submitted | available | document details (if available) | source link |
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June 11 2019 | June 11 2019 | Chan Mean Microsoft® Word for Office 365 |
various | User manual | Users Manual | 1.37 MiB | June 11 2019 |
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 1 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) Email: support@orpyx.com A manual in French can be provided on request at support@orpyx.com. Un mode demploi en Franais peut tre fourni sur demande support@orpyx.com. A manual in Spanish can be provided on request at support@orpyx.com. Contctenos por support@orpyx.com si requiere un manual en espaol. 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 Orpyx SI Table of Contents 1. Orpyx SI Sensory Insoles 2. Orpyx SI Mobile Application 3. Charging Your Orpyx SI Sensory Insoles 4. Using Your Orpyx SI Sensory Insoles 5. Maintenance and Cleaning 6. Storage and Handling 7. Frequently Asked Questions 8. Technical Information, Specifications and Warranty 9. Regulatory Compliance Information Page 5 Page 6 Page 11 Page 13 Page 18 Page 18 Page 19 Page 20 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 3 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 4 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 Power Adapter Instructions for Use Manual 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 individuals 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 5 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 6 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:
o uppercase letter o lowercase letter o number o symbol STEP 4 Review and agree to Orpyxs 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 7 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. INSOLES TO THE MOBILE STEP 6 PAIRING YOUR 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 8 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 9 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. 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 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. 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 11 of 26 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. Page 12 of 26 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. 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 13 of 26 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 14 of 26 B. SETTINGS insoles Within your Advanced Settings, you have the ability to put your connected 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 TOPOGRAPHIC MAP Without Pressure With Pressure Without Pressure With Pressure 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 15 of 26 C. RECEIVING AN ALERT Ensure that your mobile devices 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 2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners. Page 16 of 26 TYPES OF ALERTS:
High Pressure Detected Notification Insoles Disconnected Notification this screen This alert indicates that high pressure and time levels have been detected underfoot. When 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. 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. 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 17 of 26 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 2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners. Page 18 of 26 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. 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 practitioners 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 2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners. Page 19 of 26 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. Page 20 of 26 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. Q: How do I turn the system on?
A: When pressure is detected and a step is taken, 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 sensory insoles?
A: To ensure accurate readings, the sensory insoles will need to be replaced after every 12 months or at your healthcare practitioners discretion (which could be up to 3 times per year). Q: Why is my system alerting when my feet are up?
A: Ensure that both feet are up without resting on your heels or toes and check to see if your shoes are tied too tight. Q: Can my insoles get wet? What happens when it gets wet?
A: Do not submerge. To clean Orpyx SI sensory insoles, gently wipe with a damp cloth, or disinfectant wipe. If they do get slightly wet, remove them from the shoes and allow to dry thoroughly before use. If submerged, the insoles may stop functioning properly. Q: Can I take my sensory insoles system through airport security?
A: Yes. While wearing your device in flight, ensure that it is set to Airplane Mode within your settings. Q: How often should I wear my insoles?
A: It is recommended that you wear your insoles throughout daily activities, unless told otherwise by your healthcare professional. 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 21 of 26 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 Orpyx SI sensory insoles 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 Orpyx SI sensory insoles may cause interference in other electronic equipment. Therefore, please take the following precautions:
Travel or International Use If you plan to travel with the Orpyx SI sensory insoles, 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 the Orpyx SI sensory insoles at least 6 inches (15 cm) from the pacemaker when the device is active. Hearing Aid Compatibility The Orpyx SI sensory insoles 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 Orpyx SI sensory insoles. 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 Orpyx SI sensory insoles 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 Orpyx SI sensory 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 22 of 26 Operating Voltage Rated Input Voltage Rated Input Current Frequency Band Wireless Technology Number of Operation Modes Storage Conditions Operational Conditions IP Rating TECHNICAL SPECIFICATIONS FOR ORPYX SI ELECTRONIC COMPONENTS Model Power Source ORPYXSIV1 2x80 mAh Rechargeable LiPo battery Non Replaceable 3.7-4.2Vdc 5Vdc 2.4A ISM 2.4 Ghz, 2400 to 2483.5 MHz Frequency Hopping Spread Spectrum 4 On / Sleep / Charging / Airplane Temperate 0-40C / Humidity 15%-90% (non-
condensing) / 700-1060 hPA Temperature 5-40C / Humidity 15%-90% (non-
condensing) / 700-1060 hPA IP22 REQUIRED TECHNICAL SPECIFICATIONS WALL ADAPTER Model Rated Input Rated Output Certifications HDP-MD Series 100-240Vac, ~50/60Hz, 0.3A 5Vdc 1A/2.4A 60601-1/60601-1-2 WARRANTY Orpyx Medical Technologies Inc. guarantees that Orpyx SI sensory insoles will be free of defects in material and workmanship for one year, valid from the date of purchase. Warranty is void if the system has been damaged due to water, improper treatment or use. Normal wear will occur overtime. The warranty extends only to the original purchaser and is not transferable. Disregarding WARNING information may cause improper operation, inaccurate results and may void the warranty. Disregarding information for proper use may reduce the life expectancy of the product and/or damage the product; and may void the warranty. 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 23 of 26 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. Such modifications could void the users authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Connect the equipment into an outlet on a circuit different from that to which the receiver is Increase the separation between the equipment and receiver. connected. Consult the dealer or an experienced radio/TV technician for help. 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 24 of 26 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. L'metteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR d'Innovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes:
1) L'appareil ne doit pas produire de brouillage;
2) L'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA STATEMENT Complies with the Canada ICES-003 Class B specifications. Cet appareil numerique de la classe B est comforme la norme NMB-003 du Canada. This device complies with RSS 210 of Industry Canada. OTHER STANDARDS AND COMPLIANCE The Orpyx SI sensory insoles system is in compliance with the following standards:
IEC 60601-1-2:2013: Medical Electrical Equipment Part 1: General Requirements for Safety IEC 60601-1 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 25 of 26 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. Page 26 of 26
This product uses the FCC Data API but is not endorsed or certified by the FCC