eMoyo TD0102 Kuduscope User Manual

eMoyo TD0102 Kuduscope User Manual

Introduction

Purpose of this Manual
This manual provides instructions for use and describes the various functions and the features of the Kuduscope. It also describes how all the technologies involved in the Kuduscope’s function work in conjunction. This manual is not intended as a method to train Kuduscope operators to be healthcare professionals or to act as such. An operator may not act as a professional unless qualified to do so.

Medical Purpose
The medical purpose of the Kuduscope is to assist in viewing the tympanic membrane (the eardrum) and external ear canal to diagnose outer and middle ear pathologies.
The Kuduscope is intended to:

• Systematically inspect the external auditory canal and the tympanic membrane.
• To inspect for any signs of ear disease or abnormal growth

Clinical Benefits

• Serving and accessing more patients as a result of the Kuduscope portability
• Forms the first part of comprehensive testing, allowing for timely and cost-efficient auditory disorder management and direct referrals

Patient Populations
The Kuduscope is suitable for testing all patient populations, regardless of gender, age, weight, general health or ethnicity other than the following; the below is not exhaustive:

• Patients with conditions such as Microtia and Aural atresia.

During testing, patients should be calm and comfortable and free from distractions.

Indications
The Kuduscope can be used to view the tympanic membrane (the eardrum) and external ear canal to diagnose outer and middle ear pathologies. The Kuduscope is ideal to use:

1. In healthcare facilities,
2. In the clinician’s consultation room,
3. At schools, factories, shops and old age homes,
4. Alongside a hospital bed, or inside a prison cell,
5. Where there is a need to conduct a remote test as a result of not having a clinician onsite to perform the test, and
6. Where the otoscope needs to travel regularly from one test site to the next.

Contra-Indications
There are no special precautions with the Kuduscope. However, caution should be taken in patients with otitis externa, otitis media, and otalgia as ear examination may cause discomfort and pain.

Residual Risk

• Cross-infection between patients when the Otoscope Specula is not sanitized after use or it is not replaced with a new, clean one. Please do not re-use Otoscope Specula on various patients.
• Cross-contamination between patients when applied parts are not sufficiently cleaned according to the instructions provided. Please ensure that these parts are cleaned sufficiently between patients.
• Possible temporary patient discomfort caused by the adapter of the Kuduscope when inserted into the ear. Although discomfort may be experienced by some patients, please do not modify the adapter.

Device Description and Application
This Kuduscope USB otoscope camera is a portable, handheld video camera with a short focal length. It has a high resolution camera which provides great video quality. The camera is compatible with Windows and Mac computers, and with Android phones and tablets. It is not compatible with iPhone and iPad devices.

On the tip of the camera there are 6 adjustable LED lights, which light up the ear canal and increase the visual field of view. The camera can be used to view the tympanic membrane (the eardrum) and external ear canal to diagnose outer and middle ear pathologies.

Keep this device out of reach of unsupervised children.

Frequent Usage
The Kuduscope is suitable for continuous, regular use. Analysis of all its functions confirms that there is no significant risk to either the operator or patient. These functions are detailed within this document and include measures to minimise any potential risks from reasonably foreseeable misuse of the product.

Applied Parts Details
The following parts are defined as “applied parts” in accordance with BS EN 60601-1:
Otoscope Specula: The Kuduscope comes with three otoscope speculums of varying sizes. Please attach an otoscope specula to the end of the Kuduscope before using it. The Kuduscope should only be used when an otoscope specula is in place.
Also be sure to clean the surface of the otoscope specula with an alcohol swab before using it. You can also disinfect the otoscope specula with steam at 134.
Curette: The Kuduscope comes with three curettes to remove ear wax. These must be cleaned after every use.

Operator Training Requirements

Basic Requirements
The operator must be a trained healthcare professional (typically an audiologist, hearing aid acoustician, general practitioner, ENT, nurse or audiometric) or a practitioner who has been trained in audiometry. The operator must be able to read and communicate fluently in English and/or the primary language of the patient.

Training and Certification Requirements
Training is provided free of charge via an online session within the first 30 days of purchase for both facilitators and operators of the Kuduscope. Additional training resources are available via the KUDUwave academy (https://emoyo.net/kuduwave-academy/) as well as a comprehensive helpdesk available at emoyo.net/category/helpdesk/. The operator will receive a certificate of completion after successfully completing their training.

