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DS101A3
User Manual
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IMEDIPLUS DS101A3 User Manual

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Document Title:
Electronic Stethoscope DS101 User Manual
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Electronic Stethoscope DS101
Stethoscope DS101 User Manual
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Date: 2018/5/7
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CaRDIaRT Electronic Stethoscope
Model name: DS101
USER MANUAL
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 from patient and saving up to 160 10-second auscultation sound tracks. Clear acoustic performance. With auscultation sound amplify ability and 10 volume level adjustable. Ergonomic Design. Easy to use.
Document Title:
Electronic Stethoscope DS101 User Manual
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Project Name:
510(k) File Name:
Electronic Stethoscope DS101
Stethoscope DS101 User Manual
Content
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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 Changing 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 Changing the chestpiece ................................................................................... 14
7.7 Replacing the diaphragm(Silicone 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) ..................................................... 27
10. Product Parts List ................................................................................................. 40
11. Cleaning ................................................................................................................... 41
12. Warranty ................................................................................................................... 42
13. Troubleshooting .................................................................................................... 42
14. Maintenance and Repair ..................................................................................... 44
15. Transportation, Storage, and Disposal ......................................................... 44
16. Specification ........................................................................................................... 45
17. Appendix: Guidance and Manufacturer’s Declaration ............................. 46
18. FCC and IC Compliance Statement ................................................................ 51
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Document Title:
Electronic Stethoscope DS101 User Manual
Document No.:
Project Name:
510(k) File Name:
Electronic Stethoscope DS101
Stethoscope DS101 User Manual
1. Introduction
Thank you for choosing our Electronic Stethoscope DS101.
This useful stethoscope will be a great aid to your auscultation.
It has several smart and friendly features, which makes it easy to use and to properly fit user needs. The design, with an easy-to-use interface, enables the users to approach the patient with one hand. The ear-tips with the soft texture are comfortable to wear. They also provide a sealant for reducing environmental noise, offering a good sound quality for users.
Electronic Stethoscope DS101 was innovated by a group of healthcare professionals. What’s more, the user experience is an important factor in designing the stethoscope. We appreciate your selection of our Electronic Stethoscope DS101 and look forward to your valuable feedback.
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2. Safety Information
Please read, understand, and follow all safety information contained in these instructions prior to using this electronic stethoscope. Retain the user manual for future reference.
Rx only.
Document Title:
Explanation of Safety
Markings and Symbols
Explanation of Signal Word Consequences
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2.1 Symbol Definitions
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 chestpiece with diaphragm.
This product and packing does not contain natural rubber latex.
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Rx only
IPX4
NOTICE
Temperature Limits.
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.
Bluetooth transmission.
Federal law restricts this device to sale by or on the order of a physician.
Protected against splashing liquid.
Indicates hazards, if not avoided, may result in property damage.
Document Title:
NOTICE
To reduce the risks associated with an incorrect result,
personal injury
To reduce the risks associated with very strong electromagnetic fields
,
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WARNING
Electronic Stethoscope DS101
Stethoscope DS101 User Manual
Indicates hazards, if not avoided, could result in minor injury and/or property damage.
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2.2 Important Safety Information
Please follow local applicable regulations concerning proper disposal and
recycling of electronic devices and batteries to avoid polluting the environment.
No modification to the device is allowed; repair could only be conducted by
authorized IMEDIPLUS personnel. If there's any modification, the user is solely responsible for the consequence.
The Electronic Stethoscope DS101 is MR unsafe. Do not use the Electronic Stethoscope DS101 in Magnetic Resonance Imaging (MRI) environment.
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WARNING
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 to ear canal, please hold
the device tight to avoid sudden falling and make sure that the soft sealing ear-tips are snapped firmly into position.
WARNING
avoid using the stethoscope near strong radio frequency signals or portable and/or mobile RF devices. Otherwise, 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 original diaphragm.
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
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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
put the device into the pocket of a physician gowns to avoid sudden falling when hanging the device around the neck.
Do not use the unauthorized accessories, which would cause hazards.
Use the accessories provided by IMEDIPLUS only.
