IMEDIPLUS DS101 Electronic stethoscope User Manual Electronic Stethoscope Omni Steth

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IMEDIPLUS INC.
Special Submission
Electronic Stethoscope
DS101
Section 13
Document Title:ÄĄElectronic Stethoscope DS101 User Manual
File Name:ÄĄ003_Electronic Stethoscope DS101 User Manual
Document Title:
Electronic Stethoscope DS101 User Manual
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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
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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.
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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.
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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.
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2.2 Important Safety Information
NOTICE
z 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.
z 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.
z The Electronic Stethoscope DS101 is MR unsafe. Do not use the Electronic
Stethoscope DS101 in Magnetic Resonance Imaging (MRI) environment.
WARNING
z 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.
z 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.
z 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.
WARNING
z 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.
z To reduce the risk associated with an electrical shock, do not use the
stethoscope on patients without the stethoscope’s diaphragm cover in place.
z 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.
z To reduce the risks associated with a damage of stethoscope, please
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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.
Do not use the Electronic Stethoscope DS101 in Magnetic Resonance
Imaging (MRI) environment. Because of Electronic Stethoscope DS101
contain conductive, metallic and magnetic materials. Those materials include
headset, wire, connectors and inductors, which are assembled in Electronic
Stethoscope.
Do not use for children under two years old. Because the stethoscope
chest-piece is designed for use with child, adolescent and adult patients.
Before first use, battery must be charged continuously for at least 8 hours.
Failure to do so may shorten the battery's lifetime.
To prevent causing battery leaks or damaging their terminals, carefully
follow all instructions regarding the use of batteries.
If battery fluid gets into your eyes, flush your eyes immediately with clear,
cold running water and seek medical attention immediately.
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3. Product Description
When you turn on the Electronic Stethoscope DS101 for the first time, your
authorization to operate this handheld electronic stethoscope is necessary for
the normal mode of operation.
The Electronic Stethoscope DS101 picks up the sounds from the heart,
lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and
other internal organs from a patient's body. When picking up the sounds, the
phonogram of sounds could simultaneously display after pushing the button
'OK' or 'REC' for recording. When you auscultate with DS101, the sounds are
conducted simultaneously to the user's ears bilaterally by active speaker
embedded at the bottom of the DS101. At the meantime, sound processing is
operated with the aid of a digital signal processor.
The one-hand users interface includes a full-color OLED display, below the
OLED display, it has four way button and OK button, a tube connector for
output of sounds at the inferior part, and recording button is on the top of
OLED display.
After turn on the Electronic Stethoscope DS101 and connected with a
wireless device by Bluetooth Class 2, the Electronic Stethoscope DS101
could transmit digital data of recorded sounds via Bluetooth. The effective
range of Bluetooth transmission will be influenced when some objects
blocking between The Electronic Stethoscope DS101 and the connected
laptop. (Such as wall, human big objectives as barrier) Reduce the distance
or allow the line of sight between The Electronic Stethoscope DS101 and the
connected laptop will improve the Bluetooth connection.
The DS101 does not incorporate any off-the-shelf (OTS) software. The
recorded audio data only can be replayed by The Electronic Stethoscope,
and the speaker of effective range from 20 to 1000Hz. The Electronic
Stethoscope DS101 operates on two AAA1.2V rechargeable battery with an
include power management system to prolong the battery life.
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4. Intended Use
The Electronic Stethoscope DS101 is intended for the detection, amplification
and recording of sounds from the heart, lungs, anterior and posterior chest,
abdomen, neck, limbs, arteries, veins and other internal organs with selective
frequency ranges. And the stethoscope chest-piece is designed for use with
child, adolescent and adult patients. It is used for any subject undergoing a
physical examination and intended only for medical diagnostic purposes in
clinic or hospital.
5. Operator Profile
The Electronic Stethoscope DS101 is designed to be used by anyone who
wishes to listen to the sounds as described in the Intended Use section above.
