IMEDIPLUS DS3011A Users Manual
IMEDIPLUS INC.
510(k) Submission
Electronic Stethoscope
DS3011A
Section 13
Document Title: Electronic Stethoscope DS3011A User
Manual
File Name: 002_Electronic Stethoscope DS3011A User
Manual
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
2 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Feature
Auscultation for heart, Anterior/Posterior chest, neck, bowel, limbs arteries, veins and internal
organs.
Heart rate detection.
Built-in barcode reader for 1D (One dimensional) barcode scanning.
Real time recording and playing of auscultation sounds.
Recording multiple sounds in one patient and up to 600 10-second auscultation sound tracks.
Micro SD memory card for file transmission of auscultation sound tracks.
Friendly design for operation with organ mapping oriented interface
Clear acoustic performance
With 24X auscultation sound amplify ability and 10 volume level adjustable.
Ergonomic Design
Easy to use.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
3 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Content
1. Introduction .................................................................................................................. 4
2. Safety Information ...................................................................................................... 4
2.1 Symbol Definitions ................................................................................................. 4
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
7.2 Insert Battery .......................................................................................................... 11
7.3 Position Headset ................................................................................................... 12
7.4 Adjust Headset for Comfort .............................................................................. 12
7.5 Function Buttons .................................................................................................. 13
7.6 OLED display shows information ................................................................... 15
7.7 Schematic of Menu Page.................................................................................... 16
7.8 Operation Description ......................................................................................... 16
8. PhonoMagics Use ..................................................................................................... 31
8.1 Main Recording Screen ...................................................................................... 33
8.2 Profile Screen ......................................................................................................... 34
8.3 Review Screen ....................................................................................................... 34
9. Assembly Parts List ................................................................................................. 36
10. Accessory Information ....................................................................................... 37
11. Mechanical Dimension ........................................................................................ 38
12. Cleaning ................................................................................................................... 39
13. Warranty ................................................................................................................... 39
14. Troubleshooting .................................................................................................... 40
15. Maintenance and Repair ..................................................................................... 41
16. Transportation, Storage, and Disposal ......................................................... 42
17. Organ Positions Correspond to Recorded File Name ............................. 43
18. Appendix: Guidance and Manufacturer’s Declaration ............................. 45
19. EMC Compliance ................................................................................................... 48
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
4 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Explanation of Safety Markings and Symbols
Warning
Consult instructions for use.
1. Introduction
Thank you for choosing the IMEDIPLUS Electronic Stethoscope DS3011A.
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 included an easy-to-use interface that enable
the users to approach the patient with one hand. Rapid identification of recording
number and user’s identities and 2-step operation for marking the source of the
sound make the valid label while you capture the sound signals.
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.
IMEIDIPLUS Electronic Stethoscope DS3011A 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 IMEDIPLUS
DS3011A 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.
2.1 Symbol Definitions
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
5 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
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.
For ESD sensitivity connector the testing exemption.
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.
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.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
6 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
NOTICE
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 IMEDIPLUS
service personnel to repair this electric stethoscope. If user modify by self,
solely responsibility for the consequence.
The DS3011A is MR unsafe. Do not use the DS3011A in Magnetic
Resonance Imaging (MRI) environment.
WARNING
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.
2.2 Important Safety Information
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
7 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
WARNING
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.
DS3011A 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 DS3011A away from that device and/or turn
the Bluetooth feature OFF.
To reduce the risks associated with a damage of user’s eyes, do not
looking into the illumination beam of barcode reader.
To reduce the risks associated with a damage of stethoscope, please
put the device into the pocket of physician gowns to avoid sudden falling,
when you put the device hanging on the neck.
Do not use the unauthorized accessories, which would be caused hazard.
The accessories use only from IMEDIPLUS provided.
Do not immerse the stethoscope in a liquid or subject it to any
sterilization process. The device might be damaged.
Before first use, battery must be charged continuously for at least 8 hours.