Additional technical support is also available via our ticket based system, online chat, email and telephone with the KUDUwave support team. Additional group or one-one training may be provided at a cost, to be determined at such time as it is necessary.

Description of Symbols
The following important symbols are used on the KUDUwave and its components:

Getting Started

Get to know your Kuduscope™
All Kuduscope devices have the capability to take high quality photographs for Otoscopy purposes, which are saved to the Moyo-EMRsoftware.

Kuduscope™ Serial Number
The Kuduscope unique serial number can be found on the USB cable or on the Kuduscope packaging. Serial number information is required when contacting customer support

Unpacking the Kuduscope™ Hardware
The Kuduscope is packaged in a box to protect it during transportation. Inspect the case for signs of any damage and notify your supplier immediately if any signs of mechanical or physical damage are found.

Packing List
Please check that all items listed below are received in good condition. If any items are missing or damaged, immediately notify your Kuduscope™ distributor.

• The Kuduscope
• 3 speculae
• 3 curettes
• 3 alcohol swabs
• 1 USB adapter for USB type A to type C

Laptop Requirements

Laptop Minimum Requirements

• Core i3 Processor
• Windows operating system (no older than Windows 8)
• 4GB RAM
• No less than a 250GB hard drive
• WiFi enabled
• A Webcam
• 1 USB Type C port or 1 USB Type A port

If a USB hub is required, please ensure it adheres to the following specifications:

• Self-powered (it must have its own power supply from an electrical wall plug)
• Supplies 5 Volts and 1 Amp per port
• USB 2.0
• at least 3 ports available for the Kuduscope connection

Software Installation
If your Kuduscope controller PC was professionally configured by eMoyo, all the necessary software will already be installed. Should this not be the case, or should you wish to install the software on more than one computer, please visit the eMoyo website (https://emoyo.tech/). Click on SUPPORT and select Software.

In the Download eMoyo-EMR (eMoyo Medical Records) box, Submit your contact information to gain access to the downloads page.

These details will be added to our customer database so that you may be alerted of any changes or updates to the software. The change log is also publicly available on our website and is regularly reviewed for any updates. Next, download the software from the provided link and run the saved installation file as an administrator. Use the chat function in the bottom right hand corner of your screen to chat to us live if you need help. Request the Kuduscope plugin from your sales representative, and install this after Moyo-EMR has been installed.

Software Launch
You should find this Moyo-EMR shortcut on your PC’s desktop. Alternatively you can find Moyo-EMR under programs in your start menu. Launch immediately after installation or, click the icon to launch.

Software Language
The software is currently available in English, Spanish, French, Portuguese, Bahasa and Dutch.

Preparing the Test Environment
The test environment should be free from any distractions that may disturb either the operator or the patient as these may result in incorrect test results.

Preparing and Positioning the Patient
The patient should be seated in the test environment near to the test computer. Care should be taken to ensure the patient is comfortable so as to minimise distractions. If the patient is unable to sit, care must be taken to ensure they are positioned in as comfortable and relaxed a position as possible. Patients who are notably anxious should be calmed and reassured before testing.

Preparing the Kuduscope™ Equipment
Connecting the Kuduscope™
Plug the USB into the USB port of the PC, you may need to use a Type A or B adapter included in your packaging.

You will now be able to begin testing. If the device is not plugged in, it will not be possible to proceed to testing until the device is properly connected. Ensure that the cables are positioned out of the way so that they are not a hazard.

Disconnecting the Kuduscope™
If it is required that the Kuduscope be disconnected, ensure all test data is saved and close the software. The USB cable can then be unplugged. For safe storage and to extend the lifespan, please wind the USB cables in large loops when returning to the case for storage.

Positioning the Kuduscope™
Once the Kuduscope is plugged into your laptop and the software is ready for testing, hold the Kuduscope in your hand as you would a pen. Brace your hand gently on the side of the patient’s head and aim the point of the Kuduscope at the entrance of the patient’s ear canal. Using your opposite hand you can pull the pinna of the ear to open the ear canal a little more. Carefully position the Kuduscope inside the ear canal to view the canal and ear drum. Hold the

Kuduscope in this position whilst the photos are being taken by the software.

Remote Testing
The Kuduscope can easily and safely be used for remote testing over internet connections. To test remotely:

• The trained operator positions the Kuduscope in the patient’s ear or the patient is instructed to position the Kuduscope in their own ear and position the scope as requested.
• The trained facilitator can login to the patient’s PC to control the test through a remote connection (like TeamViewer), or the test can be conducted on the patient’s PC and the result emailed to the clinician at a later time.