The user manual provides complete information on how to operate the
Electronic Stethoscope DS101. Additional operating training is not proposed.
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. This 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
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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.
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
DEVICE
HEADSET
7.2 Replacing Battery
According to Figure 1, open the battery compartment cover by pulling down
the notch on the cover, and remove the old battery by lifting it. Replace the
new battery with two AAA rechargeable battery. Make sure inserting the new
battery with right position that has notice marked on the inside, then remount
the cover after replacing.
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Figure 1
IMPORTANT!
Please turn off the system before taking out the battery.
NOTICE:
The Electronic Stethoscope DS101 is available to install alkaline or Ni-MH
batteries, the chart below is voltage that alkaline and Ni-MH battery contained.
We highly recommended using rechargeable batteries which contained in the
box for longer operational period.
Voltage
Alkaline
1.5 V
Ni-MH
1.2 V
WARNING: Do not use a battery if it is cracked or broken.
7.3 Removing and applying the eartube.
As shown in the Figure 2, please tightly hold the device for replacing the ear
tubing. Twist the device to counter-clockwise direction to remove the ear
tubing. Please put the ear tubing on the safer position in case of the
unnecessary falling damage. Align the new ear tubing with the two triangle
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marks on the device and directly insert it into the device. Make sure the ear
tubing completely insert into the device with the arrow mark are matching.
Figure 2
7.4 Removing and applying the ear-tip.
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 shown in the Figure 3.
Figure 3
The user can pull ear-tips away from the eartube to remove the ear-tips, as
shown in Figure 4.
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The user can push ear-tip firmly onto eartube to apply new ear-tips, as shown
in Figure 4.
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Figure 4
7.5 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 shown in Figure 5.
Reduce Tension
Increase Tension
Figure 5
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7.6 Replacing the chestpiece
As the Figure 6 shows the position of the chestpiece. Please tightly hold the
device for replacing the chestpiece. Twist the device to counter-clockwise
direction and remove the chestpiece. Please put the chestpiece on the safer
position in case of the unnecessary falling damage. Align the new chestpiece
with the two triangle marks on the device and directly insert it into the device.
Make sure the chestpiece completely insert into the device until hearing the
click sound.
DIAPHRAGM
WITH
CHESTPIECEÄĄ
Figure 6
7.7 Replacing the disposable diaphragm(Silicon and PS)
As shown in the Figure 7, please hold the device and chestpiece tightly for
removing the diaphragm. Pull down and remove the disposable diaphragm
(Silicon) and dispose of it into medical waste bucket. To replace the new one,
place the new diaphragm inside the rim, make sure the ring of the diaphragm
is property and smoothly fit inside the rim groove.
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DIAPHRAGMÄĄ
CHESTPIECEÄĄ
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Figure 7
As shown in the Figure 8, please hold the device and chestpiece tightly for
removing the diaphragm. Pull down and remove the disposable diaphragm
(PS) and dispose of it into medical waste bucket. To replace the new one, tear
the new diaphragm package, hold the device directly bucked up the
diaphragm, and make sure the diaphragm is completely tie up with the device
until hearing the click sound.
NEW
DIAPHRAGMÄĄ
Figure 8
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7.8 Stethoscope construction
VOLUME
OK
LEFT
FREQUENCY
MODE
RECORDING
BUTTONÄĄ
RIGHT
ORGAN
POSITION
SWITCH
POWER
ON/OFF
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7.9 OLED display shows information
Date and Time
Bluetooth
Battery StatusÄĄ
Organ
Position
Auscultation
Position (Red Point
is Under
Auscultation and
Recording)
Auscultation
Modes B/D/W
Heart Rate
Volume Level
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8. Operation Description
ž Power Button (Switch On / Sleep Mode)
Power ON/OFF: As the diagram 1 shows the position of power button.
Depressing and releasing the power button for three seconds to turn on
and off the stethoscope. The information shows up on the screen to
presents the power is on. Turn off the device and the screen presents
black.
