Keeler MIO User manual

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Keeler MIO & KineXis Software
Instructions for Use

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Contents
Copyright ...................................................................................................................................3
Introduction................................................................................................................................3
Indication for use .........................................................................................................................3
Symbols information ......................................................................................................................4
Warnings and cautions ...................................................................................................................5
Installation .................................................................................................................................6
6. Installation (continued) ..................................................................................................................7
Software Setup ............................................................................................................................8
7. Software Setup (continued) .............................................................................................................9
Cleaning .................................................................................................................................. 10
Specifications............................................................................................................................ 11
Spare parts & accessories.............................................................................................................. 11
Warranty ................................................................................................................................. 11
Contact and disposal information .................................................................................................... 12

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Copyright
The information contained within this manual must not be
reproduced in whole or in part without the manufacturer’s
prior written approval.
The manufacturer reserves the right to make changes to
specifications and other information contained in this
document without prior notice.
Copyright © Keeler USA. Published in the USA 2020.
Introduction
Thank you for purchasing the Keeler MIO.
These Instructions for Use are addressed to healthcare
professionals using the MIO.
The device is intended to be used in accordance
with these instructions. Please read them carefully
and keep this document safe for future reference.
Indication for use
The Keeler MIO is intended to enable the head mounting of a
smartphone running the KineXis mobile application, for use
with a handheld condensing lens for ophthalmic diagnostic
examinations. The Keeler MIO is to be worn only by
healthcare professionals.
Please refer to the quick guide for further information on the
installation and use of the software.

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Symbols information
Please pay attention to the description of symbols below, as they will be used throughout the manual, device and packaging.
Follow instructions for use
Do not use if package is
damaged
Fragile
Caution
Keep dry
This symbol on the product or
its packaging indicates it was
put on the marketplace after
August 2006, and this product
shall not be treated as
household waste
Manufacturer’s name and
address
Temperature limits
Date of manufacture
Humidity limits
RoHS compliant
Atmospheric pressure limits
Material suitable forrecycling
This way up

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Warnings and cautions
• The product has been designed to function safely when at an ambient temperature between +10ºC and+35ºC.
• This product should be used in a room with subdued lighting.
• This product has been designed to hold phones with a weight up to 300 grams.
• Where the Universal Adaptor is applied to a mobile phone case, the case must be flat.
• Do not use if the product is visibly damaged, and periodically inspect for signs ofdamage.
• This product should notbe immersed in fluids.
• Verify that the mobile phone is mounted securely before using with a patient
• USA Federal law restricts this device to sale by, or order of a physician.

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Installation
This chapter will instruct how to unpack and prepare the MIO
for use.
When you open the package, check for any external
damage or flaws, particularly damage to the case. If
you suspect there is something wrong with the head
unit, contact the manufacturer or distributor.
Remove the MIO Universal Adaptor from the packaging.
Wipe clean the backside of the mobile phone/mobile phone
case, from any dust or dirt.
Remove the adhesive label cover from the MIO Universal
Adaptor and position the Adaptor to the back of the mobile
phone, in the approximate position shown in the image.
Press firmly to ensure good adhesion to the mobile
phone/phone case.

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6.Installation (continued)
To mount the MIO Universal Adaptor to the Mount on the flexible
arm of the MIO, ensure the lugs on the bayonet mechanism of the
mount align with the corresponding features on the MIO Universal
adaptor.
Push the adaptor onto the mount and rotate clockwise until the
mechanism clicks into engagement. The mobile phone is now
secured to the MIO flexible arm.
When required, the phone can be dettached from the flexible arm
by roating it anti-clockwise and pulling away.
Adjust the size and height of the headband using the headband
dials, so that the MIO is supported comfortably around and on
top of the head.
Position the mobile phone approximately 250mm from the
operators’face.

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Software Setup
Initial Set-Up
1) Download KineXis from the App Store.
2) Register your device on www.KeelerMIO.com/register and your password will be sent out to you.
App Use
Task
Process
Authorization
To log in to the
application
- Enter username and password on the login screen.
To reset password
- Click 'Forgot Password' on the login screen and follow further instructions.
Patient
Management
To create a patient
profile
- Click ‘Patients’tab.
- Enter either a brief or full patient profile.
To keep patient
profiles up to date
- Click ‘Patients’ tab.
- Search for the patient;
- View patient details;
- Update patient details.
Examination
recording
To record an
examination
- From a patient profile start an examination.
- Click the green button to start recording.
- Click same button to finish eye recording.
- Switch from eye to eye as required.
- Complete examination.

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7. Software Setup (continued)
Task
Process
Examination
Review
To review the
examination
- Review examination details.
- Play the recording(s).
- View the picture(s).
- Flag/unflag the examination as required.
- Edit/add a note to the examination if required.
- Close the examination.
Picture
Extraction
To get pictures auto
extracted by the
system
- This will happen automatically when the device is connected to the
internet.
- Some delay may occur if a large video file is being processed, the images
will continue to appear after the examination.
To manually create
pictures based on the
video taken
- Get all the available frames by accessing the video footage.
- Review the frames and saved required ones.
Data Sharing
To share the
examination details
- Convert the examination details to a password-protected PDF file.
- Share the PDF to the specified email.
For more information on use of the KineXis Software visit www.keelermio.com/how-to-guides.

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Cleaning
Only manual non-immersion cleaning as described should be used
for this instrument.
Do not autoclave or immerse in cleaning fluids.
1. Wipe the external surface with a clean absorbent, non-
shedding cloth dampened with de-ionised water /
detergent solution (2% detergent by volume) or de-ionised
water / isopropyl alcohol solution (70% IPA by volume).
2. Use caution to ensure cloth is not saturated with solution.
3. Surfaces must be carefully hand-dried using a clean non-
shedding cloth.
4. Safely dispose of used cleaning materials.

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Specifications
Operation
Storage
Transport
Temperature
limits
+10˚C to
+35˚C
-10˚C to
+55˚C
-40˚C to
+70˚C
Humidity
limits
30% to 90%
10% to 95%
10% to 95%
Pressure
limits
800 to
1060hPa
700 to
1060hPa
500 to
1060hPa
Spare parts & accessories
Part Number
2199-P-7136
Lens Cloth
2415-P-7037
Instructions for Use
EP79-21489
MIO Universal Adaptor
Warranty
No user serviceable parts –all preventative maintenance and servicing must only be performed by authorised Keeler
representatives. Your Keeler product is guaranteed for 3 years and will be replaced, or repaired free of charge subject to the
following:
• Any fault due to faulty manufacture.
• The instrument and Keeler manufactured accessories have been used incompliance with these instructions.
• Proof of purchase accompanies any claim.
This warranty does not extend to cover any accidental damage to any smartphone device mounted to the MIO.

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Contact and disposal information
Keeler USA
3222 Phoenixville Pike,
Building #50
Malvern, PA 19355,
United States
Toll Free: 1 800 523 5620
Tel: [phone]
Fax: [phone]
Keeler Limited
Clewer Hill Road,
Windsor,
Berkshire
SL4 4AA
Freephone: 0800 521251
Tel: [phone]
Fax: [phone]
Disposal of old Electrical and Electronic Equipment
Applicable in the European Union and other European Countries
with separate Collection Systems)
To Reduce the Environmental impact of WEEE (Waste Electrical
Electronic Equipment) and minimise the volume of WEEE entering
landfills we encourage at Product end of life that this Equipment is
recycled and reused.
This symbol on the product or its packaging indicates
that it was put on the marketplace after August 2006,
and that this product shall not be treated as
householdwaste.
EP59-70070 Issue A
Date of Issue 06/10/2020