Related Manuals for Orpyx SI000010
Summary of Contents for Orpyx SI000010
- Page 1 Instructions for Use Orpyx® Custom Sensory Insoles Sensory Insoles Important information enclosed. Do not discard.
- Page 2 Google LLC. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Orpyx is under license. All trademarks and registered trademarks are the property of their respective owners.
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Page 3: Table Of Contents
No Saved Insoles Found Terms and Conditions Unable to Pair Insoles Pairing Your Insoles Orpyx Hub Interface 4. Using the Orpyx Custom Sensory Insole System Start-Up and Diagnostic Modes Real-Time Pressure Notifications Last Status in the Past 24 Hours My Feet 8. -
Page 4: Orpyx Custom Sensory Insole System
• Wear the Orpyx Custom Sensory Insoles with socks • Do not open or modify the Orpyx Hub. Doing so may to reduce the risk of contact injuries due to friction or expose you to risks of electrical shock, malfunction, or allergic reactions/sensitivities. -
Page 5: Cautions
• To clean the Orpyx Custom Sensory Insoles, follow the • If the Orpyx Hub has been transported or stored in a hot cleaning instructions provided by Orpyx in this manual. or cold location, allow the components to acclimate to Do not submerge in water or use harsh chemicals. -
Page 6: Symbols And Definitions
Indicates the manufacturer’s catalogue number so that the device can be identified • Do not place objects on top of or cover the Orpyx Hub, ISO 15223-1 5.1.6 as this may obstruct airflow, leading to overheating or Serial number device damage. - Page 7 Section 1 - Orpyx Custom Sensory Insole System Symbols and Definitions (cont.) Symbols and Definitions (cont.) Keep dry CLASS II equipment Indicates a device that needs to be protected from Identifies equipment meeting the safety moisture requirements specified for Class II equipment IEC 60417-5172 ISO 15223-1 5.3.4...
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Page 8: Product Info
Section 1 - Orpyx Custom Sensory Insole System Symbols and Definitions (cont.) Product Info The Orpyx Custom Sensory Insole system is designed to Unique device identifier help patients at risk of foot complications. The system Indicates a carrier that contains unique device includes Orpyx Custom Sensory Insoles, the Orpyx App identifier information . -
Page 9: Getting Started
Section 2 - Getting Started Product Info (cont.) 1. Plug in the Orpyx Hub As a patient, you are the intended operator of the Orpyx Orpyx Hub automatically transfers the data Custom Sensory Insole system. No special skills, training, generated by your insoles to your Orpyx Nurse. -
Page 10: Insole Placement And Recommendations
Insole Placement and Recommendations Orpyx Hub It is recommended that the Orpyx insoles Plug the Orpyx Hub into a power outlet in an open area are worn in diabetic shoes that are properly close to where you store your shoes with the Orpyx sized and fitted by your healthcare provider. - Page 11 Orpyx Hub Interface Light Status Meaning Press the Orpyx logo button to adjust the brightness level of the nightlight, show the status of Orpyx Hub, and send Nightlight On - Medium Orpyx Hub has power diagnostic information to Orpyx. brightness...
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Page 12: Contact Customer Care
Contact Customer Care Orpyx® App Please contact the Orpyx Customer Care The Orpyx App allows you to track your foot health and Team at +1 (855) 996-7799. They will help receive pressure notifications in real-time. This is an you set up your system and answer your important component of the Orpyx Custom Sensory Insole questions. -
Page 13: Terms And Conditions
Bluetooth technology on your phone. them with the Orpyx App using the same method. Please Select Allow to enable the Orpyx App to find and connect dispose of your old insoles in accordance with your local to Bluetooth enabled devices nearby. -
Page 14: Using The Orpyx Custom Sensory Insole System
My Feet Now that you have everything set up, the next step is to There are four tabs at the bottom of the Orpyx App: My take your first steps in your new Orpyx insoles. Feet, Report, Help, and Settings The first is My Feet. -
Page 15: Report
Report Help The Report tab shows your activity, including insole The Help tab has links to call Orpyx Customer Care, which activity collected while you were away from your phone. is available Monday-Friday from 9:00 am – 5:30 pm ET, The report updates when your insoles connect to the except statutory holidays. -
Page 16: Settings
Section 4 - Using the Orpyx Custom Sensory Insole System Settings Pressure Notifications High pressure notifications are generated when there is an The Settings tab allows you to add or delete insoles. area of sustained pressure detected under your foot. -
Page 17: Offloading Pressure Notifications
Section 4 - Using the Orpyx Custom Sensory Insole System Section 5 - Discontinuing Use Offloading Pressure Notifications Discontinuing Use Your Orpyx insoles are battery powered. Once you remove Step 1: Walk Around the insoles from their packaging, the Orpyx insoles are First, try walking around to see if the red area powered continuously until the battery is depleted. -
Page 18: Product Care And Maintenance