Both the operator and facilitator need to complete the eMoyo Kuduscope training.

Getting Started with the Kuduscope™ Software

Please refer to the KUDU wave Manual for full descriptions and features of the Moyo-EMR software. For the purposes of using the Kuduscope this manual will explain how to open the software, create folders and patients, and to conduct a test with the Kuduscope.

Practitioner Details
Run the Moyo-EMR application by double clicking on the icon on your desktop, and enter your details (not mandatory). These details will appear on all reports and audiograms.
You can also select your language of choice.
Click the “Go” button to proceed.

Creating Folders and Subfolders
To create a folder click:

Enter the name of your folder in the space provided. Select “OK” to save. Patient details will only be displayed, if the folder they fall under is selected. Once a folder is selected, a subfolder can be created by clicking the icon next to its name.

Access a folder by clicking on the folder name. Double click on the folder name or click on the icon to view subfolders. To hide subfolders, double click again on the folder icon or click on the icon.

Adding a New Patient

To create a new patient, first select or create the folder under which the patient should be stored, then click . This will open the Patient Interface where you can add the patient’s details in the Patient Data Pane (4). Any test data can be previewed in the Test Data Pane (5). To edit patient details, select the field by clicking in the field and enter the new information. All tests thereafter will have the updated information. Patient information on saved tests cannot be edited.

Tips:

• Click the tab key to quickly navigate between fields.
• After entering a South African ID number, click the Tab key to automatically populate the date of birth, age and gender..
• Folder names are assumed to be company names, and subfolders as job titles. These fields will be automatically populated with these details. Correct them if necessary and the option will become available in the drop down menu for each patient which is added later. To delete an item from a drop down menu, select it, and then click the “X” icon.
• To refresh click

Notes and Tests

Moyo-EMR software bundles notes and tests within a single function. To add a new note or test click on to get access to the following options:

Request the Orca or Keystone User Manual to find out more about this added feature of the Moyo-EMR software. Ensure the Kuduscope is plugged in before attempting to conduct a test.

To do an otoscopic examination, select Photos: Kuduscope from the menu.

Position the Kuduscope in the patient’s ear and take a photograph by clicking the spacebar when you are in position. Alternatively click the camera button. To stop, click the stop button or press the spacebar again.

Select a maximum of 4 images from the photos captured by clicking on the image. Selected images will have a blue edge. Click the next arrow to continue.

On the following screen you can annotate each image and make clinical notes which will be saved to the report. Once done click the tick icon to save. The test ruleset will then continue to take further images if necessary.
Once all photos have been captured, the results will be listed. Click the save icon to save the results into the eMoyo-EMR software.

Patient History
The Patient Data Pane also contains a panel called History. Here, all Notes/tests will be ordered by date.

Patient Data Storage
Data is obfuscated locally and only accessible/readable via the eMoyo software. No data can be deleted, it is only hidden from the end user in the software. The patient database is encrypted and stored in hidden folders under GUIDs that are linked to the respective tests or patients.
eMoyo does not take responsibility for the transmission of data off the PC, if the end user requires any backup solutions (cloud or hardware) it is done at their own risk. If third party integrations are utilised then it is the responsibility of the third party application to handle the data. Unless an agreement is made with eMoyo and the risks of data transfer are appropriately mitigated.

Finding Patients
Search

The search function can only be accessed from the Home screen. Search for patients using either: Name, Surname or Date of Birth. Begin typing in the search field and the software will automatically start bringing up possible matches.

Find

The find function can only be accessed from within a folder. Search for patients using either: Name or Surname. Begin typing in the search field and the software will automatically start bringing up possible matches.

Assistance from the Distributor

Contacting eMoyo
Any serious incident that has occurred in relation to the KUDU wave should be reported to eMoyo Head Office and the competent authority of the Member State in which the user and/or patient is established.

• Email: info@emoyo.tech / support@emoyo.tech
• Phone: +27 087 231 0132 / +27 082 440 0826
• Website: https://emoyo.tech/

Remote Assistance
We offer to help you remotely by taking control of your laptop with the TeamViewer plugin.
To download the TeamViewer remote assistance plugin, please visit: https://www.teamviewer.com/en/download/windows/

Alternatively in the Moyo-EMR software, go to Plugins and install the TeamViewer app readily available there. For live remote assistance, make sure you have:

1. Downloaded and installed TeamViewer on your PC
2. An active internet connection.
3. Your TeamViewer ID and Password.

Get in contact with our Support Team at: support@emoyo.net and provide them with these details.

