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Summary of Contents for Orpyx SURROSENSE RX
- Page 1 SURROSENSE RX SYSTEM Instructions for Use ™ SURROSENSE RX SYSTEM ™ Instructions for Use...
- Page 2 SURROSENSE RX SYSTEM Instructions for Use ™ The SurroSense Rx™ system is a tool to help actively prevent peripheral neuropathy complications and track progress. ©2013 Orpyx Medical Technologies Inc. All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
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Page 3: Table Of Contents
2 1.0 The SurroSense Rx ™ Instructions for Use 5 2.0 Symbols and Definitions 6 3.0 Setting up your system 11 4.0 Using the SurroSense Rx Smartwatch ™ 15 5.0 Orpyx Connect 16 6.0 Maintenance and Cleaning 17 7.0 Storage and Handling 18 8.0 Troubleshooting –... - Page 4 The SurroSense Rx™ notifies the user when dangerous pressure levels are detected, so that behavior can be changed and damage avoided. The SurroSense Rx™ system is a tool to help actively prevent peripheral neuropathy complications and track progress. INCLUDED WITH PURCHASE A.
- Page 5 Use of the SurroSense Rx™ device does not negate the need for regular diabetic foot care with a health care professional. II. CONTRAINDICATIONS There are no known contraindications for the SurroSense Rx™ system at this time.
- Page 6 (acoustic signals and/or mechanical vibrations). ✔ The SurroSense Rx™ is not recommended for people who are unwilling or unable to actively respond to the real-time feedback the system provides, and to adhere to the recommended maintenance and insert replacement schedule.
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Page 7: Symbols And Definitions
SURROSENSE RX SYSTEM Instructions for Use ™ 2.0 Symbols and Definitions Symbol Definition Caution Operating Instructions Manufactured By EMERGO EUROPE Authorized Representative (EU Only) Molenstraat 15 2513 BH, The Hague The Netherlands Keep Dry Waste Electrical & Electronic Equipment CE Alert Mark... -
Page 8: Setting Up Your System
When in place, your existing insole can be put back into the shoe on top of the SurroSense Rx™ insert. *Note: The SurroSense Rx™ should not be used with... - Page 9 SURROSENSE RX SYSTEM Instructions for Use ™ B. HOW TO PROPERLY FIT YOUR SURROSENSE RX™ SHOE PODS The shoe pods are to be fastened on top of either a Velcro or laced shoe. For a Velcro shoe, use the clip provided. Place the clip where you would like it underneath the Velcro straps.
- Page 10 SURROSENSE RX SYSTEM Instructions for Use ™ For laced shoes, undo the laces to the bottom of the shoe. Place the shoe pod where comfortable and lace pod to shoe using lace holes. When in place, attach the connector (located at the end of the lead) into the shoe pod.
- Page 11 SURROSENSE RX SYSTEM Instructions for Use ™ *Note: The device should only be charged with the AC adaptor included with purchase. Back Mini USB AC Adaptor D. HOW TO GET STARTED WITH YOUR SMARTWATCH Your smartwatch will come wirelessly connected to your shoe pods.
- Page 12 Watch screen AC Adaptor F. DOWNLOADING THE MOBILE APP The SurroSense Rx™ comes with a free mobile app download. This is an optional tool for patients to use as an educational resource. To download the app, go to the iTunes store and search Orpyx.
- Page 13 SURROSENSE RX SYSTEM Instructions for Use ™ 4.0 Using the SurroSense Rx Smartwatch ™ The SurroSense Rx™ smartwatch Help – steps to offload high-pressure effectively tracks the pressure exerted alerts over the bottom of the feet while your inserts are in use. If the smartwatch Watch Setup –...
- Page 14 SURROSENSE RX SYSTEM Instructions for Use ™ FOOT MAP the ‘Next’ button (located on the lower right hand side) for both the time and The foot map screen is where you can date to confirm the settings. actively monitor your feet throughout...
- Page 15 SURROSENSE RX SYSTEM Instructions for Use ™ box, the IFU and within your Orpyx pressure. Irreversible pressure Connect account. damage can occur in as little as 15 minutes; therefore, it is important to ALERTS offload the pressure alert as soon as possible to avoid damage to the foot.
- Page 16 SURROSENSE RX SYSTEM Instructions for Use ™ readings from the sensors. Replacement inserts can be purchased online at Orpyx.com or through your authorized re-seller.
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Page 17: Orpyx Connect
SYSTEM Instructions for Use ™ 5.0 Orpyx Connect Creating an Orpyx Connect account (connect.orpyx.com) is quick and easy. Through this account you will be able to: register your device warranty, upload your data to track progress over time, recover your connection codes, and stay up-to-date with the latest Orpyx product updates. -
Page 18: Maintenance And Cleaning
CLEANING THE SURROSENSE RX ™ A damp cloth with mild detergent may be used to wipe the outside of the SurroSense Rx™ shoe pods. DO NOT use a strong cleaning solution that contains bleach, or immerse the SurroSense Rx™ in water. -
Page 19: Storage And Handling
AVOID dropping the SurroSense Rx™ shoe pods. Although robustly designed, damage may occur that could cause the system to malfunction. DO NOT open the SurroSense Rx™ shoe pods for any reason. DO NOT submerge the SurroSense Rx™ shoe pods in water for any reason. -
Page 20: Troubleshooting – Frequently Asked
A: This could mean that the smartwatch has run out of battery power, and requires being charged. If you are having difficulty, contact Orpyx Customer Care Representatives. Q: How often is the Foot Map screen updated? A: The image of the Foot Map is updated every minute. It is important not to expect to see a real-time, live foot map displayed on the screen. - Page 21 If problems persist, contact Orpyx Customer Care Representatives. Q: Can my SurroSense Rx™ inserts be transferred to an alternate pair of shoes? A: Once the SurroSense Rx™ inserts and shoe pods have been fitted to your shoes, it is possible to transfer them to another pair of shoes.
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Page 22: Regulatory Compliance Information
SURROSENSE RX SYSTEM Instructions for Use ™ 9.0 Regulatory Compliance Information FCC COMPLIANCE STATEMENT This device complies with part 15 of the FCC rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept interference received, including interference that may cause undesired operation. - Page 23 RSS 210 of Industry Canada. EUROPEAN COMMUNITY This device complies with the R&TTE Directive. A copy of the EU Declaration of Conformity is available online at: SOFTWARE LICENSE AGREEMENT A copy of the Orpyx Software License Agreement is available online at:...
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Page 24: Technical Information And
Persons with emission in countries such as the US, pacemakers should always keep EU and Canada, the wireless SurroSense Rx™ system at least 15 cm transmitters and electrical circuits in (6 inches) from the pacemaker when the SurroSense Rx™ may cause the device is active. - Page 25 SYSTEM Instructions for Use ™ HEALTH CARE FACILITIES OTHER WIRELESS TECHNOLOGIES Hospitals and healthcare facilities may The SurroSense Rx™ is FCC compliant. use equipment that is particularly However, there may be some newer sensitive to external RF emissions. wireless technologies that interfere Disconnect your inserts from shoe with the RF emissions of this device.
- Page 26 SURROSENSE RX SYSTEM Instructions for Use ™ Orpyx Medical Technologies Inc. ©2013 Orpyx Medical Technologies Inc. All rights reserved. All trademarks and registered trademarks are the property of their respective owners. Contents of package protected by one or more U.S. patents pending (20120109013 and PCT WO/2012/055029) as well as corresponding patents in other jurisdictions.
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