Cellscope OTO User manual
SMARTPHONE ENABLED
DIGITAL OTOSCOPE
INSTRUCTIONS FOR USE
Thank you for purchasing the CellScope Oto™ for use as
a smartphone-enabled digital otoscope. Please read these
instructions carefully to ensure safe operation.
PRODUCT DESCRIPTION
The CellScope Oto System consists of a smartphone case, optical otoscope attachment and mobile
app for image/video capture. It enables users to perform and track otoscopic exams over time.
The CellScope Oto device uses the following components:
1. A specially designed iPhone® 5/5s/SE case (for everyday use) and iPhone 6/6s connector.
2. The optical otoscope (Oto) attachment compatible with the supplied phone case.
3. A storage container for the optical attachment and tips.
4. Appropriately sized tips that attach to the Oto during an exam.
5. A user-supplied Apple iPhone 5/5s or 6/6s operating with iOS 8.4 or later. NOTE: the iPhone 6,
6s, 5, 5s, or SE must be purchased separately. CellScope Oto device is not compatible with the
iPhone 6s Plus, iPhone 6 Plus, 5c, iPhone 4s, iPhone 4, iPhone 3GS or iPhone 3.
6. A mobile application used to collect, view, save and transmit otoscopic exam data to the secure
CellScope web app. There are two applications that can be used for image/video capture and
transmission:
Seymour: Snap photos of all your family’s health concerns and record them in one place.
Send ear and other photos to our on-call doctors for an evaluation in just 2 hours.
Available for download at www.cellscope.com/getseymour
CellScope: Clinicians may use the CellScope companion app with the Oto device
in the clinic. Save magnified images of the tympanic membrane to share with patients
to engage them in their treatment plan. Available for download at www.cellscope.com/
download
7. A web app to enable review of ear exam information recorded on the mobile application. Access
the user portal at www.cellscope.com. NOTE: the CellScope web app is supported on the following
web browsers: Google Chrome on OS X and Windows 7, Internet Explorer 8 on Windows 7 and Firefox
on OS X.
PACKAGE CONTENTS
• CellScope iPhone 5/5s/SE compatible case
• CellScope iPhone 6/6s compatible connector
• Optical otoscope (Oto) attachment (with insuation bulb port,
see Compatible Insuation Accessories)
• Storage container for optical attachment and tips
• Lanyard to attach to the storage case
• 2 infant-sized reusable tips (2.5mm diameter)
• 2 standard-sized reusable tips (4.25mm diameter)
• Quick Start Guide
• Instructions for Use
ADDITIONAL ITEM FOR DOWNLOAD
One of two mobile apps can be used for image capture:
Seymour: Snap photos of all your family’s health concerns and record them in one
place. Send ear and other photos to our on-call doctors for an evaluation in just 2 hours.
Available for download at www.cellscope.com/getseymour
CellScope: Clinicians may use the CellScope companion app with the Oto device
in the clinic. Save magnified images of the tympanic membrane to share with patients
to engage them in their treatment plan. Available for download at www.cellscope.com/
download
Follow the steps within either app or visit www.cellscope.com/register to create an account. You
may proceed to login to the corresponding companion app, if a username and login were previously
provided. Contact CellScope support with any questions.
ACCESSORIES REQUIRED BUT NOT SUPPLIED
Compatible iPhone (5, 5s, SE, 6, or 6s) with iOS 9 or later (Available for purchase from Apple
Retailers. See a list of authorized retailers at http://www.apple.com/buy/)
COMPATIBLE INSUFFLATION ACCESSORIES
The Oto attachment is capable of insuation for the purpose of pneumatic otoscopy.
The following products are compatible with the Oto:
• Welch Allyn® Otoscope Insuation Bulb (21504)
• Welch Allyn MacroView Otoscope Insuation Bulb (23804)
INTENDED USE
The CellScope Oto is intended for inspection of the external ear canal and eardrum
under magnification using an external illumination source.
STORAGE AND HANDLING
Store the device in the provided container at a temperature between -20º and 45º C (-4º to 113º F)
and humidity between 5 and 95% (non-condensing). Avoid contact with dust during use or storage.
