em-tec BioProTT - 13 Manufacturers Declarations; Information on Acoustic Output Data

BioProTT
TM
Flow Measurement System Version 1.00 page 67 of 75
13 Manufacturer's Declarations
13.1 Information on Acoustic Output Data
Ultrasound signals are emitted at a low output power by the BioProTT
TM
Clamp-On
Transducer. The ultrasound signals generated are harmless to persons, protein solutions
(e.g. blood, blood cells) and the environment according to current knowledge, providing
the BioProTT
TM
flow meter and the sensors are used properly.
The Thermal Index (TI) and Mechanical Index (MI) is < 1.0 for all settings of the
BioProTT
TM
flow sensors.
The acoustic measurements have been carried out according to:
- IEC/EN 60601-2-37:2007/2008 Medical Electrical Equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
- FDA Guidance 560:2008 Guidance for Industry and FDA Staff - Information for
Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers
Acoustic Output Data of Clamp-On Transducer
Manufacturer: em-tec GmbH
Sensor type: Clamp-On Transducer CT 1/4" x 1/16" (2.25 MHz) SN: 2010-49039
Operating mode: PW
Parameter
Measured
value
Limit value for 201.12.4.2 Note 1 and 2
Power [mW]
0.3
p- [MPa]
0.11
1
Ispta [mW/cm²]
2.2
100
Iob [mW/cm²]
1.5
20
Table 1: Acoustic output values (table according to IEC/EN 60601-2-37:2007/2008)
Acoustic output values
MI
ISPTA.3
(mW/cm²)
IPA.3@MI
(W/cm²)
Global maximum values
0.07
0.02
0.25
Associated
acoustic
parameters
Pr.3
(MPa)
0.11
W0
(mW)
0.3
0.3
fc
(MHz)
2.25
2.25
2.25
zsp
(cm)
0.44
0.44
0.44
Beam
dimensions
X-6 (cm)
0.49
0.49
Y-6 (cm)
0.33
0.33
PD
(μsec)
7.98
7.98
PRF
(Hz)
1000
1000
EBD
Az. (cm)
0.49
Ele. (cm)
0.41
Operating
conditions
Default
Default
Default
Table 2: Acoustic output values (table for FDA Guideline 560.2008 Track 1 Non-Auto-Scanning Mode)