Discontinue use in the event of Do not place objects on top of or cover the Orpyx Hub, as damage and contact Orpyx Customer Care. this may obstruct airflow, leading to overheating or device Inspect your Orpyx Hub monthly for damage or defects. -
Page 19: Safe Disposal
Orpyx Hub contains electronics. instructions on the Pairing Your Insoles guide in your refill At the end of their useful life, dispose of the Orpyx kit or contact Orpyx Customer Care for support. insoles and the Orpyx Hub in accordance with all... -
Page 20: High Pressure Notifications
On the My Feet screen one or both feet have a red If your insoles cannot connect to pressure notification. These pressure notifications indicate the Orpyx App, it may be because that there are areas of sustained pressure under your foot. you need to turn on Bluetooth on your phone. -
Page 21: No Saved Insoles Found
Section 7 - Troubleshooting Unable to Pair Insoles No Saved Insoles Found The Orpyx insoles have either not been added or have If you encounter a red been removed from the Orpyx App. Add or replace insoles circle with an exclamation to continue. -
Page 22: Orpyx Hub Interface
Light pulses Indicates you No action required (diagnostic are in diagnostic All lights on the front of Orpyx Hub will turn off within 10 mode) mode minutes at start up or after 1 minute in diagnostic mode. Solid blue Bluetooth is... - Page 23 Section 7 - Troubleshooting Orpyx Hub Interface (cont.) Orpyx Hub Interface (cont.) Start-Up and Diagnostic Modes (cont.) Start-Up and Diagnostic Modes (cont.) Light Status Meaning User Action Light Status Meaning User Action Searching for Blinking blue Wait to see if the...
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Page 24: Last Status In The Past 24 Hours
Orpyx Hub show the Solid blue A left and/or No action status of the Orpyx Hub within the last 24 hours. The lights right insole has required turn off within 1 minute. connected to the... -
Page 25: Warranty Terms And Conditions
Sensory Insole system(s) do not fit properly, cannot for proper use may reduce the life expectancy of be trimmed to fit, and Orpyx is not able to provide a the Orpyx Custom Sensory Insole system(s) and/or replacement pair that resolves the issue (collectively, damage the Orpyx Custom Sensory Insole system(s) a “Fit Issue”), Orpyx will provide a full refund to the... - Page 26 Section 8 - Warranty Terms and Conditions and approved in the Calgary head office of Orpyx by CUSTOM SENSORY INSOLE SYSTEM(S) OR THE authorized personnel, who shall have final discretion PROVISION OF SERVICES RELATING TO THE in the resolution of a warranty issue. In the case of a ORPYX CUSTOM SENSORY INSOLE SYSTEM(S).
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Page 27: Technical Information And Specifications
Orpyx Medical documentation card for presentation to airport security personnel if requested. Before plugging in your Orpyx Hub, ensure the input voltage stated on the back of the Orpyx Hub is compatible with the power outlet. - Page 28 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Orpyx Custom Sensory Insoles, including cables specified by the manufacturer. Otherwise, degradation of the...
- Page 29 95% confidence between pressure 700-1060hPa / 525 - 795 mmHg 15°C to 40°C / 59°F 104°F IP rating IP22: Orpyx Custom Sensory Insoles are protected Power source 500 mAh Non Rechargeable CR3032 3V against the entry of objects greater than 12 mm...
- Page 30 / 525 - 795 mmHg Rated input 0.2 A IP rating IPX0: Orpyx Hub has no water resistance. Keep dry and current use in an indoor environment. Exposure to water could Classification Class II lead to malfunction or complete failure.
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Page 31: Electromagnetic Emissions
Compliance Electromagnetic electromagnetic environment specified in the tables below. The levels Environment Guidance Healthcare Home user of the Orpyx Custom Sensory Insoles should assure that it is environment healthcare used in such an environment. environment Electrostatic ± 8 kV contact ±... -
Page 32: Recommended Separation Distances
Section 9 - Technical Information and Specifications Electromagnetic Immunity (cont.) Recommended Separation Distances The Orpyx Custom Sensory Insoles are for use in a home Immunity Test IEC 60601-1-2 test levels Compliance Electromagnetic healthcare environment in which radiated radio frequency levels... -
Page 33: Regulatory Compliance Information
Section 10 - Regulatory Compliance Information Manufacturer’s Declaration FCC Supplier’s Declaration of Conformity Test Specifications for Immunity to Proximity Fields from RF Wireless This device complies with Part 15 of the FCC Rules. Communications Equipment (IEC 61000-4-3) Operation is subject to the following two conditions: Test Band Service... - Page 34 RF Exposure Statement • Consult the dealer or an experienced radio/TV The Orpyx Hub is intended to be installed and operated in an technician for help. area where the distance between the Orpyx Hub and operators or Canadian Compliance Statement bystanders is greater than 20 centimeters / 8 inches.
- Page 35 To view the IFU in a larger format please visit: www.orpyx.com/instructions If you have any questions or need to report unexpected operation or events, please call Orpyx Customer Care. Orpyx Customer Care +1 (855) 996-7799 Orpyx Remote Nurse +1 (833) 502-2171...
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