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 Electronic Stethoscope DS101
contains conductive, metallic and magnetic materials, including headset, wire, connectors and inductors, which are assembled in Electronic Stethoscope.
Do not use for children under two years old. The stethoscope chestpiece is designed to be used for child, adolescent and adult patients.
To prevent causing battery leaks or damaging their terminals, carefully follow all instructions regarding the use of batteries.
When the battery is not in use for a long time, remove it to avoid corrosion
of the battery connector in the battery charger.
If battery fluid gets into your eyes, flush your eyes immediately with clear, cold running water and seek medical attention immediately.
This device should not be used adjacent to or stacked with other equipment.
This device is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments.
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Document Title:
Electronic Stethoscope DS101 User Manual
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Electronic Stethoscope DS101
Stethoscope DS101 User Manual
3. Product Description
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When turning on the Electronic Stethoscope DS101 for the first time, your authorization to operate this handheld electronic stethoscope is necessary for regular 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. By pressing the buttons ‘OK’ or ‘REC’ to pick up the sounds, the phonogram of sounds could be simultaneously displayed. The sounds are also delivered to the user’s ears bilaterally through the active speaker embedded at the bottom of the DS101, while at the same time sound processing is conducted with the aid of a digital signal processor.
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The one-hand user interface includes a full-color OLED display, record button, arrow keys, OK button, and a tubing connector to output sounds via the headset tubing to the user’s ears.
After turning on the Electronic Stethoscope DS101 and connecting with a wireless device via Bluetooth 4.0, the digital data of the recordings could be transmitted. The effective range of Bluetooth transmission will be influenced by objects blocking the signal between the Electronic Stethoscope DS101 and the connected laptop, such as a wall, humans and other barriers. Reducing the distance or allowing a 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 can only be replayed by the Electronic Stethoscope, and the speaker with effective range from 20 to 1000Hz. The Electronic Stethoscope DS101 operates on two AAA1.2V rechargeable batteries with a power management system to prolong the battery life.
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Electronic Stethoscope DS101 User Manual
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4. Intended Use
The CaRDIaRT Electronic Stethoscope 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. The stethoscope chestpiece 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
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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 would 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 patient data through the use of software. If the user is unable to comply with the law or restriction that applies to use and disclosure of such data, the user should not proceed to collect or save such information.
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Electronic Stethoscope DS101 User Manual
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Stethoscope DS101 User Manual
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 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 to keep this manual for reference.
7.1 Stethoscope Interface
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DEVICE
HEADSET
7.2 Changing Battery
According to Figure 1, open the battery compartment cover by push the notch on the cover, and remove the old batteries by lifting it. Replace the batteries with two new AAA rechargeable batteries. Make sure inserting the new batteries in the right direction as the notice marked inside, then remount the cover after replacement.
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Electronic Stethoscope DS101 User Manual
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Electronic Stethoscope DS101
Stethoscope DS101 User Manual
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Figure 1
IMPORTANT!
Please turn off the system before taking out the battery.
NOTICE:
The Electronic Stethoscope DS101 can be installed with alkaline or Ni-MH batteries, the chart below shows the voltage specifications for the alkaline and Ni-MH battery. We highly recommended the use of rechargeable batteries for longer operational time.
Alkaline Ni-MH
Voltage 1.5 V 1.2 V
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WARNING: Do not use a battery if it is cracked or broken.
7.3 Removing and applying the eartube.
As shown in Figure 2, please tightly hold the device while removing/ applying the eartube. Twist the tubing connector in counterclockwise direction to remove the eartube. Please put the eartube on a safe platform to avoid unnecessary damage from falling. Align the new eartube with the two triangle marks on each side and directly insert it into the device. Make sure
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Electronic Stethoscope DS101 User Manual
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the eartube is completely inserted into the device with the arrow marks aligning.
Figure 2
7.4 Removing and applying the ear-tip.
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The ear-tips should point in the forward direction as you insert them into your ear canals. When ear-tips are properly positioned, the diaphragm will face towards your body, as shown in 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 the eartube to apply new ear-tips, as shown in Figure 4.
