Bioventus EXOGEN Manual Del Usuario página 2

EXOGEN Label Symbol Descriptions and Equipment Classification
SN
WAVEFORM
Caution
Federal Law (U.S.A.) restricts this device to sale, distribution, or use by or on the order of a physician or properly licensed practitioner.
EXOGEN is only intended for use by the individual for whom it is prescribed. EXOGEN is for single patient use ONLY.
THIS DEVICE IS NON-STERILE.
It does not require sterilization before use.
Labeling LBL-000319 [D] RELEASED
Information Symbol: refer to User Guide.
Catalog Number
CE Mark: indicates conformity with European Council Directive of 14 June 1993 concerning Medical Devices (93/42/EEC).
Type BF Applied Part. The transducer, shown in Figure 2 on page 2 is an applied part.
EU: Not for General Waste.
This symbol indicates that EXOGEN should not be disposed of with ordinary household waste at the end of its life. For details
on how to dispose of this device correctly, contact your local government waste disposal agency or your local Bioventus
representative.
Manufacturer
This symbol indicates the authorized representative in the European Community
Serial number (first four digits of the serial number indicate the month and year of manufacture)
Pulsed Signal
Rx Symbol: Federal Law (U.S.A.) restricts this device to sale, distribution, or use by or on the order
of a physician or properly licensed practitioner. This device is only intended for use by the individual
for whom it is prescribed.
Caution symbol: Indicates the need for the user to consult the instructions for use for important cautionary information.