Orpyx SurroSense PROTECT User manual

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 1 of 24
SurroSense®PROTECTTM
Custom Smart Insole System
Instructions for Use
Important Information enclosed. Do not discard.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 2 of 24
©2019 Orpyx Medical Technologies Inc.
Version 1.0 – February 2019
All rights reserved.
All trademarks and registered trademarks are the property of their respective owners.
Contents of package protected by one or more of the following U.S. Patent No. 10,004,428, U.S. Patent
No. 9,778,131, U.S. Patent No. D740,950, 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]om

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 3 of 24
SurroSense®PROTECTTM
Table of Contents
1. The SurroSense®PROTECT System Page 5
2. SurroSense®PROTECT Application Page 7
3. Charging Your SurroSense®PROTECT Custom Smart Insole System Page 12
4. Using Your SurroSense®PROTECT Custom Smart Insole System Page 13
5. Maintenance Page 17
6. Storage and Handling Page 17
7. Frequently Asked Questions Page 18
8. Technical Information, Specifications and Warranty Page 19
9. Regulatory Compliance Information Page 22

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 4 of 24
Symbols and Definitions
Symbol
Definition
Caution
System Lot Number
Keep Dry
Manufactured By
Serial Number
Waste Electrical & Electronic Equipment
Year of Manufacture

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 5 of 24
1. The SurroSense®PROTECTTM System
The SurroSense®PROTECT device is a custom smart insole system designed to help patients manage
their diabetic feet. The system warns individuals of pressure overload on the bottom of the foot via a
mobile app. The system consists of pressure sensors integrated into custom fabricated foot insoles,
connected to pods which wirelessly communicate with a mobile app on a smartphone.
INCLUDED IN PURCHASE:
• SurroSense®PROTECT Insoles
(Left and Right)
• SurroSense®PROTECT Shoe Pods
(Left and Right)
• Charging Cables:
o 6ft USB-A to USB-mini cable
o USB-mini splitter cable
• AC Adaptor
A. INDICATIONS FOR USE
The SurroSense®PROTECT custom smart insole system is a powered limb overload warning device
intended for monitoring the condition of peripheral neuropathy in diabetic patients to warn a patient
of an overload in the amount of pressure placed on a foot.
Use of the SurroSense®PROTECT system does not eliminate the need for regular diabetic foot
care as advised by a healthcare professional.
B. CONTRAINDICATIONS
There are no known contraindications for the SurroSense® PROTECT system at this time.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 6 of 24
C. FIELD OF APPLICATION
The SurroSense®PROTECT system was developed for use throughout everyday activities. The
SurroSense®PROTECT system is designed exclusively for use by one user.
Users with active skin ulceration or partial amputation must have these wounds appropriately
monitored and dressed by a healthcare professional. Users with partial amputations or active foot
ulcers should seek the advice of a healthcare professional prior to wearing a SurroSense®PROTECT.
D. WARNINGS AND PRECAUTIONS
Disregarding WARNING information may cause improper operation, inaccurate results and
may void the warranty.
Disregarding error information may reduce the life expectancy of the product and/or
damage the product; and may void the warranty.
This product uses and receives radio frequency signals. For proper operation, this product
must be configured and operated as per the instructions provided in this manual.
This product uses low power radio communications and can affect other medical electrical
equipment. Refer to Section 11 for more information.
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.
Do not use SurroSense®PROTECT if you have an open wound without consulting a
healthcare professional