WKtZ
Diagram 1
ž Sleep mode
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z In the menu, press “UP”/”DOWN” to scroll to the “SLEEP SET”, then press
the “OK” button. Here has “two minutes” , ”five minutes” and ”ten minutes”
you can choose. Use “UP”/”DOWN” to choose and then press the “OK”
button to confirm. The stethoscope will be in the sleep mode if you don’t
use it at the certain time. Press “POWER ON/OFF” again to wake it up.
Diagram 2
ž Enter the menu:
z Press “RIGHT” for 3 seconds to enter the menu. As shown in the diagram
3, play backËŁrecord time setËŁsleep time setËŁdate and time setËŁdefault
reset and product info.
z Product information will be displayed on the screen.
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Diagram 3ÄĄ
ž Record time set
z In the menu, press “UP /DOWN” button to scroll to the “RECORD TIME
SET”. As shown in the diagram 6, then press “UP /DOWN” button to scroll
to the record length then press ”OK”, as shown in the diagram 4. Here has
“10 seconds”, “20 seconds”, “30 seconds” and “40 seconds”.
ÄĄ
Diagram 4
ž Date & Time Set
ÄĄ
In the menu, press “UP /DOWN” button to scroll to the “DATE TIME SET”
then press “OK” to set the date and time. As shown in the diagram 5,
“LEFT/RIGHT” buttons are used for moving position, “UP/DOWN” button
for increase and decrease the numbers. Press “OK” to save the setting.
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Diagram 5
ž Battery set
In the menu, press “UP /DOWN” button to scroll to the “BATTERY SET”
then press “OK” to set the battery. As shown in the diagram 6, “UP
/DOWN” buttons are used for choose two different types of battery. The
user can choose “Alkaline” or “Ni-MH” based on which types of battery
installed. Press “OK” to save the setting. The default batteries in the box
are Ni-MH battery.
Diagram 6
NOTICE 烉There are two selections of battery: Alkaline and Ni-MH.
The default setting of battery selection is Ni-MH battery. An inaccurate
battery indicator will show on screen if you change with other kinds of
battery without switch to the correct selection.
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ž Default
In the menu, press “UP /DOWN” button to scroll to the “DEFAULT
RESET” then press ”OK” to enter to default reset page, as shown in the
diagram 7. Press “YES” if you’ve already make sure to reset to default
setting. This function can help you default the unexpected condition and
reset.
Diagram 7
Factory Default Setting Table
Parameters
Idle time of “Sleeping Mode” before
going to sleep
Filter mode group
Auscultation organ position
Filter Mode
Amplification level
Recording number
Battery Setting
Default
2MIN (2 minutes)
“BDW” group
HEART
B Mode
Level 5
Empty
Ni-MH
ž Product Information
The stethoscope show the software version and product name on the
“PRODUCT INFO” page.
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Diagram 8
ž Organs setting
z “ORGAN” button is used for organs setting. As shown in diagram 9, press
and release the “ORGAN” button to switch the organs pattern. For
example: Heart Æ Lung Æ Prior chest Æ Neck Æ Bowelˤ
Diagram 9
ž Sound frequency mode
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z “BDW” is used for sound frequency mode. As shown in diagram 10, press
and release the “BDW” button to switch the frequency mode. For example:
B (Bell mode) Æ D (Diaphragm mode) Æ W (Wide mode)
Diagram 10
ÄĄ
ž Volume control:
z As shown in diagram 11, press “UP” to increase the sound level and press
“DOWN” to decrease the sound level. Keep pressing “DOWN” to decrease
the volume until it turns into “MUTE” mode.
ÄĄ
Diagram 11
ž Bluetooth connect
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z As shown in the diagram 12,ÄĄwhen DS101 successfully connected with the
device, the red box in the Bluetooth icon will disappear.