Failure to do so may shorten the battery's lifetime.
Do not use the DS3011A in Magnetic Resonance Imaging (MRI)
environment. Because of DS3011A contain conductive, metallic and
magnetic materials. Those materials include headset, wire, connectors and
inductors, which are assembled in DS3011A.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
8 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
3. Product Description
The IMEDIPLUS Electronic Stethoscope DS3011A picks up the sounds from the
heart, lung, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and
other internal organs from a patient’s body. After detection and amplification, the
sounds are transferred to the user’s ears via an active speaker and passive sound
tubes. It could also identify the recording number by 1-D barcode reader, indicate
the sound location by intuitive keypad, and simultaneously record the sounds from
different sites.
The one-hand user interface includes a full-color OLED display and an intuitive
keypad at the anterior part, a barcode reader at the posterior part, a chest-piece
at the superior part, a tube connector for output of sounds at the inferior part, and
a recording button at the left part. Sound processing is operated with the aid of a
digital signal processor.
In order to transmit sounds to the “PhonoMagics” APP, the stethoscope and device
must be connected via Bluetooth, and in order to fully use certain functions, the
mobile device must be connected to the internet via cellular data connection or WiFi.
The DS3011A uses a Bluetooth Class 2 wireless data link. The Bluetooth range
will be reduced when objects (walls, furniture, people, etc) are between the
DS3011A and a paired mobile device. To improve Bluetooth connection, reduce
the distance and/or allow a line of sight between the DS3011A and mobile device.
It is highly recommended that users of the (PhonoMagics Dashboard and)
PhonoMagics use device and networking security features to protect patient data
created and stored using this software, in addition to security features embedded
in the system. Please consult your institution’s technical services to implement
appropriate security measures.
The DS3011A could also exchange audio data with an external personal
computing device using micro SD card. Every single audio file stored in micro SD
card was labeled with the user’s ID, recording number and indicated position. And
the recorded audio data can only be replayed by DS3011A, but cannot be replayed
by personal computing device.
The DS3011A does not incorporate any off-the-shelf (OTS) software.
DS3011A Document For SGS Certification
The DS3011A operates on one (1) NP-120 lithium battery with an included power
management system to prolong the battery life.
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
9 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
4. Intended Use
The IMEDIPLUS Electronic stethoscope DS3011A is intended for the detection,
amplification and recording of sounds from the heart, lung, anterior and posterior
chest, abdomen, neck, limbs, arteries, veins and other internal organs with
selective frequency ranges. The stethoscope chest-piece is designed for
application to child, adolescent and adult patients. It is used for any subject
undergoing a physical examination and intended only for medical diagnostic
purpose in clinic or hospital.
5. Operator Profile
The IMEDIPLUS Electronic Stethoscope DS3011A is designed to be used by
anyone who wishes to listen to sounds as described in the Intended Use section
above. The user manual provides complete information on how to operate the
DS3011A so that no additional operating training is required.
6. Patient Privacy
The privacy of patient health information may be protected by state, federal, or
international/foreign laws that regulate how such information can be used, stored,
transmitted, and disclosed. The IMEDIPLUS system employs security features
that are compliant with HIPAA policies. Third party access may be prohibited to
such information without obtaining written authorization from the patient.
The user is fully responsible for understanding and following all laws that regulate
storage, transmission, and disclosure of any electronic patient data through the
use of software. If the user becomes unable to comply with a law or restriction that
applies to use and disclosure of such data, the user should not proceed to collect
or save such information.
This application may require entry of individually identifiable health information in
order to function. Records are stored and recalled through the use of patient name,
date of birth, and/or patient ID #. By entering this information, the user assumes
any and all risks of and liabilities incurred with using or transmitting such
information.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
10 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Chest-piece
(Microphone)
OLED
Screen
Keypad
Audio Output
eartube Connector
Barcode
Reader
Micro SD
Card Slot
Recording
Button
7. Instructions for Use
Please read through the user manual carefully before using the product and
operate it according to the user manual. It is advised that you should keep this
manual for reference anytime.
