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: info@orpyx.com
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
Q: What happens when I get replacement inserts?
A: When you receive replacement inserts, you will have to
disconnect and remove your old insert from your shoes.
Place the new inserts into the shoe and connect to the
shoe pod.
Q: What error message will show up when the shoe pods are
not working?
A: If there is no data being transmitted from one or both of
the shoe pods, a ‘lost signal message’ indicating this will
pop up. Additionally, the foot map screen will show a
“NOT CONNECTED” icon beside the insert of concern.
Ensure that the inserts are connected to the shoe pod and
that the connection codes are entered correctly. 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. Carefully unlace your shoelaces
and release both of the shoe pods. If using the shoe pod
clip, simply feed the Velcro strap through the clip to
release the shoe pods. The shoe pods and inserts should
stay connected throughout the transfer process. If they
disconnect, plug the connector back into the shoe pod.
Then, place the inserts into an alternate pair of shoes,
and re-secure the nodes to the top of the shoe using
either the lace holes, or the Velcro straps.
SURROSENSE RX™ SYSTEM Instructions for Use 19
for any changes or modifications not
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.
NOTE: The grantee is not responsible
expressly approved by the party
responsible for compliance. Such modifications could void the user’s
authority to operate the equipment.
9.0 Regulatory Compliance Information
20 SURROSENSE RX™ SYSTEM Instructions for Use
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
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:
CANADIAN COMPLIANCE
STATEMENT
This device complies with Industry
Canada license-exempt RSS
standard(s). Operation is subject to the
following two conditions: (1) this device
may not cause interference, and (2) this
device must accept any interference,
including interference that may cause
undesired operation of the device.
Le présent appareil est conforme aux
CNR d’Industrie 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, et (2)
l’utilisateur de l’appareil doit accepter
tout brouillage radioélectrique subi,
même si le brouillage est susceptible
d’en compromettre le fonctionnement.
INDUSTRY CANADA STATEMENT
Complies with the Canada ICES-003
Class B specifications. Cet appareil
numerique de la classe B est
comforme à la norme NMB-003 du
Canada. This device complies with
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:
SURROSENSE RX™ SYSTEM Instructions for Use 21
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 SurroSense
Rx™ is designed, tested, and
manufactured to comply with
regulations governing radio frequency
emission in countries such as the US,
EU and Canada, the wireless
transmitters and electrical circuits in
the SurroSense Rx™ may cause
interference in other electronic
equipment. Therefore, please take the
following precautions:
TRAVEL OR INTERNATIONAL USE
If you plan to travel with the
SurroSense Rx™ device, please note
that the product uses wireless
communication, and is not to be used
during flight. We recommend that you
disconnect your inserts from the shoe
pods when traveling. This will ensure
your device is in not in transmitting
mode. 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 15 cm (6
inches) 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 Rx™ system at least 15 cm
(6 inches) from the pacemaker when
the device is active.
HEARING AID COMPATIBILITY
The SurroSense Rx™ 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 SurroSense Rx™.
10.0 Technical Information and Specifications
22 SURROSENSE RX™ SYSTEM Instructions for Use
HEALTH CARE FACILITIES
Hospitals and healthcare facilities may
use equipment that is particularly
sensitive to external RF emissions.
Disconnect your inserts from shoe
pods to ensure they are not
transmitting when hospital staff or
signage instructs you to do so.
OTHER WIRELESS TECHNOLOGIES
The SurroSense Rx™ 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 SurroSense Rx™.
Size 70mm x 30mm x 12mm (L x W x H)
Weight 20 grams
Power Source 80mAh Rechargeable LiPo battery
Frequency of Operation 2406-2475 MHz
Max.20 dB Bandwidth 1 Mhz
Max.Output Power +0 dBm
Number of operation modes 1 – ON
Storage Temperature -20 to +55 Celsius / 95% humidity
Operation Temperature -20 to +55 Celsius / 95% humidity
Environmental Protection IPx4
SURROSENSE RX™ SYSTEM Instructions for Use 23
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. Purchase of this
package does not act to grant a use license under
these patents in any jurisdiction outside of the
United States.
24 SURROSENSE RX™ SYSTEM Instructions for Use