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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
Recording Auscultation Organ and
Recording
Recording
Recording
Auscultation Organ and
Auscultation Organ and
Auscultation Organ and
Position for Sound Track
Position for Sound Track
Position for Sound Track
Position for Sound Track
Recording setting
Recording setting
Recording setting
Recording setting
Recording pause
Recording pause
Recording pause
Recording pause
Time Display
Time Display
Time Display
Time Display
Date Display
Date Display
Date Display
Date Display
Organ Display
Organ Display
Organ Display
Organ Display
Sleep mode
Sleep mode
Sleep mode
Sleep mode
Sleep mode wake- - - - up
Sleep mode wake
Sleep mode wake
Sleep mode wake
Heart Rate Detection
Heart Rate Detection
Heart Rate Detection
Heart Rate Detection
phonocardiography display
phonocardiography display
phonocardiography display
phonocardiography display
Data Wire e e e less Transfer
Data Wir
less Transfer
Data Wir
Data Wir
less Transfer
less Transfer
Sound Tracks Recording (Files
Sound Tracks Recording (Files
Sound Tracks Recording (Files
Sound Tracks Recording (Files
Storage)
Storage)
Storage)
Storage)
17. Appendix: Guidance and Manufacturer's Declaration
The DS101 is intended for use in the electromagnetic environment (for professional healthcare) specified below.
The customer or the user of the DS101 should assure that it is used in such an environment.
Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
/flicker emissions IEC
61000-3-3
Electronic Stethoscope DS101 User Manual
up
up up
Manufacturer's declaration-electromagnetic emissions
Compliance
Group 1
Class A
Not applicable
Not applicable
Yes
10 sec, 20 sec, 30 sec, 40 sec
> 5 sec
00:00:00 (hour: minutes: second)
XXXX-XX-XX (year-month-date)
Heart / Lung / Posterior Chest/ Neck / Bowel
2min / 5min / 10min / never
2 sec
Yes (Heart Organ display), 30-180 bpm
Yes, 3 second display
Bluetooth 4.0
Save up to 160 10-second patient sound tracks
Electromagnetic environment-guidance
(for professional healthcare environment)
The DS101 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
equipment.
The DS101 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.
Page:
44 of 50
Ver.:
A1
Date:
2017/8/26
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