Orpyx SI Manuale utente
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 1 of 26
Orpyx®SI
Sensory Insoles
Instructions for Use
Important information enclosed. Do not discard.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 2 of 26
All rights reserved.
All trademarks and registered trademarks are the property of their respective owners.
Contents of package protected by one or more of U.S. patents pending as well as corresponding
patents in other jurisdictions. Purchase of this package does not act to grant a use license under
these patents in any jurisdiction outside of the United States.
Manufactured by:
Orpyx®Medical Technologies Inc.
Bay 2, 1440 –28 Street N.E.
Calgary, AB T2A 7W6 Canada
www.orpyx.com
Orpyx Customer Care
Toll Free: 1-855-99ORPYX (67799)
Un mode d’emploi en Français peut être fourni sur demande à [email protected]m.
A manual in Spanish can be provided on request at support@orpyx.com.
Contáctenos por support@orpyx.com si requiere un manual en español.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 3 of 26
Orpyx®SI
Table of Contents
1. Orpyx®SI Sensory Insoles Page 5
2. Orpyx®SI Mobile Application Page 6
3. Charging Your Orpyx®SI Sensory Insoles Page 11
4. Using Your Orpyx®SI Sensory Insoles Page 13
5. Maintenance and Cleaning Page 18
6. Storage and Handling Page 18
7. Frequently Asked Questions Page 19
8. Technical Information, Specifications and Warranty Page 20
9. Regulatory Compliance Information Page 22
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 4 of 26
Symbols and Definitions
Symbol
Definition
Caution
Serial Number
System Lot Number
Year of Manufacture
Manufactured By
Keep Dry
Waste Electrical & Electronic Equipment
TYPE BF Applied Part
Manual Must Be Read
IP Rating
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 5 of 26
1. Orpyx®SI Sensory Insoles
The Orpyx®SI sensory insole system is designed to help patients at risk of foot ulceration. The system
consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly
communicate with a display application running on a smartphone or companion device. In addition to
pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by
the device and sent to the cloud for remote monitoring purposes.
INCLUDED IN PURCHASE:
•Orpyx®SI Sensory Insoles
(Left and Right)
•USB Cable
•Instructions for Use Manual
•Power Adapter
A. INDICATIONS & INTENDED USE
Orpyx SI Sensory Insoles are custom insoles embedded with powered limb overload warning
technology intended for monitoring physiologic parameters, including plantar pressure, tracking
movements and temperature. It provides the user with real-time, individualized cues for pressure
offloading. It is intended to act as an adjunct to standard foot care, not a replacement.
Orpyx SI sensory insoles are designed for use throughout everyday activities.
When using Orpyx SI sensory insoles with an active foot ulcer, please notify your healthcare
professional.
The custom insoles are made specific to an individual’s foot and are not transferable to
another user.
Use of Orpyx SI sensory insoles does not eliminate the need for regular diabetic foot care as
advised by a healthcare professional.
Users should continue to consult their healthcare provider in addition to checking feet daily
and wearing proper footwear. In the event there is any evidence of tissue breakdown, consult
your healthcare provider immediately.
B. CONTRAINDICATIONS
There are no known contraindications for the Orpyx SI sensory insoles at this time.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 6 of 26
2. Orpyx®SI Mobile Application
STEP 1
DOWNLOADING THE MOBILE APPLICATION
The Orpyx SI mobile application is free and
compatible with an iPhone 6 or newer and with
devices operating iOS 10.1 or newer. You can find
the Orpyx SI mobile application by typing “Orpyx SI”
in the search bar on the App Store for iOS.
Download and install the mobile application and
enable Bluetooth on your smartphone (this can be
done in the device settings).
STEP 2
CREATE AN ORPYX SI ACCOUNT
Click on the Orpyx SI icon to launch the Orpyx SI
mobile application.
Click the “Sign Up” button on the Login page.
Enter your email address and click the “Send
Verification Code” button. If you do not already have
an email address, you will need to setup one.
A verification code will be sent to your email. Enter
in the verification code to verify your account. This
step helps us confirm your identity and secure your
account.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 7 of 26
STEP 3
Complete the creation of your account by entering
your New Password, Confirm New Password, First
Name, Last Name, Display Name. For security
purposes, your password requires:
•minimum 8 characters
•maximum 16 characters in length
•include 3 of 4 character classes:
ouppercase letter
olowercase letter
onumber
osymbol
STEP 4
Review and agree to Orpyx’s Privacy Policy and
Terms of Use. Click submit.
You have now signed in successfully. The mobile
application will walk you through the Setup and
Tutorial.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 8 of 26
STEP 5
Fully charge your insoles prior to wearing. For
detailed information on how to charge your insoles,
please refer to section 3 in the Instructions for Use
Manual or press “Care” on your mobile application
for “How to Charge your Sensory Insoles”.
STEP 6
PAIRING YOUR INSOLES TO THE MOBILE
APPLICATION
To start using your system, you will need to pair
your Orpyx SI sensory insoles with the mobile
application.
Plug in your insoles and connect to a power source.
Please refer to section 3 in the Instructions for Use
Manual or press “Care” on your mobile application
for “How to Charge your Sensory Insoles”. If they
are already connected to power, unplug and re-
plug your insoles.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 9 of 26
STEP 7
Click the settings icon in the upper right-hand
corner of the mobile application and click the
“Select Devices” button.
You have 60 seconds to pair with your insoles. Find
your left and right insole serial numbers listed on
the back of your box (see image below).
STEP 8
When you plug in your insoles, two grey footprints
will appear and their corresponding serial
numbers. Select the left and right insoles by
tapping on the footprint icons (once selected they
will turn blue). Click the “Done” button on the
bottom.
Your device will timeout after 60 seconds if not
selected.*
If pairing is unsuccessful, please repeat steps 6 to
8.
Orpyx®SI –Instructions for Use
Version 1.0 –August 2019
©2019 Orpyx®Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 10 of 26
STEP 9
You have successfully paired your system and will
be automatically directed to the My Feet screen.
To receive alerts, ensure that your mobile
device is within 1m of your person, and
placed in a location where you can hear, feel or see
the alert indications on the device.
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