Diagram 12
ž Recording the Auscultation Sound
The recording button is on the top of the display. Press the recording
button
to record sound and the Phonocardiogram will show on the
screen. The red horizontal red bar presents the recording time shown at
the bottom on the screen. The default setting for recording time is 10
seconds, after recording the sound track the screen will go back to the
home page.
WARNING: To avoid the damage of ears, do not tap hard or scratch the
chest-piece with diaphragm while wearing the ear-tips with the
stethoscope powered on.
ž Playing Back a Sound Track
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In the menu, press “UP /DOWN” button to scroll to the “PLAYBACK” then
press”OK” to enter playlist. File name is YYYYMMDD_HHMMSS. As
shown in the diagram 13, press “UP/DOWN” button to scroll to” FILE
NAME” and confirm with “OK” to check the organ mapping(as shown in
the diagram). Press “OK” again to play back the sound track. The
Phonocardiogram will be shown on the screen while a sound track is
playing. Press “LEFT” to return to the menu.
ÄĄ
Diagram 13
9. DS101_DM Software (Data Management)
ž Installation for Android System
Turn on the Android App Store using a supported mobile device. Ensure that
the device is connected to the internet. Follow the instructions to download
the App and wait until it has finished installing.
ž Create the first account
First, create the account to access the DS101_DM Software (Data
Management) and also, keep patients data in your account. Now turn on the
DS101_DM Software (Data Management) on the mobile device. Enter your
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own user name and password.
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ž Sign in
After create a first account, use that account to sign-in. Please type your user
name and password correctly.
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ž Bluetooth Pairing
Bluetooth must be enabled in the device Bluetooth settings in the DS101_DM
Software App.
First, enable Bluetooth on the selected mobile device. On the mobile device
go to Settings > Bluetooth > and tap the slider to turn Bluetooth ON. Searching
the mobile device’s name and tap to pair.
Then, turn on the DS101_DM Software (Data Management) and tap the
Bluetooth symbol icon to display the Bluetooth devices. You can tap “Scan” if
the paired Bluetooth device is not displayed.
After the paired Bluetooth device is displayed, tap on it to connect with the
device.
Scan
Tap to scan the
paired Bluetooth
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The system will pop-up, asking to pair with the stethoscope, if it is the true
one, tap “Pair” to confirm.
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ž Using the app to receive recordings
After paired with the stethoscope, the mobile device page will turn to record
received page. The mobile device is now ready to receive sounds from the
DS101. Tap “RECEIVE” button and the DS101_DM Software (Data
Management) start to receive recordings from DS101. If Bluetooth pairing is
unsuccessful, the Bluetooth mark will flash on the OLED screen of DS101 and
no sounds will be recorded. If the Bluetooth connection is successful the mark
will keep in bright blue of the device.
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ž Using the app to transmit recordings to DS101
Turn on the DS101_DM Software (Data Management) and log in. Ensure that
the DS101 Device is paired to the mobile device (See Section 8).
In the home screen, press “Transmit” and the original record will transmit back
to DS101.
NOTICE: For showing better sounds quality, we highly recommend transmit
recordings back to DS101 and listen with eartube.
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9.1
The Main Recording Page
The Main Recording Page allows users to view audio data captured by
DS101, begin the recording process, retrieve patient specific data, or
adjust settings. Audio data is represented in real-time as a
phonocardiogram. A period of recording is 10-second intervals.
Recordings
How many
recordings to
transmit and
received
Organ Mark
Indicate the
listening position
Receive
Tap to receive
recordings from
DS101
Cancel
Tap to cancel
transmission and
disconnect from
DS101
Audio wave form
Received from the
DS101
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9.2
Records Page
The recordings received from DS101 will save to records page. Tab on
any recording to review the detail information.
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9.3
Review Page
More information on a specific recording can be viewed by tapping on a
recording listing. This page displays the recording number, organ mark,
recording time, operator ID, and clinical opinion. User can add suggestion
or diagnosis opinion on it.
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This also includes a waveform of the recording with zoom in / zoom out,
and playback the sound.