Eartube
Electronic Stethoscope DS101
Stethoscope DS101 User Manual
Ear-tip
Apply Ear-tip
Figure 4
Eartube
Remove Ear-tip
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Ear-tip
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7.5 Adjust Headset for Comfort
To reduce the spring tension of the headset, hold each eartube at the bend part near the ear-tips and gradually pull apart until fully extended (180 degrees), as shown in Figure 5.
To increase spring tension, grasp the headset with one hand where the metal eartube enters the plastic tubing, and squeeze until the plastic tubing on one eartube touches the other, as shown in Figure 5.
Repeat the steps to adjust the headset to suitable tension.
Reduce Tension Increase Tension
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7.6 Changing the chestpiece
The location of the chestpiece is shown in Figure 6. Please tightly hold the device while changing the chestpiece. Twist the chestpiece in counterclockwise direction to remove it. Please put the chestpiece on a safe platform to avoid unnecessary damage from falling. Align the triangle marks on the device and the chestpiece to directly insert the chestpiece. Twist the chestpiece until hearing a click sound to make sure it is completely fixed into the device.
Figure 5
Figure 6
DIAPHRAGM WITH CHESTPIECE
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7.7 Replacing the diaphragm (Silicone and PS)
As shown in Figure 7, when changing the silicone diaphragm, please follow the directions below:
- To remove the diaphragm, place your nail under the rim of the stethoscope head and gently separate the rim from the head.
- Place the new diaphragm inside the rim, making sure the diaphragm is properly and smoothly fitted into the rim groove.
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- Place the combined diaphragm and rim over the edge of the chestpiece, then press the rim down with both thumbs until the whole rim is fitted onto the chestpiece groove.
CHESTPIECE
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Figure 7
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DIAPHRAGM
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As shown in Figure 8, please hold the device and chestpiece tightly while removing the diaphragm. Pull down and remove the diaphragm (PS) and dispose of it into medical waste bucket. To mount the diaphragm, tear the new diaphragm package, pluck the device directly to the diaphragm, and make sure the diaphragm completely fits to the device until hearing the click sound.
NEW DIAPHRAGM
Figure 8
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Recording Button
Filter Modes
Switch
Arrow Keys
and OK Button
Organ
Position Switch
ON/OFF
OK
MODE
VOLUME
BUTTON
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7.8 Stethoscope construction
LEFT
FREQUENCY
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RECORDING
RIGHT
ORGAN
POSITION
POWER
Power Button
To turn on the device or to enter the sleep mode.
During auscultation (in the HOME page), press the recording button to record auscultation sounds of 10 seconds. (Default)
During auscultation (in the HOME page) and playback of the recorded sound track, press this button to select the auscultation filter mode from “Bell”, “Diaphragm”, and “Wide” modes.
The “Arrow keys” 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 is to set and confirm the selection item
The “Organ Position Switch” is used to change the organ positions among “Heart” “Anterior Chest”, “Posterior Chest”, “Neck”, and “Bowel”.
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7.9 OLED display shows information
Date and Time
Auscultation Position (Red Point Indicates the Position under Auscultation and Recording)
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Bluetooth
Battery Status
Auscultation
Modes B/D/W
Heart Rate
Organ
Position
Volume Level
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POWER
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8. Operation Description
Power Button (Switch On / Sleep Mode)
Power ON/OFF: The position of power button is shown in Diagram 1. Pressing the power button for three seconds to turn on or off the stethoscope. The information shows up on the screen indicates the power is on. Turn off the device and the screen turns dark.
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Diagram 1
Sleep mode
In the menu, there are “two minutes”, ”five minutes” and ”ten minutes” of idle time you can choose for sleep mode. Use “UP”/”DOWN” to choose and then press the “OK” button to confirm. The stethoscope will enter the sleep mode after not being used within the time you select. Press “POWER ON/OFF” again to wake it up.
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Enter the menu:
Diagram 2
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Press “RIGHT” for 3 seconds to enter the menu and the menu options
become available as shown in Diagram 3.
Product information will be displayed on the screen.
