1. No category

SMARTPHONE ENABLED
DIGITAL OTOSCOPE
INSTRUCTIONS FOR USE
TABLE OF CONTENTS:
Product Description All Users1-4
Intended Use All Users5
Storage and Handling All Users5
Maintenance All Users6
Cleaning Instructions All Users6
Set Up Instructions All Users7-9
Downloading and Preparing the CellScope
Oto Mobile Application All Users
10
Launching the Mobile Application All Users10
Mobile App Operating Instructions Clinicians11
In-App Icon Glossary
11
Contraindications Clinicians12
General Safety Precautions Clinicians12
Conducting Ear Exam At Home-Users13-14
Mobile App Operating Instructions
At Home-Users14
Contraindications At Home-Users15
General Safety Precautions Home-Users15
Troubleshooting All Users16
Symbol Glossary Clinicians17
Warranty All Users17
Technical Description All Users18
CellScope® Oto™
For support, please email [email protected]
or visit www.cellscope.com.
ALL USERS
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. Data (videos
and images) collected using the Oto
system is uploaded to CellScope’s HIPAAcompliant server, which is accessible from
CellScope’s secure web app.
THE CELLSCOPE OTO DEVICE USES
THE FOLLOWING COMPONENTS:
1. A specially designed iPhone ® 5/5s case
(for everyday use).
2. The optical otoscope attachment (Oto)
that connects to the case. [Note: the Oto
attachment is designed for use with usersupplied standard otoscope specula (tips)
that are not provided]
3. A storage container for the Oto and tips.
4. A user-supplied iPhone 5/5s operating
with iOS 7.0.4 or later.
[Note: the iPhone 5 or 5s must be
purchased separately. CellScope Oto
device is not compatible with iPhone 5c,
iPhone 4s, iPhone 4, iPhone 3GS or
iPhone 3.]
1
ALL USERS
5. A mobile application (‘CellScope Oto
mobile app’) used to collect, view, save
and transmit otoscopic exam data to
the secure CellScope web server. The
CellScope Oto mobile app can be
downloaded from the App Store (SM).
Access via a username and password
will be provided upon purchase of the
CellScope Oto device. Contact CellScope
support with questions.
[Note: the CellScope Oto mobile app will
not function correctly with any version of
iOS prior to 7.0.4.]
6. The CellScope web app. Users can review
ear exam and information logged on the
mobile application by accessing 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.]
2
ALL USERS
Figure 1. CellScope Oto,
connection to iPhone 5/5s,
standard otoscope specula,
with Mobile Application
Otoscope attachment
Tip*
(not included)
iPhone 5/5s*
(not included)
CellScope Oto mobile
app (downloaded from
the iTunes App Store)
iPhone 5/5s
compatible case
* iPhone 5/5s and tips must be
purchased separately
3
ALL USERS
INCLUDED IN THIS PACKAGE
• A CellScope iPhone 5/5s case
• Optical otoscope attachment (Oto)
• Storage container for optical attachment
and tips
• Lanyard to attach to the storage case
• Instructions for Use
ADDITIONAL ITEM FOR DOWNLOAD
• CellScope Oto Mobile Application
available in the App Store℠ (To find,
search for “CellScope” within the App
Store℠).
ACCESSORIES REQUIRED
BUT NOT SUPPLIED
• iPhone 5 or 5s with iOS 7.0.4 or later
(Available for purchase from Apple
Retailers. See a list of authorized retailers
at http://www.apple.com/buy/)
• Disposable otoscope tips
(KleenSpec® tips available for over
the counter purchase online via
Amazon.com). Consult a physician for
specification on appropriately sized
tips for each individual.
4
ALL USERS
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).
For access to a CellScope Oto device or to
the associated applications please contact
[email protected]
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.
45º C
(113º F)
-20º C
(-4º F)
95%
5%
5
ALL USERS
MAINTENANCE
No preventative maintenance is required.
Use a new otoscope tip for each exam to
prevent cross-contamination between
patients. Any modification or repair of this
device is strictly prohibited.
CLEANING INSTRUCTIONS
The Oto attachment can be cleaned
with a 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 is not watertight
so it 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.
6
ALL USERS
SET UP INSTRUCTIONS
Prepare to attach the Oto
attachment to the phone
by first placing the case on
the phone (Figure 2). To
attach, slide the case onto
your iPhone 5/5s. Connect
the attachment and slide
into place (Figure 3). Attach
a large or small tip (the
CellScope Oto system is
compatible with KleenSpec®
tips) to the end of speculum
cone (Figure 4). Begin use
in conjunction with the
application. When the exam
is complete, discard the
used tip and slide the Oto
off the case (Figure 5).
