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Document Title:
Document No.: DS101-SDUS01-01303
Product Name: Electronic Stethoscope DS101
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
2.2 Important Safety Information
To reduce the risks associated with environmental contamination follow
applicable regulations in local when disposing of this stethoscope. Properly
dispose of, or recycle, spent batteries.
No modification of this device is allowed. Use only authorized service
personal to repair this electronic stethoscope. If user modify by self, solely
responsibility for the consequence.
The Electronic Stethoscope DS101 is MR unsafe. Do not use the Electronic
Stethoscope DS101 in Magnetic Resonance Imaging (MRI) environment.
To reduce the risks associated with an incorrect result, personal injury
and equipment damage, stethoscope shall be stored and operated by
medical professionals only as instructed in this manual.
To reduce the risks associated with infection follow all cleaning and
disinfecting instructions included in this manual. Establish and follow a
cleaning and disinfecting schedule.
To reduce the risks associated with a damage of ear canal, please hold
tight the device to avoid sudden falling and make sure that the soft sealing
ear-tips are snapped firmly into position.
To reduce the risks associated with very strong electromagnetic fields,
avoid using the stethoscope near strong radio frequency signals or portable
and/or mobile RF devices. The stethoscope might be damaged. If you hear
sudden or unexpected sounds, move away from any radio transmitting
antennas.
To reduce the risk associated with an electrical shock, do not use the
stethoscope on patients without the stethoscope's diaphragm cover in place.
The electronic stethoscope DS101 contains a Bluetooth Class 2
wireless data link. The maximum radio frequency field strength generated
by the stethoscope is below three volts per meter, a level that is considered
safe to use with other medical devices. However, audio, video, and other
similar equipment may cause electromagnetic interference. If such devices
are encountered and cause interference, immediately move Electronic
Stethoscope DS101 away from that device.
To reduce the risks associated with a damage of stethoscope, please
Electronic Stethoscope DS101 User Manual
NOTICE
WARNING
WARNING
Page:
6 of 50
Ver.:
A1
Date:
2017/8/26
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