hearX hearScope User manual

USER MANUAL

hearScope™ - Ground Floor, Building 2, Ashlea
Gardens Oce Park, 180 Garsfontein Road, Ashlea
Gardens, Pretoria, 0081, South Africa
hearScope v2.
HSCP-MN-EN hearScope IFU v1.0
For more information visit www.hearxgroup.com or
contact hearX: [e-mail]
ZA: [phone]
US: [phone]
UK: [phone]

Congratulations! This is your hearScope™
smartphone video-otoscope.
hearScope™ consists of a handheld video otoscope with
a light source and ear tips of various sizes that connects
to an Android smartphone (can be user-supplied). The
device is supplied with a protective case. The intended
use of hearScope™ is to visually inspect the outer ear
canal and tympanic membrane under magnication.
Imaging of the outer ear canal and tympanic membrane
is viewed on the smartphone, using the hearScope™
application.
For a list of compatible Android smartphones go to
www.hearxgroup.com/hearscope
WHAT IS hearScope™?
Please read this guide carefully to ensure correct setup
and safe operation.
1

WHAT’S IN THE BOX?
Protective case
1
hearScope™
Smartphone video otoscope with Micro USB cable
2
Reusable ear tips
3
2x Small, 2x Medium and 2x Large
reusable ear tips included with
initial purchase.
2

• Switch on the smartphone, download and open
the hearScope™ application.
https://play.google.com/store/apps/details?id=com.hearxgroup.hearscope
• Connect the hearScope™ to your smartphone (use
the micro USB to USB-C adaptor if required).
• Grant your smartphone permission to access the
hearScope™.
SET UP INSTRUCTIONS
Phone stand
5
Micro USB to USB-C adaptor
Required for some phone models
4
3

Please refer to the in-app tutorial for operating
instructions with images. Go to Menu/Tutorial.
1. Open the hearScope™ application on your
smartphone.
2. Orientate your hearScope™ right side up by pointing it
at an object and rotating the hearScope until the image
on the hearScope™ application is the right way up.
OPERATING INSTRUCTIONS
4

3. Point the hearScope™ at an object about 25mm from
the front of the scope and adjust the focus wheel until
the object is in focus to set initial focus.
4. The light intensity can be adjusted by turning the
wheel attached to the cable, it is recommended to
turn the intensity up to maximum for rst use.
5. Select an ear tip and t it to your hearScope™ so that
your thumb ts comfortably on the focus wheel. Note:
The rst few ts can be tight so push the ear tip onto
the hearScope™ until you hear a 'click' sound.
5

6. Gently insert the ear tip into the ear. Use your thumb
to make small focus adjustments as needed. Take
caution in not inserting the tip too deeply.
7. View the image on the screen of the smartphone. Use
the on screen buttons to capture images, record video,
zoom in and out, switch ears and nish the session.
6

8. After nishing the session select images to crop,
add text/audio notes and request diagnostic support
(coming soon).
9. All images are saved automatically, press-and-hold
to delete multiple images.
hearScope™ should not be used in individuals with
visible obstructions of the outer ear canal. In individuals
with uid draining from the outer ear canal, hearScope™
should be used with caution, with strict infection control
protocols in place. hearScope™ should not be used for
any purpose other than visually inspecting the outer ear
canal and tympanic membrane.
CONTRAINDICATIONS
7

