Device Description; Intended Use - COOK Medical DP-M350 Instrucciones De Uso

ENGLISH
Cook Doppler Blood Flow Monitor - DP-M350
Federal law restricts this device to sale by or on the order of a physician.

DEVICE DESCRIPTION

The Cook Doppler Blood Flow Monitor (DP-M350) is designed to provide audible (primary) and visual
(secondary) feedback of blood fl ow when connected to Cook-Swartz Doppler Flow Probes and extension
cables. Blood fl ow can be monitored continuously or periodically as required.
System: The Charger for Blood Flow Monitor DP-M350 (DP-M350-CHG1) is to be used with the Cook Doppler
Blood Flow Monitor (DP-M350).
Accessory Items:
Cook-Swartz Doppler Flow Probe
Cook-Swartz Doppler Flow Probe and Extension Cable
Charger for Cook Blood Flow Monitor DP-M350
Doppler Blood Flow Monitor Channel/Cable Verifi er

INTENDED USE

For monitoring blood fl ow in vessels intraoperatively, and following reconstructive micro-vascular
procedures, re-implantation, and free-fl ap transfers.
CONTRAINDICATIONS
None Known.
WARNINGS
• No modifi cation of the Cook Doppler Blood Flow Monitor System (DP-M350) is allowed.
• The Cook Doppler Blood Flow Monitor System (DP-M350) is not for use in the presence of a fl ammable
anesthetics mixture with air or oxygen or with nitrous oxide.
• Portable and Mobile RF communications equipment can aff ect the Cook Doppler Blood Flow Monitor
System (DP-M350) as detailed in table 1 below.
• The Cook Doppler Blood Flow Monitor System (DP-M350) should not be used adjacent to or stacked with
other equipment. If the Cook Doppler Blood Flow Monitor System (DP-M350) must be used under such
conditions please verify the system operates normally.
• The Cook Doppler Blood Flow Monitor System (DP-M350) is not to be used with High Frequency surgical
equipment.
• To isolate equipment from mains remove the battery charger from the AC mains socket.
• If the integrity of the earth ground is in doubt, operate the unit on internal battery power only.
• The Cook Doppler Blood Flow Monitor System (DP-M350) emits and detects 20MHz signals. External 20
MHz signals may also be detected.
• Electrostatic discharges may cause changes to monitor settings. Always verify proper monitor settings
when checking for the audible presence of blood fl ow.
• The use of accessories, transducers, and cables other than those specifi ed for use with the Cook Doppler
Blood Flow Monitor System (DP-M350) as detailed in the technical specifi cations below may result in
increased emissions or decreased immunity of the equipment or system.
Product Catalog Number
DP-SDP001 and DP-SDP002
DP-CAB01
DP-M350-CHG1
DP-MCV01
2
Instructions for Use
FM-2891
FM-2891
FM-2895
Within this IFU