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 7 of 24
2. SurroSense®PROTECTTM Application
STEP 1
DOWNLOADING THE MOBILE APPLICATION
The SurroSense®PROTECT is free and compatible
with devices operating iOS 10.1 or newer. You can
find the SurroSense®PROTECT application by
typing “SurroSense®PROTECT” in the search bar
on the App Store for iOS. Download and install the
application and enable Bluetooth on your
smartphone, this can be done in the device settings.
STEP 2
CREATE A SURROSENSE®PROTECT ACCOUNT
Launch the SurroSense®PROTECT application and
click the “Sign Up” button on the Login page.
Enter your email address and click the “Send
Verification Code” button.
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.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 8 of 24
STEP 3
Complete the creation of your account by entering
your New Password, Confirm New Password, First
Name, Last Name, Display Name.
STEP 4
Review and agree to Orpyx’s Privacy Policy and
Terms of Use.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 9 of 24
STEP 5
SIGN IN SUCCESSFUL
The application will now walk you through the
Setup and Tutorial.
STEP 6
INSTALLING YOUR SURROSENSE®PROTECT
SENSOR INSOLES
The SurroSense®PROTECT insoles fit inside your
diabetic or walking shoe.
To install, remove the existing insole or sock liner
from your shoes. Place the appropriate left and
right SurroSense®PROTECT insole into each shoe.
The lead should run along the inside instep of the
shoe, up and over the shoe tongue.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 10 of 24
STEP 7
HOW TO PROPERLY FASTEN YOUR SURROSENSE®
PROTECT SHOE PODS
Attach the shoe pods to the lead on the insoles.
Each lead and shoe pod are labeled with a L or R
to indicate that it is the left or right.
STEP 8
Fasten shoe pods using the removeable clip
provided. Ensure the shoe pods sits on the side of
the shoe and secure using the clip.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 11 of 24
STEP 9
PAIRING YOUR SYSTEM TO THE APPLICATION
To start using your device, you will need to pair your
system with the mobile application.
Pressure must be detected on the insoles to
connect. With you shoes on and standing, click the
settings button in the upper right hand corner and
then click the “Select Devices” button. Select the
left and right devices by clicking the footprint icons
(once selected they will turn blue). Click the “Done”
button on the bottom.*
*Connecting your system may take up to 30
seconds. If the application still does not connect to
your system, please contact Orpyx Customer Care.
STEP 10
You have successfully paired your system.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 12 of 24
3. Charging Your SurroSense®PROTECTTM Custom Smart Insole System
A. HOW TO CHARGE THE SHOE PODS
With regular use, the shoe pods will require daily charging. It is recommended that the pods are
charged overnight.
To charge the shoe pods, lift the black cover and insert the mini USB cable into the mini USB port on
the back of the shoe pod. You should hear a click when in place. The other end of the cable should be
inserted into the AC adaptor, which plugs directly into an electrical outlet.
The system should only be charged with the AC adaptor included with the system.
B. CHARGING INDICATIONS
Charging – Green light flashes
Fully Charged – Green light is ON
Back
Mini USB

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 13 of 24
4. Using Your SurroSense® PROTECTTM Custom Smart Insole System
A. RECEIVING AN ALERT
Ensure that the default system settings is selected to allow
notifications. You can check this by going into your iOS system
Settings, Notifications, and selecting SurroSense.
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 feedback.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 14 of 24
TYPES OF ALERTS:
High Pressure Detected Notification
High Pressure Detected Alert in App
This alert indicates that dangerous
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.
If the user does not offload pressure
effectively, the alert will be re-issued
every 3 minutes until the alert is
offloaded successfully.
Insoles Disconnected Notification
Insoles Disconnected Alert in App
If your insole becomes disconnected
from a shoe pod, the application will
notify you that your insole disconnected.
Make sure the insole is connected to the
shoe pod.
Ensure that pressure is applied when
wearing your insoles. The application
will automatically try to re-establish
wireless connection.
If the application still does not connect
to your system, please contact Orpyx
Customer Care.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 15 of 24
Shoe Pods Disconnected
Shoe Pods Disconnected Alert in App
An alert will notify you when the paired
shoe pods are disconnected. Ensure
that your mobile device is in range with
your insoles and that your shoe pods are
fully charged.
If your shoes are off, your system will
disconnect automatically. Therefore,
ignore the “Shoe Pod Disconnected”
alert.
Ensure that pressure is applied when
wearing your insoles. The application
will automatically try to re-establish
wireless connection.
If the application still does not connect
to your system, please contact Orpyx
Customer Care.
Low Battery
Low Battery Alert in App
With regular use your custom smart
insole, your battery should last on
average, twelve hours per day. When the
custom smart insole battery runs low, a
low battery alert will appear. For
guidance on how to charge your system,
click “Care” in the lower right-hand
corner.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 16 of 24
B. PRESSURE OFFLOADING STEPS
The areas of high pressure are displayed on the My feet screen. In order to
relieve pressure, follow the steps below until the high pressure region fades
back to grey.
STEP ACTION
1. Walk around (or on the spot) until the red region has turned grey. If this is
ineffective after three minutes, then:
2. Sit down and take pressure off red region of the foot. If this is ineffective after
three minutes, then:
3. Ensure that footwear laces are not too tight and that there are no foreign
objects (ie. rocks) in the shoe
4. Check your feet for cuts, blisters, redness and swelling. If none of these steps
prove effective, please contact your healthcare practitioner
C. CONTACTING ORPYX CUSTOMER CARE
If you have any additional questions or concerns, please contact Orpyx
Customer Care by clicking the Care button on your application, or:
Toll Free: 1-855-99ORPYX (67799)
Email: suppo[email protected]
www.orpyx.com

