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.
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.
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.
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.
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.
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 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: o uppercase letter o lowercase letter o number o symbol STEP 4 Review and agree to Orpyx’s Privacy Policy and Terms of Use. Click submit. You have now signed in successfully.
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.
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).
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 ©2019 Orpyx® Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
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.
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 ©2019 Orpyx® Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
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.
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.
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.
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.
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.
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 highpressure 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 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: support@orpyx.com www.orpyx.com 5. Maintenance & Cleaning A.
For environmental storage conditions, please refer to the Technical Specifications table on page 21. 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.
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 three 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. Your insoles can also be put in airplane mode within your settings.
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 SPECIFICATIONS FOR ORPYX® SI ELECTRONIC COMPONENTS Model ORPYXSIV1 Power Source 2x80 mAh Rechargeable LiPo battery Non Replaceable Operating Voltage 3.7-4.2Vdc Rated Input Voltage 5Vdc Rated Input Current 2.4A Frequency Band ISM 2.4 Ghz, 2400 to 2483.
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.
©2019 Orpyx® Medical Technologies Inc. Version 1.0 – August 2019 All rights reserved. All trademarks and registered trademarks are the property of their respective owners. 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.
