Cellscope Oto FG1199 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
CellScope mobile app. 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 case (for everyday use).
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 operating with ios 7.1.1 or later. NOTE: the iPhone 5 or 5s must
be purchased separately. CellScope Oto device is not compatible with the iPhone 5c, iPhone 4s,
iPhone 4, iPhone 3GS or iPhone 3.
6. A mobile application ('CellScope Oto mobile app') used to collect, view, save and transmit
otoscopic exam data to the secure CellScope web app. The CellScope Oto mobile app can be
downloaded from the app store 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 compatible case.
• Optical otoscope (Oto) attachment (with insufflation bulb port,
see Compatible Insufflation Accessories).
• Storage container for optical attachment and tips.
• Lanyard to attach to the storage case.
• 2 pediatric-sized reusable tips (2.5mm diameter).
• 2 adult-sized reusable tips (4.25mm diameter).
• Quick Start Guide.
• Instructions for Use.
ADDITIONAL ITEM FOR DOWNLOAD
CellScope Oto Mobile Application available in the App Store(SM). To find, search for "CellScope"
within the App Store (SM). Follow the steps within the app or visit www.cellscope.com/register to
create an account if a username and login were not previously provided. Contact CellScope support
with any questions.
ACCESSORIES REQUIRED BUT NOT SUPPLIED
iPhone 5 or 5s with iOS 7.1.1 or later (Available for purchase from Apple Retailers.
See a list of authorized retailers at www.Apple.com/buy/)
COMPATIBLE INSUFFLATION ACCESSORIES
The Oto attachment is capable of insufflation for the purpose of pneumatic otoscopy.
The following products are compatible with the Oto:
• Welch Allyn® Otoscope Insufflation Bulb (21504)
• Welch Allyn MacroView Otoscope Insufflation 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 (e.g. the iPhone 5 or 5s).
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 off the tip and store for
future use.
SET UP INSTRUCTIONS
• Download the mobile app at www.cellscope.com/download
• Attach the case to the iPhone. To attach, slide the case onto your iPhone.
• Connect the Oto attachment and slide into place.
• Place a tip on the end of Oto attachment and twist lightly to firmly attach it.
• Launch the mobile application and login using your username and password.
• 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
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 on a bed 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 pediatric-sized tip and look at the iPhone screen to see inside the canal.
NOTE: Look for the logo of a baby to identify the pediatric-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 pull the outer flap of the ear DOWNWARD 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.
SMARTPHONE ENABLED
DIGITAL OTOSCOPE
INSTRUCTIONS FOR USE
Pediatric-sized tip
Model #FG1199
Adult-sized tip