Diagram 3
Record time set
In the menu, press “UP/DOWN” button to scroll to the “RECORD TIME SET”. As shown in Diagram 4, press “UP/DOWN” button to scroll to the record length then press ”OK”; the selections include “10 seconds”, “20 seconds”, “30
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seconds” and “40 seconds”.
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Diagram 4
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Date & Time Set
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 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.
Diagram 5
Battery set
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In the menu, press “UP/DOWN” button to scroll to the “BATTERY SET” then press “OK” to set the battery. As shown in Diagram 6, “UP /DOWN” buttons are used for choosing the types of battery installed, “Alkaline” or “Ni-MH”. Press “OK” to save the setting. The batteries accessorized with the stethoscope are Ni-MH ones.
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Diagram 6
NOTICE ：：：：There are two selections for the battery: Alkaline and Ni-MH.
The default selection of battery is Ni-MH battery. An inaccurate battery indicator will show on screen if you change the batteries without changing the setting.
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 Diagram 7. Press “YES” if you want to reset to default settings. This is to help you avoid unexpected condition and reset.
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Idle time of “Sleeping Mode” before going to sleep Auscultation organ position HEART Filter Mode B Mode Amplification level Level 5 Recording time 10 seconds Battery Setting Ni-MH
Electronic Stethoscope DS101
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Diagram 7
Factory Default Setting Table
Parameters Default
2MIN (2 minutes)
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Product Information
The product version and product name are shown on the “PRODUCT INFO” page.
Diagram 8
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Organ settings
“ORGAN” button is used for organ settings. As shown in Diagram 9, press and release the “ORGAN” button to switch the organ patterns. For example: Heart Anterior Chest Posterior chest Neck Bowel。
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Diagram 9
Sound frequency mode
The stethoscope allows the users to select these three different filter modes (B/D/W modes) for diverse application to different clinical scenario. Which can emphasize the specific patient sounds of interest. As shown in Diagram 10, press the “BDW” button to switch the frequency mode.
The Bell mode amplifies sounds between 20-1000Hz, but emphasizes
lower frequency sounds between 20-200Hz.
The Diaphragm mode amplifies sounds between 20-2000Hz, but
emphasizes sounds between 100-500Hz.
The Wide mode amplifies sounds between 20-2000Hz.
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Volume control:
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Diagram 10
As shown in Diagram 11, press “UP” to increase the sound level and press “DOWN” to decrease it. To “Mute” the device, keep pressing “DOWN”.
Diagram 11
Bluetooth connect
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As shown in Diagram 12, when DS101 successfully connected with an external device, the red cross on the Bluetooth icon will disappear.
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Diagram 12
Recording the Auscultation Sound
The recording button is on the top of the display. Press the recording button to record the sound and the phonocardiogram will show on the screen. The red horizontal bar presents the recording time shown at the bottom on the screen. The default setting for recording time is 10 seconds and you will be automatically return to the home page after the sound track recording is done.
WARNING: To avoid the damage of ears, do not tap hard or scratch the
chestpiece with diaphragm while wearing the ear-tips with the stethoscope powered on.
Playing Back a Sound Track
In the menu, press “UP /DOWN” button to scroll to the “PLAYBACK” then press “OK” to enter playlist. File name is “XXXO-YYMMDDHHMM” shown in 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
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sound track is being playing. Press “LEFT” to return to the menu.
Diagram 13
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Heart rate detection
As shown in Diagram 14, place the electronic stethoscope where the heart rate is to be detected; the patient's heart rate would be displayed on the screen in 10 seconds, ranging from 30 to 180 bpm with the accuracy deviation of about +/-
5bpm. When the stethoscope is away from the patient, it will reset to zero within
5 seconds.
Diagram 14
IMPORTANT!
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Heart rate auscultations performed in a noisy environment or by placing the electronic stethoscope in the wrong position, may yield inaccurate heart rate result.
9. DS101_DM Software (Data Management)
Installation for Android System
Please ensure the mobile phone or tablet for installation connects with the Internet. Enter the official website of CaRDIaRT (http://www.cardiart.com) and
log in your member account, go to Download to install the app. After the installation complete, tap on the app icon to open it.