Cleaning and Maintenance

General Care
The Kuduscope is a highly sensitive, state of the art device that must be treated with care. It must be cleaned and disinfected regularly and care should be taken not to damage any of the sensitive camera or LED lights when cleaning or handling the device.

Cleaning Procedure
The Kuduscope must be thoroughly cleaned and disinfected after each and every use (i.e. before each new patient is tested) with a cleaning and disinfection wipes complying with EN1276 that are intended for use on plastic items.

When Cleaning the Kuduscope:

1. Disconnect the USB cable and use an antibacterial wipe to clean the Kuduscope.
2. It is important to ensure that during cleaning no liquid enters any holes.
3. Used otoscope specula must be submerged in sanitizing solutions containing alcohol after each test or disposed of as medical waste.
4. When cleaning the device, avoid bending or twisting any of the cables.
5. Check that the otoscope specula has not become blocked or obstructed over time.

Warning: Never use acetone based cleaning products when cleaning the Kuduscope.
Note: Ear wax and debris can collect in the otoscope specula. Make sure that there is no
debris on or inside the otoscope specula. Once debris or any foreign material has lodged into the little holes of the otoscope specula, it may be possible to remove the debris from the holes. If debris enters the holes, then the debris must be removed, cleaned and disinfected.

Storage and Shipping

Warning: When shipping the Kuduscope please use the robust shock absorbing carry case used to store the KUDUwave audiometer to reduce the risk of damage to the device during transit.
Remember to seal the shipping container securely and to mark the container FRAGILE. Always store the Kuduscope out of direct sunlight in a clean and dry environment within the temperature and humidity limits detailed in the Technical Specifications.

Expected Service Life

The Kuduscope has an expected service life of at least 2 years of continuous use, or 5000 uses. The Kuduscope can be used any number of times without restriction as long as it is cleaned in accordance with the instructions in this User Manual.

Disposal and Recycling

It is advisable that the unit is returned to eMoyo for disposal and recycling. Please call +27 87 231 0132, or email support@emoyo.net, for instructions. Alternatively contact your international distributor or EU representative for disposal and recycling instructions.

Traveling with Your Kuduscope™

When traveling or shipping the Kuduscope it is important to use its original case. This casing is specifically designed for traveling and to absorb shock.
Please make sure to perform the following tasks:

• Always unplug all USB cables before placing the Kuduscope into the case.
• Make sure no cables are caught up between the lid and the case before closing it.
• Always perform a biological test after traveling with your Kuduscope.

Maintenance and Support

Frequently Asked Questions (FAQs)
Please refer to https://emoyo.tech/pages/helpdesk for more information.

Support Service
At eMoyo we are confident that we can deliver a unique support service specifically designed for clients in remote areas. Contact us directly on our website by going to https://emoyo.tech/pages/helpdesk and going to our support page for useful information. Or you can fill us in on your Kuduscope related problems by leaving a message on our contact us page.

Online Virtual Support and Training
You can obtain online training using video conferencing software on your laptop. To receive online virtual support, you will need to be located in an area with a good broadband internet connection.

Service, Support and Maintenance Contract
The latest service, support and maintenance contract can be obtained from your local sales representative.

Troubleshooting

If you experience problems, kindly send an email with as much information as possible (including the specific error message(s) and under which circumstances they occurred) to support@emoyo.net or contact your local sales representative. Additional support information can also be accessed at https://emoyo.tech/pages/helpdesk.

Troubleshooting Checklist

In Need of Assistance?
Please contact your local IT consultant if you need assistance with confirming your personal computer’s specifications, or need an upgrade to meet the minimum requirements.

Technical Specifications

WARNING: No modification of this equipment is allowed.

Standards

The Kuduscope has been independently examined, tested to ensure Safety and Design Standards detailed in the General and Audiometry Specifications. This device has been tested by Shenzhen United Testing Technology Co., Ltd., and the test results show that the equipment under test (EUT) is in compliance with the EMC Directive 2014/30/EU requirements.

Instrument Specifications

Electromagnetic Compatibility (EMC)

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Following the guidelines in this section will help prevent this.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Kuduscope is intended for use in the electromagnetic environment specified below. The customer or operator of the Kuduscope must ensure that it is used in such an environment.