9.4
Setup Page
In setup page, it can change user name, email, belonging company, and
belonging department.
Change Password
Tap to change
Sign-out
Tap to sign-out
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ž Other Operating Considerations
z Operating range is 32ÂşF to 104ÂşF (0ÂşC to 40ÂşC), 15 to 93% relative
humidity.
z Maximum operating altitude is 2000m.
z Maximum expected service life is 5 years.
z Storage and transport range is -4ÂşF to 158ÂşF (-20ÂşC to 70ÂşC), 0 to 93%
relative humidity.
z To keep the life of your electronic stethoscope, please avoid operating
under extremely hot and extremely cold condition.
z Don’s use solvents and oils to prevent unexpected hazards.
z Remove the battery if the electronic stethoscope will not be used for
several months.
z Failure to follow care and maintenance recommendations could result in
damage to the internal components of the Electronic Stethoscope DS101.
Internal damage could cause malfunction of the product, ranging from a
slight decrease in auditory response to complete failure of the product.
NOTICE 烉If you experience any problems with the Electronic
Stethoscope DS101, do not attempt to repair it yourself. Please notify our
customer service center for directions on shipping and receiving.
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10. Product Parts List
1. '6'HYLFH,WFRQVLVWV RIFKHVWSLHFH 2. '6 +HDGVHW ,QFOXGLQJ HDUWXEH 
ZLWK GLDSKUDJP VFUHHQ LQWXLWLYH NH\SDG
FRQQHFWRUDQGHDUWLSV
DQGHDUWXEHFRQQHFWRURIDXGLRRXWSXW
3. 'LDSKUDJP
4. $$$9%DWWHU\
5. %DWWHU\&KDUJHUÄĄ
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6. $FFHVVDU\3DFNDJH LQFOXGHVWZRSDLUVRIHDUWLSVWZR$$$$ONDOLQHUHFKDUJHDEOHEDWWHULHV
ÄĄ
ÄĄ
WARNING: Do not use the unauthorized accessories which would
lead to unexpected hazards.
11. Cleaning
z Electronic stethoscope:
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1) Before start to cleaning, please check the tubbing connector and all
structure of stethoscope are stable to avoid liquid infiltration.
NOTICE 烉 To clean the chestpiece, you may take off the diaphragm for the
sterilizing process.
1) Avoid directly wiping up with alcohol or detergent solution in case of
the unnecessary damage, spray 70%~75% alcohol solution on the
dry, clean tissue paper or cotton sheet that we highly recommended.
2) Wipe the electronic stethoscope.
3) After wiping out the dust and dirt, please check the electronic
stethoscope is working as usual.
z Ear tubing and ear-tips: It can be wiped clean with alcohol. Ear-tips may
be removed for the advanced cleaning and disinfection.
Diaphragm: you can wipe the diaphragm with 70%~75% alcohol
solution on the dry, clean tissue paper or cotton sheet that we highly
recommended. Otherwise, replace the new diaphragms after the device
is dirty or used in high contamination patient.
WARNING: To reduce the risk of infection, cleaning of stethoscope
should be done between each patient use.
WARNING: Do not immerse the stethoscope in a liquid or subject it
to any sterilization process. The device might be damaged.
12. Warranty
Your Electronic Stethoscope is warranted against any defects in material and
manufacture for a period of one year. If a material or manufacturing defect is
discovered during the warranty period, repairs will be made without charge
upon the return of the instrument to vendor, except in cases of obvious abuse
or accidental damage.
13. Troubleshooting
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Item
Questions
1. No “Powered”, after “Turn ON”.
2.
No “Powered”, after “Turn ON”.
3.
No “auscultation sound”, after “Turn
ON”.
4.
No “auscultation sound”, after “Turn
ON”.
5.
The
screen
displays
WARNING” after “Turn ON”
6.
The device has no response when
you are operating the device.
“DATE
Answer
Please check battery whether
properly installed, and then try
again after reinstall the battery.
