Cellscope Oto FG1199 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
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insuationbulbport,
seeCompatibleInsuation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insuationforthepurposeofpneumaticotoscopy.
The following products are compatible with the Oto:
•WelchAllyn®OtoscopeInsuationBulb(21504)
•WelchAllynMacroViewOtoscopeInsuation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o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rmly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oor.
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ap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ap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.
Pediatric-sized tip Adult-sized tip
Model #FG1199

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apoftheaected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
MOBILE APP OPERATING INSTRUCTIONS
1. Select a patient to begin.
2. Position the patient according to the suggested methods.
3. SelectLeftorRighttoindicatetheearthatyouwillberecordingrst.
4. Tap on the camera button to begin the recording.
5. Gentlyinserttheappropriately-sizedtipintothepatient’searcanalandndtheeardrum.
6. Dependingonthesizeofthetipsused,youmayneedtoadjustthebrightnessbyswipingupon
the recording screen.
7. Once you have captured a view of the eardrum on the iPhone screen, tap the camera button
again to end the recording (there is no required video length).
8. Repeatstepsfor3-6fortheotherear.
9. Follow the instructions within the app to add additional information to the exam,
and to save or send the exam.
10.Whentheexamiscomplete,removetheOtofromthecaseandstoresafely.
11. Clean the reusable tip for future use.
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conrmation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5/5sLightning®connector,
theheadphonejackorothernon-standardareasoftheiPhone5/5s.
• Donotuseinthepresenceofammable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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.
WARRANTY
CellScope provides a limited warranty for the CellScope Oto product.
Please visit www.cellscope.com/warranty for a full description of the warranty.
IMPORTANT
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
[e-mail]
[phone]
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
CELLSCOPE OTO MODEL NUMBER: FG1199 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
Dimensions:5.0”x2.5”x0.5”
(128mmx63.7mmx11.85mm)
Weight:0.90oz(25.5g)
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 Pediatric Specula
Dimensions:1.3”x0.7”x0.7”
(33.0mmx18.0mmx18.0mm)
Weight:0.02oz(0.6g)
CellScope Adult 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 [e-mail]
LB1193Rev.BJune,2014
Review instructions
for use.
The CellScope Oto is
atypeBFappliedpart.
BatchCode Catalog Number
SYMBOL GLOSSARY
-20ºC
(-4ºF)
45ºC
(113ºF)
5%
95%