![eMoyo TD0102 Kuduscope User Manual - Guidance and Manufacturer’s Declaration

• Electromagnetic Immunity](https://manuals.plus/wp-content/uploads/2022/05 /eMoyo-TD0102-Kuduscope-User-Manual-Guidance-and-Manufacturers-Declaration- Electromagnetic-Immunity.jpg)

Conducted Emissions From The AC Mains Power Ports

End User License Agreement (EULA)

The eMoyoDotNetza (Pty) Ltd. End-User License Agreement (EULA) is a legal agreement between you, either an individual or a single entity and eMoyo, for the Kuduscope device and software. Software includes the personal computer software and the Kuduscope device firmware.
1 If the highest frequency of the internal sources of the EUT is less than 108 MHz, the measurement shall only be made up to 1 GHz. If the highest frequency of the internal sources of the EUT is between 108 MHz and 500 MHz, the measurement shall only be made up to 2 GHz. If the highest frequency of the internal sources of the EUT is between 500 MHz and 1GHz, the measurement shall only be made up to 5 GHz. If the highest frequency of the internal sources of the EUT is above 1 GHz, the measurement shall be made up to 5 times of the highest frequency or 6 GHz, whichever is less. 2 The power consumption of EUT is less than 75W and no Limits apply. 3 Voltage Dip: 100% reduction ­ Performance Criteria B Voltage Dip: 30% reduction ­ Performance Criteria C Voltage Interruption: 100% Interruption ­ Performance Criteria C

Software may be installed and used by any number of people (either an individual or a single entity). The software may be installed on any number of computers. The software can be operated over a network by any number of people from any number of computers. When it is plugged in, the Kuduscope will check that the Personal Computer Software is suitable to control it. Additional software functionality purchased will be associated with a single device and such software will only work for devices that have the license to use the new software.

The hardware may be used by any number of people (either an individual or a single entity). The hardware may be used on any number of Personal Computers and can be operated over a network by any number of people. eMoyo took all reasonable care to ensure a safe and compliant device, but there is always the slightest possibility for error. eMoyo and its employees and consultants do not take responsibility for any complications that may be the result of errors in the device or software. Specifications are subject to change without notice due to the continued development and enhancement of the Kuduscope. eMoyo reserves all rights not expressly granted.

Warranty and Disclaimer

Limited Warranty
eMoyoDotNetza (Pty) Ltd. t/a eMoyo warrants that the Kuduscope, if properly used and installed as per eMoyo’s instructions, will be free from defects in material and workmanship. The Kuduscope will conform to eMoyo’s high quality specifications for a period of one year, as stipulated on the Terms and Conditions found on the invoice.
This warranty

• begins on the date of purchase, (for your convenience, please keep the dated tax invoice as evidence of this date)
• is extended through distributors,
• covers defect(s)
• and does not cover tamper, drop, misuse or modifications.

If the Kuduscope, which is the subject of this Limited Warranty, fails during the warranty period for reasons covered by this Limited Warranty, eMoyo will retain the option to repair or replace the Kuduscope. All shipping costs required to repair or replace the device remain the responsibility of the purchaser.

Disclaimer
The Purchaser shall have no claim against eMoyo whatsoever, notwithstanding the termination or lapse of any contract. eMoyo will not be held responsible for loss or damage of any nature whatsoever, whether direct or indirect, consequential or otherwise, sustained as a result of any goods or equipment supplied or any advice given or any installation affected or any maintenance undertaken by eMoyo being in any way defective or absent or not conforming to the description thereof as a result of any other cause whatsoever.

Under no circumstances will eMoyo be liable for damages arising from misuse or abuse of the goods. The Customer does hereby indemnify and hold eMoyo harmless against any claim by any third person arising directly or indirectly out of any defect(s) in the goods or equipment supplied and or advice given to the Customer.

www.emoyo.tech

References

• Helpdesk – eMoyo South Africa
• eMoyo Technologies - Portable Audiometers – eMoyo South Africa
• eMoyo Technologies - Portable Audiometers – eMoyo South Africa
• Helpdesk – eMoyo South Africa
• Kuduwave Training – eMoyo South Africa
• eMoyo Technologies - Portable Audiometers – eMoyo South Africa
• Helpdesk – eMoyo South Africa
• TeamViewer Windows Download for Remote Desktop access and collaboration

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