MAINTENANCE
No preventative maintenance is required. To prevent cross-contamination between patients, clean the
reusable tips in between each exam using the cleaning instructions below. Any modification or repair
of this device is strictly prohibited.
CLEANING INSTRUCTIONS
The Oto attachment can be cleaned with a dry, non-scratching, lint-free microfiber cloth. The
attachment and case can be disinfected with a cloth dampened with alcohol. Only use EPA-approved
disinfectant. Use of improper cleaning solutions or methods may damage the device. The attachment
should not be submerged in liquid. Care should also be taken not to scratch the lens of the otoscope
attachment. Failure to clean the device may cause blurry images.
The reusable tips should be disinfected after each use. Submerge the tip in rubbing alcohol (minimum
70% isopropyl alcohol) for 20 minutes. Wipe clean of any excess debris. Dry o the tip and store for
future use.
SET UP INSTRUCTIONS
1. Download the appropriate mobile app for the intended use
• Seymour for home use of the Oto can be downloaded here: www.cellscope.com/get
seymour
• CellScope for Clinician use of the Oto can be downloaded here: www.cellscope.com/
download
2. Attach the case to the iPhone. To attach, slide the case onto your iPhone.
3. Connect the Oto attachment and slide into place.
4. Place a tip on the end of Oto attachment and twist lightly to firmly attach it.
5. Launch the mobile application and login using your username and password.
6. Begin an exam and follow the instructions within the app to store or share the image or video.
NOTE: A small info button on the bottom right of important screens will display a help overlay.
For answers to Frequently Asked Questions and Troubleshooting Tips,
visit www.cellscope.com/support
MOBILE APP OPERATING INSTRUCTIONS
1. To start an ear exam, select Left or Right to indicate the ear that you will be recording first.
2. Start the recording.
3. Gently insert the appropriately sized tip into the patient’s ear canal and find the eardrum.
4. Once you have captured a view of the eardrum on the iPhone screen, end the recording. Note:
there is no required video length.
5. Repeat steps 2-4 for the other ear.
6. Follow the instructions within the app to add additional information and save the exam.
7. When the exam is complete, detach the Oto from the case and store safely. Clean the reusable
tip for future use.
IMPORTANT: Always use the mobile app while connected to the internet to ensure correct operation.
Infant-sized tip Standard-sized tip
CONDUCTING AN EAR EXAM
The following instructions are guidelines for conducting an ear exam on a child. If one method does
not work with your child, try one of the other two methods. Before trying this on your child, try on
an adult for practice. You will then get a feel for how far the device needs to be inserted into the
canal in order to correctly capture a view of the eardrum.
FOR BABIES UNDER 1 YEAR OF AGE:
1. Lay the child on her back or on a blanket on the floor.
2. It may be helpful to have a second adult hold the child’s legs or body to prevent sudden
movement during the exam.
3. Gently press the child’s head to one side.
4. Gently pull the outer flap of the ear (called the pinna) DOWNWARD and BACKWARD to
straighten the ear canal.
5. Insert a infant-sized tip and look at the iPhone screen to see inside the canal. Note: Look for the
logo of a baby to identify the infant-sized tip.
6. Aim towards the darkest area as this indicates a deeper area of the canal where the eardrum is
found.
FOR CHILDREN AGES 1 TO 3:
1. Distract the child with a toy or game.
2. It may be helpful to have a second adult hold the child’s head in an upright position during the
exam to prevent them from moving suddenly.
3. Gently press the child’s head to one side.
4. Gently pull the outer flap of the ear DOWNWARD and BACKWARD to straighten the ear canal.
5. Aim towards the darkest area as this indicates a deeper area of the canal where the eardrum is
found.
FOR ADULTS AND CHILDREN OVER AGE 3:
1. Sit your child in a comfortable place and ask your child to stay as still as possible.
2. It’s helpful for the child to be in an upright position during the exam.
3. Gently pull the outer flap of the aected ear UPWARD and BACKWARD to straighten the ear
canal.
4. Insert the tip and look at the iPhone screen to see inside the canal.
5. Aim towards the darkest area as this indicates a deeper area of the canal where the eardrum is
found.
Video tutorials (which include sample images of the eardrum are available for viewing within the
mobile app and on the web at www.cellscope.com/support/videos
CONTRAINDICATIONS
This device may only be used for inspection of the external ear canal and eardrum. Do not use for
any purpose other than an otoscopic exam to avoid injury or damage to the device. If you can see
something stuck in the ear canal, do not insert the otoscope.
