Orpyx Si User manual

Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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

Page 2 of 26

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)

Email: [email protected]

A manual in French can be provided on request at [email protected].

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

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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

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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

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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

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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.

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Version 1.0 –August 2019

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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

You have now signed in successfully. The mobile

application will walk you through the Setup and

Tutorial.

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Version 1.0 –August 2019

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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

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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

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Version 1.0 –August 2019

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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.

Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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3. Charging Your Orpyx®SI Sensory Insoles

With regular use, the insoles will require daily charging, therefore it is recommended they are

charged overnight. For detailed information on how to charge your insoles, press “Care” for How to

Charge your Sensory Insoles.

STEP 1

Insert the other end of the cable into the power

adaptor, which plugs directly into an electrical

outlet.

STEP 2

Align the magnetic USB cable with the USB port on

the back of the insoles. Your mobile application

displays the battery levels when your insoles are

charging.

When plugged in to the wall adapter, a blue light

will appear on the USB indicating a powered

connection.

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Version 1.0 –August 2019

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STEP 3

Charging is complete when the battery level on the

mobile application is full and green.

Do not wear your device when it is charging.

Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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4. Using Your Orpyx®SI Sensory Insoles System

A. STARTING YOUR ORPYX SI SENSORY INSOLE SYSTEM

STEP 1

Start the Mobile Application on your smartphone by clicking the Orpyx SI icon.

STEP 2

Your Orpyx SI sensory insoles are made to fit inside your diabetic or walking shoes. First, remove the

existing insole or sock liner from your shoes. With standard shoes, the sock liners may need to be

removed.

Orpyx SI Sensor Insoles may come in contact with a patient during normal use. It is

recommended the user wears sock with their Orpyx SI Sensor Insoles

Failure to remove an existing insole or sock liner from your shoe before inserting the Orpyx

SI sensory insole may result in a persistent high pressure state.

Place the appropriate left and right Orpyx SI sensory insoles into each shoe and run your hand over

the entire insole to ensure that the insole is lying flat. It is recommended that you wear your insole

system with the shoes that have been fitted by a professional.

Do not modify the Orpyx SI Sensory Insole, if required a professional orthotist or podiatrist

can modify insole outside the indicated margin to ensure proper fit.

When the insoles have been stored at a temperature below 5C, or above 40C, please allow 30 minutes

for the insoles to acclimate before using the system.

STEP 3

To start using your system, put on your shoes and apply pressure by standing and walking. This will

“wake up” the system and re-establish a wireless connection to your mobile application.

If your device is not connected, ensure that your device is fully charged and pair your device. Please

refer to section 2 in the Instructions for Use Manual or press “Care” on your mobile application for

“Setting up your Sensory Insoles”.

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Version 1.0 –August 2019

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Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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B. SETTINGS

Within your Advanced Settings, you have the

ability to put your connected insoles in

Airplane Mode..*

*You will not receive alerts when the system

is put into airplane mode.

To disable airplane mode, insert the magnetic

USB cable with the USB port on the back of

the insoles. Insert the other end of the cable

into the power adaptor, which plugs directly

into an electrical outlet. Your mobile

application will alert you when your insoles

are charging meaning you are now ready to

use your system.

In Settings, you have the ability to Change the “My Feet” Pressure Map style to Pins or Topographic

Map (see images below).

PINS

Without Pressure With Pressure

TOPOGRAPHIC MAP

Without Pressure With Pressure

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Version 1.0 –August 2019

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C. RECEIVING AN ALERT

Ensure that your mobile device’s settings allow

notifications to be sent by the Orpyx SI mobile

application. You can check this by going into your

mobile device. On iOS go to Settings, Notifications,

and select Orpyx SI. Turn on Allow Notifications,

Sounds and Badges.

If notifications are turned off, you may not

receive high pressure alerts from your

system. It is recommended to turn notifications on

in order to receive system alerts.

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.

Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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TYPES OF ALERTS:

High Pressure Detected Notification

This alert indicates that high pressure

and time levels have been detected

underfoot. When this screen is

displayed, you can click on the

notification which will take you to the

foot map screen. For guidance on how

to offload pressure, click “Care” in the

lower right-hand corner of the mobile

application.

If the user does not offload pressure

effectively, the alert will be re-issued

every three minutes until the alert is

offloaded successfully.

Insoles Disconnected Notification

If an insole becomes disconnected from

the mobile application, the application

will notify you.

When putting on your insoles, apply

pressure by standing and walking. This

will “wake up” the system and re-

establish a wireless connection.

Double check that you are within range

of your phone and that the insoles are

fully charged. You will also receive an

alert if Bluetooth is turned off.

If the mobile application still does not

connect to your phone, please contact

Orpyx Customer Care.

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Version 1.0 –August 2019

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D. PRESSURE OFFLOADING STEPS

When areas of high pressure are detected, they will be displayed on the My

Feet screen. To relieve pressure, follow the steps below until the high-

pressure area goes away.

STEP ACTION

1. Walk around (or on the spot) until the red region has gone away.

2. If that is ineffective after two minutes, sit down and take pressure off red region

of the foot.

3. If that is ineffective after two minutes, ensure that footwear laces are not too

tight and that there are no foreign objects (i.e. rocks) in the shoe.

4. If that is ineffective after two minutes, check your feet for cuts, blisters,

redness and swelling.

5. If none of these steps above prove effective after several attempts or

approximately 15 minutes, please contact Orpyx Customer Care for resolving

the alerts.

E. CONTACTING ORPYX CUSTOMER CARE

Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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If you have any additional questions, concerns , require assistance setting up

and maintaining your device, or have encountered an unexpected operation

or event, please contact Orpyx Customer Care by clicking the Care button on

your application or via the following:

Toll Free: 1-855-99ORPYX (67799)

Address: 1440 –28 Street N.E., Calgary, Alberta Canada T2A 7W6

Email: [email protected]

www.orpyx.com

5. Maintenance & Cleaning

A. ORPYX®SI MAINTENANCE

This system requires daily charging; therefore, it is recommended that the insoles are charged

overnight. For additional guidance on how to charge your system, please refer to section 2 in the

Instructions for Use Manual or press “Care” on your mobile application for “How to Charge your

Sensory Insoles”.

To clean Orpyx SI sensory insoles, gently wipe with a damp cloth, or disinfectant wipe as needed

or on a monthly basis.

B. ORPYX®SI SENSORY INSOLES REPLACEMENT

Your insoles will need to be replaced after every 12 months or at your healthcare practitioner’s

discretion (which could be up to 3 times per year).

C. ORPYX®SI SENSORY INSOLES ACCESSORIES

The accessories provided along with the insoles such as the charging cable and the power adapter

are expected to last 100K hours of use.

D. DISPOSAL OF THE DEVICE

There are no user repairable components in Orpyx SI sensory insoles. The system contains

batteries and electronics, please dispose of properly in accordance with all local and national

regulations.

6. Storage and Handling

ORPYX®SI SENSORY INSOLES SYSTEM HANDLING

Keep dry.

DO NOT cut, trim or alter Orpyx SI sensory insoles, this could damage sensors and prevent

the device from working properly.

Orpyx®SI –Instructions for Use

Version 1.0 –August 2019

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For environmental storage conditions, please refer to the Technical Specifications table on page

21.

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