Bioventus EXOGEN Guia Del Usuario página 16

Technical Information
EXOGEN Operating Specifications
Ultrasound frequency 1.5 +/- 5% MHz
Modulating signal burst width 200+/- 10% microsecond (µs)
Repetition Rate 1.0+/- 10% kilohertz(kHz)
Duty Factor 20%
Effective radiating area (ERA) 3.88 +/- 1% square cm (cm
Temporal average power 117 +/- 30% milliwatts(mW)
Spatial avg.-temporal avg. (SATA) 30+/- 30% mW/cm
Beam non-uniformity ratio (BNR) 4.0 maximum
Battery 3.7 VDC, 700 mAh
Battery Type Lithium-ion
Input Voltage (USB) 5.0 VDC, 2.6A max.
Beam type Collimated
The essential performance of EXOGEN includes the following:
• Free from the display of incorrect numerical values (numbers) associated
with the ultrasound therapy
• Free from the production of unwanted ultrasound output
• Free from the production of excessive ultrasound output
• Free from the production of unintended or excessive transducer surface temperature
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EXOGEN Classifications
Guidance and manufacturer's declaration – electromagnetic emissions
EXOGEN has the following classifications:
• Internally Powered Equipment
EXOGEN is intended for use in the electromagnetic environment specified below. The customer or the user
• Type BF Applied Part of EXOGEN should assure that it is used in such an environment.
• EXOGEN device: IP-22 protection against Emissions Test
ingress of water
RF emissions
• Transducer: IP-67 protection against ingress of dust
CISPR 11
• Equipment not suitable for use in the presence of a
flammable anaesthetic mixture with air or with
RF emissions
oxygen or with nitrous oxide. CISPR 11
Harmonic emissions
• Mode of operation – Intermittent
IEC 61000-3-2
Voltage fluctuations /
Guidance and Manufacturer's
flicker emissions
Declaration – Electromagnetic
IEC 61000-3-3
Emissions and Immunity Testing
Electromagnetic
Compatibility Testing
Summary: Testing Report for:
Bioventus LLC.
Equipment Under Test: EXOGEN
®
Used for Life Support: No
Use in shielded enclosure: No
Compliance Electromagnetic environment – guidance
Group 1 EXOGEN uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic equip-
ment.
Class B EXOGEN is suitable for use in all establishments other than domestic and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Class A
Complies
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