Orpyx SURROSENSE RX User manual

SURROSENSE RX™SYSTEM
Instructions for Use
SURROSENSE RX™SYSTEM Instructions for Use 1

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.
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.
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.
Calgary, AB, T2G 1R7, Canada
Orpyx Customer Care Representatives
Toll Free: 1-855-99ORPYX (67799)
Email: [email protected]
www.orpyx.com
2013
EC REP
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
2 SURROSENSE RX™SYSTEM Instructions for Use

SURROSENSE RX™SYSTEM
Instructions for Use
TABLE OF CONTENTS
2 1.0 The SurroSense Rx™
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 – Frequently Asked
Questions
20 9.0 Regulatory Compliance Information
21 10.0 Technical Information and
Specifications
SURROSENSE RX™SYSTEM Instructions for Use 1

Peripheral neuropathy is a condition
that results in loss of feeling in the
feet. This inability to sense and
respond to tissue damage can lead to
the development of blisters and ulcers,
which can lead to surgical amputation.
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. SurroSense Rx™ Insert
(Left and Right)
B. SurroSense Rx™ Smartwatch
C. SurroSense Rx™ Shoe Pod
(Left and Right)
D. SurroSense Rx™ Mobile App
Download (not shown)
1.0 The SurroSense Rx™
2 SURROSENSE RX™SYSTEM Instructions for Use

I. INTENDED USE
The SurroSense Rx™ is a wearable
plantar pressure monitoring system
that is indicated for patients who have
decreased or absent sensation in the
feet resulting from a condition known
as peripheral neuropathy. As the
patient goes about their daily routine,
data from the inserts are wirelessly
transmitted to the SurroSense Rx™
smartwatch. The device can be worn
both indoors and outdoors as often as
desired by the patient; or as
recommended by Podiatrist/ Physician.
If the feedback is properly adhered to,
the medical benefits of using the
system may include the prevention of
peripheral neuropathy-related
complications including the
development of blisters and ulcers,
which can lead to surgical amputation.
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.
III. WARNINGS AND PRECAUTIONS
WARNING: Disregarding WARNING
information may cause improper
operation and inaccurate results.
CAUTION: Disregarding CAUTION
information may reduce the life
expectancy of the product and/or
damage to the product.
CAUTION: This product uses and
receives radio frequency signals. For
proper operation, this product must be
configured and operated as per the
instructions provided in the manual.
WARNING: This product uses low
power radio communications and can
affect other medical electrical;
equipment.
SURROSENSE RX™SYSTEM Instructions for Use 3

FIELD OF APPLICATION
The SurroSense Rx™ was developed
for everyday activities. For the
necessary environmental conditions,
please see Section 10.0. The
SurroSense Rx™ is designed
exclusively for use on one patient. In
order to effectively use this device, the
patient must meet the following
requirements:
✔The patient must meet the physical
and mental requirements with
regard to the perception of alert-
based feedback (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.
✔If the patient does have active skin
ulceration or partial amputation, it is
necessary that the patient have
these wounds appropriately
monitored and dressed by a
healthcare professional.
*Approved for patients weighing up to
136 kg/300 lbs.
4 SURROSENSE RX™SYSTEM Instructions for Use

2.0 Symbols and Definitions
Symbol Definition
Caution
Operating Instructions
Manufactured By
Authorized Representative (EU Only)
Keep Dry
Waste Electrical & Electronic Equipment
CE Alert Mark
Year of Manufacture
EC REP
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
SURROSENSE RX™SYSTEM Instructions for Use 5

A. HOW TO PROPERLY FIT YOUR SURROSENSE RX™
INSERTS
The SurroSense Rx™ inserts are made to fit under your
existing shoe insole. Whether it’s a custom orthotic,
over-the-counter or manufacturers insole, the SurroSense
Rx™ insert will fit underneath. Simply remove the existing
insole, and place the appropriate left or right SurroSense
Rx™ insert into the shoe. The lead, (which is on the inside
edge of the insert) should run along the inside of the shoe,
up towards the tongue. 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
insoles that have a hard plastic heel cup as it damages the
Your insole
SurroSense Rx™ insert
3.0 Setting up your system
6 SURROSENSE RX™SYSTEM Instructions for Use