GENERAL SAFETY PRECAUTIONS:
CAUTION: This device is not designed or intended to provide a diagnosis of ear infections or
other ailments of the ear. This device should not be used as a basis for starting or modifying
treatment without independent confirmation by medical examination. Do not attempt
self-diagnosis or self-treatment based on the recording results and analysis. Self-diagnosis or
self-treatment may lead to deterioration of your health.
CAUTION: Proper care and handling is essential for satisfactory performance of the Oto device.
Examine the device thoroughly before and after use. If any damage or irregularities are found,
do not use the device.
• To avoid injury, do not place Oto attachment directly against skin or other objects. Light emitted
from the Oto may be intense enough to increase surface temperature or cause damage to
objects or living beings.
• Use appropriate tips for the age and anatomy of the patient to avoid possible discomfort.
• Patients should always consult their physician if they notice changes in their health,
regardless of ear exam results.
• To avoid cross-contamination between patients, do not reuse the same tip without disinfecting it
prior to use. See Cleaning Instructions.
• Do not use the device with any objects plugged into the iPhone Lightning® connector,
the headphone jack or other non-standard areas of the iPhone.
• Do not use in the presence of flammable anesthetics, drugs or pressurized oxygen (such as in a
hyperbaric chamber, ultraviolet sterilizer or oxygen tent).
• Do not place other equipment adjacent to the phone and device during use.
• Store out of reach of infants, small children, or anyone incapable of using the device properly.
• Do not use the device anywhere that usage of the iPhone is not permitted. The Oto was not
tested for immunity to electromagnetic disturbances and may not function correctly in an
environment where electromagnetic disturbances generated by other equipment are present.
• Do not use the device in conjunction with water, or in a wet environment.
Review instructions
for use.
The CellScope Oto is
a type BF applied part.
Batch Code Catalog Number
SYMBOL GLOSSARY
-20º C
(-4 º F )
45º C
(113º F)
5%
95%
CELLSCOPE OTO MODEL NUMBER: FG1455 TECHNICAL DESCRIPTION
Optical Oto Attachment
Dimensions: 1.4” x 0.7” x 1.0”
(34.2mm x 18.9mm x 25.5mm)
Weight: 0.25oz (7g)
Magnification Factor: 4.14x
CellScope Case (iPhone 5/5s/SE)
Dimensions: 5.0” x 2.5” x 0.5”
(128mm x 63.7mm x 11.85mm)
Weight: 0.90oz (25.5g)
CellScope Case (iPhone 6/6s)
Dimensions: 1.1’’ x 2.8’’ x 0.7’’
(28.6 mm x 70.0 mm x 17.2 mm)
Weight: 0.25 oz (7g)
Storage Container with Specula Attachment
Dimensions: 1.7” x 1.1” x 4.2”
(43.3mm x 27.7mm x 105.5mm)
Weight: 1.05oz (30g)
CellScope Infant Specula
Dimensions: 1.3” x 0.7” x 0.7”
(33.0mm x 18.0mm x 18.0mm)
Weight: 0.02oz (0.6g)
CellScope Standard Specula
Dimensions: 1.3” x 0.7” x 0.7”
(33.0mm x 18.0mm x 18.0mm)
Weight: 0.02oz (0.6g)
www.cellscope.com | facebook.com/cellscope | @CellScope
For support, visit www.cellscope.com/support or email us at support@cellscope.com
LB1193 Rev. F May, 2016
WARRANTY
CellScope provides a limited warranty for the CellScope Oto product.
Please visit www.cellscope.com/warranty for a full description of the warranty.
IMPO RTANT
Report any injury or adverse event to a physician immediately. For general or product related
comments, questions, concerns or experiences, please contact CellScope, Inc. directly.
CellScope, Inc.
530 Howard St. Suite 300
San Francisco, CA 94105
(888) 930-6490
CellScope is a registered trademark owned by CellScope, Inc. Other parties’ trademarks or
registered trademarks are the property of their respective owners and should be treated as such.
U.S. and Foreign Patent information is available online at www.cellscope.com/legal
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