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Create the first account
First, create a secure account to access the DS101_DM Software (Data Management) and to store recording data. Now open the DS101_DM Software (Data Management) on the mobile device. Enter your own user
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name and password.
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Diagram 15
Sign in
After creating the first account, please sign-in with it. Please make sure to type your user name and password correctly.
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Diagram 16
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Bluetooth Pairing
Bluetooth must be enabled in the Bluetooth settings in the DS101_DM Software app.
First, enable Bluetooth on the mobile device. Second, to turn on the Bluetooth, go to Settings > Bluetooth > tap the slider. Finally, search for the name of the device and tap to pair.
Then, open the DS101_DM Software (Data Management) and tap the Bluetooth symbol icon to display the Bluetooth devices. You can tap “Scan” if the Bluetooth device to be paired is not displayed.
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Diagram 17
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Scan
Tap to scan the
Bluetooth devices to be
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After the Bluetooth device to be paired is displayed, tap on it to connect with the device.
Using the app to receive recordings
After pairing with the stethoscope, users will be entering the record received page on the DS101_DM Software (Data Management). The mobile device is now ready to receive recording data from the DS101. Tap “RECEIVE” button, and the DS101_DM Software (Data Management) starts to receive recordings from DS101.
If Bluetooth pairing is successful, the red cross on the Bluetooth icon on the OLED screen of DS101 will disappear.
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Diagram 18
Using the app to transmit recordings to DS101
For better acoustic expression, the user can transmit recording data back to the DS101 and play. Open the app (Data Management) and log in. Ensure that the DS101 is paired to the mobile device (See Section 8).
Enter the home page, press “TRANSMIT” and the recording data will be transmitted back to DS101. The recording data won’t be saved after playing.
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Diagram 19
NOTICE: For better sound quality, we highly recommend listening to the recordings with eartube on DS101.
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9.1 The Main Recording Page
The Main Recording Page allows users to view audio data captured by DS101, conduct the recording process, retrieve specific patient data, or adjust settings. Audio data is represented in real-time phonocardiogram. The period of recording is 10-second intervals.
Organ Mark
Indicate the
listening position.
Recordings
How many
recordings to
transmit and
received.
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Receive
Tap to receive
recordings from
DS101.
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Cancel
Tap to cancel
transmission and
disconnect from
DS101.
Audio waveform
Received from the
DS101.
Diagram 20
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9.2 Records Page
The recordings received from DS101 will be saved to record page. Tap on any recording to review the detail information.
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Diagram 21
9.3 Review Page
More information of a specific recording can be viewed by tapping on the recording. This page displays the recording number, organ mark, recording time, operator ID, and comments. User can add suggestion or comments on it.
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Diagram 22
A waveform of the recording with zoom in / zoom out, and playback function is also included.
9.4 User List Page
In the user list page, users are able to identify their account in this software. Click the Add User button on the top right of screen to create a new user account.
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Add User
Tap to add new user account.
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9.5 Setup Page
Diagram 23
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In the setup page, users are able to change user name, email, company, and department.
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Diagram 24
Document Title:
Tap to change
password
Tap to sign-out
Tap to update
profile
Electronic Stethoscope DS101 User Manual
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Stethoscope DS101 User Manual
Update
Change Password
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Sign-out
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Diagram 25
Other Operating Considerations
Temperature ranges from 32ºF to 104ºF (0ºC to 40ºC), and 15 to 93% for
relative humidity.
Maximum operating altitude is 2000m. Maximum expected service life is 5 years. Temperature for storage and transport ranges from -4ºF to 158ºF (-20ºC
to 70ºC), and 0 to 93% for relative humidity.
To retain the life of your electronic stethoscope, please avoid operating in
an extremely hot or cold condition.
Avoid solvents and oils to prevent unexpected hazards. Remove the battery if the electronic stethoscope is not expected to be
used for months.
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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 ：：：：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. DS101 Device: It consists of chestpiece
with diaphragm, screen, intuitive keypad and tubing connector.