Please replace a new one
battery, and then try again after
reinstall battery.
Please check headset whether
properly installed, and then try
again after reassembly headset.
Please use the “amplification
level control” button to adjust
amplification level properly.
This stands for unsetting of the
date and the time. Please refer to
the section "Setting Date”
(setting date section 6-8) to set
date.
Please reinsert the battery, and
then make sure the device has
response
when
you
are
operating.
IMPORTANT!
•
If you have tried all of the solutions to the questions and that still failed to
solve your problem, please call local service branches for assistance.
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14. Maintenance and Repair
For maintenance or repair Services, please register your name, physical
address, e-mail address, and phone number with your Electronic Stethoscope
DS101.
NOTICE: No modification of this device is allowed. Use only authorized
service personnel to repair this electric stethoscope. If user modify
by himself, the user will take all of the responsibility for the
consequence.
If you have any questions or comments, please feel free to contact Customer
Service Center.
In the Taiwan (R.O.C.):
IMEDIPLUS Inc.
Address: 2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County 30261,
Taiwan (R.O.C.)
Email: service@IMEDIPLUS.com
Tel: +886-3-658-7700
Fax +886-3-658-9535
http://www.imediplus.com
15. Transportation, Storage, and Disposal
—
Transportation and Storage
z General transportation of the unit should correspond to the conditions
outlined in the 'Other Operating Considerations' section of this manual.
The Electronic Stethoscope DS101 needs to be sent to an authorized service
center for inspection and repair. The storage environment conditions must be
follow the 'Other Operating Considerations' section of this manual.
—
Disposal
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You shall properly dispose of the Electronic Stethoscope and follow the local
regulations. The AAA 1.2V rechargeable battery must be disposed of
separately or recycled from regular waste.
NOTICE: To reduce the risks associated with environmental contamination,
we need to follow the applicable regulations in local when disposing of this
stethoscope. The AAA 1.2V rechargeable battery must be disposed of
separately or recycled from regular waste.
16. Specification
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WƌŽĚƵĐƚ^ƉĞĐŝĨŝĐĂƚŝŽŶ
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tŝĚĞ;ϮϬͲϭϬϬϬ,njͿ
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sŽůƵŵĞĐŽŶƚƌŽů
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ɼɧĥ
sŽůƵŵĞůĞǀĞůĚĞŐƌĞĞ
sŽůƵŵĞůĞǀĞůĚĞŐƌĞĞ
ϭϬůĞǀĞů
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ZĞĐŽƌĚŝŶŐ
ZĞĐŽƌĚŝŶŐƵƐĐƵůƚĂƚŝŽŶKƌŐĂŶĂŶĚ
WŽƐŝƚŝŽŶĨŽƌ^ŽƵŶĚdƌĂĐŬ
WŽƐŝƚŝŽŶĨŽƌ^ŽƵŶĚdƌĂĐŬ
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ZĞĐŽƌĚŝŶŐƉĂƵƐĞ
dŝŵĞŝƐƉůĂLJ
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17. Appendix: Guidance and Manufacturer’s Declaration
Manufacturer’s declaration-electromagnetic emissions
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
Compliance
Electromagnetic environment-guidance
(for professional healthcare environment)
RF emissions CISPR 11
Group 1
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.
RF emissions CISPR 11
Class A
The DS101 is suitable for use
in all establishments other than domestic and those
Harmonic emissions
Not applicable
directly connected to the public low-voltage power supply
IEC 61000-3-2
network that supplies buildings used for domestic
Voltage fluctuations
Not applicable
purposes.
/flicker emissions IEC
61000-3-3
Document Title:
Electronic Stethoscope DS101 User Manual
Document No.: DS101-SDUS01-01303
Page:
45 of 50
Product Name: Electronic Stethoscope DS101
Ver.:
A1
Date:
2017/8/26
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
ÄĄ
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Manufacturer’s declaration-electromagnetic immunity
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.
