Imediplus DS101 User manual

IMEDIPLUS INC.
Special Submission
Electronic Stethoscope
DS101
Section 13
Document Title: Electronic Stethoscope DS101 User Manual
File Name: 003_Electronic Stethoscope DS101 User Manual

Document Title:
Electronic Stethoscope DS101 User Manual
Document No.:
DS101-SDUS01-01303
Page:
2of 50
Product Name:
Electronic Stethoscope DS101
Ver.:
A1
510(k) File Name:
003_Electronic Stethoscope DS101 User Manual
Date:
2017/8/26
Model name: DS101
Feature
Auscultation for heart, Anterior/Posterior chest, neck, bowel, limbs arteries, veins and internal
organs.
Heart rate detection.
Real time recording and playing of auscultation sounds.
Recording multiple sounds in one patient and up to 160 10-second auscultation sound tracks.
Clear acoustic performance.
With auscultation sound amplify ability to 27dB and 10 volume level adjustable.
Ergonomic Design.
Easy to use.
Rx only

Document Title:
Electronic Stethoscope DS101 User Manual
Document No.:
DS101-SDUS01-01303
Page:
3of 50
Product Name:
Electronic Stethoscope DS101
Ver.:
A1
510(k) File Name:
003_Electronic Stethoscope DS101 User Manual
Date:
2017/8/26
Content
1. Introduction .................................................................................................4
2. Safety Information .......................................................................................4
2.1 Symbol Definitions ..................................................................................5
2.2 Important Safety Information..................................................................6
3. Product Description ....................................................................................8
4. Intended Use................................................................................................9
5. Operator Profile ...........................................................................................9
6. Patient Privacy.............................................................................................9
7. Instructions for Use...................................................................................10
7.1 Stethoscope Interface ...........................................................................10
7.2 Replacing Battery ..................................................................................10
7.3 Removing and applying the eartube. ...................................................11
7.4 Removing and applying the ear-tip. .....................................................12
7.5 Adjust Headset for Comfort ..................................................................13
7.6 Replacing the chestpiece......................................................................14
7.7 Replacing the disposable diaphragm(Silicon and PS) .......................14
7.8 Stethoscope construction.....................................................................16
7.9 OLED display shows information.........................................................17
8. Operation Description...............................................................................18
9. DS101_DM Software (Data Management)................................................26
10. Product Parts List..................................................................................38
11. Cleaning..................................................................................................39
12. Warranty .................................................................................................40
13. Troubleshooting.....................................................................................40
14. Maintenance and Repair........................................................................42
15. Transportation, Storage, and Disposal ................................................42
16. Specification...........................................................................................43
17. Appendix: Guidance and Manufacturer’s Declaration.錯誤! 尚未定義書
籤。
18. FCC and IC Compliance Statement ......................錯誤! 尚未定義書籤。9

Document Title:
Electronic Stethoscope DS101 User Manual
Document No.:
DS101-SDUS01-01303
Page:
4of 50
Product Name:
Electronic Stethoscope DS101
Ver.:
A1
510(k) File Name:
003_Electronic Stethoscope DS101 User Manual
Date:
2017/8/26
1. Introduction
Thank you for choosing our Electronic Stethoscope DS101.
This useful stethoscope will be a great aid in your auscultation.
It has several smart and friendly design, which makes it easy to use and
properly fit the needs for users. The design includes an easy-to-use interface
that enable the users to approach the patient with one hand. The ear-tips are
comfortable to wear with the soft texture. As well, it could provide a good
tightness for reduction of environmental noise to offer a good sound quality
for users.
Electronic Stethoscope DS101 was innovated from a group of healthcare
professionals. Therefore, the user experience is an important factor of
designing the stethoscope. We appreciate for your adoption of Electronic
Stethoscope DS101 and look forward to your valuable feedback
2. Safety Information
Please read, understand, and follow all safety information contained in these
instructions prior to using this electronic stethoscope. Retain these
instructions for future reference.

Document Title:
Electronic Stethoscope DS101 User Manual
Document No.:
DS101-SDUS01-01303
Page:
5of 50
Product Name:
Electronic Stethoscope DS101
Ver.:
A1
510(k) File Name:
003_Electronic Stethoscope DS101 User Manual
Date:
2017/8/26
2.1 Symbol Definitions
Explanation of Safety Markings and Symbols
Warning
Consult instructions for use.
Indicates Type BF Equipment: The equipment provides
protection against electrical shock and electrical current
leakage. Applied parts are considered to be the complete
chest-piece with diaphragm.
This product and packing does not contain natural rubber
latex.
Temperature Limit
This product contains electrical and electronic components
and must not be disposed of using standard refuse collection.
Please consult local directives for disposal of electrical and
electronic equipment.
This product uses wireless Bluetooth communication.
Rx only Federal law restricts this device to sale by or on the order of
a physician.
Explanation of Signal Word Consequences
NOTICE
Indicates a hazardous situation, which, if not avoided, may
result in property damage.
WARNING
Indicates a hazardous situation, which, if not avoided, could
result in minor injury and/or property damage.