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2. DS101 Headset: Includes tubing ,
connector, and ear-tips
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3. Diaphragm 4. Battery charger and cable
5. Accessary Package(includes two pairs of ear-tips and two AAA Ni-MH rechargeable
batteries)
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Consumable Information
Part Name Part Number Diaphragm F000200600003
Accessory Information
Part Name Part Number Battery charger B002011100005 Battery cable B00202900002 Ear-tips B050112T2KS01 AAA Ni-MH rechargeable batteries
A014070000003
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WARNING: Do not use the unauthorized accessories which would
lead to unexpected hazards.
11. Cleaning
Before starting to clean, please check if the tubing connector and the structure
of stethoscope are intact to avoid liquid infiltration.
Do not wipe the stethoscope directly with alcohol or detergent solution in
avoidance of the unnecessary damage; we highly recommend cleaning with a dry and clean tissue paper or cotton sheet sprayed with 70%~75% alcohol solution.
After wiping out the dust and dirt, please check if the electronic stethoscope
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works as usual.
Eartube and ear-tips: These parts could be cleaned with alcohol wipes, and
the ear-tips could be removed for a more thorough cleaning.
Diaphragm: We highly recommend cleaning the diaphragm with a dry and
clean tissue paper or cotton sheet sprayed with 70%~75% alcohol solution. Alternatively, dispose of the dirty or contaminated diaphragm and mount the new diaphragms.
NOTICE：To clean the chestpiece, you may take off the diaphragm for the cleaning process.
WARNING: Do not immerse the stethoscope in a liquid or subject it
to any sterilization process. The device might be damaged.
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12. Warranty
Your Electronic Stethoscope is warranted against any defects in material and manufacture for 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 obvious abuse or accidental damage.
13. Troubleshooting
Item
1. No “Power”, after “Turn ON”. Please check if battery is
2. No “Power”, after “Turn ON”. Please install a new battery, and
3. No “auscultation sound”, after “Turn ON”.
Issues Answer
properly installed, and try again after reinstall the battery.
try again after installing. Please check if headset is properly installed, and try again after reassembly headset.
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4. No “auscultation sound”, after “Turn ON”.
5. The screen displays “DATE WARNING” after “Turn ON”
6. The device has no response when you are operating the device.
IMPORTANT!
• If you have tried all of the suggestions to the issues listed and still failed
to solve the problems, please call local service branches for assistance.
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Please use the “amplification level control” button to adjust amplification level properly. This is to inform you to set the date and time. Please refer to the section "Setting Date” (setting date section 6-8) for settings. Please reinsert the battery, and then check if there’s any operational response.
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anufactured by:
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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 on your Electronic Stethoscope DS101.
NOTICE: No modification of this device is allowed. Only authorized service
personnel could repair this electronic stethoscope; if the device is modified by users, the user would take full responsibility for the consequences.
If you have any questions or comments, please feel free to contact Customer Service Center.
In the U.S.A:
U.S Agent Contact Name: Mr. JAMES WANG U.S Agent Full Address: 31 Trillium Lane, San Carlos, California, 94070,
UNITED STATES U.S Agent Email: jwjwang5@gmail.com U.S Agent Tel: +1-650-8629968
2F, 12 ShengYi Rd. Sec. 2, Chupei City, Hsinchu County 302, Taiwan (R.O.C.) Tel: +886-3-658-7700 Fax: +886-3-658-9535
IMEDIPLUS Inc.
http://www.imediplus.com
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15. Transportation, Storage, and Disposal
Transportation and Storage
General transportation of the unit should correspond to the conditions
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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 correspond to the 'Other Operating Considerations' section of this manual.
Disposal
You should properly dispose of the Electronic Stethoscope in accordance with the local regulations. The AAA 1.2V rechargeable battery must be disposed of or recycled separately from regular waste.
NOTICE: To reduce the risks associated with environmental contamination, please follow the applicable local regulations when disposing of this stethoscope. The AAA 1.2V rechargeable battery must be disposed of or recycled separately from regular waste.