7
ALL USERS
Figure 2. Attach the
case to the phone by
sliding in the side with
the volume control
buttons first.
Figure 3. Insert the
Oto attachment into
the case and slide
left over the phone
camera and flash.
Figure 4. Once the Oto attachment is
securely attached to the phone case,
hold the end of the speculum tip gently
between your pointer finger and thumb.
Press the tip down lightly onto the speculum
cone and twist clockwise until you feel
resistance. The tip should be securely
attached to the cone. Now you are ready to
conduct an exam.
8
ALL USERS
Figure 5. When exam is
complete, discard the
disposable tip and remove
the Oto attachment from
the case by sliding it back
towards the right. Keep
the Oto attachment in the
storage case.
Figure 6: The CellScope case is designed
for everyday use, but it can be removed.
Separate the case from the phone starting
from the bottom right corner of the screen
(the corner furthest from the volume
buttons). Simultaneously, push on the phone
through the cutout of the case (avoiding the
phone’s camera and LED) to fully remove
the phone from the case.
Cutout
9
ALL USERS
DOWNLOADING AND
PREPARING THE CELLSCOPE
OTO MOBILE APPLICATION
The CellScope Oto mobile
app may be downloaded to
the phone from the App StoreSM.
Search “CellScope” in the App
Store or follow the link from the
CellScope website.
Create a username and password
on the CellScope website or
contact [email protected]
to request an account.
LAUNCHING THE MOBILE
APPLICATION
Before launching the application
and recording, be sure that the
device is firmly attached to
your phone’s case and a tip has
been securely attached to the
speculum cone.
10
CLINICIAN USERS
MOBILE APP OPERATING INSTRUCTIONS
1. Login using your email and password.
2. To begin recording an exam video or image, select L
(left) or R (right) to indicate the ear that you will be
recording first.
3. Tap on the record icon to begin.
4. Gently insert the tip into the patient’s ear.
5. Adjust the light source by swiping up or down on
the screen.
6. Tap the record icon again to end the recording.
Note: you can select the camera icon to capture a
still image.
7. Repeat the process with the other ear.
Once a video or image has been recorded, you can
review by pressing the ‘Current Exam’ thumbnail in
the bottom left which will take you to the Exam page.
On the Exam page, you will have access to extract
and save images from the video, annotate images,
add the patient’s name, and add other information
about the exam including reported symptoms,
diagnosis and treatments.
NOTE: A small info button on the bottom right of
important screens will display a help overlay.
For answers to Frequently Asked Questions, visit:
http://www.cellscope.com/support
IN-APP ICON GLOSSARY
Exam library
Help screen overlay
Share or email
Add a new patient
to this exam
Patient library
Create a new exam
11
CLINICIAN USERS
CONTRAINDICATIONS
This device may only be used for inspection of the
external ear canal and eardrum. Do not use for any
purpose (such as ear wax or foreign body removal)
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: 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 objects or tissue
directly against the Oto speculum cone. Light
emitted from the Oto may be intense to enough
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.
•
Do not use the same otoscope tip between patients
or between examinations. Always use a new tip for
each examination. Dispose of tips after use.
•
Do not use the device with any objects plugged
into the iPhone 5 or 5s Lightning® connector, the
headphone jack or other non-standard areas of the
iPhone 5 or 5s.
•
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
device during use.
•
Keep out of reach of infants, small children, or
anyone incapable of using the device properly.
•
Do not use the device anywhere where usage
of the iPhone 5/5s 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
12
AT-HOME USERS
EAR ANATOMY
CONDUCTING EAR EXAM
The following instructions are guidelines. 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 the eardrum.
SUGGESTED METHODS FOR
BABIES UNDER 1 YEAR OF AGE:
1. Lay the child on his or 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 the one side.
4. Gently pull the pinna (or outer flap of the ear)
DOWNWARD and BACKWARD to straighten
the ear canal.
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 pinna (or outer flap of the ear) of
the affected ear DOWNWARD and BACKWARD to
straighten the ear canal.
13
AT-HOME USERS
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 pinna (or outer flap of the ear) of
the affected ear UPWARD and BACKWARD to
straighten the ear canal.
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
MOBILE APP OPERATING INSTRUCTIONS
1. Login using your email and password.
2. Select a Patient Profile to begin.
3. Start a new ear exam and select the appropriate ear.
4. Position the patient according to the suggested
methods on page 13.
