the probe to the vessel. - If a strong audible signal is not identified, irrigate the crystal with saline at its interface with the blood vessel adventitia. During irrigation of the crystal, an audible signal from the monitor verifies proper function of the device.
- For operation of the flow monitor, refer to the following suggested INSTRUCTIONS FOR USE for the Cook Doppler Blood Flow Monitor.
- Following verification of proper function of the Cook-Swartz Doppler Flow Probe, close the incision site using standard techniques.
- To remove the Cook-Swartz Doppler Flow Probe, first free the retention tab and braided wires to the skin by cutting the sutures (and/or removing the tape). Remove the probe by applying gentle traction to the braided wires at the skin entry site until the transducer assembly is withdrawn. (The silicone cuff remains in situ.)
- Upon removal of the Cook-Swartz Doppler Flow Probe, examine the distal tip of the probe to ensure that the transducer assembly is present. In the unlikely event that the transducer assembly has become detached and remains in the cuff in the patient, the transducer assembly should be removed surgically.
How Supplied
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.