Bottom
Velcro clip
Bottom
Lead
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. Attach the connector (located at the end of the lead)
into the back of the shoe pod. Once connected, slide the
rounded top of the shoe pod into the clip, then push the
bottom of the shoe pod into the clip so that the clip posts
snap into the eyelets on the top and bottom of the shoe pod.
This will ensure the shoe pods are secure.
*Note: The clip for the shoe pod can also be used with laced
shoes. Simply place the clip underneath the existing lacing
and fasten the shoe pod on top.
SURROSENSE RX™SYSTEM Instructions for Use 7

Bottom
Lead
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.
*Note: We recommend fully charging shoe pods before use
to ensure optimal battery performance.
C. HOW TO CHARGE THE SHOE PODS
With regular use, the shoe pods will require a charge
approximately once per week. Battery life for the shoe pods
can be monitored from the foot map screen on the
smartwatch. To charge the shoe pods, remove the
connector from the back of the shoe pod and insert the mini
USB cable into the mini USB port. The other end of the
cable is to be inserted into the AC adaptor, which plugs
directly into an electrical outlet. When the shoe pods are
charging they flash a green light, when they are fully
charged there is a solid green light.
8 SURROSENSE RX™SYSTEM Instructions for Use

AC Adaptor
Back
Mini USB
D. HOW TO GET STARTED WITH YOUR SMARTWATCH
Your smartwatch will come wirelessly connected to your
shoe pods. To turn the watch on, press the top left button.
The screen will light up and you will see the general date
and time display. To set the date and time please see section
4.0.
*Note: We recommend fully charging the smartwatch
before use to ensure optimal battery performance.
*Note: The device should only be charged with the AC
adaptor included with purchase.
SURROSENSE RX™SYSTEM Instructions for Use 9

E. HOW TO CHARGE THE SMARTWATCH
Your smartwatch should be charged every night. Battery life
is displayed on the upper right hand side of the watch. To
charge the smartwatch, attach the alligator clip to the watch
so that the side with the rubber pads is on the watch screen.
The USB end of the cable fits into the AC adaptor, and can
be plugged into an electrical outlet. If the alligator cable is
connected correctly, the smartwatch screen will light up.
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. Click “Install App” and enter your
Apple ID information. Please note that the SurroSense Rx™
device DOES NOT include a smartphone with purchase.
Watch screen
AC Adaptor
Alligator clip
10 SURROSENSE RX™SYSTEM Instructions for Use

4.0 Using the SurroSense Rx™Smartwatch
The SurroSense Rx™ smartwatch
effectively tracks the pressure exerted
over the bottom of the feet while your
inserts are in use. If the smartwatch
has not detected activity on any of the
sensors for one minute, the device will
go into sleep mode to preserve battery
life. As soon as pressure is detected on
the insert again, the smartwatch will
continue to monitor pressure.
In addition to providing the 1:1
feedback, the smartwatch also tracks
and stores data over time. In order to
access your data to track progress sign
up for an Orpyx Connect account.
Menu – takes you to the main
navigation screen
Shoes – shortcut to the foot map
Top left – takes you to the time screen
from any other screen. This button will
wake up the watch after the display
goes to sleep.
Bottom left – takes you to the foot map
from any other screen.
Foot Map – display of pressure exerted
over the bottom of the feet
Help – steps to offload high-pressure
alerts
Watch Setup – set the date and time for
the watch
Connect – here you will enter the
connection codes for the device
SURROSENSE RX™SYSTEM Instructions for Use 11

FOOT MAP
The foot map screen is where you can
actively monitor your feet throughout
the day to check for undue stress or
damage. When the inserts are
connected to the smartwatch the foot
display will be glowing and the 4
regions of the foot are visible. Direct
feedback is provided from the feet
notifying the user of three possible
pressure levels: low, medium and
alert. If one of the four regions on
either foot has exceeded recommended
pressure, the user will receive an alert
(vibrate and beep on the smartwatch)
notifying them to offload pressure to
avoid complications. For guidance on
how to offload pressure, click the
‘Help’ button located on the lower right
hand side of the foot map.
HELP
To read the offloading steps vertically
slide your finger down the watch
screen. To move to the next step, slide
your finger horizontally across the
watch screen.
WATCH SETUP
You will be prompted to set the time
followed by the date. You must press
the ‘Next’ button (located on the lower
right hand side) for both the time and
date to confirm the settings.
CONNECT
Your smartwatch will come connected
to your shoe pods. In the event that
your device loses the stored connection
codes, follow this procedure to
re-establish connection:
You will be prompted to enter the
values for the right connection code,
followed by the left. When the
information has been entered, click
‘connect’. The ‘connecting’ screen will
last up to 90 seconds.
If you receive the re-enter codes
screen, go through the steps again to
ensure the codes entered are correct.
When both the right and left inserts
have been connected a screen will
appear that says ‘successfully
connected’. Pressing ‘Next’ will take
you directly to the foot map.
*Note: Your connection codes are the
unique serial codes for your shoe pods
and can be found: on the back of the
12 SURROSENSE RX™SYSTEM Instructions for Use

