Siren Diabetic Sock User manual

Siren Diabetic Sock
Beta
User Manual
Siren, Inc
Find Injury Early

User Assistance Information
Should you have any questions, please contact a customer service
representative at Siren Inc. They may be contacted either by:
Phone: [phone]
Email: [e-mail]
General Warning and Cautions
The Siren Diabetic Sock is designed for a person that has been
diagnosed with neuropathy of the feet. People that have neuropathy
(reduced feeling in their feet) are at a high-risk to develop foot ulcers
that can potentially lead to amputation. Clinical studies have shown that
before an ulcer breaks the surface of the skin, inflammation or heat may
develop. The Siren Diabetic Sock is designed to detect and measure this
heat/inflammation earlier. The Siren Diabetic Sock should be used
every day by the patient to detect the inflammation earlier. Once the
inflammation is detected, actions can be taken by the patient, in
consultation with their doctor, to potentially avoid the ulcer and further
complications such as infection, gangrene, and amputation. The Siren
Diabetic Sock integrated micro thermometer in the fabric that is

non-invasive and is not painful to use. It is using non-replaceable
battery operated and the battery life is approximately six months (7
pairs), assuming daily use.
IT IS RECOMMENDED THAT A PERSON WITH DIABETES AND
NEUROPATHY USE THE SIREN DIABETIC SOCK TO TAKE TEMPERATURE
MEASUREMENTS ON THEIR FEET EVERY DAY.
USER’S MANUAL
Glossary �
Diabetic Neuropathy –Diabetic neuropathy is a peripheral nerve disorder
caused by diabetes. The symptoms of diabetic neuropathy are often slight
at first; numbness, pain or tingling in the feet or legs may lead to weakness
in the muscles of the feet. The loss of sensation in the feet may increase the
possibility for foot injuries to go unnoticed and develop into ulcers or
lesions that become infected. �Inflammation –A local response to
cellular injury that is marked by capillary dilatation, leukocytic infiltration,
redness, heat, pain and that serves as a mechanism initiating the
elimination of noxious agents and of damaged tissue.
Included in the box
5 pairs of sock
1 Smart hub
1 wash bag
1 user manual
1 QRCODE printed on the inner top

How it Works
Wear the Siren Diabetic Socks every day, just like normal socks.
Check your feet with Siren App. All socks will be connected to your phone
by Bluetooth low energy technology.
Wash it in the end of the week.
Enjoy your life
Instructions for Setup
The Siren sock is used to track foot temperature on the bottom of your feet
Let’s get start
Step1: prepare what we need to start:
1 Siren box with at least a pair of sock
2 Smart phone / tablet and your phone number (which can receive txt msg
during the process)
3 Know your wifi’s name and password

4 Connect your phone to your home’s wifi
5 Find an outlet which near where you spend most time in your house
6 Prepare your foot medical records in 6 months if you have (optional)
Step2: Download siren app and install it.
1 Make sure your phone or tablet has already connected to internet
2 Open google store / App store and search “siren sock”
3 Download “siren sock” app to your smart phone / tablet and install it
4 You can also download from Siren’s website
www.siren.care/app
5 Install the App

You can find the app at following address:
Or you can directly download from Ios App store or google App store
Siren App is available for Android v4.4 upper and IOS v9.0 upper
Step3: Open app and register your account
Please follow instructions on the APP to finish registration
1 Make sure your phone can receive Text msg
2 Enter your phone number when the app required
3 You will receive a 4-dig code on your phone, enter the code to the App
and Siren will active your account
4 If you don’t have phone with you, you can use your email to receive the
code and enter the code to Siren App (optional)

Step4: Report your foot health situation
please note this part takes 3~5 mins, it is very important for us to provide
the best service to you. Please follow the instruction on the App.
1 Prepare and review your medical record in 6 months
2 Enter information we required on the APP
Step5: Setup your sock and device
Thank you so much for your patient, let’s start to setup your device. Please
follow instructions on the APP and let’s do it step by step.
Note: During the setup process you will been asked to allow several
permissions for Siren APP to work properly, please allow it.
1 Take out you wifi’s name and password, we will use it in this part
2 Make sure your smart phone / tablet already connected to your home
wifi
3 Open your siren box, find the QRCODE and scan it