5. Tap the camera button to begin the recording.
6. Gently insert the appropriately-sized tip into the
patient’s ear canal and find the eardrum.
7. Depending on the size of the tips used, you may
need to adjust the brightness by swiping up on the
recording screen.
8. Once you have been able to visualize the eardrum
on the iPhone screen, tap the camera button
again to end the recording (there is no required
video length).
9. Select the other ear and repeat steps 4–8.
10. Once you have captured a video for each ear,
the mobile app will ask you to note the child’s
symptoms, and any additional information
that a doctor would find helpful to assess your
child’s health.
11. Submit the exam for review by following the steps
within the mobile app.
NOTE: A small info button on the bottom right of the
recording screen will guide you along.
14
AT-HOME USERS
CONTRAINDICATIONS
This device may only be used for inspection of the external ear
canal and eardrum. Do not use for any purpose (such as ear wax
or foreign body removal) 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 objects or tissue directly against
the Oto speculum cone. Light emitted from the Oto may be
intense to enough 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.
•
Do not use the same otoscope tip between patients or
between examinations. Always use a new tip for each
examination. Dispose of tips after use.
•
Do not use the device with any objects plugged into the
iPhone 5/5s Lightning® connector, the headphone jack or
other non-standard areas of the iPhone 5/5s.
•
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 device
during use.
•
Keep out of reach of infants, small children, or anyone
incapable of using the device properly.
•
Do not use the device anywhere where usage of the iPhone
5/5s 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.
15
ALL USERS
TROUBLESHOOTING
PROBLEM
SOLUTION
The CellScope
case doesn’t fit
on my phone.
The CellScope case is designed to fit
over the standard iPhone 5 or 5s. No
other case can be used simultaneously.
I cannot login to
my account
The first time you login to the CellScope
Oto app, make sure you are connected
to the Internet. If you don’t have a data
plan available, connect to Wifi.
If you cannot remember your password,
press the Forgot Password link and
you will be prompted to reset your
password.
The tips fall off
the Oto.
Make sure to use appropriate sized
tips (as instructed by your physician)
and twist onto the Oto module in the
clockwise direction until fully engaged.
I see the image
upside down.
Only use the Oto module with the
CellScope Oto mobile application.
I am
experiencing
poor image
quality or am
unable to view
an image on the
screen
Attach the Oto modular attachment
properly by sliding it into the CellScope
case from right to left until you hear
it click.
Use device with the appropriate tip
(as instructed by your physician).
Make sure to clean the device as
instructed to avoid debris from blocking
the light source or optical path.
If all of the above have been determined,
your device may be broken. Contact
CellScope Support for additional
assistance.
An error
message is
shown when I
try to record an
exam
Make sure your phone has enough free
space available by viewing available
Storage from the phone’s Settings <
General < Usage menu. If less than 120
MB of space is available, a CellScope
error will be displayed.
I accidently
recorded the
right ear in the
space for the
left ear exam
(Clinicians Only)
You can move any video or image to
the correct ear by pressing and holding
the thumbnail of the video or image
on the Exam screen. The app will give
you the option to switch the association.
16
ALL USERS
SYMBOL GLOSSARY
Review instructions
for use.
The CellScope Oto is
a type BF applied part.
Batch Code
Catalog Number
Caution
95%
5%
45º C
(113º F)
-20º C
(-4º F)
WARRANTY
CellScope, Inc. provides a limited warranty
for the CellScope Oto product. Please visit
http://www.cellscope.com/warranty
for a full description of the warranty.
Important: Report any injury or adverse event
to your physician immediately.
For general or product related comments,
questions, concerns or experiences, please
contact CellScope directly.
17
CellScope, Inc.
530 Howard St. Suite 300,
San Francisco, CA 94104
[email protected]
(866) 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 Patents Pending.
www.cellscope.com
facebook.com/cellscope
@cellscope
CELLSCOPE OTO MODEL NUMBER: FG1103
Technical Description
Optical Oto Attachment
Dimensions: 1.5” x 0.8” x 1.0” (36.8mm x
19.2mm x 24.8mm) Weight: 0.25oz (7g)
Magnification Factor: 3.5x
CellScope Case
Dimensions: 5.0” x 2.4” x 0.4” (127.2mm x
61.8mm x 11.1mm)
Weight: 0.55oz (15g)
Storage Container with Specula Attachment
Dimensions: 1.2” x 1.1” x 4.1” (30.7mm x 27.7mm
x 104.6mm) Weight: 1.15oz (32g)
LB068 B January, 2014
18