Immunity test
IEC 60601
Compliance level
Electromagnetic environmenttest level
guidance
(for professional
healthcare environment)
Electrostatic
Floors should be wood, concrete or
Contact:s8 kV
Contact:s8 kV
discharge(ES
Airs2 kV,s4 kV,s8 kV,s
Airs2 kV,s4 kV,s8 kV,s15 kV ceramic tile. If floors are covered with
D) IEC 61000synthetic material, the relative
15 kV
4-2
humidity should be at least 30%
Electrical fast
+ 2kV for power supply
Not applicable
Mains power quality should be that of
lines
transient/burst
Not applicable
a typical professional healthcare
IEC 61000-4-4 + 1kV for input/output
environment.
lines
Not applicable
Mains power quality should be that of
Surge IEC
+ 0.5kV, +1kV line(s) to
Not applicable
a typical professional healthcare
61000-4-5
line(s)
environment.
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
Voltage dips:
Mains power quality should be that of
Voltage Dips,
Voltage dips:
a typical professional healthcare
0 Not applicable
short
0 % UT; 0,5 cycle
Not applicable
environment. If the user of the
% UT; 1 cycle
interruptions
Not applicable
DS101 requires continued operation
70 % UT; 25/30 cycles
and voltage
during power mains interruptions, it
variations on
Voltage interruptions:
is recommended that the DS101 be
Voltage interruptions:
power supply
Not applicable
powered from an uninterruptible
0 % UT; 250/300 cycle
input lines IEC
power supply or a battery.
61000-4-11
Power
30 A/m
30 A/m
The DS101 power frequency
magnetic fields should be at levels
frequency(50,
50 Hz or 60 Hz
50 Hz and 60 Hz
characteristic of a typical location in
60 Hz)
a typical professional healthcare
magnetic field
environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Document Title:
Electronic Stethoscope DS101 User Manual
Document No.: DS101-SDUS01-01303
Page:
46 of 50
Product Name: Electronic Stethoscope DS101
Ver.:
A1
Date:
2017/8/26
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
ÄĄ
ÄĄ
Manufacturer’s declaration-electromagnetic immunity
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 is used in such and environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
(for professional healthcare environment)
Portable and mobile RF communications
3 Vrms:
Conducted RF
Not applicable
equipment should be used no closer to any
IEC 61000-4-6
0,15 MHz – 80 MHz
part of the DS101 including cables, than the
6 Vrms:
Not applicable
in ISM bands between
recommended separation distance calculated
0,15 MHz and 80
from the equation applicable to the frequency of
MHz
the transmitter.
80 % AM at 1 kHz e)
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz b)
80 % AM at 1 kHz c)
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Recommended separation distance:
d = 1,2 ÂĽP
d = 1,2 ÂĽP 80MHz to 800 MHz
d = 2,3 ÂĽP 800MHz to 2,7 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the DS101 is used exceeds the applicable RF
compliance level above, the DS101 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the DS101
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Document Title:
Electronic Stethoscope DS101 User Manual
Document No.: DS101-SDUS01-01303
Page:
47 of 50
Product Name: Electronic Stethoscope DS101
Ver.:
A1
Date:
2017/8/26
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
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Recommended separation distance between
portable and mobile RF communications equipment and the DS101
The DS101 is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF
disturbances are controlled. The customer or the user of the DS101 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
DS101 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
Separation distance according to frequency of transmitter
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,7 GHz
d =1,2ÂĽP
d =1,2ÂĽP
d =2,3ÂĽP
0,01
N/A
0,12
0,23
0,1
N/A
0,38
0,73
N/A
1,2
2,3
10
N/A
3,8
7,3
100
N/A
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Document Title:
Electronic Stethoscope DS101 User Manual
Document No.: DS101-SDUS01-01303
Page:
48 of 50
Product Name: Electronic Stethoscope DS101
Ver.:
A1
Date:
2017/8/26
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
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Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
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.