4 Find the Hub in your box. Plug in your hub, please select the place where
you spend most of your time in your house and make sure on blocks in
front of the hub
5 select your home’s wifi in the list and enter your password and wait for
feedback
6 pick up a pair of siren sock, remove the label and put it
Please wear the sock correctly like the picture showing:

7 Check your first temperature reading!
Siren will help you track your feet’s temperature once the sock has been
worn, so please wear siren sock as much as you can
Enjoy
CARE AND MAINTENANCE
Wash: Siren Diabetic Sock is machine washable
Dryer: Please dry Siren Diabetic Sock under 63C / 145F degree (Medium / Low heat
mode)
Battery: Siren Diabetic is water proof, user don’t need to take out batteries when
washing or drying.
Store/Carry: Please put your Siren Diabetic socks together in the Siren package box,
so you can manage them better. If you take them with you on flight, you should
take them with you based on FFC principles.
Product Specification/Technical Information
Clinical Accuracy ± 1.0º F or ± 0.5º C
Temperature Range 69 to 114º F (20 to 45º C)

Operating Environment 50 to 130º F (10 to 54º C)
Resolution 0.1º F or 0.1 º C
Response Time Approximately 1 second
Battery life a pair of sock have 1 month for daily use, 6 months in standby mode. So
7 pairs of sock can use for at least 7 month
Sizing M: Men shoe size 8.5-10.5 Women shoe size 10-12
Type: Crew
Environmental Conditions for Storage and Transportation: Temperature: 10 - 40 º C,
60-105 ºF Humidity: 30 – 75% Altitude: 700 –1060 hPa 0843
EC REP: MDSS GmbH, Schiffgraben 41, 30175 Hannover German
Limited Warranty and Disclaimer Information
Limited warranty
Siren Inc. warrants each Siren Diabetic Sock against defects in materials or
workmanship for a period of 1 year from the date of purchase, and agrees to repair

or replace any defective product without charge. IMPORTANT: This warranty does
not cover damage resulting from accident, misuse or abuse, lack of reasonable care,
the affixing of any attachment not provided with the product. Use of unauthorized
replacement parts will void this warranty. Siren Inc. will not pay for warranty service
performed by a non-authorized repair service and will not reimburse the customer
for damage resulting from warranty service performed by a non-authorized repair
service. No responsibility is assumed for any special, incidental or consequential
damages. In order to obtain warranty service, simply call Diabetica Solutions Inc.
Customer Service, 415-855-1744, for a Return Material Authorization Number
(RMA). Then send the product, postage or shipping prepaid, to Siren Inc. in
accordance with the instructions given with the RMA number. It is suggested that
for your protection, you ship the product, insurance prepaid. Damage occurring
during shipment is not covered by this warranty.
NOTE: Siren Inc. authorizes no other warranty, written or verbal. This warranty gives
you specific legal rights and you may also have other rights which vary from state to
state. Some states do not allow the exclusion or limitation of incidental or
consequential damages, so the above exclusion and limitations may not apply to you.
Disclaimer and venue
The Siren Diabetic Sock is intended to act as an aid in caring your feet, and are not
intended to replace, be used without, or in lieu of, monitoring by a responsible
adult.
Warning: Siren Diabetic Sock is not a medical device
Do not use Siren Diabetic Sock as a diagnostic tool.

It does not diagnose, cure, lessen, monitor, treat, nor prevent disease or injury;
Our products and services are only intended to be a health and wellness product
and are not intended for use in the diagnosis of disease or other conditions or in
the cure, mitigation, treatment or prevention of disease.
Siren Diabetic Socks help you to keep track of your foot health data, but should not
be used as a diagnostic.
[REFERENCE TO STANDARD DIABETIC FOOT CARE GUIDELINES]
[REFERENCE TO CLINICAL TRIALS BY LAVERY + ARMSTRONG]
FCC COMPLIANCE STATEMENT

FCC Caution.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause
undesired operation.
Any Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
Note: 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:
-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 complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance 20cm
between the radiator & your body.
IC Warning
This device complies with Industry Canada licence-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

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance 20cm
between the radiator & your body.
Ce matériel est complété par une exposition de rayonnements FCC pour un environnement
naturel. Ce matériel doit être installé et se faire avec une distance minimale de 20cm entre les
radiateurs et les autresYour body shop.