To ensure optimum and safe use of the hearScope™
smartphone video otoscope, please read carefully
through the following safety precautions:
• Although the hearScope™ may aid in diagnosing
conditions of the outer ear and tympanic
membrane,it does not replace the advice of and
prescribed treatment by a medical professional.
• hearScope™ ear examinations should only
be conducted by individuals who have received
appropriate training on using an otoscope.
• Examine the device thoroughly for damage before
every use. Do not use the device if any damage or
irregularities are found.
• Ensure that appropriately-sized tips are used and
that they are not inserted too deeply into
the outer ear canal. Deep insertion may result in
harm to the outer ear canal or tympanic membrane.
• Ensure strict infection control by disinfecting each
ear tip after use. Do not use a single ear tip on more
than one patient at a time.
• Store the hearScope™ and its parts out of reach of
infants, small children and pets.
• Avoid exposing the device to any uid and/or dust.
• All precautions relevant to a smartphone device
are applicable. Please refer to the smartphone
manufacturer’s documentation for more
information.
• Do not use the hearScope™ anywhere where the
usage of a smartphone is not permitted.
hearScope™ was not tested for electromagnetic
disturbance or immunity and may not function
in an environment where electromagnetic
disturbances are present.
• Do not use this device in the presence of
ammable anesthetics or pressurised oxygen.
• Follow local rules and regulations regarding
SAFETY PRECAUTIONS
8

Ensure that the hearScope™ is disconnected from
the smartphone when not in use. Turn o the light to
preserve the LED lamp life. Store the device in the
provided protective case at all times to avoid damage.
The device and ear tips should be disinfected prior to
storage. Avoid exposing the device to any uid and/or
dust. Be careful not to touch the hearScope™ lens.
STORAGE & HANDLING
disposal or recycling of this device and its
components.
• No modication of this device is allowed.
Before use, check the cables and connectors for signs
of wear and/or damage. If found, please arrange for
servicing or checking by the seller before continuing
with the use of the device. No further maintenance is
required. No modications or repairs should be made to
the device by anyone other than the seller.
The hearScope™ body and case can be disinfected with
a cloth dampened with EPA-approved alcohol. Use of
improper cleaning methods or solutions may damage
the device. If the lens becomes dirty carefully wipe the
lens with a dry, non-scratching microber cloth. Take
care to ensure all components of the hearScope™ are
dry before the next use.
The reusable ear tips should be disinfected after every
use. Submerge the ear tips in rubbing alcohol (minimum
70% isopropyl alcohol) for 20 minutes and wipe excess
debris and moisture o before next use.
DEVICE MAINTENANCE & CLEANING
9

For Troubleshooting tips and answers to Frequently
Asked Questions, please visit www.hearxgroup.com/
hearscope.
hearScope™ comes with a limited out-of-box 2 year
warranty. Within the limited range of the warranty,
defective products or parts will be repaired or replaced
by the manufacturer of authorised technical service
groups to the extent permitted by law.
Faults on the hearScope™ must be reported to the
Manufacturer within 60 days of discovering the fault
for the warranty to be applicable. This warranty is
non-transferable and does not cover damages due
to negligence, accidents, abuse, misapplication,
modication and repairs not made by the manufacturer
or authorised service groups. This warranty does
not cover shipping costs associated with repairs or
replacements.
TROUBLESHOOTING
WARRANTY
hearScope™ is a trademark owned by hearX SA (Pty)
Ltd. Trademarks of other products and companies are
registered trademarks of that company and should be
treated as such.
TRADEMARK INFO
10

TECHNICAL DESCRIPTION
Packaging as shipped (approximate)
Dimensions 200mm x 55mm
x 125mm
Weight ± 220g
hearScope™ body
Dimensions 135mm x Ø11mm
Weight ± 61g
Ear Tip (speculum)
Dimensions 72mm x Ø11mm
Weight ± 2g
Camera 2 MP CMOS
Light source LED, variable
intensity
Power source
Powered via
the smartphone
battery
Operating conditions
Temperature 10°C to 40°C
Relative humidity 15% to 75%
Non-Condensing
Shipping/storage conditions
Temperature -20°C to 50°C
Relative humidity 15% to 90%
Non-Condensing
11

Manufacturer name and address
Caution/Precaution.
CE mark indicating conformity with Health and
Safety requirements set out in European Directives.
Not for general waste.
Device is fragile
Keep product dry
Consult instructions for use
SYMBOL GLOSSARY
12