box, the IFU and within your Orpyx
Connect account.
ALERTS
DOWNLOAD YOUR DATA
We recommend you download your
data every week. The smartwatch
display will notify you when data
storage is getting full.
Download your data 75% = you have
approximately 2.5 days left until data
storage in the device is full
Download your data 90% = you have
under a day before your device is full
When the data storage reaches
capacity (100%) there will be no new
data recorded. Once you download the
data onto your Orpyx Connect account
you are able to start recording new
data again.
HIGH PRESSURE DETECTED
This alert is to let you know that
dangerous pressure levels have been
detected on your foot. When this
screen is displayed you can either
press ‘dismiss’, which will take you to
the foot map screen, or ‘help’ which
provides instructions on how to offload
pressure. Irreversible pressure
damage can occur in as little as 15
minutes; therefore, it is important to
offload the pressure alert as soon as
possible to avoid damage to the foot.
When the insert has detected the user
offloading pressure the ‘offloading’
screen will appear.
LOST SIGNAL
If the smartwatch loses connection
with the shoe pods, a lost signal alert
will appear. Press ‘connect’ to
automatically re-establish connection.
If unsuccessful, the user will be
prompted to manually re-enter
connection codes by pressing ‘ok’.
Pressing ‘menu’ will take you to the
foot map screen.
LOW BATTERY
With regular use, your smartwatch
battery should last for 12 hours a day,
on average. If you press ‘dismiss’ the
low battery warning will not be issued
again.
REPLACE SENSOR INSERTS
Your inserts start to reach the end of
their life cycle at approximately 12
months. Replacing them at this time
will ensure the most accurate pressure
SURROSENSE RX™SYSTEM Instructions for Use 13

readings from the sensors.
Replacement inserts can be purchased
online at Orpyx.com or through your
authorized re-seller.
14 SURROSENSE RX™SYSTEM Instructions for Use

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.
Watch screenAlligator clip
Your PC
5.0 Orpyx Connect
SURROSENSE RX™SYSTEM Instructions for Use 15

SURROSENSE RX™MAINTENANCE
This system does not require any user maintenance. There
are no user repairable components in the SurroSense Rx™.
If problems occur, contact Orpyx Customer Care.
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.
DISPOSAL OF THE DEVICE
When the device has reached the end of its useful
life, please dispose of properly, in accordance with
all local and national regulations.
6.0 Maintenance and Cleaning
16 SURROSENSE RX™SYSTEM Instructions for Use

SURROSENSE RX™ 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. They have been designed to be water
resistant, not waterproof.
Keep Dry.
SURROSENSE RX™ STORAGE
Keep Dry.
7.0 Storage and Handling
SURROSENSE RX™SYSTEM Instructions for Use 17

Q: How long does it take to offload an alert?
A: The length of time it takes to offload an alert depends on
how long that alert has been present for. When proper
offloading steps have been taken (available on the
smartwatch ‘Help’ screen), you can effectively offload an
alert within 3 minutes.
Q: Do I need to turn the system off when not in use?
A: No, if pressure has not been detected on the inserts for
over a minute, they will intuitively go into sleep mode.
While in sleep mode, the device is not transmitting
information. When pressure is applied to the inserts, it
will take one minute for the device to fully turn on and
start collecting data again.
Q: What should I do if the screen on my smartwatch has
gone black?
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. This is done to ensure the
lowest possible battery consumption with the shoe pods.
8.0 Troubleshooting – Frequently Asked Questions
18 SURROSENSE RX™SYSTEM Instructions for Use