Preface
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Preface
Intended Use
The Doppler Flow 403 (Model 1425B) ultrasound phantom is intended to provide the user (trained
ultrasound personnel) a reference as part of a quality assurance program for clinical B-Mode, M-
Mode and Doppler Ultrasound systems.
User Needs:
1
A phantom that can:
a. Be used to perform a QC survey of Doppler ultrasound systems at installation.
b. Be used to perform annual QC surveys.
c. Test the flow velocities from constant flow rates to pulsatile flow rates.
d. Mimic the speed of sound, attenuation and echogenicity in blood and tissue.
2
A phantom that is lightweight, durable, easily portable, easy to use and reliable.
Quality and Regulatory Systems
Gammex meets worldwide standards including EN ISO 13485, FDA 21 CFR 820, and IEC 60601-1.
Gammex Quality Management System is certified to 13485 by SGS.
Gammex employs self-certification in the application of the CE mark to this class I device in
accordance with the Medical Device Directive, 93/42/EEC, Annex VII.
Gammex Class I medical products are listed in Europe with the Competent Authority of Germany.
Health and Safety Instructions
For instructions to report health or safety related concerns, see
Reporting Health or Safety Related
WARNING: To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth (ground). Do not
bypass the device’s grounding system.
WARNING: Use only the Gammex-approved power supply that was
shipped with the Doppler 403 Flow Phantom. The power supply is
designed to power the system and charge the Li-ion battery.
WARNING: Do not use the phantom if the power supply or power supply
cord appear to be damaged.
WARNING: Do not immerse the phantom in liquid.
WARNING: Use only Gammex-supplied blood mimicking fluid to ensure
functionality meets specifications. Use of other blood mimicking
material will void your warranty.
WARNING: To avoid fault conditions, check for physical damage to
Doppler 403 Flow Phantom prior to and after each use.