Test
frequency
(MHz)
385
450
Band a)
(MHz)
380 Í´390 TETRA 400
870
930
1 720
1 845
1 970
2 450
5 785
IMMUNITY
TEST LEVEL
(V/m)
Compliance
LEVEL
(V/m)
(for professional
healthcare)
Pulse
modulation b)
18 Hz
1,8
0,3
27
27
Modulation
FM c)
ˢƲ5 kHz
deviation
1 kHz sine
0,3
28
28
704 Í´
787
LTE Band
13,
17
Pulse
modulation b)
217 Hz
0,2
0,3
0,3
28
28
0,3
28
28
0,3
28
28
0,2
0,3
GSM
800/900,
Pulse
TETRA
800 Í´
modulation b)
800,
960
18 Hz
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA
1900;
Pulse
1 700 Í´
GSM
modulation b)
1 990
1900;
217 Hz
DECT;
LTE Band 1,
3,
Bluetooth,
WLAN,
Pulse
2 400 Í´
802.11 b/g/n, modulation b)
2 570
RFID 2450,
217 Hz
LTE Band 7
5 240
5 500
Distance
(m)
GMRS 460,
FRS 460
780
810
Maximum
power
(W)
b)
430 Í´
470
710
745
Service
a)
5 100 Í´
5 800
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
NOTE If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting antenna and
the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a)
b)
c)
For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
Document Title:
Electronic Stethoscope DS101 User Manual
Document No.: DS101-SDUS01-01303
Page:
49 of 50
Product Name: Electronic Stethoscope DS101
Ver.:
A1
Date:
2017/8/26
510(k) File Name: 003_Electronic Stethoscope DS101 User Manual
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18. FCC and IC Compliance Statement
15.21
You are cautioned that changes or modifications not expressly approved by the
part responsible for compliance could void the user’s authority to operate the
equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
&RQQHFWWKHHTXLSPHQWLQWRDQRXWOHWRQDFLUFXLWGLIIHUHQWIURPWKDWWRZKLFKWKH
UHFHLYHULVFRQQHFWHG
-Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of the FCC Rules. Operation is subject to
the following two conditions:
1) This device may not cause harmful interference and
2) This device must accept any interference received, including interference that
may cause undesired operation of the device.
FCC RF Radiation Exposure Statement:
1) This Transmitter must not be co-located or operating in conjunction with any
other antenna or transmitter.
Document Title:
Electronic Stethoscope DS101 User Manual
Document No.: DS101-SDUS01-01303
Page:
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Product Name: Electronic Stethoscope DS101
Ver.:
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Date:
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2) For body worn operation, this device has been tested and meets FCC RF
exposure guidelines. When used with an accessory that contains metal may not
ensure compliance with FCC RF exposure guidelines.
ÄĄ
ÄĄ
Canada, Industry Canada (IC)
This device complies with Industry Canada licence-exempt RSS standard(s).
Operation is subject
to the following two conditions:
(1) This device may not cause interference, and
(2) This device must accept any interference, including interference that may
cause undesired operation of the device
Le prĂŠsent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence.
L'exploitation est autorisĂŠe aux deux conditions suivantes:
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage
radioĂŠlectrique subi, mĂŞme si le
brouillage est susceptible d'en compromettre le fonctionnement.
RF Radiation Exposure Statement:
For body worn operation, this phone has been tested and meets RF exposure
guidelines when used with an accessory that contains no metal. Use of other
accessories may not ensure compliance with RF exposure guidelines.
DĂŠclaration de l'exposition aux radiations RF:
Pour le fonctionnement du corps, ce tĂŠlĂŠphone a ĂŠtĂŠ testĂŠ et rĂŠpond aux
directives d'exposition RF lorsqu'il est utilisĂŠ avec un accessoire qui ne contient
pas de mĂŠtal. Utilisation d'autres accessoires peut ne pas assurer le respect des
directives d'exposition RF.

---

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