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16. Specification
IMEDIPLUS Electronic Stethoscope
IMEDIPLUS Electronic Stethoscope DS101
IMEDIPLUS Electronic Stethoscope IMEDIPLUS Electronic Stethoscope
Batteries Enclosed
Batteries Enclosed
Batteries EnclosedBatteries Enclosed Battery indication
Battery indication
Battery indication Battery indication Monitor battery level degrees
Monitor battery level degrees
Monitor battery level degreesMonitor battery level degrees Chest
Chestpiece Technology
piece Technology
ChestChest
piece Technologypiece Technology
Device Dimension
Device Dimension
Device DimensionDevice Dimension Chestpiece Weight
Chestpiece Weight
Chestpiece WeightChestpiece Weight Clinical Area
Clinical Area
Clinical AreaClinical Area Waterproof requirement
Waterproof requirement
Waterproof requirement Waterproof requirement Screen
Screen
ScreenScreen Three Filter Modes
Three Filter Modes
Three Filter ModesThree Filter Modes Mode Frequency Range
Mode Frequency Range
Mode Frequency RangeMode Frequency Range
Product Specification
AAA 1.5V Alkaline/1.2V Ni-MH Battery 100%/ 75% / 50% / 25% 4 degrees Changeable chestpiece L127.05xW45.56xH46.98 mm 23g Auscultation IPX4 OLED 1.46” Full Color 128x128 RGB B/D/W Bell (20-200 Hz)、 Diaphragm (100-500 Hz) and
Wide (20-1000Hz)
Document Title:
M
anufacturer’s declaration
-
electromagnetic emissions
Emission test
Compliance
Electromagnetic environment
-
guidance
Electronic Stethoscope DS101 User Manual
Document No.:
Project Name:
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Recording Position control
Recording Position control
Recording Position controlRecording Position control Volume control
Volume control
Volume controlVolume control Volume level degree
Volume level degree
Volume level degreeVolume level degree Recording
Recording Auscultation Organ and
RecordingRecording Position of Sound Track
Position of Sound Track
Position of Sound TrackPosition of Sound Track Record time set
Record time set
Record time setRecord time set Recording pause
Recording pause
Recording pauseRecording pause Time Display
Time Display
Time DisplayTime Display Date Display
Date Display
Date DisplayDate Display Organ Display
Organ Display Heart / Anterior Chest / Posterior Chest/ Neck
Organ DisplayOrgan Display
Electronic Stethoscope DS101
Stethoscope DS101 User Manual
Auscultation Organ and
Auscultation Organ and Auscultation Organ and
← → ↑↓
10 level
Yes
10 sec, 20 sec, 30 sec, 40 sec > 5 sec 00:00:00 (hour: minutes: second) XXXX-XX-XX (year-month-date)
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/ Bowel
Sleep mode
Sleep mode
Sleep modeSleep mode Sleep mode wake
Sleep mode wake----up
Sleep mode wakeSleep mode wake Heart Rate Detection
Heart Rate Detection
Heart Rate DetectionHeart Rate Detection Phonocardiogram display
Phonocardiogram display
Phonocardiogram displayPhonocardiogram display Data Wireless Transfer
Data Wireless Transfer
Data Wireless TransferData Wireless Transfer Sound Track Recordings (Files
Sound Track Recordings (Files
Sound Track Recordings (Files Sound Track Recordings (Files Storage)
Storage)
Storage)Storage)
up
upup
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
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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.
(for professional healthcare environment)
RF emissions CISPR 11
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /flicker emissions IEC 61000-3-3
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.
Class A The DS101 is suitable for use in all establishments
other than domestic and those directly connected
Not applicable
Not applicable
to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Document Title:
M
anufacturer’s declaration
-
electromagnetic immunity
Immunity test
IEC 60601
Compliance level
Electromagnetic
Electronic Stethoscope DS101 User Manual
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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 level
environment-guidance
(for professional
healthcare environment)
Electrostatic discharge(ESD) IEC 61000-4-2
Contact:±8 kV Air±2 kV,±4 kV,±8 kV,±15 kV
Contact:±8 kV Air±2 kV,±4 kV,± 8 kV,±15 kV
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be
at least 30% Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000­4-5
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
+ 2kV for power supply lines + 1kV for input/output lines + 0.5kV, +1kV line(s) to line(s) + 0.5kV, +1kV,+ 2kV line(s) to earth Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles
Voltage interruptions: 0 % UT; 250/300 cycle
Not applicable Not applicable
Not applicable Not applicable
Voltage dips: Not applicable Not applicable Not applicable
Voltage interruptions: Not applicable
Mains power quality
should be that of a typical
professional healthcare
environment.
