Orpyx SurroSense PROTECT Instructions For Use Manual Download Page 3

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SurroSense® PROTECT – Instructions for Use

Page 3 of 24

SurroSense

PROTECT

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. Regulatory Compliance Information

Page 22

Summary of Contents for SurroSense PROTECT

Page 1: ...2019 Orpyx Medical Technologies Inc All rights reserved All trademarks and registered trademarks are the property of their respective owners Page 1 of 24 SurroSense PROTECTTM Custom Smart Insole System Instructions for Use Important Information enclosed Do not discard ...

Page 2: ...y 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 Manufactured by Orpyx Medical Technologies Inc Bay 2 1440 28 Street N E Calgary AB T2A 7W6 Canada www orpyx com...

Page 3: ...OTECTTM 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 Regula...

Page 4: ...logies Inc All rights reserved All trademarks and registered trademarks are the property of their respective owners Page 4 of 24 Symbols and Definitions Symbol Definition Caution System Lot Number Keep Dry Manufactured By Serial Number Waste Electrical Electronic Equipment Year of Manufacture ...

Page 5: ... which wirelessly communicate with a mobile app on a smartphone INCLUDED IN PURCHASE SurroSense PROTECT Insoles Left and Right SurroSense PROTECT Shoe Pods Left and Right Charging Cables o 6ft USB A to USB mini cable o USB mini splitter cable AC Adaptor A INDICATIONS FOR USE The SurroSense PROTECT custom smart insole system is a powered limb overload warning device intended for monitoring the cond...

Page 6: ...ARNINGS AND PRECAUTIONS Disregarding WARNING information may cause improper operation inaccurate results and may void the warranty Disregarding error information may reduce the life expectancy of the product and or damage the product and may void the warranty This product uses and receives radio frequency signals For proper operation this product must be configured and operated as per the instruct...

Page 7: ...ind 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 2 CREATE A SURROSENSE PROTECT ACCOUNT Launch the SurroSense PROTECT application and click the Sign Up button on the Login page Enter your email address and click the S...

Page 8: ...ights reserved All trademarks and registered trademarks are the property of their respective owners Page 8 of 24 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 ...

Page 9: ... 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 t...

Page 10: ...y of their respective owners Page 10 of 24 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 ...

Page 11: ...th 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 Connecting your system may take up to 30 seconds If the a...

Page 12: ... 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 The system should only be charged w...

Page 13: ... 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 notific...

Page 14: ... foot map screen For guidance on how to offload pressure click Care in the lower right hand corner If the user does not offload pressure effectively the alert will be re issued every 3 minutes until the alert is offloaded successfully Insoles Disconnected Notification Insoles Disconnected Alert in App If your insole becomes disconnected from a shoe pod the application will notify you that your ins...

Page 15: ... charged If your shoes are off your system will disconnect automatically Therefore ignore the Shoe Pod Disconnected alert Ensure that pressure is applied when wearing your insoles The application will automatically try to re establish wireless connection If the application still does not connect to your system please contact Orpyx Customer Care Low Battery Low Battery Alert in App With regular use...

Page 16: ...he 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 Ensure that footwear laces are not too tight and that there are no foreign objects ie rocks in the shoe 4 Check your feet for cuts blisters redness and swelling If none of these steps prove effective please contact y...

Page 17: ...eed 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 DISPOSAL OF THE DEVICE There are no user repairable components in the SurroSense PROTECT system When the device has reached the end of its useful life please dispose of properly in accordance with all local and national regulations 6 Storage...

Page 18: ...the mobile application provided the app is running and within range of the system Q When should I replace my custom smart insole system A To ensure accurate readings the custom smart insoles will need to be replaced approximately every twelve months Q Why is my system alerting when my feet are up A Ensure that booth feet are up without resting on your heels or toes Check to see if your shoes are t...

Page 19: ...ur 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 SurroSense PROTECT system at least 6 inches 15 cm from the pacemaker when the device is act...

Page 20: ...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 Do not submerge SHOE POD INDICATOR LIGHTS There are red yellow green and orange lights inside each shoe pod to indicate system status The meaning of the lights is as follows INDICATOR LIGHT STATUS Flashing green while plugged in Charging Solid gree...

Page 21: ...ng red while wearing system 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 WARRANTY Orpyx Medical Technologies Inc guarantees that the SurroSense PROTECT system will be free of defects in material and workmanship for one year valid from the date of purchase Warranty is v...

Page 22: ... 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...

Page 23: ...le présent appareil est conforme aux CNR d Innovation Sciences et Développement économique Canada applicables aux appareils radio exempts de licence L exploitation est autorisée aux deux conditions suivantes 1 L appareil ne doit pas produire de brouillage 2 L appareil doit accepter tout brouillage radioélectrique subi même si le brouillage est susceptible d en compromettre le fonctionnement INNOVA...

Page 24: ...e property of their respective owners Page 24 of 24 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 ...

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