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 17 of 24
5. Maintenance
A. SURROSENSE®PROTECT SYSTEM MAINTENANCE
This system with require daily charging. It is recommended that the pods are charged overnight. For
guidance on how to charge your system, please refer to page 12.
B. SURROSENSE®PROTECT CUSTOM SMART INSOLE REPLACEMENT
Your insole will need to be replaced after approximately one year.
DO NOT use a strong cleaning solution that contains bleach or immerse the SurroSense®
PROTECT system in water.
D. DISPOSAL OF THE DEVICE
There are no user repairable components in the SurroSense®PROTECT system. When the
device has reached the end of its useful life, please dispose of properly in accordance with
all local and national regulations.
6. Storage and Handling
SURROSENSE®PROTECT SYSTEM HANDLING
DO NOT open the SurroSense®PROTECT shoe pods for any reason.
DO NOT submerge the SurroSense®PROTECT shoe pods in water for any reason.
DO NOT cut, trim or alter the SurroSense®PROTECT insoles, this could damage sensors
and prevent the device from working properly.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 18 of 24
7. Frequently Asked Questions
Q: How long does it take to offload an alert?
A:
The time to offload an alert depends on the length of time that alert has been present. With proper
offloading, alerts can be offloaded within 3 minutes.
Q: How do I turn the system off when not in use?
A:
If pressure is not detected on the insoles for a period of time, they will go into sleep mode
automatically.
Q: How do I turn the system on?
A:
When pressure is detected, the system will automatically turn on and connect to the mobile
application provided the app is running and within range of the system.
Q: When should I replace my custom smart insole system?
A:
To ensure accurate readings, the custom smart insoles will need to be replaced approximately
every twelve months.
Q: Why is my system alerting when my feet are up?
A:
Ensure that booth feet are up without resting on your heels or toes. Check to see if your shoes are
tied too tight.
Q: Can my insoles get wet? What happens when it gets wet?
A:
The insoles are water resistant but not water proof. If submerged, the insole may stop functioning
properly.
Q: Can I take my smart insole system through airport security?
A:
Yes, we recommend packing your system in your luggage and be prepared to show the device
working if asked by security, but not wear it.
Q: How often should I wear my insoles?
A:
It is recommended that you wear your insoles daily, unless told otherwise by your healthcare
professional.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 19 of 24
8. Technical Information, Specifications and Warranty
RADIO FREQUENCY STANDARDS
This device produces radio-frequency emissions. Radio-frequency (RF) emissions from electronic
equipment can impact the operation of other electronic equipment, causing them to malfunction.
Although the SurroSense®PROTECT system is designed, tested and manufactured to comply with
regulations governing radio frequency emission in countries such as the US and Canada, the wireless
transmitters and electrical circuits in the SurroSense®PROTECT may cause interference in other
electronic equipment. Therefore, please take the following precautions:
Travel or International Use
If you plan to travel with the SurroSense®PROTECT device, please note that the product uses wireless
communication, and is not to be used during flight. If you are traveling outside of the United States
or Canada, check with your travel agent prior to travel to ensure that the use of wireless products is
permitted in your country of destination.
Pacemakers
The Health Industry Manufacturers Association recommends that a minimum separation of 6 inches
(15 cm) be maintained between certain RF emitting devices and pacemakers in order to avoid
potential interference between these devices. Persons with pacemakers should always keep
SurroSense®PROTECT system at least 6 inches (15 cm) from the pacemaker when the device is
active.
Hearing Aid Compatibility
The SurroSense®PROTECT system may interfere with some hearing aids. If you experience
interference, consult your hearing aid manufacturer or your physician for solutions or alternatives.
Other Medical Devices
If you use any other personal medical devices, consult the medical device manufacturer to ensure
that these devices are adequately shielded from RF emissions produced by devices such as the
SurroSense®PROTECT system.
Health Care Facilities
Hospitals and healthcare facilities may use equipment that is particularly sensitive to external RF
emissions. Disconnect your system to ensure it is not transmitting when hospital staff or signage
instructs you to do so.
Other Wireless Technologies
The SurroSense®PROTECT system is FCC compliant. However, there may be some newer wireless
technologies that interfere with the RF emissions of this device. Please consult the manufacturers of
these devices to ensure compatibility with the SurroSense®PROTECT system.

SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
Page 20 of 24
TECHNICAL SPECIFICATION FOR SURROSENSE®PROTECT
Size
2.75in x 1.18in x 0.47in (L x W x H)
Weight
0.7oz. (20g)
Power Source
160mAh Rechargeable LiPo battery
Frequency Band
ISM 2.4 Ghz, 2400 to 2483.5 MHz
Wireless Technology
Frequency Hopping Spread Spectrum
Number of Operation Modes
2 – ON / Sleep
Storage Temperature
Temperature -4 to 131 Fahrenheit / -20 to +55
Celsius / 95%humidity
Operation
Temperature -4 to 131 Fahrenheit / -20 to +55
Celsius / 95%humidity
Water Resistance
No. Do not submerge
SHOE POD INDICATOR LIGHTS
There are red, yellow, green and orange lights inside each shoe pod to indicate system status. The
meaning of the lights is as follows:
INDICATOR LIGHT
STATUS
Flashing green while plugged in
Charging.
Solid green while plugged in
Charging is complete.
All colors (Red, Yellow, Green,
Orange) flashing simultaneously
The system has been reset and is initializing.
Constant light of all colors (Red,
Green, Orange)
Sensor error.
Plug the shoe pod into charger, wait 30 seconds
then remove. If the error re-appears after a
reset, contact Orpyx Customer Care.