Mains power quality
should be that of a typical
professional healthcare
environment.
Mains power quality
should be that of a typical
professional healthcare
environment. If the user
of the DS101 requires
continued operation during
power mains interruptions,
it is recommended that the
DS101 be powered from
an uninterruptible power
supply or a battery. Power frequency(50, 60 Hz) magnetic field IEC 61000-4-8
30 A/m 50 Hz or 60 Hz
30 A/m 50 Hz and 60 Hz
The DS101 power
frequency magnetic fields
should be at levels
characteristic of a typical
location in a typical
professional healthcare
environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
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Document Title:
M
anufacturer’s
declaration
-
electromagnetic immunity
Immunity test
IEC 60601 test
Compliance
Electromagnetic environment
-
Portab
le and mobile RF
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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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.
level
level
guidance (for professional
healthcare environment)
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms: 0,15 MHz – 80 MHz 6 Vrms: in ISM bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz e)
3 V/m 80 MHz – 2,7 GHz b) 80 % AM at 1 kHz c)
Not applicable
Not applicable
3 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz
communications equipment should be used no closer to any part of the DS101 including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 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 meters (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:
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NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is
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.
Document Title:
Rated maximum
Separation distance according to frequency of transmit term
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,
7 GHz
For transmitters rated at a maximum output power not listed above, the recommended
affected by absorption and reflection from structures, objects and people.
Maximum
Compliance
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portable and mobile RF communications equipment and the DS101
The DS101 is intended for use in an electromagnetic environment (for professional healthcare)
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
output power of
transmitter
W
0,01 N/A 0,12 0,23
0,1 N/A 0,38 0,73
1 N/A 1,2 2,3
10 N/A 3,8 7,3
100 N/A 12 23
Recommended separation distance between
in which radiated RF disturbances are controlled.
power of the communications equipment.
d =1,2√P
d =1,2√P
d =2,3√P
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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
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)
Band
(MHz)
a)
Service
a)
Modulation
b)
power
(W)
Dis-
tance
(m)
IMMUNITY
TEST
LEVEL
(V/m)
LEVEL
(V/m)
(for
professional
Document Title:
RFID 2450,
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385
450
380 –
430 –
710
704 –
780
810
870
800 –
930
Electronic Stethoscope DS101
Stethoscope DS101 User Manual
Pulse
390
TETRA 400
modulation b)
18 Hz
FM c)
±5 kHz deviation
470
GMRS 460,
FRS 460
1 kHz sine
787
LTE Band
13,
17
Pulse
modulation b)
217 Hz
GSM
800/900,
960
TETRA
800,
iDEN 820,
CDMA 850,
Pulse
modulation b)
18 Hz
LTE Band
5
Page:
1,8 0,3
2 0,3
0,2 0,3
2 0,3
27 27
28 28
9 9 745
28 28
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1 720
1 845
1 970
1 700 –
1 990
GSM 1800;
CDMA
1900;
GSM
1900;
DECT;
Pulse
modulation b)
217 Hz
2 0,3
28 28
Bluetooth,
2 450
5 240
5 500
5 785
2 400 –
2 570
5 100 –
5 800
WLAN,
802.11 b/g/n,
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
Pulse
modulation b)
217 Hz
2 0,3
0,2 0,3
28 28
9 9
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)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
As an alternative to FM m odulation, 50 % pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.
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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.
-Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
-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
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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:
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1) This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
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.
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
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Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même 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.
Déclaration de l'exposition aux radiations RF:
Pour le fonctionnement du corps, ce téléphone a été testé et répond aux directives d'exposition RF lorsqu'il est utilisé avec un accessoire qui ne contient pas de métal. Utilisation d'autres accessoires peut ne pas assurer le respect des directives d'exposition RF.
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