Orpyx SURROSENSE RX Instruction 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 alertbased 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
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