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Doppler Blood Flow Monitor
Device Description
The Doppler Blood Flow Monitor (DP-M350) is designed to provide audible (primary) and visual (secondary) blood flow signals when connected to a
Cook-Swartz Doppler Probe and Doppler Extension Cable. Blood flow may be monitored continuously or periodically, as needed.
The Doppler Charger (DP-M350-CHG1) is intended for use with the Doppler Blood Flow Monitor (DP-M350).
Intended Use
To monitor blood flow during interventional vascular procedures and postoperatively following microsurgical vascular reconstruction in replantation
and free tissue flap transfer.
Cook-Swartz Doppler Probe and Doppler Extension Cable
Device Description
The distal end of the Doppler blood flow probe contains a 20 MHz ultrasound transducer assembly that can be secured around a blood vessel
using a silicone cuff. A flexible lead extends proximally from the transducer through a strain relief to a terminal connector. The Cook-Swartz
Doppler Extension Cable connects the probe’s proximal connector to an output channel on the Doppler Blood Flow Monitor.
Intended Use
To monitor blood flow during interventional vascular procedures and postoperatively following microsurgical vascular reconstruction in replantation
and free tissue flap transfer.
Doppler Blood Flow Monitor
Warnings
．Do not the Doppler Blood Flow Monitor (DP-M350).．Do not use the Doppler Blood Flow Monitor (DP-M350) in the presence of flammable anesthetic mixtures with air, oxygen, or nitric oxide.
．Portable and mobile RF communications equipment may affect the Doppler Blood Flow Monitor (DP-M350), as shown in Table 1.
．Do not use the Doppler Blood Flow Monitor (DP-M350) adjacent to or stacked with other equipment. If such use is necessary, verify that the
system operates normally in that configuration.
．Do not use the Doppler Blood Flow Monitor (DP-M350) with high-frequency surgical equipment.
．To isolate the equipment from the AC mains supply, disconnect the charger from the AC mains outlet.
．If the integrity of the protective earth connection is uncertain, operate the instrument using only its internal battery.
．The original Chinese statement regarding the detection of 20 MHz signals is unclear and requires verification against the
manufacturer’s instructions for use.
．Electrostatic discharge may change the monitor settings. Whenever an audible blood flow signal is confirmed, verify that the monitor settings
are appropriate.
．Using accessories, transducers, or cables that do not comply with the Doppler Blood Flow Monitor (DP-M350) technical specifications may result
in increased emissions or reduced system immunity.
．Do not expose the Doppler Blood Flow Monitor (DP-M350) to temperatures above 65°C (149°F).
．The Doppler Blood Flow Monitor (DP-M350) contains no user-serviceable components and requires no maintenance or calibration.
．If necessary, the DP-M350 lithium-ion battery pack must be replaced at the manufacturer’s service facility by personnel trained by the
manufacturer. Improper replacement may pose unacceptable risks to untrained personnel, the monitor, or the surrounding environment.
．The Doppler Blood Flow Monitor (DP-M350) must be returned to the manufacturer’s service facility for servicing or repair by the manufacturer’s
personnel. If servicing is required, contact the manufacturer or its distributor for return instructions.
．This product is an adjunctive diagnostic instrument and must be used together with primary clinical methods for assessing blood flow and tissue
perfusion. If the system’s audible signal is lost, immediately contact the responsible healthcare team for prompt assessment of tissue perfusion
and determination of whether intervention is required.
Cook-Swartz Doppler Probe and Doppler Extension Cable
Warnings
．Not for fetal use.．Do not use the Cook-Swartz Doppler Probe in the central circulatory system.
．Use the Cook-Swartz Doppler Probe only with the Doppler Blood Flow Monitor.
．As with all ultrasound equipment, operators must follow the ALARA (As Low As Reasonably Achievable) principle to minimize patient exposure to
ultrasound energy.
．Avoid excessive force when removing the transducer assembly from the patient, as this may damage the blood vessel. If the transducer assembly
cannot be removed easily, it must be removed surgically.
．Any change in the audible signal from the Doppler Blood Flow Monitor must be documented immediately and reported to the healthcare team.
．Warning: Do not remove the probe lead and crystal assembly, leaving only the cuff in place around the vessel, until vascular monitoring is complete
, typically after 3–5 days. The probe lead and crystal assembly must not remain implanted for more than 29 days. Only the cuff may remain in the
patient indefinitely.
．Avoid applying electrosurgical energy on or near the Cook-Swartz Doppler Probe or Extension Cable, as this may damage the monitor.
Doppler Blood Flow Monitor
How Supplied
The Doppler Blood Flow Monitor (DP-M350), Doppler Charger, and Doppler Blood Flow Monitor Channel/Cable Verifier are supplied non-sterile.
Cook-Swartz Doppler Probe and Doppler Extension Cable
How Supplied
These devices are intended for single use only. Attempts to reprocess, resterilize, and/or reuse the devices may result in device damage and/or
disease transmission. If the packaging is damaged, do not use the device; discard it.
Disposal
Upon completion of the procedure, dispose of the devices in accordance with applicable regulations for biohazardous waste.
Doppler Blood Flow Monitor
Precautions
．The Doppler Blood Flow Monitor (DP-M350) emits ultrasound energy. As with all ultrasound equipment, operators must follow the ALARA (As LowAs Reasonably Achievable) principle to minimize patient exposure to ultrasound energy.
．The Doppler Blood Flow Monitor (DP-M350) is resistant to splashes and spills; however, care must be taken to prevent liquid ingress.
．Tension on the lead may cause the transducer assembly to separate and detach from the monitored blood vessel. Therefore, do not position the
Doppler Blood Flow Monitor (DP-M350) where the lead may be subjected to tension.
．Any change in the audible signal from the Doppler Blood Flow Monitor (DP-M350) must be documented immediately and reported to the
healthcare team.
．When blood flow is monitored using the LED display, confirm the corresponding audible signal from the system within two hours.
．Avoid applying electrosurgical energy near the Cook-Swartz Doppler Probe or Extension Cable, as this may damage the monitor.
．Not for fetal use.
Cook-Swartz Doppler Probe and Doppler Extension Cable
Potential Adverse Events
1.Use of the Cook-Swartz Doppler Probe involves potential risks commonly associated with implanted devices, including infection, vessel perforation
or laceration, erosion, implant rejection, or device dislodgement/migration.
2.Device-specific risks include separation of the Doppler crystal from the cuff, inability to remove the crystal percutaneously after completion of the
procedure, and poor reception or transmission of ultrasound signals.
Doppler Blood Flow Monitor Charger
1.Read the operating manual carefully before use.
2.This device is intended for indoor use only. Do not expose it to water or dust. Avoid overheating, and do not cover the device during use.
3.The mains socket must be readily accessible. In the event of a malfunction, immediately disconnect the plug from the socket.
4.This product contains hazardous voltages. Do not remove the cover. Contact the manufacturer’s representative to arrange servicing or
maintenance by qualified personnel.
5.This unit is double-insulated (Class II equipment).
The Doppler Charger (DP-M350-CHG1) must be used with the Doppler Blood Flow Monitor (DP-M350).