7.1 Stethoscope Interface
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
11 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
7.2 Insert Battery
Insert one NP-120 lithium battery (provided in package) into the IMEDIPLUS
Electronic Stethoscope DS3011A.
Unlock of the battery cap, and then remove the battery cap, as follows.
Insert the battery with correct direction, as follows.
Remount the battery cap, as follows.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
12 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Eartube
Ear-tip
Ear-tip
Eartube
Remove Ear-tip
Apply Ear-tip
7.3 Position Headset
The ear-tips should point in the forward direction as you insert them into your ear
canals. When ear-tips are properly positioned, diaphragm will face towards your
body, as follows.
The user can pull ear-tips away from the eartube to remove the ear-tips, as follows.
The user can push ear-tip firmly onto eartube to apply new ear-tips, as follows.
7.4 Adjust Headset for Comfort
To reduce the spring tension in the headset, hold each eartube at the bend part
near the ear-tips and gradually pull apart until fully extended (180 degrees), as
follows.
To increase spring tension, grasp the headset with one hand where the metal
eartube enter the plastic tubing, and squeeze until the plastic tubing on one
eartube touches the other. Repeat as necessary, as follows.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
13 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Reduce Tension
Increase Tension
Power Button
To turn on the device or enter the sleep mode.
Recording Button
During auscultation (in the HOME page), press recording button to record
auscultation sounds of 10 seconds.
Filter Modes Switch
Lock Button
Filter Modes
Switch (B/D/W)
Power
Button
Four-way and
OK Button
Barcode
Reader Button
Organ Position
Anterior Chest /
Posterior Chest
Switch
Audio Output &
Tube Connector
Recording
Button
7.5 Function Buttons
Number Keys
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
14 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
During auscultation (in the HOME page) and playback the recorded sound track,
this button can select one of the auscultation filter mode, including “Bell”,
“Diaphragm”, and “Wide” modes.
Number Keys
During auscultation (in the HOME page), the “Number” keys on the intuitive
keypad illustrated with heart and lung are used to choose the auscultation position.
For “DATE SET” page, Number keys are used to set the date and time.
Lock Button (Lock/Unlock Switch)
During auscultation (in the HOME page), the “Lock” button is used to “lock” most
of the function keys, besides Recording Button. When pressing the button again,
you will “unlock” the locked status.
Four-way Button and OK Button (Red key)
The “Four-way” button is used for selection.
The “Right” and “Left” keys are used to enter or exit the pages.
The “Up” and “Down” keys are used to adjust the sound amplification level.
Using the “Up” and “Down” can move the indicator upward and downward.
The “OK” button(Red key) is to set and confirm the selection item
Barcode Reader Button
For one-dimensional barcode scanning.
Organ Position Switch
The “Organ Position Switch” is used to change the organ positions among “Heart
and Lung”, “Neck”, and “Bowel”.
A/P CHEST Image Switch (Anterior and Posterior Chest)
A/P CHEST Image Switch is used to change the organ images between “Anterior
Chest” and “Posterior Chest”.
DS3011A Document For SGS Certification
Document Title:
Electronic Stethoscope DS3011A User Manual
Document No.:
DS3011A-SDUS001-01302
Page:
15 of 50
Product Name:
Electronic Stethoscope DS3011A
Ver.:
A1
510(k) File Name:
002_Electronic Stethoscope DS3011A User Manual
Date:
2017/6/23
Volume Level
Date and Time
User’s ID
Position
Auscultation
Recording)
Recording Tips
Heart Rate
Modes B/D/W
Battery Status
Key Lock Icon
Unlock
Lock
Micro SD Card Tip
No micro SD Card
Micro SD Card Full
Blinking
Number
7.6 OLED display shows information
Organ
Position (Red Point
is Under
Auscultation and
Bluetooth
Recording
DS3011A Document For SGS Certification
Auscultation
Loading...