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.
©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.
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.
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.
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.
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.
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 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.
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.
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.
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.
3. Charging Your SurroSense® PROTECTTM Custom Smart Insole System A. HOW TO CHARGE THE SHOE PODS Back Mini USB 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.
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.
TYPES OF ALERTS: High Pressure Detected Notification High Pressure Detected Alert in App Insoles Disconnected Notification 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.
Shoe Pods Disconnected 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. Shoe Pods Disconnected Alert in App Ensure that pressure is applied when wearing your insoles. The application will automatically try to re-establish wireless connection.
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.
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.
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.
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.
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.
Flashing yellow once every 10 seconds When not connected to iOS device, indication that pod is alive and ready to connect. Flashing system wearing When not connected to iOS device, an alert has been triggered. See application display. Flashing orange while wearing system When not connected to iOS device, battery level is low. red while WARRANTY Orpyx Medical Technologies Inc.
9. Regulatory Compliance Information FCC COMPLIANCE STATEMENT This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CAUTION: The grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance.
CANADIAN COMPLIANCE STATEMENT This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada license-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device.
Orpyx Medical Technologies Inc. The SurroSense® PROTECTTM system is a tool to help actively prevent peripheral neuropathy complications and track progress. ©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. SurroSense® PROTECT – Instructions for Use Version 0.8 – February 2019 ©2019 Orpyx Medical Technologies Inc. - All rights reserved.
